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Drug Information

Product NDC: 51660-072

Proprietary Name: Guaifenesin

Non Proprietary Name: Guaifenesin

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

Administration Route(s): ORAL


Labeler Information

Product Type: HUMAN OTC DRUG
FDA Application Number: NDA021282
Marketing Category: NDA
Start Marketing Date:12/10/2017

Package Information

No. Package Code Package Description Billing Unit
151660-072-541 BLISTER PACK in 1 CARTON (51660-072-54) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
251660-072-862 BLISTER PACK in 1 CARTON (51660-072-86) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC Record

Field Name Field Value Definition
PRODUCT NDC51660-072The 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 NAMEGuaifenesinThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXExtended ReleaseA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
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 DATE12/10/2017This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 NUMBERNDA021282This 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 NAMEOHM LABORATORIES INCName 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.

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