Dimetapp Elixir
NDC Package 80070-310-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Dimetapp (brompheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride) elixirs is 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. This formulation utilizes a elixir delivery system. Marketed by Foundation Consumer Brands, this product is identified by NDC 80070-310 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
80070-310-04
Package Description
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code
80070-310
11-Digit Billing Format
80070031004
RxNorm Crosswalk
  • RxCUI: 1090463 - brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution
  • RxCUI: 1090463 - brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1090463 - brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution
  • RxCUI: 1090463 - brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution
  • RxCUI: 1236048 - diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution

Clinical Specifications

Proprietary Name
Dimetapp Cold And Cough
Non-Proprietary Name
Brompheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
Substance Name
Brompheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
Dosage Form
Elixir - A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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

Regulatory & Marketing

Labeler Name
Foundation Consumer Brands
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-15-2021
End Marketing Date
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (80070-310). Click a package code to view its specific billing and regulatory data.

80070-310-08
1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 80070-310-04 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Dimetapp Cold And Cough, a human over the counter drug labeled by Foundation Consumer Brands. This elixir is formulated for oral use and contains brompheniramine maleate; dextromethorphan hydrobromide; phenylephrine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Foundation Consumer Brands on September 15, 2021.

How is this Foundation Consumer Brands product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80070031004. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
80070-310-04
11-Digit CMS (5-4-2)
80070-0310-04

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.