guaifenesin

Generic: guaifenesin

Labeler: health pharma usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin
Generic Name guaifenesin
Labeler health pharma usa llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 400 mg/1

Manufacturer
Health Pharma USA LLC

Identifiers & Regulatory

Product NDC 71679-309
Product ID 71679-309_45395c54-4eb3-fd26-e063-6294a90a9f93
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-02-07

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 71679309
Hyphenated Format 71679-309

Supplemental Identifiers

RxCUI
359601
UPC
0371679309023
UNII
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 (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 38500 TABLET in 1 BOTTLE (71679-309-00)
  • 200 TABLET in 1 BOTTLE (71679-309-02)
source: ndc

Packages (2)

71679-309-00 38500 TABLET in 1 BOTTLE (71679-309-00) 71679-309-02 200 TABLET in 1 BOTTLE (71679-309-02)

Ingredients (1)

guaifenesin (400 mg/1)

Linked Drug Pages (1)

Guaifenesin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45395c54-4eb3-fd26-e063-6294a90a9f93", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0371679309023"], "unii": ["495W7451VQ"], "rxcui": ["359601"], "spl_set_id": ["31755594-3e1c-b290-e063-6394a90aba61"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Health Pharma USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "38500 TABLET in 1 BOTTLE (71679-309-00)", "package_ndc": "71679-309-00", "marketing_start_date": "20240307"}, {"sample": false, "description": "200 TABLET in 1 BOTTLE (71679-309-02)", "package_ndc": "71679-309-02", "marketing_start_date": "20240207"}], "brand_name": "Guaifenesin", "product_id": "71679-309_45395c54-4eb3-fd26-e063-6294a90a9f93", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "71679-309", "generic_name": "Guaifenesin", "labeler_name": "Health Pharma USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "400 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240207", "listing_expiration_date": "20261231"}