0031-8737 NDC - ROBITUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN)

Drug Information

Product NDC: 0031-8737

Proprietary Name: Robitussin Peak Cold Sugar-Free Cough Plus Chest Congestion DM

Non Proprietary Name: dextromethorphan hydrobromide and guaifenesin

Active Ingredient(s):
  • 10 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE;
  • 100 mg/5mL GUAIFENESIN


Administration Route(s): ORAL

Dosage Form(s): SOLUTION

Labeler Information

Labeler Name: Richmond Division of Wyeth
Product Type: HUMAN OTC DRUG
FDA Application Number: part341
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:6/15/2011
End Marketing Date:8/31/2020

Package Information

No. Package Code Package Description Billing Unit
10031-8737-121 BOTTLE in 1 CARTON (0031-8737-12) > 118 mL in 1 BOTTLEML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0031-8737The 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 NAMERobitussin Peak Cold Sugar-Free Cough Plus Chest Congestion DMThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEdextromethorphan hydrobromide and guaifenesinThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTIONThe 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 DATE6/15/2011This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE8/31/2020This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMEOTC MONOGRAPH FINALProduct 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.
APPLICATION NUMBERpart341This 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 NAMERichmond Division of WyethName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESINThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH10; 100 
ACTIVE INGRED UNITmg/5mL; mg/5mL 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 7/15/2019