guaifenesin 200mg

Generic: guaifenesin

Labeler: healthlife of usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin 200mg
Generic Name guaifenesin
Labeler healthlife of usa llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 200 mg/1

Manufacturer
HEALTHLIFE OF USA LLC

Identifiers & Regulatory

Product NDC 69517-148
Product ID 69517-148_3cf7d8e6-a2ef-d0be-e063-6294a90a84ef
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-08-22

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 69517148
Hyphenated Format 69517-148

Supplemental Identifiers

RxCUI
197741
UPC
0033683000081
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
  • 300 TABLET in 1 BOTTLE (69517-148-03)
source: ndc

Packages (1)

69517-148-03 300 TABLET in 1 BOTTLE (69517-148-03)

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": "3cf7d8e6-a2ef-d0be-e063-6294a90a84ef", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0033683000081"], "unii": ["495W7451VQ"], "rxcui": ["197741"], "spl_set_id": ["d6aa1493-bc22-a318-e053-2995a90a6381"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["HEALTHLIFE OF USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 TABLET in 1 BOTTLE (69517-148-03)", "package_ndc": "69517-148-03", "marketing_start_date": "20250822"}], "brand_name": "Guaifenesin 200mg", "product_id": "69517-148_3cf7d8e6-a2ef-d0be-e063-6294a90a84ef", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "69517-148", "generic_name": "Guaifenesin", "labeler_name": "HEALTHLIFE OF USA LLC", "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": "20250822", "listing_expiration_date": "20261231"}