Diphenhydramine Hcl
NDC Package 53329-650-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Diphenhydramine Hcl is diphenhydramine injection is an antihistamine used to treat life-threatening allergic reactions (anaphylaxis) along with epinephrine and other treatments. Marketed by Medline Industries, Lp, this product is identified by NDC 53329-650 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
53329-650-30
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
11-Digit Billing Format
53329065030

Clinical Specifications

Proprietary Name
Diphenhydramine Hcl Allergy Antihistamine
Dosage Form
-
Usage Information
Diphenhydramine injection is an antihistamine used to treat life-threatening allergic reactions (anaphylaxis) along with epinephrine and other treatments. It is also used to relieve symptoms of household allergies, hay fever and the common cold when medication cannot be given by mouth. Common allergy symptoms relieved by antihistamines include rash, itching, watery eyes, itchy eyes/nose/throat, cough, runny nose and sneezing. It is also used to treat nausea, vomiting and dizziness caused by motion sickness when medication cannot be given by mouth. Diphenhydramine works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its drying effects on such symptoms as watery eyes and runny nose are caused by blocking another natural substance made by your body (acetylcholine). Diphenhydramine should not be used in newborns or premature infants because of an increased risk of side effects. It should not be used for common cold symptoms in children less than 6 years of age due to the risk of serious side effects, such as slow/shallow breathing. Cough-and-cold products have not been shown to be safe or effective in children younger than 6.

Regulatory & Marketing

Labeler Name
Medline Industries, Lp
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
03-30-2013
End Marketing Date
10-31-2022
Listing Expiration
10-31-2022
Exclude Flag
D
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 53329-650-30 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Diphenhydramine Hcl Allergy Antihistamine, labeled by Medline Industries, Lp. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Medline Industries, Lp on March 30, 2013. The current certification is valid through October 31, 2022.

What are the primary indications for this medication?

Diphenhydramine injection is an antihistamine used to treat life-threatening allergic reactions (anaphylaxis) along with epinephrine and other treatments. It is also used to relieve symptoms of household allergies, hay fever and the common cold when medication cannot be given by mouth. Common allergy symptoms relieved by antihistamines include rash, itching, watery eyes, itchy eyes/nose/throat, cough, runny nose and sneezing. It is also used to treat nausea, vomiting and dizziness caused by motion sickness when medication cannot be given by mouth. Diphenhydramine works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its drying effects on such symptoms as watery eyes and runny nose are caused by blocking another natural substance made by your body (acetylcholine). Diphenhydramine should not be used in newborns or premature infants because of an increased risk of side effects. It should not be used for common cold symptoms in children less than 6 years of age due to the risk of serious side effects, such as slow/shallow breathing. Cough-and-cold products have not been shown to be safe or effective in children younger than 6.

How is this Medline Industries, Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53329065030. 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)
53329-650-30
11-Digit CMS (5-4-2)
53329-0650-30

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