guaifenesin

Generic: guaifenesin

Labeler: reliable 1 laboratories llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin
Generic Name guaifenesin
Labeler reliable 1 laboratories llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 400 mg/1

Manufacturer
Reliable 1 Laboratories LLC

Identifiers & Regulatory

Product NDC 69618-061
Product ID 69618-061_2bc81e27-90e3-930d-e063-6394a90a699d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-08-01

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 69618061
Hyphenated Format 69618-061

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 (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
  • 60 TABLET in 1 BOTTLE, PLASTIC (69618-061-06)
source: ndc

Packages (1)

69618-061-06 60 TABLET in 1 BOTTLE, PLASTIC (69618-061-06)

Ingredients (1)

guaifenesin (400 mg/1)

Linked Drug Pages (1)

Guaifenesin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2bc81e27-90e3-930d-e063-6394a90a699d", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["359601"], "spl_set_id": ["ae469d4f-91c4-cff0-e053-2995a90a0497"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Reliable 1 Laboratories LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (69618-061-06)", "package_ndc": "69618-061-06", "marketing_start_date": "20200801"}], "brand_name": "Guaifenesin", "product_id": "69618-061_2bc81e27-90e3-930d-e063-6394a90a699d", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "69618-061", "generic_name": "Guaifenesin", "labeler_name": "Reliable 1 Laboratories LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "400 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200801", "listing_expiration_date": "20261231"}