duratuss ac

Generic: codeine phosphate, dexbrompheniramine maleate

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

Drug Facts

Product Profile

Brand Name duratuss ac
Generic Name codeine phosphate, dexbrompheniramine maleate
Labeler poly pharmaceuticals, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

codeine phosphate 10 mg/5mL, dexbrompheniramine maleate 1 mg/5mL

Manufacturer
Poly Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50991-540
Product ID 50991-540_3e5ed178-d5d8-b8d4-e063-6394a90a91db
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2025-09-08

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50991540
Hyphenated Format 50991-540

Supplemental Identifiers

RxCUI
2727418
UNII
GSL05Y1MN6 BPA9UT29BS

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 duratuss ac (source: ndc)
Generic Name codeine phosphate, dexbrompheniramine maleate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 1 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (50991-540-16)
  • 20 mL in 1 BOTTLE (50991-540-20)
source: ndc

Packages (2)

50991-540-16 473 mL in 1 BOTTLE (50991-540-16) 50991-540-20 20 mL in 1 BOTTLE (50991-540-20)

Ingredients (2)

codeine phosphate (10 mg/5mL) dexbrompheniramine maleate (1 mg/5mL)

Linked Drug Pages (1)

Duratuss AC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e5ed178-d5d8-b8d4-e063-6394a90a91db", "openfda": {"unii": ["GSL05Y1MN6", "BPA9UT29BS"], "rxcui": ["2727418"], "spl_set_id": ["3e5ed178-d5d9-b8d4-e063-6394a90a91db"], "manufacturer_name": ["Poly Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (50991-540-16)", "package_ndc": "50991-540-16", "marketing_start_date": "20250908"}, {"sample": false, "description": "20 mL in 1 BOTTLE (50991-540-20)", "package_ndc": "50991-540-20", "marketing_start_date": "20250908"}], "brand_name": "Duratuss AC", "product_id": "50991-540_3e5ed178-d5d8-b8d4-e063-6394a90a91db", "dosage_form": "LIQUID", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "50991-540", "dea_schedule": "CV", "generic_name": "Codeine Phosphate, Dexbrompheniramine Maleate", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Duratuss AC", "active_ingredients": [{"name": "CODEINE PHOSPHATE", "strength": "10 mg/5mL"}, {"name": "DEXBROMPHENIRAMINE MALEATE", "strength": "1 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250908", "listing_expiration_date": "20261231"}