NIGHTTIME COLD AND FLU
- Product NDC
- 37835-525
- 11-digit product format
- 378350525
- Labeler code
- 37835
- Product ID
- 37835-525_3590d417-272f-ae4d-e063-6394a90a5dc6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Doxylamine succinate and Dextromethorphan HBr
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- BI-MART
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-01
- 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
- NIGHTTIME COLD AND FLU
- 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 |
|---|
| 37835-525-12 | NIGHTTIME COLD AND FLU | 355 mL in 1 BOTTLE | LIQUID | 355 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 37835-525 | NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DOXYLAMINE SUCCINATE AND DEXTROMETHORPHAN HBR) LIQUID [BI-MART] | 1 | Current NDC, 1 package rows | 20250523_36aa5df7-8722-4b80-aa04-d869bc944311.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 |
|---|
| 37835-525-12 | 37835052512 | 355 mL in 1 BOTTLE (37835-525-12) | 355 ml | 2025-05-01 | No | No | Current |