TOPCARE
- Product NDC
- 76162-201
- 11-digit product format
- 761620201
- Labeler code
- 76162
- Product ID
- 76162-201_431146ca-c8d1-8d10-e063-6294a90a4a0c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Topco Associates, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-16
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 12.5 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| TC2D6JAD40 | DIPHENHYDRAMINE HYDROCHLORIDE | 147-24-0 | DIPHENHYDRAMINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76162-201-20 | 76162020120 | 2 BLISTER PACK in 1 CARTON (76162-201-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK | 2 blister pack | 2025-05-16 | No | No | Historical |