NDC 80070-350 Dimetapp Cold And Cough And Nighttime Cold And Congestion

Diphenhydramine Hyrdochloride, Phenylephrine Hydrochloride, Brophiramine Maleate, And Dextromethorphan Hydrobromide

NDC Product Code 80070-350

NDC CODE: 80070-350

Proprietary Name: Dimetapp Cold And Cough And Nighttime Cold And Congestion 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.

Non-Proprietary Name: Diphenhydramine Hyrdochloride, Phenylephrine Hydrochloride, Brophiramine Maleate, And Dextromethorphan Hydrobromide 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.

Product Characteristics

Color(s):
PURPLE (C48327)
Flavor(s):
GRAPE (C73391)

NDC Code Structure

  • 80070 - Foundation Consumer Brands
    • 80070-350 - Dimetapp Cold And Cough And Nighttime Cold And Congestion

NDC 80070-350-08

Package Description: 1 KIT in 1 CARTON * 1 BOTTLE in 1 CARTON (80070-340-04) > 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (80070-310-04) > 118 mL in 1 BOTTLE

NDC Product Information

Dimetapp Cold And Cough And Nighttime Cold And Congestion with NDC 80070-350 is a a human over the counter drug product labeled by Foundation Consumer Brands. The generic name of Dimetapp Cold And Cough And Nighttime Cold And Congestion is diphenhydramine hyrdochloride, phenylephrine hydrochloride, brophiramine maleate, and dextromethorphan hydrobromide. The product's dosage form is kit and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1090463, 1236048 and 1666116.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug 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.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Foundation Consumer Brands
Labeler Code: 80070
FDA Application Number: part341 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 09-15-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Dimetapp Cold And Cough And Nighttime Cold And Congestion Product Label Images

Dimetapp Cold And Cough And Nighttime Cold And Congestion Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Dimetapp®Nighttime Cold and CongestionDrug Facts

Dimetapp®Cold and CoughDrug Facts

Distributed by: Foundation Consumer Brands, LLC, Pittsburgh, PA 15212

Otc - Purpose

Active ingredients (in each 10 mL)PurposesDiphenhydramine HCl, 12.5 mgAntihistamine/cough suppressantPhenylephrine HCl, 5 mgNasal decongestant

Active ingredients (in each 10 mL)PurposesBrompheniramine maleate, 2 mgAntihistamineDextromethorphan HBr, 10 mgCough suppressantPhenylephrine HCl, 5 mgNasal decongestant

Uses

  • Temporarily relieves:nasal congestionrunny nosecoughsneezingitching of the nose or throatitchy, watery eyes due to hay fevertemporarily restores freer breathing through the nose

  • Temporarily relieves:nasal congestionrunny nosecoughsneezingitching of the nose or throatitchy, watery eyes due to hay fevertemporarily restores freer breathing through the nose

Do Not Use

  • To sedate a child or to make a child sleepyIf you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.with any other product containing diphenhydramine, even one used on skin

  • To sedate a child or to make a child sleepyif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • Heart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate glandglaucomacough that occurs with too much phlegm (mucus)a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

  • Heart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate glandglaucomacough that occurs with too much phlegm (mucus)a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking any other oral nasal decongestant or stimulanttaking sedatives or tranquilizers

  • Taking any other oral nasal decongestant or stimulanttaking sedatives or tranquilizers

When Using This Product

  • Do not use more than directedmay cause marked drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children

  • Do not use more than directedmay cause marked drowsinessavoid alcoholic beveragesalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children

Stop Use And Ask A Doctor If

  • Nervousness, dizziness or sleeplessness occurssymptoms do not get better within 7 days or are accompanied by fevercough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

  • Nervousness, dizziness or sleeplessness occurssymptoms do not get better within 7 days or are accompanied by fevercough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Do not take more than 6 doses in any 24-hour periodmeasure only with dosage cup providedkeep dosage cup with productmL = milliliteragedoseadults and children 12 years and over20 mL every 4 hourschildren 6 to under 12 years10 mL every 4 hourschildren under 6 yearsdo not use

  • Do not take more than 6 doses in any 24-hour periodmeasure only with dosage cup providedkeep dosage cup with productmL = milliliteragedoseadults and children 12 years and over20 mL every 4 hourschildren 6 to under 12 years10 mL every 4 hourschildren under 6 yearsdo not use

Other Information

  • Each 10 mL contains: sodium 8 mgstore at 20-25°C (68-77°F)do not refrigerate

  • Each 10 mL contains: sodium 6 mgstore at 20-25°C (68-77°F)

Inactive Ingredients

Anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

* Please review the disclaimer below.