Childrens Allergy Relief Liquid
NDC Package 81522-293-04

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

Package Information

Childrens Allergy Relief (diphenhydramine hydrochloride) liquids is do not take more than 6 doses in 24 hours take every 4 to 6 hours, or as directed by a doctor measure only with dosing cup provided. This formulation utilizes a liquid delivery system. Marketed by Fsa Store Inc. (caring Mills), this product is identified by NDC 81522-293 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
81522-293-04
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC
Product Code
81522-293
11-Digit Billing Format
81522029304
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
Childrens Allergy Relief Dye Free Bubble Gum
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
Pharmacologic Class
Usage Information
Do not take more than 6 doses in 24 hours take every 4 to 6 hours, or as directed by a doctor measure only with dosing cup provided. Do not use any other dosing device. mL = milliliter keep dosing cup with product find the right dose on the chart belowage (yr)dose (mL) children 6 to 11 years 5 mL to 10 mL  children 2 to 5 years do not use unless directed by a doctor children under 2 years do not use

Regulatory & Marketing

Labeler Name
Fsa Store Inc. (caring Mills)
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-18-2022
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 81522-293-04 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic of Childrens Allergy Relief Dye Free Bubble Gum, a human over the counter drug labeled by Fsa Store Inc. (caring Mills). This liquid 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 Fsa Store Inc. (caring Mills) on April 18, 2022. The current certification is valid through December 31, 2026.

How is this Fsa Store Inc. (caring Mills) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81522029304. 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)
81522-293-04
11-Digit CMS (5-4-2)
81522-0293-04

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