Dimetane Capsule, Liquid Filled
NDC Package 57237-367-01

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

Dimetane (diphenhydramine hydrochloride) capsules is take every 4 to 6 hours, or as directed by a doctordo not take more than 6 doses in 24 hours adults and children 12 years and over                      1 softgel children under 12 years                                         do not use . This formulation utilizes a capsule, liquid filled delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 57237-367 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
57237-367-01
Package Description
100 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code
57237-367
11-Digit Billing Format
57237036701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dimetane
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
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 doses in 24 hours adults and children 12 years and over                      1 softgel children under 12 years                                         do not use 

Regulatory & Marketing

Labeler Name
Rising Pharma Holdings, Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-27-2026
Listing Expiration
12-31-2027
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 (57237-367). Click a package code to view its specific billing and regulatory data.

57237-367-99
1000 CAPSULE, LIQUID FILLED 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 57237-367-01 identifies a specific commercial package of 100 capsule, liquid filled in 1 bottle of Dimetane, a human over the counter drug labeled by Rising Pharma Holdings, Inc.. This capsule, liquid filled 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 Rising Pharma Holdings, Inc. on January 27, 2026. The current certification is valid through December 31, 2027.

How is this Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57237036701. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
57237-367-01
11-Digit CMS (5-4-2)
57237-0367-01

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