Careone Nighttime Sleep Aid Tablet, Film Coated
NDC Package 41520-431-67

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

Package Information

Careone Nighttime Sleep Aid (diphenhydramine hydrochloride) tablets is adults and children 12 years and overtake 2 caplets at bedtime if needed, or as directed by a doctorchildren under 12 yearsdo not use. This formulation utilizes a tablet, film coated delivery system. Marketed by American Sales Company, this product is identified by NDC 41520-431 and is authorized under FDA application M010.

Identification & Billing

NDC Package Code
41520-431-67
Package Description
24 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
41520-431
11-Digit Billing Format
41520043167
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Careone Nighttime Sleep Aid
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Pharmacologic Class
Usage Information
Adults and children 12 years and overtake 2 caplets at bedtime if needed, or as directed by a doctorchildren under 12 yearsdo not use

Regulatory & Marketing

Labeler Name
American Sales Company
Product Type
Human Otc Drug
FDA Application #
M010
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-13-2004
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (41520-431). Click a package code to view its specific billing and regulatory data.

41520-431-62
12 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK

* 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 41520-431-67 identifies a specific commercial package of 24 blister pack in 1 carton / 2 tablet, film coated in 1 blister pack of Careone Nighttime Sleep Aid, a human over the counter drug labeled by American Sales Company. This tablet, film coated 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 American Sales Company on April 13, 2004. The current certification is valid through December 31, 2026.

How is this American Sales Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41520043167. 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)
41520-431-67
11-Digit CMS (5-4-2)
41520-0431-67

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