dextromethorphan hydrobromide and guaifenesin (85722-0001)

Drug Facts

Product Profile

Brand Name dextromethorphan hydrobromide and guaifenesin

Generic Name dextromethorphan hydrobromide and guaifenesin

Labeler kjd pharma private limited

Dosage Form SYRUP

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 10 mg/5mL, guaifenesin 100 mg/5mL

Manufacturer

KJD Pharma Private Limited

Identifiers & Regulatory

Product NDC 85722-0001

Product ID 85722-0001_a2cca1a0-64ab-4650-beb5-1265425eac7b

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2026-12-31

Marketing Start 2021-02-01

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 857220001

Hyphenated Format 85722-0001

Supplemental Identifiers

RxCUI

996520

UNII

9D2RTI9KYH 495W7451VQ

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 dextromethorphan hydrobromide and guaifenesin (source: ndc)

Generic Name dextromethorphan hydrobromide and guaifenesin (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/5mL
100 mg/5mL

source: ndc

Packaging

118 mL in 1 BOTTLE (85722-0001-4)
473 mL in 1 BOTTLE (85722-0001-6)
236 mL in 1 BOTTLE (85722-0001-8)

source: ndc

Packages (3)

85722-0001-4 118 mL in 1 BOTTLE (85722-0001-4) 85722-0001-6 473 mL in 1 BOTTLE (85722-0001-6) 85722-0001-8 236 mL in 1 BOTTLE (85722-0001-8)

Ingredients (2)

dextromethorphan hydrobromide (10 mg/5mL) guaifenesin (100 mg/5mL)

Linked Drug Pages (1)

DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "a2cca1a0-64ab-4650-beb5-1265425eac7b", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["8877bb8d-479f-4968-8033-5c269d449a46"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["KJD Pharma Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (85722-0001-4)", "package_ndc": "85722-0001-4", "marketing_start_date": "20210201"}, {"sample": false, "description": "473 mL in 1 BOTTLE (85722-0001-6)", "package_ndc": "85722-0001-6", "marketing_start_date": "20210201"}, {"sample": false, "description": "236 mL in 1 BOTTLE (85722-0001-8)", "package_ndc": "85722-0001-8", "marketing_start_date": "20210201"}], "brand_name": "DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN", "product_id": "85722-0001_a2cca1a0-64ab-4650-beb5-1265425eac7b", "dosage_form": "SYRUP", "pharm_class": ["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]"], "product_ndc": "85722-0001", "generic_name": "DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN", "labeler_name": "KJD Pharma Private Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210201", "listing_expiration_date": "20261231"}