guaifenesin

Generic: guaifenesin

Labeler: cvs pharmacy, inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin
Generic Name guaifenesin
Labeler cvs pharmacy, inc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 1200 mg/1

Manufacturer
CVS PHARMACY, INC

Identifiers & Regulatory

Product NDC 69842-335
Product ID 69842-335_4653e896-cfea-4625-e063-6394a90a4c7f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213420
Listing Expiration 2026-12-31
Marketing Start 2021-03-01

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 69842335
Hyphenated Format 69842-335

Supplemental Identifiers

RxCUI
310621
UPC
0050428296905
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 ANDA213420 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1200 mg/1
source: ndc
Packaging
  • 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69842-335-16)
  • 28 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69842-335-28)
  • 42 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69842-335-42)
source: ndc

Packages (3)

69842-335-16 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69842-335-16) 69842-335-28 28 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69842-335-28) 69842-335-42 42 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69842-335-42)

Ingredients (1)

guaifenesin (1200 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": "4653e896-cfea-4625-e063-6394a90a4c7f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0050428296905"], "unii": ["495W7451VQ"], "rxcui": ["310621"], "spl_set_id": ["bdaf7359-8698-87d6-e053-2a95a90ada28"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["CVS PHARMACY, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69842-335-16)", "package_ndc": "69842-335-16", "marketing_start_date": "20210301"}, {"sample": false, "description": "28 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69842-335-28)", "package_ndc": "69842-335-28", "marketing_start_date": "20210301"}, {"sample": false, "description": "42 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69842-335-42)", "package_ndc": "69842-335-42", "marketing_start_date": "20210301"}], "brand_name": "Guaifenesin", "product_id": "69842-335_4653e896-cfea-4625-e063-6394a90a4c7f", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "69842-335", "generic_name": "Guaifenesin", "labeler_name": "CVS PHARMACY, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA213420", "marketing_category": "ANDA", "marketing_start_date": "20210301", "listing_expiration_date": "20261231"}