Benadryl Ultratabs Tablet, Film Coated
NDC Package 67751-166-01

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

Benadryl Ultratabs (diphenhydramine hydrochloride) tablets is take every 4 to 6 hours, or as directed by a doctordo not take more than 6 times in 24 hoursadults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use. This formulation utilizes a tablet, film coated delivery system. Marketed by Navajo Manufacturing Company Inc., this product is identified by NDC 67751-166 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
67751-166-01
Package Description
1 POUCH in 1 CARTON / 2 TABLET, FILM COATED in 1 POUCH
Product Code
67751-166
11-Digit Billing Format
67751016601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Benadryl Ultratabs
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Pharmacologic Class
Usage Information
Take every 4 to 6 hours, or as directed by a doctordo not take more than 6 times in 24 hoursadults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use

Regulatory & Marketing

Labeler Name
Navajo Manufacturing Company Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-22-2016
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 (67751-166). Click a package code to view its specific billing and regulatory data.

67751-166-02
1 POUCH in 1 CARTON / 4 TABLET, FILM COATED in 1 POUCH

* 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 67751-166-01 identifies a specific commercial package of 1 pouch in 1 carton / 2 tablet, film coated in 1 pouch of Benadryl Ultratabs, a human over the counter drug labeled by Navajo Manufacturing Company Inc.. This tablet, film 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 Navajo Manufacturing Company Inc. on September 22, 2016. The current certification is valid through December 31, 2026.

How is this Navajo Manufacturing Company Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67751016601. 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)
67751-166-01
11-Digit CMS (5-4-2)
67751-0166-01

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