mucus relief

Generic: guaifenesin

Labeler: advanced rx llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mucus relief
Generic Name guaifenesin
Labeler advanced rx llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
Advanced Rx LLC

Identifiers & Regulatory

Product NDC 80513-403
Product ID 80513-403_20ccaea1-80da-f1df-e063-6394a90a7dda
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213420
Listing Expiration 2026-12-31
Marketing Start 2020-05-08

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 80513403
Hyphenated Format 80513-403

Supplemental Identifiers

RxCUI
636522
UPC
0380513000781
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 (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number ANDA213420 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 200 TABLET, EXTENDED RELEASE in 1 BOTTLE (80513-403-20)
source: ndc

Packages (1)

80513-403-20 200 TABLET, EXTENDED RELEASE in 1 BOTTLE (80513-403-20)

Ingredients (1)

guaifenesin (600 mg/1)

Linked Drug Pages (1)

Mucus Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "20ccaea1-80da-f1df-e063-6394a90a7dda", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0380513000781"], "unii": ["495W7451VQ"], "rxcui": ["636522"], "spl_set_id": ["6046a5c6-96b1-4c20-acac-2716025c1665"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 TABLET, EXTENDED RELEASE in 1 BOTTLE (80513-403-20)", "package_ndc": "80513-403-20", "marketing_start_date": "20240829"}], "brand_name": "Mucus Relief", "product_id": "80513-403_20ccaea1-80da-f1df-e063-6394a90a7dda", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "80513-403", "generic_name": "Guaifenesin", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucus Relief", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA213420", "marketing_category": "ANDA", "marketing_start_date": "20200508", "listing_expiration_date": "20261231"}