Duraflu
- Product NDC
- 50991-535
- 11-digit product format
- 509910535
- Labeler code
- 50991
- Product ID
- 50991-535_2683803e-5e2f-b2bc-e063-6394a90a4feb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Poly Pharmaceuticals, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-10-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 325; 20; 200; 60 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Duraflu
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 6V9V2RYJ8N |
| Rxcui | 1673869 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50991-535-01 | Duraflu | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 50991-535-02 | Duraflu | 6 in 1 CARTON | TABLET | 6 | | 8 |
| 50991-535-02 | Duraflu | 2 in 1 BLISTER PACK | TABLET | 2 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | DURAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | DURAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | DURAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | DURAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | DURAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | DURAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | DURAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | DURAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DURAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DURAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | DURAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50991-535 | DURAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 3 package rows | 20241111_55fffc1d-8449-4c28-a391-c6f60dd85622.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 |
|---|
| 50991-535-01 | 50991053501 | 100 TABLET in 1 BOTTLE (50991-535-01) | 100 tablet | 2015-10-01 | 0000-00-00 | No | No | Current |
| 50991-535-02 | 50991053502 | 6 BLISTER PACK in 1 CARTON (50991-535-02) / 2 TABLET in 1 BLISTER PACK | 6 blister pack | 2015-10-01 | 0000-00-00 | No | No | Current |