Diphenhydramine Hcl
NDC Package 17856-6985-1

11-digit billing NDC: 17856698501
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Diphenhydramine Hcl is do not take more than 6 doses in 24 hoursmL = milliliter; FL OZ = fluid ouncefind right dose on chart belowtake every 4 to 6 hours, or as directed by a doctorAgeDoseadults and children 12 years and over2 - 4 teaspoonsful (25 mg to 50 mg)children 6 to 11 years1 - 2 teaspoonsful (12.5 mg to 25 mg)children 2 to 5 yearsdo not use unless directed by a doctorchildren under 2 yearsdo not use. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-6985 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
17856-6985-1
Package Description
72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 5 mL in 1 CUP, UNIT-DOSE
Product Code
17856-6985
11-Digit Billing Format
17856698501
RxNorm Crosswalk
  • RxCUI: 1049906 - diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 2.5 MG/ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine HCl 12.5 MG per 5 ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution

Clinical Specifications

Proprietary Name
Diphenhydramine Hcl
Dosage Form
-
Usage Information
Do not take more than 6 doses in 24 hoursmL = milliliter; FL OZ = fluid ouncefind right dose on chart belowtake every 4 to 6 hours, or as directed by a doctorAgeDoseadults and children 12 years and over2 - 4 teaspoonsful (25 mg to 50 mg)children 6 to 11 years1 - 2 teaspoonsful (12.5 mg to 25 mg)children 2 to 5 yearsdo not use unless directed by a doctorchildren under 2 yearsdo not use

Regulatory & Marketing

Labeler Name
Atlantic Biologicals Corp.
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
08-27-2019
Listing Expiration
12-31-2022
Exclude Flag
I
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 (17856-6985). Click a package code to view its specific billing and regulatory data.

17856-6985-2
72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 10 mL in 1 CUP, UNIT-DOSE

* 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 17856-6985-1 identifies a specific commercial package of 72 cup, unit-dose in 1 box, unit-dose / 5 ml in 1 cup, unit-dose of Diphenhydramine Hcl, labeled by Atlantic Biologicals Corp.. 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 Atlantic Biologicals Corp. on August 27, 2019. The current certification is valid through December 31, 2022.

How is this Atlantic Biologicals Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856698501. 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)
17856-6985-1
11-Digit CMS (5-4-2)
17856-6985-01

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