mucinex

Generic: guaifenesin

Labeler: bryant ranch prepack
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mucinex
Generic Name guaifenesin
Labeler bryant ranch prepack
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-7115
Product ID 63629-7115_9889ac23-e24f-4e1f-a23c-488b2f304e0e
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 636297115
Hyphenated Format 63629-7115

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
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-1)
  • 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-2)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-3)
  • 40 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-4)
  • 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-5)
source: ndc

Packages (5)

63629-7115-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-1) 63629-7115-2 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-2) 63629-7115-3 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-3) 63629-7115-4 40 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-4) 63629-7115-5 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-5)

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": "9889ac23-e24f-4e1f-a23c-488b2f304e0e", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["636522", "891301"], "spl_set_id": ["a898b584-e17e-45c4-8a28-9f686b95dca0"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-1)", "package_ndc": "63629-7115-1", "marketing_start_date": "20240402"}, {"sample": false, "description": "20 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-2)", "package_ndc": "63629-7115-2", "marketing_start_date": "20161017"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-3)", "package_ndc": "63629-7115-3", "marketing_start_date": "20240402"}, {"sample": false, "description": "40 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-4)", "package_ndc": "63629-7115-4", "marketing_start_date": "20190204"}, {"sample": false, "description": "14 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-5)", "package_ndc": "63629-7115-5", "marketing_start_date": "20240402"}], "brand_name": "Mucinex", "product_id": "63629-7115_9889ac23-e24f-4e1f-a23c-488b2f304e0e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "63629-7115", "generic_name": "Guaifenesin", "labeler_name": "Bryant Ranch Prepack", "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"}