Acetaminophen , Aspirin And Caffeine Capsule
NDC Package 35916-0709-1

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

Package Information

Acetaminophen , Aspirin And Caffeine capsules is usesTemporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual and menstrual cramps. This formulation utilizes a capsule delivery system. Marketed by Softgel Healthcare Pvt Ltd, this product is identified by NDC 35916-0709 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
35916-0709-1
Package Description
1500 CAPSULE in 1 BAG
Product Code
35916-0709
11-Digit Billing Format
35916070901

Clinical Specifications

Proprietary Name
Acetaminophen , Aspirin And Caffeine
Non-Proprietary Name
Acetaminophen , Aspirin And Caffeine
Substance Name
Acetaminophen; Aspirin; Caffeine
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)
Pharmacologic Class
Usage Information
UsesTemporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual and menstrual cramps

Regulatory & Marketing

Labeler Name
Softgel Healthcare Pvt Ltd
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-08-2026
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 35916-0709-1 identifies a specific commercial package of 1500 capsule in 1 bag of Acetaminophen , Aspirin And Caffeine, a human over the counter drug labeled by Softgel Healthcare Pvt Ltd. This capsule is formulated for oral use and contains acetaminophen; aspirin; caffeine 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 Softgel Healthcare Pvt Ltd on January 08, 2026. The current certification is valid through December 31, 2027.

How is this Softgel Healthcare Pvt Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35916070901. 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)
35916-0709-1
11-Digit CMS (5-4-2)
35916-0709-01

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