Sleep Aid
- Product NDC
- 51316-368
- 11-digit product format
- 513160368
- Labeler code
- 51316
- Product ID
- 51316-368_36d83207-9c02-4d9b-aa06-315941b4889a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Doxylamine succinate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Application
- ANDA040564
- Marketing category
- ANDA
- Marketing start
- 2025-06-25
- 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
- Sleep Aid
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXYLAMINE SUCCINATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V9BI9B5YI2 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51316-368-22 | Sleep Aid | 3 in 1 CARTON | TABLET | 3 | | 2 |
| 51316-368-22 | Sleep Aid | 16 in 1 BLISTER PACK | TABLET | 16 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51316-368-22 | 51316036822 | 3 BLISTER PACK in 1 CARTON (51316-368-22) / 16 TABLET in 1 BLISTER PACK | 3 blister pack | 2025-06-25 | No | No | Current |