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Drug Information

Product NDC: 53041-191

Proprietary Name: Mucus Relief Maximum Strength 1200 mg

Non Proprietary Name: Guaifenesin

Active Ingredient(s):
  • 1200 mg/1 GUAIFENESIN

Administration Route(s): ORAL


Pharmacy Class(es):
  • Decreased Respiratory Secretion Viscosity [PE];
  • Expectorant [EPC];
  • Increased Respiratory Secretions [PE]

Labeler Information

Labeler Name: Guardian Drug Company
Product Type: HUMAN OTC DRUG
FDA Application Number: ANDA209215
Marketing Category: ANDA
Start Marketing Date:6/24/2020

Package Information

No. Package Code Package Description Billing Unit
153041-191-484 BLISTER PACK in 1 CARTON (53041-191-48) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
253041-191-582 BLISTER PACK in 1 CARTON (53041-191-58) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC Record

Field Name Field Value Definition
PRODUCT NDC53041-191The 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 Relief Maximum Strength 1200 mgThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEGuaifenesinThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, EXTENDED RELEASEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE6/24/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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 under Structured Product Labeling Resources.
APPLICATION NUMBERANDA209215This 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.
LABELER NAMEGuardian Drug CompanyName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEGUAIFENESINAn 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.
PHARM CLASSESDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE] 

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This page was last updated on: 2/1/2023