Kirkland Signature Allerclear D 24 Hr Tablet, Extended Release
NDC Package 63981-138-22

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

Package Information

Kirkland Signature Allerclear D 24 Hr (loratadine, pseudoephedrine sulfate) tablets is •do not divide, crush, chew or dissolve the tabletadults and children 12 years and over1 tablet daily with a full glass of water; not more than 1 tablet in 24 hourschildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor. This formulation utilizes a tablet, extended release delivery system. Marketed by Costco Wholesale Company, this product is identified by NDC 63981-138 and is authorized under FDA application ANDA075989.

Identification & Billing

NDC Package Code
63981-138-22
Package Description
15 BLISTER PACK in 1 CARTON / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
63981-138
11-Digit Billing Format
63981013822

Clinical Specifications

Proprietary Name
Kirkland Signature Allerclear D 24 Hr
Non-Proprietary Name
Loratadine, Pseudoephedrine Sulfate
Substance Name
Loratadine; Pseudoephedrine Sulfate
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
•do not divide, crush, chew or dissolve the tabletadults and children 12 years and over1 tablet daily with a full glass of water; not more than 1 tablet in 24 hourschildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Costco Wholesale Company
Product Type
Human Otc Drug
FDA Application #
ANDA075989
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-03-2025
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 63981-138-22 identifies a specific commercial package of 15 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack of Kirkland Signature Allerclear D 24 Hr, a human over the counter drug labeled by Costco Wholesale Company. This tablet, extended release is formulated for oral use and contains loratadine; pseudoephedrine sulfate 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 Costco Wholesale Company on October 03, 2025. The current certification is valid through December 31, 2027.

How is this Costco Wholesale Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63981013822. 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)
63981-138-22
11-Digit CMS (5-4-2)
63981-0138-22

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