Childrens Allergy Relief
NDC Package 76281-301-24

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Childrens Allergy Relief is •    if needed, take every 4-6 hours•    do not take more than 6 doses in 24 hoursChildren under 4 years of age:                                    do not useChildren 4 to under 6 years of age:                             do not use unless directed by a doctorChildren 6 to under 12 years of age:                           1 to 2 teaspoonfuls                                                                               (12.5 mg to 25 mg). Marketed by Aptapharma Inc., this product is identified by NDC 76281-301 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
76281-301-24
Package Description
118 mL in 1 BOTTLE
Product Code
76281-301
11-Digit Billing Format
76281030124
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
Dosage Form
-
Usage Information
•    if needed, take every 4-6 hours•    do not take more than 6 doses in 24 hoursChildren under 4 years of age:                                    do not useChildren 4 to under 6 years of age:                             do not use unless directed by a doctorChildren 6 to under 12 years of age:                           1 to 2 teaspoonfuls                                                                               (12.5 mg to 25 mg)

Regulatory & Marketing

Labeler Name
Aptapharma Inc.
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
08-21-2013
Listing Expiration
12-31-2021
Exclude Flag
I
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 76281-301-24 identifies a specific commercial package of 118 ml in 1 bottle of Childrens Allergy Relief, labeled by Aptapharma Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Aptapharma Inc. on August 21, 2013. The current certification is valid through December 31, 2021.

How is this Aptapharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76281030124. 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)
76281-301-24
11-Digit CMS (5-4-2)
76281-0301-24

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