Nicotine
Nicotine Polacrilex · Lozenge · Oral, Transdermal, Buccal
Active ingredient
Active ingredient Step 1 (in each patch) Nicotine, 21 mg delivered over 24 hours Active ingredient Step 2 (in each patch) Nicotine, 14 mg delivered over 24 hours Active ingredient Step 3 (in each patch) Nicotine, 7 mg delivered over 24 hours
Purpose
Purpose Stop smoking aid
Uses
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Warnings
Warnings If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Ask a doctor before use if you have
• heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
• high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
• an allergy to adhesive tape or have skin problems because you are more likely to get rashes
• stomach ulcers or diabetes
• history of seizures Ask a doctor or pharmacist before use if you are
• using a non-nicotine stop smoking drug
• taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. When using this product
• if you have vivid dreams or other sleep disturbances remove this patch at bedtime Stop use and ask a doctor if
• skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash
• irregular heartbeat or palpitations occur
• you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness and rapid heartbeat
• you have symptoms of an allergic reaction (such as difficulty breathing or rash) Keep out of reach of children and pets. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.
Ask a doctor before use
Ask a doctor before use if you have
• heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
• high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
• an allergy to adhesive tape or have skin problems because you are more likely to get rashes
• stomach ulcers or diabetes
• history of seizures
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are
• using a non-nicotine stop smoking drug
• taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.
When using this product
When using this product
• if you have vivid dreams or other sleep disturbances remove this patch at bedtime
Stop use and ask a doctor
Stop use and ask a doctor if
• skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash
• irregular heartbeat or palpitations occur
• you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness and rapid heartbeat
• you have symptoms of an allergic reaction (such as difficulty breathing or rash)
Pregnancy or breast-feeding
If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.
Keep out of reach of children
Keep out of reach of children and pets. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.
Directions
Directions
• if you are under 18 years of age, ask a doctor before use
• before using this product, read the enclosed User’s Guide for complete directions and other information
• begin using the patch on your quit day
• if you smoke more than 10 cigarettes per day, use according to the following 10 week schedule: STEP 1 STEP 2 STEP 3 Use one 21mg patch/day Use one 14mg patch/day Use one 7mg patch/day Weeks 1-6 Weeks 7-8 Weeks 9-10
• if you smoke 10 or less cigarettes per day, do not use STEP 1 (21mg). Start with STEP 2 (14mg) for 6 weeks, then STEP 3 (7mg) for 2 weeks and then stop.
• steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully.
• apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use.
• remove backing from patch and immediately press onto skin. Hold for 10 seconds.
• wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User’s Guide for safety and handling.
• you may wear the patch for 16 or 24 hours.
• if you crave cigarettes when you wake up, wear the patch for 24 hours.
• if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning
• the used patch should be removed and a new one applied to a different skin site at the same time each day
• do not wear more than one patch at a time
• do not cut patch in half or into smaller pieces
• do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours
• it is important to complete treatment. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.
Inactive ingredients
Inactive ingredients ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings
Questions?
Questions or comments? call toll-free 1-888-367-7919
Label text from the FDA structured product label by Target Corporation (revised Jun 10, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Nicotine in 241 products
Nicotine NDC products (244)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-6674 | Nicotine 4 mg/1 Gum, Chewing | A-S Medication Solutions | ANDA |
| 50090-1697 | Nicotine 21 mg/24h Patch | A-S Medication Solutions | ANDA |
| 50090-1694 | Nicotine 7 mg/24h Patch | A-S Medication Solutions | ANDA |
| 50090-1148 | Nicotine 14 mg/24h Patch | A-S Medication Solutions | ANDA |
| 72288-969 | Nicotine 2 mg/1 Lozenge | Amazon.com Services LLC | ANDA |
| 72288-888 | Nicotine 2 mg/1 Lozenge | Amazon.com Services LLC | ANDA |
| 72288-869 | Nicotine 4 mg/1 Lozenge | Amazon.com Services LLC | ANDA |
| 72288-863 | Nicotine 4 mg/1 Gum, Chewing | Amazon.com Services LLC | ANDA |
| 72288-771 | Nicotine 2 mg/1 Lozenge | Amazon.com Services LLC | ANDA |
| 72288-651 | Nicotine 4 mg/1 Lozenge | Amazon.com Services LLC | ANDA |
| 72288-540 | Nicotine 4 mg/1 Gum, Chewing | Amazon.com Services LLC | ANDA |
| 72288-518 | Nicotine 2 mg/1 Gum, Chewing | Amazon.com Services LLC | ANDA |
| 46122-732 | Nicotine 4 mg/1 Lozenge | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | ANDA |
| 46122-724 | Nicotine 2 mg/1 Gum, Chewing | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | ANDA |
| 46122-734 | Nicotine 2 mg/1 Lozenge | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | ANDA |
| 46122-719 | Nicotine 2 mg/1 Gum, Chewing | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | ANDA |
| 46122-733 | Nicotine 4 mg/1 Gum, Chewing | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | ANDA |
| 58602-722 | Nicotine 2 mg/1 Lozenge | Aurohealth LLC | ANDA |
| 58602-723 | Nicotine 4 mg/1 Lozenge | Aurohealth LLC | ANDA |
| 58602-835 | Nicotine 2 mg/1 Lozenge | Aurohealth LLC | ANDA |
| 58602-836 | Nicotine 4 mg/1 Lozenge | Aurohealth LLC | ANDA |
| 58602-854 | Nicotine 2 mg/1 Lozenge | Aurohealth LLC | ANDA |
| 58602-855 | Nicotine 4 mg/1 Lozenge | Aurohealth LLC | ANDA |
| 58602-903 | Nicotine 2 mg/1 Lozenge | Aurohealth LLC | ANDA |
| 58602-904 | Nicotine 4 mg/1 Lozenge | Aurohealth LLC | ANDA |
| 58602-905 | Nicotine 2 mg/1 Lozenge | Aurohealth LLC | ANDA |
| 58602-906 | Nicotine 4 mg/1 Lozenge | Aurohealth LLC | ANDA |
| 82966-001 | Nicotine 2 mg/1 Lozenge | BLIP PRODUCTS, INC. | ANDA |
| 82966-002 | Nicotine 4 mg/1 Lozenge | BLIP PRODUCTS, INC. | ANDA |
| 70000-0562 | Nicotine 2 mg/1 Lozenge | Cardinal Health (Leader) 70000 | ANDA |
| 55154-6818 | Nicotine 2 mg/1 Gum, Chewing | Cardinal Health 107, LLC | ANDA |
| 59779-397 | Nicotine 2 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 59779-344 | Nicotine 2 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 69842-957 | Nicotine 2 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 69842-932 | Nicotine 2 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 69842-858 | Nicotine 4 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 69842-828 | Nicotine 4 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 69842-662 | Nicotine 2 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 69842-605 | Nicotine 2 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 69842-595 | Nicotine 4 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 69842-587 | Nicotine 2 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 69842-564 | Nicotine 4 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 59779-957 | Nicotine 4 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 59779-873 | Nicotine 4 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 59779-734 | Nicotine 2 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 59779-424 | Nicotine 4 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 59779-201 | Nicotine 2 mg/1 Lozenge | CVS Pharmacy | ANDA |
| 51316-787 | Nicotine 4 mg/1 Lozenge | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | ANDA |
| 51316-319 | Nicotine 2 mg/1 Lozenge | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | ANDA |
| 51316-309 | Nicotine 4 mg/1 Gum, Chewing | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | ANDA |
| 51316-190 | Nicotine 4 mg/1 Lozenge | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | ANDA |
| 51316-151 | Nicotine 2 mg/1 Gum, Chewing | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | ANDA |
| 55910-918 | Nicotine 4 mg/1 Gum, Chewing | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA |
| 37808-683 | Nicotine 4 mg/1 Gum, Chewing | H E B | ANDA |
| 37808-781 | Nicotine 2 mg/1 Gum, Chewing | H E B | ANDA |
| 37808-707 | Nicotine 4 mg/1 Lozenge | H E B | ANDA |
| 37808-711 | Nicotine 2 mg/1 Gum, Chewing | H E B | ANDA |
| 37808-739 | Nicotine 4 mg/1 Gum, Chewing | H E B | ANDA |
| 37808-383 | Nicotine 4 mg/1 Lozenge | H E B | ANDA |
| 37808-682 | Nicotine 2 mg/1 Gum, Chewing | H E B | ANDA |
| 37808-658 | Nicotine 4 mg/1 Gum, Chewing | H E B | ANDA |
| 37808-617 | Nicotine 2 mg/1 Lozenge | H E B | ANDA |
| 37808-611 | Nicotine 4 mg/1 Gum, Chewing | H E B | ANDA |
| 37808-563 | Nicotine 4 mg/1 Lozenge | H E B | ANDA |
| 37808-533 | Nicotine 2 mg/1 Lozenge | H E B | ANDA |
| 37808-820 | Nicotine 2 mg/1 Gum, Chewing | H E B | ANDA |
| 37808-821 | Nicotine 4 mg/1 Gum, Chewing | H E B | ANDA |
| 37808-849 | Nicotine 4 mg/1 Gum, Chewing | H E B | ANDA |
| 37808-900 | Nicotine 2 mg/1 Lozenge | H E B | ANDA |
| 37808-909 | Nicotine 2 mg/1 Gum, Chewing | H E B | ANDA |
| 59640-099 | Nicotine 2 mg/1 Lozenge | H E B | ANDA |
| 59640-151 | Nicotine 4 mg/1 Lozenge | H E B | ANDA |
| 83253-978 | Nicotine 2 mg/1 Lozenge | HC Jones, Inc. | ANDA |
| 83253-979 | Nicotine 4 mg/1 Lozenge | HC Jones, Inc. | ANDA |
| 42507-343 | Nicotine 2 mg/1 Gum, Chewing | HyVee Inc | ANDA |
| 42507-344 | Nicotine 2 mg/1 Lozenge | HyVee Inc | ANDA |
| 42507-690 | Nicotine 4 mg/1 Lozenge | HyVee Inc | ANDA |
| 42507-309 | Nicotine 4 mg/1 Gum, Chewing | HyVee Inc | ANDA |
| 30142-309 | Nicotine 4 mg/1 Gum, Chewing | Kroger Company | ANDA |
| 30142-124 | Nicotine 2 mg/1 Lozenge | Kroger Company | ANDA |
| 30142-190 | Nicotine 4 mg/1 Lozenge | Kroger Company | ANDA |
| 30142-873 | Nicotine 4 mg/1 Lozenge | Kroger Company | ANDA |
| 30142-848 | Nicotine 4 mg/1 Gum, Chewing | Kroger Company | ANDA |
| 30142-797 | Nicotine 4 mg/1 Lozenge | Kroger Company | ANDA |
| 30142-749 | Nicotine 2 mg/1 Gum, Chewing | Kroger Company | ANDA |
| 30142-696 | Nicotine 2 mg/1 Lozenge | Kroger Company | ANDA |
| 30142-208 | Nicotine 2 mg/1 Gum, Chewing | Kroger Company | ANDA |
| 30142-344 | Nicotine 2 mg/1 Lozenge | Kroger Company | ANDA |
| 72224-931 | Nicotine 4 mg/1 Gum, Chewing | Lucy Goods, Inc. | ANDA |
| 72224-930 | Nicotine 4 mg/1 Gum, Chewing | Lucy Goods, Inc. | ANDA |
| 63739-369 | Nicotine 4 mg/1 Gum, Chewing | McKesson Corporation dba SKY Packaging | ANDA |
| 63739-371 | Nicotine 2 mg/1 Gum, Chewing | McKesson Corporation dba SKY Packaging | ANDA |
| 41250-190 | Nicotine 4 mg/1 Lozenge | Meijer Distribution Inc | ANDA |
| 41250-201 | Nicotine 2 mg/1 Lozenge | Meijer Distribution Inc | ANDA |
| 41250-209 | Nicotine 2 mg/1 Gum, Chewing | Meijer Distribution Inc | ANDA |
| 41250-344 | Nicotine 2 mg/1 Lozenge | Meijer Distribution Inc | ANDA |
| 41250-424 | Nicotine 4 mg/1 Lozenge | Meijer Distribution Inc | ANDA |
| 41250-456 | Nicotine 2 mg/1 Gum, Chewing | Meijer Distribution Inc | ANDA |
| 41250-510 | Nicotine 4 mg/1 Gum, Chewing | Meijer Distribution Inc | ANDA |
| 41250-529 | Nicotine 2 mg/1 Gum, Chewing | Meijer Distribution Inc | ANDA |
| 41250-532 | Nicotine 4 mg/1 Gum, Chewing | Meijer Distribution Inc | ANDA |
| 41250-689 | Nicotine 4 mg/1 Gum, Chewing | Meijer Distribution Inc | ANDA |
| 41250-700 | Nicotine 2 mg/1 Lozenge | Meijer Distribution Inc | ANDA |
| 41250-734 | Nicotine 2 mg/1 Lozenge | Meijer Distribution Inc | ANDA |
| 41250-854 | Nicotine 4 mg/1 Gum, Chewing | Meijer Distribution Inc | ANDA |
| 41250-873 | Nicotine 4 mg/1 Lozenge | Meijer Distribution Inc | ANDA |
| 41250-957 | Nicotine 4 mg/1 Lozenge | Meijer Distribution Inc | ANDA |
| 41250-170 | Nicotine 4 mg/1 Gum, Chewing | Meijer Distribution Inc | ANDA |
| 41250-029 | Nicotine 2 mg/1 Gum, Chewing | Meijer Distribution Inc | ANDA |
| 79481-1123 | Nicotine 2 mg/1 Lozenge | Meijer, Inc. | ANDA |
| 79481-1100 | Nicotine 4 mg/1 Lozenge | Meijer, Inc. | ANDA |
| 79481-0052 | Nicotine 21 mg/24h Patch | Meijer, Inc. | ANDA |
| 79481-0053 | Nicotine 14 mg/24h Patch | Meijer, Inc. | ANDA |
| 79481-0054 | Nicotine 7 mg/24h Patch | Meijer, Inc. | ANDA |
| 79481-0100 | Nicotine 2 mg/1 Gum, Chewing | Meijer, Inc. | ANDA |
| 79481-0103 | Nicotine 4 mg/1 Gum, Chewing | Meijer, Inc. | ANDA |
| 79481-0601 | Nicotine 4 mg/1 Gum, Chewing | Meijer, Inc. | ANDA |
| 79481-0755 | Nicotine 2 mg/1 Gum, Chewing | Meijer, Inc. | ANDA |
| 59726-913 | Nicotine 4 mg/1 Gum, Chewing | P & L Development, LLC | ANDA |
| 59726-592 | Nicotine 2 mg/1 Gum, Chewing | P & L Development, LLC | ANDA |
| 59726-650 | Nicotine 2 mg/1 Lozenge | P & L Development, LLC | ANDA |
| 59726-935 | Nicotine 4 mg/1 Gum, Chewing | P & L Development, LLC | ANDA |
| 59726-929 | Nicotine 2 mg/1 Gum, Chewing | P & L Development, LLC | ANDA |
| 45802-651 | Nicotine 4 mg/1 Gum, Chewing | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 45802-827 | Nicotine 2 mg/1 Gum, Chewing | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 63548-0264 | Nicotine 4 mg/1 Lozenge | PLD Acquisitions LLC DBA Avma Pharma Solutions | ANDA |
| 63548-0262 | Nicotine 2 mg/1 Lozenge | PLD Acquisitions LLC DBA Avma Pharma Solutions | ANDA |
| 56062-734 | Nicotine 2 mg/1 Lozenge | Publix Super Markets Inc | ANDA |
| 56062-957 | Nicotine 4 mg/1 Lozenge | Publix Super Markets Inc | ANDA |
| 56062-812 | Nicotine 4 mg/1 Gum, Chewing | Publix Super Markets Inc | ANDA |
| 56062-671 | Nicotine 4 mg/1 Lozenge | Publix Super Markets Inc | ANDA |
| 56062-646 | Nicotine 2 mg/1 Gum, Chewing | Publix Super Markets Inc | ANDA |
| 56062-636 | Nicotine 2 mg/1 Lozenge | Publix Super Markets Inc | ANDA |
| 56062-509 | Nicotine 4 mg/1 Lozenge | Publix Super Markets Inc | ANDA |
| 56062-499 | Nicotine 2 mg/1 Lozenge | Publix Super Markets Inc | ANDA |
| 56062-298 | Nicotine 2 mg/1 Gum, Chewing | Publix Super Markets Inc | ANDA |
| 56062-019 | Nicotine 4 mg/1 Gum, Chewing | Publix Super Markets Inc | ANDA |
| 57237-321 | Nicotine 4 mg/1 Lozenge | Rising Pharma Holdings, Inc. | ANDA |
| 57237-320 | Nicotine 2 mg/1 Lozenge | Rising Pharma Holdings, Inc. | ANDA |
| 11822-0201 | Nicotine 2 mg/1 Lozenge | Rite Aid Corporation | ANDA |
| 11822-0309 | Nicotine 4 mg/1 Gum, Chewing | Rite Aid Corporation | ANDA |
| 11822-0344 | Nicotine 2 mg/1 Lozenge | Rite Aid Corporation | ANDA |
| 11822-0424 | Nicotine 4 mg/1 Lozenge | Rite Aid Corporation | ANDA |
| 11822-1103 | Nicotine 4 mg/1 Gum, Chewing | Rite Aid Corporation | ANDA |
| 11822-1649 | Nicotine 4 mg/1 Lozenge | Rite Aid Corporation | ANDA |
| 11822-0456 | Nicotine 2 mg/1 Gum, Chewing | Rite Aid Corporation | ANDA |
| 11822-0269 | Nicotine 2 mg/1 Gum, Chewing | Rite Aid Corporation | ANDA |
| 11822-0971 | Nicotine 4 mg/1 Gum, Chewing | Rite Aid Corporation | ANDA |
| 11822-0905 | Nicotine 4 mg/1 Lozenge | Rite Aid Corporation | ANDA |
| 11822-0170 | Nicotine 4 mg/1 Gum, Chewing | Rite Aid Corporation | ANDA |
| 11822-0124 | Nicotine 2 mg/1 Lozenge | Rite Aid Corporation | ANDA |
| 11822-0029 | Nicotine 2 mg/1 Gum, Chewing | Rite Aid Corporation | ANDA |
| 11822-0009 | Nicotine 4 mg/1 Lozenge | Rite Aid Corporation | ANDA |
| 11822-1720 | Nicotine 2 mg/1 Lozenge | Rite Aid Corporation | ANDA |
| 11822-0699 | Nicotine 4 mg/1 Gum, Chewing | Rite Aid Corporation | ANDA |
| 11822-0873 | Nicotine 4 mg/1 Lozenge | Rite Aid Corporation | ANDA |
| 0536-3029 | Nicotine 2 mg/1 Gum, Chewing | Rugby Laboratories | ANDA |
| 0536-1362 | Nicotine 2 mg/1 Gum, Chewing | Rugby Laboratories | ANDA |
| 0536-1372 | Nicotine 4 mg/1 Gum, Chewing | Rugby Laboratories | ANDA |
| 0536-3030 | Nicotine 4 mg/1 Gum, Chewing | Rugby Laboratories | ANDA |
| 0536-5896 | Nicotine 21 mg/24h Patch | Rugby Laboratories | ANDA |
| 0536-5895 | Nicotine 14 mg/24h Patch | Rugby Laboratories | ANDA |
| 0536-5894 | Nicotine 7 mg/24h Patch | Rugby Laboratories | ANDA |
| 0536-3405 | Nicotine 4 mg/1 Gum, Chewing | Rugby Laboratories | ANDA |
| 0536-3404 | Nicotine 2 mg/1 Gum, Chewing | Rugby Laboratories | ANDA |
| 0536-3113 | Nicotine 4 mg/1 Gum, Chewing | Rugby Laboratories | ANDA |
| 0536-3112 | Nicotine 2 mg/1 Gum, Chewing | Rugby Laboratories | ANDA |
| 0536-1337 | Nicotine 2 mg/1 Lozenge | Rugby Laboratories, Inc. | ANDA |
| 21130-389 | Nicotine 2 mg/1 Gum, Chewing | Safeway | ANDA |
| 21130-636 | Nicotine 4 mg/1 Lozenge | Safeway | ANDA |
| 59368-463 | Nicotine 2 mg/1 Lozenge | Sixarp, LLC | ANDA |
| 70677-0032 | Nicotine 21 mg/24h Patch | Strategic Sourcing Services LLC | ANDA |
| 30142-859 | Nicotine 2 mg/1 Gum, Chewing | The Kroger Co. | ANDA |
| 30142-671 | Nicotine 4 mg/1 Gum, Chewing | The Kroger Co. | ANDA |
| 0363-7971 | Nicotine 4 mg/1 Gum, Chewing | Walgreen Company | ANDA |
| 0363-7050 | Nicotine 2 mg/1 Gum, Chewing | Walgreen Company | ANDA |
| 0363-0124 | Nicotine 2 mg/1 Lozenge | Walgreen Company | ANDA |
| 0363-7044 | Nicotine 4 mg/1 Lozenge | Walgreen Company | ANDA |
| 0363-7269 | Nicotine 2 mg/1 Gum, Chewing | Walgreen Company | ANDA |
| 0363-7103 | Nicotine 4 mg/1 Gum, Chewing | Walgreen Company | ANDA |
| 0363-4190 | Nicotine 4 mg/1 Lozenge | Walgreen Company | ANDA |
| 0363-4049 | Nicotine 2 mg/1 Lozenge | Walgreen Company | ANDA |
| 0363-0201 | Nicotine 2 mg/1 Lozenge | Walgreen Company | ANDA |
| 0363-2511 | Nicotine 2 mg/1 Lozenge | Walgreen Company | ANDA |
| 0363-2309 | Nicotine 4 mg/1 Gum, Chewing | Walgreen Company | ANDA |
| 0363-1825 | Nicotine 2 mg/1 Lozenge | Walgreen Company | ANDA |
| 0363-0411 | Nicotine 2 mg/1 Lozenge | Walgreen Company | ANDA |
| 0363-1012 | Nicotine 2 mg/1 Gum, Chewing | Walgreen Company | ANDA |
| 0363-0424 | Nicotine 4 mg/1 Lozenge | Walgreen Company | ANDA |
| 0363-0919 | Nicotine 4 mg/1 Gum, Chewing | Walgreen Company | ANDA |
| 0363-0873 | Nicotine 4 mg/1 Lozenge | Walgreen Company | ANDA |
| 0363-0456 | Nicotine 2 mg/1 Gum, Chewing | Walgreen Company | ANDA |
| 0363-9290 | Nicotine 2 mg/1 Gum, Chewing | Walgreens | ANDA |
| 0363-0979 | Nicotine 4 mg/1 Lozenge | Walgreens | ANDA |
| 0363-5770 | Nicotine 4 mg/1 Lozenge | Walgreens | ANDA |
| 0363-3911 | Nicotine 4 mg/1 Gum, Chewing | Walgreens | ANDA |
| 0363-5760 | Nicotine 2 mg/1 Lozenge | Walgreens | ANDA |
| 0363-9610 | Nicotine 2 mg/1 Lozenge | Walgreens | ANDA |
| 0363-9620 | Nicotine 4 mg/1 Lozenge | Walgreens | ANDA |
| 0363-9250 | Nicotine 2 mg/1 Gum, Chewing | Walgreens | ANDA |
| 0363-9780 | Nicotine 2 mg/1 Lozenge | Walgreens | ANDA |
| 0363-9590 | Nicotine 2 mg/1 Lozenge | Walgreens | ANDA |
| 0363-9580 | Nicotine 4 mg/1 Lozenge | Walgreens | ANDA |
| 0363-9570 | Nicotine 2 mg/1 Lozenge | Walgreens | ANDA |
| 0363-9350 | Nicotine 4 mg/1 Gum, Chewing | Walgreens | ANDA |
| 0363-9310 | Nicotine 4 mg/1 Gum, Chewing | Walgreens | ANDA |
| 50090-6383 | Nicotine 7 mg/24h Patch, Extended Release | A-S Medication Solutions | NDA |
| 63868-735 | Nicotine 21 mg/24h Patch, Extended Release | Chain Drug Marketing Association INC | NDA |
| 63868-734 | Nicotine 14 mg/24h Patch, Extended Release | Chain Drug Marketing Association INC | NDA |
| 59779-443 | Nicotine 7 mg/24h Patch, Extended Release | CVS Pharmacy | NDA |
| 59779-445 | Nicotine 14 mg/24h Patch, Extended Release | CVS Pharmacy | NDA |
| 59779-448 | Nicotine 21 mg/24h Patch, Extended Release | CVS Pharmacy | NDA |
| 55910-313 | Nicotine 21 mg/24h Patch, Extended Release | DOLGENCORP, LLC | NDA |
| 55741-449 | Kit | Dr. Reddy's Laboratories Inc. | NDA |
| 43598-447 | Nicotine 14 mg/24h Patch, Extended Release | Dr. Reddy's Laboratories Inc. | NDA |
| 43598-446 | Nicotine 7 mg/24h Patch, Extended Release | Dr. Reddy's Laboratories Inc. | NDA |
| 43598-448 | Nicotine 21 mg/24h Patch, Extended Release | Dr. Reddy's Laboratories Inc. | NDA |
| 43598-445 | Kit | Dr. Reddys Laboratories Inc. | NDA |
| 60429-443 | Nicotine 7 mg/24h Patch, Extended Release | Golden State Medical Supply, Inc. | NDA |
| 60429-445 | Nicotine 21 mg/24h Patch, Extended Release | Golden State Medical Supply, Inc. | NDA |
| 60429-444 | Nicotine 14 mg/24h Patch, Extended Release | Golden State Medical Supply, Inc. | NDA |
| 11822-4974 | Nicotine 14 mg/24h Patch, Extended Release | Rite Aid Corporation | NDA |
| 11822-4973 | Nicotine 7 mg/24h Patch, Extended Release | Rite Aid Corporation | NDA |
| 11822-3627 | Kit | Rite Aid Corporation | NDA |
| 11822-4975 | Nicotine 21 mg/24h Patch, Extended Release | Rite Aid Corporation | NDA |
| 0536-1106 | Nicotine 7 mg/24h Patch, Extended Release | Rugby Laboratories | NDA |
| 0536-1107 | Nicotine 14 mg/24h Patch, Extended Release | Rugby Laboratories | NDA |
| 0536-1108 | Nicotine 21 mg/24h Patch, Extended Release | Rugby Laboratories | NDA |
| 68196-194 | Nicotine 21 mg/24h Patch, Extended Release | Sam's West Inc | NDA |
| 70677-1266 | Nicotine 21 mg/24h Patch, Extended Release | Strategic Sourcing Services LLC | NDA |
| 70677-1265 | Nicotine 14 mg/24h Patch, Extended Release | Strategic Sourcing Services LLC | NDA |
| 70677-1264 | Nicotine 7 mg/24h Patch, Extended Release | Strategic Sourcing Services LLC | NDA |
| 11673-194 | Nicotine 21 mg/24h Patch, Extended Release | Target Corporation | NDA |
| 11673-195 | Nicotine 14 mg/24h Patch, Extended Release | Target Corporation | NDA |
| 11673-196 | Nicotine 7 mg/24h Patch, Extended Release | Target Corporation | NDA |
| 59450-001 | Nicotine 7 mg/24h Patch, Extended Release | The Kroger Co. | NDA |
| 59450-002 | Nicotine 14 mg/24h Patch, Extended Release | The Kroger Co. | NDA |
| 59450-003 | Nicotine 21 mg/24h Patch, Extended Release | The Kroger Co. | NDA |
| 0363-0455 | Nicotine 21 mg/24h Patch, Extended Release | Walgreens Company | NDA |
| 0363-0457 | Nicotine 14 mg/24h Patch, Extended Release | Walgreens Company | NDA |
| 0363-0451 | Nicotine 7 mg/24h Patch, Extended Release | Walgreens Company | NDA |
| 49035-194 | Nicotine 21 mg/24h Patch, Extended Release | Wal-Mart Stores Inc | NDA AUTHORIZED GENERIC |
| 49035-196 | Nicotine 7 mg/24h Patch, Extended Release | Wal-Mart Stores Inc | NDA AUTHORIZED GENERIC |
| 49035-195 | Nicotine 14 mg/24h Patch, Extended Release | Wal-Mart Stores Inc | NDA AUTHORIZED GENERIC |
Nicotine recalls
- D-0550-2026 Jun 3, 2026 · Class III · Ongoing
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Frequently asked questions
What is Nicotine used for?
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Who makes Nicotine?
Nicotine is listed by 41 labelers in the FDA NDC directory, including A-S Medication Solutions, Amazon.com Services LLC, AmerisourceBergen (Good Neighbor Pharmacy) 46122, Aurohealth LLC.
Has Nicotine been recalled?
The FDA enforcement database lists 1 recall for Nicotine, most recently D-0550-2026 (class iii): Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of…