mucinex

Generic: guaifenesin

Labeler: rb health (us) llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mucinex
Generic Name guaifenesin
Labeler rb health (us) llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 63824-008
Product ID 63824-008_3246dc5b-9f37-2dd3-e063-6294a90a52d3
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 63824008
Hyphenated Format 63824-008

Supplemental Identifiers

RxCUI
636522 891301
UPC
0363824008202
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 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
  • 5 BLISTER PACK in 1 CARTON (63824-008-15) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (63824-008-27) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (63824-008-32) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (63824-008-34) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (63824-008-36) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63824-008-50)
  • 3 BLISTER PACK in 1 CARTON (63824-008-69) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-008-72)
  • 24 POUCH in 1 CARTON (63824-008-74) / 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-008-73)
  • 4 BLISTER PACK in 1 CARTON (63824-008-80) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (63824-008-86) / 17 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 6 BLISTER PACK in 1 CARTON (63824-008-92) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (12)

63824-008-15 5 BLISTER PACK in 1 CARTON (63824-008-15) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-008-27 4 BLISTER PACK in 1 CARTON (63824-008-27) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-008-32 1 BLISTER PACK in 1 CARTON (63824-008-32) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-008-34 2 BLISTER PACK in 1 CARTON (63824-008-34) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-008-36 1 BLISTER PACK in 1 CARTON (63824-008-36) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-008-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63824-008-50) 63824-008-69 3 BLISTER PACK in 1 CARTON (63824-008-69) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-008-72 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-008-72) 63824-008-74 24 POUCH in 1 CARTON (63824-008-74) / 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-008-73) 63824-008-80 4 BLISTER PACK in 1 CARTON (63824-008-80) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-008-86 4 BLISTER PACK in 1 CARTON (63824-008-86) / 17 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 63824-008-92 6 BLISTER PACK in 1 CARTON (63824-008-92) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

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": "3246dc5b-9f37-2dd3-e063-6294a90a52d3", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0363824008202"], "unii": ["495W7451VQ"], "rxcui": ["636522", "891301"], "spl_set_id": ["dd379cdd-90ab-42e0-ad89-f50d3220f611"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (63824-008-15)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-008-15", "marketing_start_date": "20120703"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (63824-008-27)  / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-008-27", "marketing_start_date": "20120703"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63824-008-32)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-008-32", "marketing_start_date": "20120703"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (63824-008-34)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-008-34", "marketing_start_date": "20120703"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63824-008-36)  / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-008-36", "marketing_start_date": "20120703"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63824-008-50)", "package_ndc": "63824-008-50", "marketing_start_date": "20120703"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (63824-008-69)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-008-69", "marketing_start_date": "20120703"}, {"sample": false, "description": "2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-008-72)", "package_ndc": "63824-008-72", "marketing_start_date": "20120703"}, {"sample": false, "description": "24 POUCH in 1 CARTON (63824-008-74)  / 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-008-73)", "package_ndc": "63824-008-74", "marketing_start_date": "20120703"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (63824-008-80)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-008-80", "marketing_start_date": "20120703"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (63824-008-86)  / 17 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-008-86", "marketing_start_date": "20120703"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (63824-008-92)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63824-008-92", "marketing_start_date": "20120703"}], "brand_name": "Mucinex", "product_id": "63824-008_3246dc5b-9f37-2dd3-e063-6294a90a52d3", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "63824-008", "generic_name": "Guaifenesin", "labeler_name": "RB Health (US) 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"}