Diphenhydramine Hydrochloride Capsule, Liquid Filled
NDC Package 53345-007-01

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

Package Information

Diphenhydramine Hydrochloride capsules is take every 4 to 6 hoursdo not take more than 6 doses in 24 hoursadults and children 12 years of age and over   take 1 to 2 softgelschildren 6 to under 12 years of age   take 1 softgelchildren under 6 years   do not use this product in children under 6 years of age. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Humanwell Puracap Pharmaceutical (wuhan), Ltd., this product is identified by NDC 53345-007 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
53345-007-01
Package Description
1 BAG in 1 BOX / 20000 CAPSULE, LIQUID FILLED in 1 BAG
Product Code
53345-007
11-Digit Billing Format
53345000701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diphenhydramine Hydrochloride
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 hoursdo not take more than 6 doses in 24 hoursadults and children 12 years of age and over   take 1 to 2 softgelschildren 6 to under 12 years of age   take 1 softgelchildren under 6 years   do not use this product in children under 6 years of age

Regulatory & Marketing

Labeler Name
Humanwell Puracap Pharmaceutical (wuhan), Ltd.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-15-2013
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53345-007-01 identifies a specific commercial package of 1 bag in 1 box / 20000 capsule, liquid filled in 1 bag of Diphenhydramine Hydrochloride, a human over the counter drug labeled by Humanwell Puracap Pharmaceutical (wuhan), Ltd.. 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 Humanwell Puracap Pharmaceutical (wuhan), Ltd. on September 15, 2013. The current certification is valid through December 31, 2026.

How is this Humanwell Puracap Pharmaceutical (wuhan), Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53345000701. 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)
53345-007-01
11-Digit CMS (5-4-2)
53345-0007-01

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