guaifenesin 400mg

Generic: guaifenesin

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

Drug Facts

Product Profile

Brand Name guaifenesin 400mg
Generic Name guaifenesin
Labeler marlex pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 400 mg/1

Manufacturer
Marlex Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 10135-790
Product ID 10135-790_437e33ae-1e1d-56a8-e063-6294a90abc66
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 10135790
Hyphenated Format 10135-790

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 guaifenesin 400mg (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (10135-790-30)
  • 60 TABLET in 1 BOTTLE (10135-790-60)
source: ndc

Packages (2)

10135-790-30 30 TABLET in 1 BOTTLE (10135-790-30) 10135-790-60 60 TABLET in 1 BOTTLE (10135-790-60)

Ingredients (1)

guaifenesin (400 mg/1)

Linked Drug Pages (1)

Guaifenesin 400mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "437e33ae-1e1d-56a8-e063-6294a90abc66", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["359601"], "spl_set_id": ["13f4db4e-687e-9d7b-e063-6294a90ab088"], "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": "30 TABLET in 1 BOTTLE (10135-790-30)", "package_ndc": "10135-790-30", "marketing_start_date": "20240301"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (10135-790-60)", "package_ndc": "10135-790-60", "marketing_start_date": "20240301"}], "brand_name": "Guaifenesin 400mg", "product_id": "10135-790_437e33ae-1e1d-56a8-e063-6294a90abc66", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "10135-790", "generic_name": "Guaifenesin", "labeler_name": "Marlex Pharmaceuticals Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin 400mg", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "400 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}