guaifenesin

Generic: guaifenesin

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin
Generic Name guaifenesin
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 200 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-5154
Product ID 0904-5154_cec9f1e6-0f50-44af-866c-d87f8f8975d1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2009-10-05

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 09045154
Hyphenated Format 0904-5154

Supplemental Identifiers

RxCUI
197741
UPC
0309045154601
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
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0904-5154-60)
source: ndc

Packages (1)

0904-5154-60 100 TABLET in 1 BOTTLE, PLASTIC (0904-5154-60)

Ingredients (1)

guaifenesin (200 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": "cec9f1e6-0f50-44af-866c-d87f8f8975d1", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0309045154601"], "unii": ["495W7451VQ"], "rxcui": ["197741"], "spl_set_id": ["aa662428-e61f-4e22-af4d-8cf63df68c99"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0904-5154-60)", "package_ndc": "0904-5154-60", "marketing_start_date": "20091005"}], "brand_name": "Guaifenesin", "product_id": "0904-5154_cec9f1e6-0f50-44af-866c-d87f8f8975d1", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "0904-5154", "generic_name": "Guaifenesin", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "200 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20091005", "listing_expiration_date": "20261231"}