Topcare Sleep Aid
- Product NDC
- 76162-159
- 11-digit product format
- 761620159
- Labeler code
- 76162
- Product ID
- 76162-159_d7fff893-f18b-4114-91fe-e9c1b1e3bbc6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Doxylamine Succinate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA040167
- Marketing category
- ANDA
- Marketing start
- 2023-06-16
- 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 |
|---|
| 76162-159-62 | Topcare Sleep Aid | 1 in 1 BLISTER PACK | TABLET | 1 | | 2 |
| 76162-159-62 | Topcare Sleep Aid | 24 in 1 CARTON | TABLET | 24 | | 2 |
| 76162-159-67 | Topcare Sleep Aid | 48 in 1 CARTON | TABLET | 48 | | 2 |
| 76162-159-67 | Topcare Sleep Aid | 1 in 1 BLISTER PACK | TABLET | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76162-159 | TOPCARE SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [TOPCO ASSOCIATES LLC] | 2 | Current NDC, 4 package rows | 20240402_d0295e0b-aba8-4cc7-b83c-b494d552413b.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 |
|---|
| 76162-159-62 | 76162015962 | 24 BLISTER PACK in 1 CARTON (76162-159-62) / 1 TABLET in 1 BLISTER PACK | 24 blister pack | 2023-06-16 | No | No | Current |
| 76162-159-67 | 76162015967 | 48 BLISTER PACK in 1 CARTON (76162-159-67) / 1 TABLET in 1 BLISTER PACK | 48 blister pack | 2024-01-24 | No | No | Current |