guaifenesin

Generic: guaifenesin

Labeler: american health packaging
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin
Generic Name guaifenesin
Labeler american health packaging
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

guaifenesin 200 mg/10mL

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-863
Product ID 60687-863_24b1b6f4-c113-8adc-e063-6394a90a546c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-10-20

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 60687863
Hyphenated Format 60687-863

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
  • 200 mg/10mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (60687-863-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-863-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-863-42)
source: ndc

Packages (1)

60687-863-56 10 TRAY in 1 CASE (60687-863-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-863-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-863-42)

Ingredients (1)

guaifenesin (200 mg/10mL)

Linked Drug Pages (1)

Guaifenesin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "24b1b6f4-c113-8adc-e063-6394a90a546c", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310604"], "spl_set_id": ["2fd702ea-3069-472c-b99e-c527f1375705"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["American Health Packaging"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (60687-863-56)  / 10 CUP, UNIT-DOSE in 1 TRAY (60687-863-48)  / 10 mL in 1 CUP, UNIT-DOSE (60687-863-42)", "package_ndc": "60687-863-56", "marketing_start_date": "20241020"}], "brand_name": "Guaifenesin", "product_id": "60687-863_24b1b6f4-c113-8adc-e063-6394a90a546c", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "60687-863", "generic_name": "Guaifenesin", "labeler_name": "American Health Packaging", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "200 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241020", "listing_expiration_date": "20261231"}