mucinex

Generic: guaifenesin

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mucinex
Generic Name guaifenesin
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 67544-149
Product ID 67544-149_cc734890-e42c-454a-b771-3ecd169d161a
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021282
Listing Expiration 2026-12-31
Marketing Start 2012-07-03

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 67544149
Hyphenated Format 67544-149

Supplemental Identifiers

RxCUI
636522 891301
UNII
495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

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 mucinex (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number NDA021282 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-149-53)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-149-70)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-149-80)
source: ndc

Packages (3)

67544-149-53 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-149-53) 67544-149-70 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-149-70) 67544-149-80 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-149-80)

Ingredients (1)

guaifenesin (600 mg/1)

Linked Drug Pages (1)

Mucinex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cc734890-e42c-454a-b771-3ecd169d161a", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["636522", "891301"], "spl_set_id": ["1c84bf00-ebaa-4e69-a2c6-716631d209d9"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-149-53)", "package_ndc": "67544-149-53", "marketing_start_date": "20120709"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-149-70)", "package_ndc": "67544-149-70", "marketing_start_date": "20120822"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-149-80)", "package_ndc": "67544-149-80", "marketing_start_date": "20120712"}], "brand_name": "Mucinex", "product_id": "67544-149_cc734890-e42c-454a-b771-3ecd169d161a", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "67544-149", "generic_name": "Guaifenesin", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucinex", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "NDA021282", "marketing_category": "NDA", "marketing_start_date": "20120703", "listing_expiration_date": "20261231"}