Cold and Flu
- Product NDC
- 55301-310
- 11-digit product format
- 553010310
- Labeler code
- 55301
- Product ID
- 55301-310_dd4f47ab-ca4e-47fe-910a-3c03cac289ce
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ARMY AND AIR FORCE EXCHANGE SERVICE
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-08-13
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 362O9ITL9D | ACETAMINOPHEN | 103-90-2 | ACETAMINOPHEN |
| 9D2RTI9KYH | DEXTROMETHORPHAN HYDROBROMIDE | 6700-34-1 | DEXTROMETHORPHAN HYDROBROMIDE |
| V9BI9B5YI2 | DOXYLAMINE SUCCINATE | 562-10-7 | DOXYLAMINE SUCCINATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55301-310-02 | 55301031002 | 355 mL in 1 BOTTLE, PLASTIC (55301-310-02) | 355 ml | 2024-08-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Exchange Select 44-013 | ARMY AND AIR FORCE EXCHANGE SERVICE | LNK International, Inc. | 2025-08-13 | HUMAN OTC DRUG LABEL | 2 |