Allergy Relief Diphenhydramine Hcl Capsule, Liquid Filled
NDC Package 70000-0585-1

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

Package Information

Allergy Relief Diphenhydramine Hcl (diphenhydramine hydrochloride) capsules is •take every 4 to 6 hours, or as directed by a doctor•do not take more than 6 doses in 24 hoursadults and children 12 years and older 1 to 2 softgelschildren 6 to under 12 years 1 softgelchildren under 6 years do not use. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Cardinal Health 110, Llc. Dba Leader, this product is identified by NDC 70000-0585 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
70000-0585-1
Package Description
2 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code
70000-0585
11-Digit Billing Format
70000058501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Allergy Relief Diphenhydramine Hcl
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 doctor•do not take more than 6 doses in 24 hoursadults and children 12 years and older 1 to 2 softgelschildren 6 to under 12 years 1 softgelchildren under 6 years do not use

Regulatory & Marketing

Labeler Name
Cardinal Health 110, Llc. Dba Leader
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-15-2021
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 70000-0585-1 identifies a specific commercial package of 2 blister pack in 1 carton / 12 capsule, liquid filled in 1 blister pack of Allergy Relief Diphenhydramine Hcl, a human over the counter drug labeled by Cardinal Health 110, Llc. Dba Leader. 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 Cardinal Health 110, Llc. Dba Leader on September 15, 2021. The current certification is valid through December 31, 2026.

How is this Cardinal Health 110, Llc. Dba Leader product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70000058501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 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 (5-4-1)
70000-0585-1
11-Digit CMS (5-4-2)
70000-0585-01

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