NDC 0031-8770 Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime
Acetaminophen And Diphenhydramine Hydrochloride Solution Oral

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0031-8770?
    5. Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime Uses
    6. Active Ingredients
    7. Active Ingredients UNII Codes
    8. Inactive Ingredients UNII Codes
    9. NDC to RxNorm Crosswalk
    10. Pharmacologic Classes
    11. Patient Education

Product Information

NDC Product Code0031-8770
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Acetaminophen And Diphenhydramine Hydrochloride
Substance Name What is the Substance Name?
An 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.		Acetaminophen; Diphenhydramine Hydrochloride
Product Type What kind of product is this?
Indicates 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.		Human Otc Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0031
SPL SET ID:7decc168-e847-4bbe-910b-26081469406f
FDA Application Number What is the FDA Application Number?
This 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.		part341
Marketing Category What is the Marketing Category?
Product 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.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		06-15-2020
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

Product Characteristics

Color(s)ORANGE (C48331)

Product Packages

NDC Code 0031-8770-12

Package Description: 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE

NDC Code 0031-8770-18

Package Description: 1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE

Product Details

What is NDC 0031-8770?

The NDC code 0031-8770 is assigned by the FDA to the product Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime is acetaminophen and diphenhydramine hydrochloride. The product's dosage form is solution and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0031-8770-12 1 bottle in 1 carton / 118 ml in 1 bottle, 0031-8770-18 1 bottle in 1 carton / 237 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime?

Usestemporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies:cough due to minor throat and bronchial irritationminor aches and painssore throat painheadacherunny nose, sneezing, itchy watery eyesitching of the nose and throattemporarily relieves your cough to help you sleeptemporarily reduces fever

What are Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime Active Ingredients?

An 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.
  • ACETAMINOPHEN 650 mg/20mL - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/20mL - A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.

Which are Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 2374554 - acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG 20 mL Oral Solution
  • RxCUI: 2374554 - acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral Solution
  • RxCUI: 2374554 - acetaminophen 650 MG / diphenhydramine HCl 25 MG 20 mL Oral Solution
  • RxCUI: 2374554 - APAP 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral Solution

Which are the Pharmacologic Classes for Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Acetaminophen


Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
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Diphenhydramine


Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
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Product Label

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