Cvs Dye-free Childrens Allergy Syrup
NDC Package 51316-710-08

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

Package Information

Cvs Dye-free Childrens Allergy (diphenhydramine hydrochloride) syrups is ▪find right dose on chart below▪take every 4 to 6 hours, or as directed by a doctor▪do not take more than 6 doses in 24 hours▪mL = milliliterAge (yr)Dose (mL)children under 2 yearsdo not usechildren 2 to 5 yearsdo not use unless directed by a doctorchildren 6 to 11 years5 mL to 10 mLAttention: use only enclosed dosing cup designed for use with this product. This formulation utilizes a syrup delivery system. Marketed by Cvs Pharmacy, this product is identified by NDC 51316-710 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
51316-710-08
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 236 mL in 1 BOTTLE, PLASTIC
Product Code
51316-710
11-Digit Billing Format
51316071008
RxNorm Crosswalk
  • RxCUI: 1049906 - diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 2.5 MG/ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine HCl 12.5 MG per 5 ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution

Clinical Specifications

Proprietary Name
Cvs Dye-free Childrens Allergy
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
Pharmacologic Class
Usage Information
▪find right dose on chart below▪take every 4 to 6 hours, or as directed by a doctor▪do not take more than 6 doses in 24 hours▪mL = milliliterAge (yr)Dose (mL)children under 2 yearsdo not usechildren 2 to 5 yearsdo not use unless directed by a doctorchildren 6 to 11 years5 mL to 10 mLAttention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

Regulatory & Marketing

Labeler Name
Cvs Pharmacy
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-22-2022
Listing Expiration
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51316-710-08 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 236 ml in 1 bottle, plastic of Cvs Dye-free Childrens Allergy, a human over the counter drug labeled by Cvs Pharmacy. This syrup is formulated for oral use and contains diphenhydramine 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 Cvs Pharmacy on July 22, 2022. The current certification is valid through December 31, 2026.

How is this Cvs Pharmacy product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316071008. 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)
51316-710-08
11-Digit CMS (5-4-2)
51316-0710-08

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