Sleep Aid Tablet
NDC Package 51316-368-22

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

Package Information

Sleep Aid (doxylamine succinate) tablets is adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctorchildren under 12 years of age: do not use. This formulation utilizes a tablet delivery system. Marketed by Cvs Woonsocket Prescription Center, Incorporated, this product is identified by NDC 51316-368 and is authorized under FDA application ANDA040564.

Identification & Billing

NDC Package Code
51316-368-22
Package Description
3 BLISTER PACK in 1 CARTON / 16 TABLET in 1 BLISTER PACK
Product Code
51316-368
11-Digit Billing Format
51316036822

Clinical Specifications

Proprietary Name
Sleep Aid
Non-Proprietary Name
Doxylamine Succinate
Substance Name
Doxylamine Succinate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DOXYLAMINE SUCCINATE 25 mg/1
Pharmacologic Class
Usage Information
Adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctorchildren under 12 years of age: do not use

Regulatory & Marketing

Labeler Name
Cvs Woonsocket Prescription Center, Incorporated
Product Type
Human Otc Drug
FDA Application #
ANDA040564
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-25-2025
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 51316-368-22 identifies a specific commercial package of 3 blister pack in 1 carton / 16 tablet in 1 blister pack of Sleep Aid, a human over the counter drug labeled by Cvs Woonsocket Prescription Center, Incorporated. This tablet is formulated for oral use and contains doxylamine succinate 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 Cvs Woonsocket Prescription Center, Incorporated on June 25, 2025. The current certification is valid through December 31, 2027.

How is this Cvs Woonsocket Prescription Center, Incorporated product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316036822. 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)
51316-368-22
11-Digit CMS (5-4-2)
51316-0368-22

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