Nighttime Sleep Aid
- Product NDC
- 55319-439
- 11-digit product format
- 553190439
- Labeler code
- 55319
- Product ID
- 55319-439_02992add-e605-4c92-a970-3b398c497024
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nighttime Sleep Aid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Family Dollar Stores, Inc
- Application
- ANDA040564
- Marketing category
- ANDA
- Marketing start
- 2023-10-31
- Substance
- DOXYLAMINE SUCCINATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nighttime 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 |
| Rxcui | 1101446 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55319-439-16 | Nighttime Sleep Aid | 2 in 1 CARTON | TABLET | 2 | | 9 |
| 55319-439-16 | Nighttime Sleep Aid | 8 in 1 BLISTER PACK | TABLET | 8 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55319-439 | NIGHTTIME SLEEP AID TABLET [FAMILY DOLLAR STORES, INC] | 8 | Current NDC, 2 package rows | 20231101_d91f0c21-28f0-4d32-a1d2-fae406b90bf7.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 |
|---|
| 55319-439-16 | 55319043916 | 2 BLISTER PACK in 1 CARTON (55319-439-16) / 8 TABLET in 1 BLISTER PACK | 2 blister pack | 2023-10-31 | No | No | Current |