Cold and Flu
- Product NDC
- 55301-712
- 11-digit product format
- 553010712
- Labeler code
- 55301
- Product ID
- 55301-712_1dd81bff-1464-47d6-8413-d48d3668945a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ARMY AND AIR FORCE EXCHANGE SERVICE
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-09-12
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- 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 |
| 04JA59TNSJ | PHENYLEPHRINE HYDROCHLORIDE | 61-76-7 | PHENYLEPHRINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55301-712-02 | 55301071202 | 355 mL in 1 BOTTLE, PLASTIC (55301-712-02) | 355 ml | 2024-09-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Exchange Select 44-012 | ARMY AND AIR FORCE EXCHANGE SERVICE | LNK International, Inc. | 2025-06-03 | HUMAN OTC DRUG LABEL | 1 |