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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- topcare sleep aid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXYLAMINE SUCCINATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V9BI9B5YI2 |
| Rxcui | 1101446 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76162-603-67 | topcare sleep aid | 48 in 1 BOTTLE | TABLET, COATED | 48 | | 2 |
| 76162-603-67 | topcare sleep aid | 1 in 1 CARTON | TABLET, COATED | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76162-603 | TOPCARE SLEEP AID (DOXYLAMINE SUCCINATE) TABLET, COATED [TOPCO ASSOCIATES LLC] | 2 | Current NDC, 2 package rows | 20250402_c8b24ed8-34a1-4857-8fcb-6e3f9d407903.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |