NDC 41520-431 – Careone nighttime sleep aid
Diphenhydramine Hydrochloride 25 mg/1 · Tablet, Film Coated · Oral
Product NDC41520-431
Product details
- Brand name
- Careone nighttime sleep aid
- Generic name
- Diphenhydramine Hydrochloride
- Labeler
- American Sales Company
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- OTC MONOGRAPH DRUG · M010
- Marketed since
- April 13, 2004
- Listing expires
- December 31, 2026
- Pharmacologic class
- Histamine-1 Receptor Antagonist
Active ingredients
- Diphenhydramine Hydrochloride 25 mg/1
Uses, dosage, side effects and warnings for CareOne Nighttime Sleep Aid →
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 41520-431-62 | 12 BLISTER PACK in 1 CARTON (41520-431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK | Apr 13, 2004 |
| 41520-431-67 | 24 BLISTER PACK in 1 CARTON (41520-431-67) / 2 TABLET, FILM COATED in 1 BLISTER PACK | Aug 8, 2008 |
Recalls mentioning this NDC
- D-0413-2026 Apr 8, 2026 · Class II
Lack of Assurance of Sterility - D-0897-2023 Jul 19, 2023 · Class II
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Other CareOne Nighttime Sleep Aid products
- 41520-634 Doxylamine Succinate 25 mg/1 · Tablet · American Sales Company