Calmco Solution
NDC Package 73282-2525-2

11-digit billing NDC: 73282252502
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Calmco (diphenhydramine hcl) solution is do not take more than directedfollow the “Easy to Use” instructions on pouchAgeDoseAdults and children 12 years and oldertake 2 vials at bedtime, if neededchildren under 12 yearsdo not use. This formulation utilizes a solution delivery system. Marketed by Calmco Llc, this product is identified by NDC 73282-2525 and is authorized under FDA application M010.

Identification & Billing

NDC Package Code
73282-2525-2
Package Description
18 VIAL, SINGLE-DOSE in 1 POUCH / 10 mL in 1 VIAL, SINGLE-DOSE (73282-2525-1)
Product Code
73282-2525
11-Digit Billing Format
73282252502

Clinical Specifications

Proprietary Name
Calmco Sleep Aid
Non-Proprietary Name
Diphenhydramine Hcl
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/5mL
Pharmacologic Class
Usage Information
Do not take more than directedfollow the “Easy to Use” instructions on pouchAgeDoseAdults and children 12 years and oldertake 2 vials at bedtime, if neededchildren under 12 yearsdo not use

Regulatory & Marketing

Labeler Name
Calmco Llc
Product Type
Human Otc Drug
FDA Application #
M010
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 73282-2525-2 identifies a specific commercial package of 18 vial, single-dose in 1 pouch / 10 ml in 1 vial, single-dose (73282-2525-1) of Calmco Sleep Aid, a human over the counter drug labeled by Calmco Llc. This solution 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 Calmco Llc on January 01, 2026. The current certification is valid through December 31, 2027.

How is this Calmco Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73282252502. 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)
73282-2525-2
11-Digit CMS (5-4-2)
73282-2525-02

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