0031-8739 NDC - ROBITUSSIN PEAK COLD MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM ()

Drug Information

  • Product NDC: 0031-8739
  • Proprietary Name: ROBITUSSIN PEAK COLD MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM
  • Non Proprietary Name:
  • Active Ingredient(s): 20 mg/20mL DEXTROMETHORPHAN HYDROBROMIDE; 400 mg/20mL GUAIFENESIN
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Decreased Respiratory Secretion Viscosity [PE]; Expectorant [EPC]; Increased Respiratory Secretions [PE]; Sigma-1 Agonist [EPC]; Sigma-1 Receptor Agonists [MoA]; Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]; Uncompetitive NMDA Receptor Antagonists [MoA]

Labeler Information

Field Name Field Value
Labeler Name: Richmond Division of Wyeth
Product Type:
FDA Application Number: part341
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:6/6/2011
End Marketing Date:6/8/2011

Package Information

No. Package Code Package Description Billing Unit
10031-8739-121 BOTTLE in 1 CARTON (0031-8739-12) / 118 mL in 1 BOTTLEML
20031-8739-162 BLISTER PACK in 1 CARTON (0031-8739-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
30031-8739-181 BOTTLE in 1 CARTON (0031-8739-18) / 237 mL in 1 BOTTLEML
40031-8739-421 BOTTLE in 1 CARTON (0031-8739-42) / 355 mL in 1 BOTTLEML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0031-8739The 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 NAMEROBITUSSIN PEAK COLD MAXIMUM STRENGTH 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.
START MARKETING DATE6/6/2011This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
PRODUCT NDC0031-8739The 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 NAMEROBITUSSIN MAXIMUM STRENGTH 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.
START MARKETING DATE6/1/2016This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct 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 NUMBERM012This 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 NAMEHaleon US Holdings LLCName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 5/26/2025

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