guaifenesin 200mg

Generic: guaifenesin

Labeler: marlex pharmaceuticals inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin 200mg
Generic Name guaifenesin
Labeler marlex pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 200 mg/1

Manufacturer
Marlex Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 10135-789
Product ID 10135-789_437e388b-2293-0064-e063-6394a90add05
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

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 10135789
Hyphenated Format 10135-789

Supplemental Identifiers

RxCUI
197741
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 guaifenesin 200mg (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (10135-789-01)
source: ndc

Packages (1)

10135-789-01 100 TABLET in 1 BOTTLE (10135-789-01)

Ingredients (1)

guaifenesin (200 mg/1)

Linked Drug Pages (1)

Guaifenesin 200mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "437e388b-2293-0064-e063-6394a90add05", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["197741"], "spl_set_id": ["13b8f480-d1ac-d70c-e063-6394a90ab4f4"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Marlex Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (10135-789-01)", "package_ndc": "10135-789-01", "marketing_start_date": "20240301"}], "brand_name": "Guaifenesin 200mg", "product_id": "10135-789_437e388b-2293-0064-e063-6394a90add05", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "10135-789", "generic_name": "Guaifenesin", "labeler_name": "Marlex Pharmaceuticals Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin 200mg", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "200 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}