guaifenesin

Generic: guaifenesin

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin
Generic Name guaifenesin
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

guaifenesin 300 mg/15mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-2232
Product ID 0121-2232_25a970c7-0016-4f22-9e94-1e20e1319e3e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2002-09-01

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 01212232
Hyphenated Format 0121-2232

Supplemental Identifiers

RxCUI
310604
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
  • 300 mg/15mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (0121-2232-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-2232-15)
source: ndc

Packages (1)

0121-2232-00 10 TRAY in 1 CASE (0121-2232-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-2232-15)

Ingredients (1)

guaifenesin (300 mg/15mL)

Linked Drug Pages (1)

GUAIFENESIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "25a970c7-0016-4f22-9e94-1e20e1319e3e", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310604"], "spl_set_id": ["c2e53fb5-2798-47c8-9285-d1077d46e629"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0121-2232-00)  / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-2232-15)", "package_ndc": "0121-2232-00", "marketing_start_date": "20020901"}], "brand_name": "GUAIFENESIN", "product_id": "0121-2232_25a970c7-0016-4f22-9e94-1e20e1319e3e", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "0121-2232", "generic_name": "GUAIFENESIN", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN OTC DRUG", "brand_name_base": "GUAIFENESIN", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "300 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20020901", "listing_expiration_date": "20261231"}