topcare sleep aid
- Product NDC
- 76162-603
- 11-digit product format
- 761620603
- Labeler code
- 76162
- Product ID
- 76162-603_9e5b860c-237c-48e6-a2a0-91ab1492bae3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- doxylamine succinate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA040167
- Marketing category
- ANDA
- Marketing start
- 2025-03-26
- Substance
- DOXYLAMINE SUCCINATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| V9BI9B5YI2 | DOXYLAMINE SUCCINATE | 562-10-7 | DOXYLAMINE SUCCINATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76162-603-67 | 76162060367 | 1 BOTTLE in 1 CARTON (76162-603-67) / 48 TABLET, COATED in 1 BOTTLE | 1 bottle | 2025-03-26 | No | No | Historical |