Nighttime Sleep Aid Tablet, Coated
NDC Package 71679-110-06

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 hcl 25 mg) tablets is do not take more than directed (see overdose warning)adults and children 12 years of age and over: - take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years of age: do not use. This formulation utilizes a tablet, coated delivery system. Marketed by Health Pharma Usa Llc, this product is identified by NDC 71679-110 and is authorized under FDA application M010.

Identification & Billing

NDC Package Code
71679-110-06
Package Description
600 TABLET, COATED in 1 BOTTLE
Product Code
71679-110
11-Digit Billing Format
71679011006
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nighttime Sleep Aid
Non-Proprietary Name
Diphenhydramine Hcl 25 Mg
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Pharmacologic Class
Usage Information
Do not take more than directed (see overdose warning)adults and children 12 years of age and over: - take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years of age: do not use

Regulatory & Marketing

Labeler Name
Health Pharma Usa Llc
Product Type
Human Otc Drug
FDA Application #
M010
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-18-2025
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 (71679-110). Click a package code to view its specific billing and regulatory data.

71679-110-03
300 TABLET, COATED in 1 BOTTLE
71679-110-10
1000 TABLET, COATED 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 71679-110-06 identifies a specific commercial package of 600 tablet, coated in 1 bottle of Nighttime Sleep Aid, a human over the counter drug labeled by Health Pharma Usa Llc. This tablet, coated 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 Health Pharma Usa Llc on June 18, 2025. The current certification is valid through December 31, 2026.

How is this Health Pharma Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71679011006. 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)
71679-110-06
11-Digit CMS (5-4-2)
71679-0110-06

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