Night Time Sleep Aid
- Product NDC
- 80513-371
- 11-digit product format
- 805130371
- Labeler code
- 80513
- Product ID
- 80513-371_2f0e58dc-121b-d508-e063-6294a90a34ff
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Doxylamine Succinate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx LLC
- Application
- ANDA040564
- Marketing category
- ANDA
- Marketing start
- 2004-08-27
- 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
- Night Time 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 |
|---|
| 80513-371-25 | Night Time Sleep Aid | 225 in 1 BOTTLE | TABLET | 225 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80513-371 | NIGHT TIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [ADVANCED RX LLC] | 2 | Current NDC, 1 package rows | 20250228_db8b730a-1553-4682-96bf-41e670ed0347.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 |
|---|
| 80513-371-25 | 80513037125 | 225 TABLET in 1 BOTTLE (80513-371-25) | 225 tablet | 2024-08-29 | No | No | Current |