topco mucus relief

Generic: guaifenesin

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

Drug Facts

Product Profile

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

guaifenesin 600 mg/1

Manufacturer
Topco Associates, LLC

Identifiers & Regulatory

Product NDC 36800-226
Product ID 36800-226_201dbdbd-483f-46ee-8db2-e540d0b5cb9d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209215
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

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 36800226
Hyphenated Format 36800-226

Supplemental Identifiers

RxCUI
636522
UPC
0036800483880
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 topco mucus relief (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number ANDA209215 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (36800-226-16)
source: ndc

Packages (1)

36800-226-16 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (36800-226-16)

Ingredients (1)

guaifenesin (600 mg/1)

Linked Drug Pages (1)

Topco Mucus Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "201dbdbd-483f-46ee-8db2-e540d0b5cb9d", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0036800483880"], "unii": ["495W7451VQ"], "rxcui": ["636522"], "spl_set_id": ["03c17c06-6919-4ef4-9d0a-4c039940c671"], "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, EXTENDED RELEASE in 1 BOTTLE (36800-226-16)", "package_ndc": "36800-226-16", "marketing_start_date": "20210601"}], "brand_name": "Topco Mucus Relief", "product_id": "36800-226_201dbdbd-483f-46ee-8db2-e540d0b5cb9d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "36800-226", "generic_name": "Guaifenesin", "labeler_name": "Topco Associates, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topco Mucus Relief", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA209215", "marketing_category": "ANDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}