Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate Capsule, Liquid Filled
NDC Package 35916-0189-1

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

Package Information

Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate capsules is • do not take more than the recommended dose• adults and children 12 years and over: take 2 capsules with water every 4 hours. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Softgel Healthcare Private Limited, this product is identified by NDC 35916-0189 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
35916-0189-1
Package Description
1000 CAPSULE, LIQUID FILLED in 1 BAG
Product Code
35916-0189
11-Digit Billing Format
35916018901
RxNorm Crosswalk
  • RxCUI: 1426334 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral Capsule
  • RxCUI: 1426334 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule
  • RxCUI: 1426334 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule

Clinical Specifications

Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
• do not take more than the recommended dose• adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.• children under 12 years: do not use

Regulatory & Marketing

Labeler Name
Softgel Healthcare Private Limited
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-04-2025
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 35916-0189-1 identifies a specific commercial package of 1000 capsule, liquid filled in 1 bag of Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate, a human over the counter drug labeled by Softgel Healthcare Private Limited. This capsule, liquid filled is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; 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 Softgel Healthcare Private Limited on April 04, 2025. The current certification is valid through December 31, 2027.

How is this Softgel Healthcare Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35916018901. 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)
35916-0189-1
11-Digit CMS (5-4-2)
35916-0189-01

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