duraflu

Generic: acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hcl

Labeler: poly pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name duraflu
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hcl
Labeler poly pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 20 mg/1, guaifenesin 200 mg/1, pseudoephedrine hydrochloride 60 mg/1

Manufacturer
Poly Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50991-535
Product ID 50991-535_2683803e-5e2f-b2bc-e063-6394a90a4feb
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2015-10-01

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50991535
Hyphenated Format 50991-535

Supplemental Identifiers

RxCUI
1673869
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 6V9V2RYJ8N
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name duraflu (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 20 mg/1
  • 200 mg/1
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (50991-535-01)
  • 6 BLISTER PACK in 1 CARTON (50991-535-02) / 2 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

50991-535-01 100 TABLET in 1 BOTTLE (50991-535-01) 50991-535-02 6 BLISTER PACK in 1 CARTON (50991-535-02) / 2 TABLET in 1 BLISTER PACK

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (20 mg/1) guaifenesin (200 mg/1) pseudoephedrine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Duraflu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2683803e-5e2f-b2bc-e063-6394a90a4feb", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "6V9V2RYJ8N"], "rxcui": ["1673869"], "spl_set_id": ["55fffc1d-8449-4c28-a391-c6f60dd85622"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Poly Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (50991-535-01)", "package_ndc": "50991-535-01", "marketing_start_date": "20151001"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (50991-535-02)  / 2 TABLET in 1 BLISTER PACK", "package_ndc": "50991-535-02", "marketing_start_date": "20151001"}], "brand_name": "Duraflu", "product_id": "50991-535_2683803e-5e2f-b2bc-e063-6394a90a4feb", "dosage_form": "TABLET", "pharm_class": ["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]"], "product_ndc": "50991-535", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Duraflu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20151001", "listing_expiration_date": "20261231"}