mucinex

Generic: guaifenesin

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

Drug Facts

Product Profile

Brand Name mucinex
Generic Name guaifenesin
Labeler american health packaging
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-572
Product ID 68084-572_1e137707-60f2-51ee-e063-6294a90afe82
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021282
Listing Expiration 2026-12-31
Marketing Start 2016-02-19

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 68084572
Hyphenated Format 68084-572

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
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-572-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-572-11)
source: ndc

Packages (1)

68084-572-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-572-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-572-11)

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": "1e137707-60f2-51ee-e063-6294a90afe82", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["636522", "891301"], "spl_set_id": ["0129f47d-abc2-414c-b4e1-1064c5d6a623"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-572-01)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-572-11)", "package_ndc": "68084-572-01", "marketing_start_date": "20160219"}], "brand_name": "Mucinex", "product_id": "68084-572_1e137707-60f2-51ee-e063-6294a90afe82", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "68084-572", "generic_name": "Guaifenesin", "labeler_name": "American Health Packaging", "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": "20160219", "listing_expiration_date": "20261231"}