guaifenesin and dextromethorphan hydrobromide

Generic: guaifenesin and dextromethorphan hydrobromide

Labeler: invatech pharma solutions llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin and dextromethorphan hydrobromide
Generic Name guaifenesin and dextromethorphan hydrobromide
Labeler invatech pharma solutions llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/1, guaifenesin 400 mg/1

Manufacturer
InvaTech Pharma Solutions LLC

Identifiers & Regulatory

Product NDC 57631-013
Product ID 57631-013_402896d4-831f-c53d-e063-6294a90a21b3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2021-01-13

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 57631013
Hyphenated Format 57631-013

Supplemental Identifiers

RxCUI
1147685
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 guaifenesin and dextromethorphan hydrobromide (source: ndc)
Generic Name guaifenesin and dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
  • 400 mg/1
source: ndc
Packaging
  • 26500 TABLET in 1 BOX (57631-013-10)
source: ndc

Packages (1)

57631-013-10 26500 TABLET in 1 BOX (57631-013-10)

Ingredients (2)

dextromethorphan hydrobromide (20 mg/1) guaifenesin (400 mg/1)

Linked Drug Pages (1)

Guaifenesin and Dextromethorphan Hydrobromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "402896d4-831f-c53d-e063-6294a90a21b3", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1147685"], "spl_set_id": ["40288ecf-043d-eb9e-e063-6394a90ac0a7"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["InvaTech Pharma Solutions LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "26500 TABLET in 1 BOX (57631-013-10)", "package_ndc": "57631-013-10", "marketing_start_date": "20210113"}], "brand_name": "Guaifenesin and Dextromethorphan Hydrobromide", "product_id": "57631-013_402896d4-831f-c53d-e063-6294a90a21b3", "dosage_form": "TABLET", "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": "57631-013", "generic_name": "Guaifenesin and Dextromethorphan Hydrobromide", "labeler_name": "InvaTech Pharma Solutions LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin and Dextromethorphan Hydrobromide", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "GUAIFENESIN", "strength": "400 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210113", "listing_expiration_date": "20261231"}