TopCare Sleep Aid
- Product NDC
- 36800-441
- 11-digit product format
- 368000441
- Labeler code
- 36800
- Product ID
- 36800-441_ce0fbc49-ced3-4bff-bbaa-0e5439f154f1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Doxylamine succinate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA040167
- Marketing category
- ANDA
- Marketing start
- 1997-01-29
- 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 |
|---|
| 36800-441-64 | TopCare Sleep Aid | 1 in 1 BLISTER PACK | TABLET | 1 | | 6 |
| 36800-441-64 | TopCare Sleep Aid | 32 in 1 CARTON | TABLET | 32 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-441 | TOPCARE SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [TOPCO ASSOCIATES LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250313_15dc89c4-b7ce-4d36-8107-f501daaf289b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 36800-441-64 | 36800044164 | 32 BLISTER PACK in 1 CARTON (36800-441-64) / 1 TABLET in 1 BLISTER PACK | 32 blister pack | 1997-01-29 | 0000-00-00 | No | No | Current |