First Aid Direct Anti-diarrheal Capsule
NDC Package 42961-103-02

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

Package Information

First Aid Direct Anti-diarrheal capsules is drink plenty of clear fluids to help prevent dehydration caused by diarrheafind right dose on chart. This formulation utilizes a capsule delivery system. Marketed by Cintas Corp, this product is identified by NDC 42961-103 and is authorized under FDA application ANDA076497.

Identification & Billing

NDC Package Code
42961-103-02
Package Description
2 BLISTER PACK in 1 BOX / 6 CAPSULE in 1 BLISTER PACK
Product Code
42961-103
11-Digit Billing Format
42961010302
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
First Aid Direct Anti-diarrheal
Non-Proprietary Name
First Aid Direct Anti-diarrheal
Substance Name
Loperamide Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LOPERAMIDE HYDROCHLORIDE 2 mg/1
Pharmacologic Class
Usage Information
Drink plenty of clear fluids to help prevent dehydration caused by diarrheafind right dose on chart. If possible, use weight to dose; otherwise, use age.adults and children 12 years and over  2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hourschildren 9-11 years (60-95 lbs)1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children 2-5 years (34-47 lbs) ask a doctor children under 2 years (up to 33 lbs)do not use 

Regulatory & Marketing

Labeler Name
Cintas Corp
Product Type
Human Otc Drug
FDA Application #
ANDA076497
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-20-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42961-103-02 identifies a specific commercial package of 2 blister pack in 1 box / 6 capsule in 1 blister pack of First Aid Direct Anti-diarrheal, a human over the counter drug labeled by Cintas Corp. This capsule is formulated for oral use and contains loperamide 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 Cintas Corp on October 20, 2021. The current certification is valid through December 31, 2026.

How is this Cintas Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42961010302. 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)
42961-103-02
11-Digit CMS (5-4-2)
42961-0103-02

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