67091-404 NDC - MUCUS RELIEF (GUAIFENESIN)

Drug Information

  • Product NDC: 67091-404
  • Proprietary Name: Mucus Relief
  • Non Proprietary Name: Guaifenesin
  • Active Ingredient(s): 1200 mg/1 GUAIFENESIN
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, EXTENDED RELEASE
  • Pharmacy Class(es): Decreased Respiratory Secretion Viscosity [PE]; Expectorant [EPC]; Increased Respiratory Secretions [PE]

Labeler Information

Field Name Field Value
Labeler Name: WINCO FOODS, LLC
Product Type: HUMAN OTC DRUG
FDA Application Number: ANDA213420
Marketing Category: ANDA
Start Marketing Date:4/11/2023

Package Information

No. Package Code Package Description Billing Unit
167091-404-022 BLISTER PACK in 1 CARTON (67091-404-02) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC Record

Field Name Field Value Definition
PRODUCT NDC67091-404The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEMucus ReliefThe labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAME SUFFIXMaximum StrengthThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEGuaifenesinThis is the date that the labeler indicates was the start of its marketing of the drug product.
DOSAGE FORM NAMETABLET, EXTENDED RELEASEProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ROUTE NAMEORALThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
START MARKETING DATE4/11/2023This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
MARKETING CATEGORY NAMEANDAName of Company corresponding to the labeler code segment of the Product NDC.
APPLICATION NUMBERANDA213420An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
LABELER NAMEWINCO FOODS, LLC 
SUBSTANCE NAMEGUAIFENESIN 
ACTIVE NUMERATOR STRENGTH1200 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE] 

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This page was last updated on: 12/6/2025

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