Nocto Sleep Aid
- Product NDC
- 27854-375
- 11-digit product format
- 278540375
- Labeler code
- 27854
- Product ID
- 27854-375_200f8580-e4b0-4d64-b4c0-615b47e688cd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Doxylamine succinate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Belmora LLC
- Application
- ANDA040564
- Marketing category
- ANDA
- Marketing start
- 2019-10-31
- 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
- Nocto 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, 2257285 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 27854-375-01 | Nocto Sleep Aid | 24 in 1 BOTTLE, PLASTIC | TABLET | 24 | | 8 |
| 27854-375-01 | Nocto Sleep Aid | 1 in 1 CARTON | TABLET | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27854-375 | NOCTO SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [BELMORA LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240802_d255309b-0023-48fe-890f-6a4fe04dbb85.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 27854-375-01 | 27854037501 | 1 BOTTLE, PLASTIC in 1 CARTON (27854-375-01) / 24 TABLET in 1 BOTTLE, PLASTIC | 2019-10-31 | 0000-00-00 | No | No | Current |