Nite-Time
- Product NDC
- 76281-501
- 11-digit product format
- 762810501
- Labeler code
- 76281
- Product ID
- 76281-501_46e2c8b6-bd83-7100-e063-6294a90ac998
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- AptaPharma Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-03-09
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA 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
- Nite-Time
- Brand name suffix
- COLD/FLU Medicine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2 |
| Rxcui | 1043400 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76281-501-25 | Nite-TimeCOLD/FLU Medicine | 177 mL in 1 BOTTLE | LIQUID | 177 | | 9 |
| 76281-501-28 | Nite-TimeCOLD/FLU Medicine | 354 mL in 1 BOTTLE | LIQUID | 354 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76281-501 | NITE-TIME COLD/FLU MEDICINE (ACETAMINOPHEN) LIQUID [APTAPHARMA INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20231212_344440bc-d810-4296-93ec-e6ae6673856b.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 |
|---|
| 76281-501-25 | 76281050125 | 177 mL in 1 BOTTLE (76281-501-25) | 177 ml | 2018-03-09 | 0000-00-00 | No | No | Current |
| 76281-501-28 | 76281050128 | 354 mL in 1 BOTTLE (76281-501-28) | 354 ml | 2018-03-09 | 0000-00-00 | No | No | Current |