mucus relief immediate release

Generic: guaifenesin 400mg

Labeler: topco associates, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name mucus relief immediate release
Generic Name guaifenesin 400mg
Labeler topco associates, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 400 mg/1

Manufacturer
TopCo Associates, LLC

Identifiers & Regulatory

Product NDC 76162-004
Product ID 76162-004_bf64ce65-6978-4634-bd02-ab1389acf47d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-12-23

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 76162004
Hyphenated Format 76162-004

Supplemental Identifiers

RxCUI
359601
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 mucus relief immediate release (source: ndc)
Generic Name guaifenesin 400mg (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76162-004-01)
source: ndc

Packages (1)

76162-004-01 100 TABLET in 1 BOTTLE (76162-004-01)

Ingredients (1)

guaifenesin (400 mg/1)

Linked Drug Pages (1)

Mucus Relief Immediate Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bf64ce65-6978-4634-bd02-ab1389acf47d", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["359601"], "spl_set_id": ["7d91c6ab-d161-42b9-b353-0aa8f59619f8"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["TopCo Associates, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76162-004-01)", "package_ndc": "76162-004-01", "marketing_start_date": "20141223"}], "brand_name": "Mucus Relief Immediate Release", "product_id": "76162-004_bf64ce65-6978-4634-bd02-ab1389acf47d", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "76162-004", "generic_name": "Guaifenesin 400mg", "labeler_name": "TopCo Associates, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucus Relief", "brand_name_suffix": "Immediate Release", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "400 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20141223", "listing_expiration_date": "20261231"}