Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate
- Product NDC
- 35916-0185
- 11-digit product format
- 359160185
- Labeler code
- 35916
- Product ID
- 35916-0185_50036e03-a441-a430-e063-6394a90a72c7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Softgel Healthcare Private Limited
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-17
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 325; 10; 6.25 mg/1; mg/1; mg/1
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2 |
| Rxcui | 1426334 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 35916-0185-2 | Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | 3000 in 1 POUCH | CAPSULE, LIQUID FILLED | 3000 | | 5 |
| 35916-0185-3 | Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | 2000 in 1 POUCH | CAPSULE, LIQUID FILLED | 2000 | | 5 |
| 35916-0185-3 | Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | | 5 |
| 35916-0185-4 | Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | | 5 |
| 35916-0185-4 | Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | 1500 in 1 BAG | CAPSULE, LIQUID FILLED | 1500 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 35916-0185-2 | 35916018502 | 3000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0185-2) | | 2025-05-17 | No | No | Current |
| 35916-0185-3 | 35916018503 | 2 POUCH in 1 BOX (35916-0185-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH | 2 pouch | 2025-09-25 | No | No | Current |
| 35916-0185-4 | 35916018504 | 2 BAG in 1 BOX (35916-0185-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG | 2 bag | 2026-01-16 | No | No | Current |