Drug Information

Product NDC: 0031-8758

Proprietary Name: Robitussin Honey Maximum Strength Nighttime Cough DM

Non Proprietary Name: dextromethorphan HBr, doxylamine succinate

Active Ingredient(s):

Administration Route(s): ORAL

Dosage Form(s): SOLUTION

Pharmacy Class(es):
  • Antihistamine [EPC];
  • Histamine Receptor Antagonists [MoA];
  • Sigma-1 Agonist [EPC];
  • Sigma-1 Receptor Agonists [MoA];
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC];
  • Uncompetitive NMDA Receptor Antagonists [MoA]

Labeler Information

Labeler Name: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Product Type: HUMAN OTC DRUG
FDA Application Number: part341
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:6/25/2018

Package Information

No. Package Code Package Description Billing Unit
10031-8758-121 BOTTLE in 1 CARTON (0031-8758-12) / 118 mL in 1 BOTTLEML
20031-8758-181 BOTTLE in 1 CARTON (0031-8758-18) / 237 mL in 1 BOTTLEML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0031-8758The 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 Honey Maximum Strength Nighttime Cough 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 HBr, doxylamine succinateThe 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 DATE6/25/2018This 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 NAMEGlaxoSmithKline Consumer Healthcare Holdings (US) LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATEAn 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 CLASSESAntihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] 

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