mucus relief guaifenesin extended-release 600 mg

Generic: guaifenesin

Labeler: twin med llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mucus relief guaifenesin extended-release 600 mg
Generic Name guaifenesin
Labeler twin med llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
TWIN MED LLC

Identifiers & Regulatory

Product NDC 55681-301
Product ID 55681-301_0e12d44c-f957-c1b1-e063-6394a90a7483
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213420
Listing Expiration 2026-12-31
Marketing Start 2022-03-02

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 55681301
Hyphenated Format 55681-301

Supplemental Identifiers

RxCUI
636522
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 guaifenesin extended-release 600 mg (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
  • 100 TABLET in 1 BOTTLE (55681-301-01)
source: ndc

Packages (1)

55681-301-01 100 TABLET in 1 BOTTLE (55681-301-01)

Ingredients (1)

guaifenesin (600 mg/1)

Linked Drug Pages (1)

MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0e12d44c-f957-c1b1-e063-6394a90a7483", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["636522"], "spl_set_id": ["d9d13c67-51a1-aa79-e053-2995a90abdbb"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["TWIN MED LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (55681-301-01)", "package_ndc": "55681-301-01", "marketing_start_date": "20220302"}], "brand_name": "MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg", "product_id": "55681-301_0e12d44c-f957-c1b1-e063-6394a90a7483", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "55681-301", "generic_name": "GUAIFENESIN", "labeler_name": "TWIN MED LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MUCUS RELIEF", "brand_name_suffix": "GUAIFENESIN EXTENDED-RELEASE 600 mg", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA213420", "marketing_category": "ANDA", "marketing_start_date": "20220302", "listing_expiration_date": "20261231"}