guaifenesin 200mg

Generic: guaifenesin

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin 200mg
Generic Name guaifenesin
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 200 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-434
Product ID 71610-434_2b4b8161-b037-f244-e063-6294a90ae372
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-03-01

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 71610434
Hyphenated Format 71610-434

Supplemental Identifiers

RxCUI
197741
UNII
495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

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
  • 3000 TABLET in 1 BOTTLE (71610-434-18)
source: ndc

Packages (1)

71610-434-18 3000 TABLET in 1 BOTTLE (71610-434-18)

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": "2b4b8161-b037-f244-e063-6294a90ae372", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["197741"], "spl_set_id": ["45ac210a-8c54-4469-8e10-e6fe52b89cb5"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "3000 TABLET in 1 BOTTLE (71610-434-18)", "package_ndc": "71610-434-18", "marketing_start_date": "20200616"}], "brand_name": "Guaifenesin 200mg", "product_id": "71610-434_2b4b8161-b037-f244-e063-6294a90ae372", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "71610-434", "generic_name": "Guaifenesin", "labeler_name": "Aphena Pharma Solutions - Tennessee, 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": "20190301", "listing_expiration_date": "20261231"}