Nighttime Sleep-aid Liquid
NDC Package 76281-522-24

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

Nighttime Sleep-aid (diphenhydramine hci) liquids is ■ take only as recommended■ Use dosage cup or tablespoon       Age                                     DoseAdults & children 12          One Dose = 2 tablespoons (30 mL) at bedyears & over                    time if needed or as directed by a doctor. This formulation utilizes a liquid delivery system. Marketed by Aptapharma Inc., this product is identified by NDC 76281-522 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
76281-522-24
Package Description
118 mL in 1 BOTTLE
Product Code
76281-522
11-Digit Billing Format
76281052224
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nighttime Sleep-aid Non-habit Forming
Non-Proprietary Name
Diphenhydramine Hci
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 50 mg/30mL
Pharmacologic Class
Usage Information
■ take only as recommended■ Use dosage cup or tablespoon       Age                                     DoseAdults & children 12          One Dose = 2 tablespoons (30 mL) at bedyears & over                    time if needed or as directed by a doctor

Regulatory & Marketing

Labeler Name
Aptapharma Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76281-522). Click a package code to view its specific billing and regulatory data.

76281-522-25
177 mL in 1 BOTTLE
76281-522-28
354 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 76281-522-24 identifies a specific commercial package of 118 ml in 1 bottle of Nighttime Sleep-aid Non-habit Forming, a human over the counter drug labeled by Aptapharma Inc.. 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 Aptapharma Inc. on January 01, 2018. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76281052224. 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)
76281-522-24
11-Digit CMS (5-4-2)
76281-0522-24

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