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  5. NDC Package Code: 35916-0185-2 Acetaminophen, Dextromethorphan Hbr And Doxylamine Succinate

NDC Package 35916-0185-2 Acetaminophen, Dextromethorphan Hbr And Doxylamine Succinate

Capsule, Liquid Filled Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
35916-0185-2
Package Description:
3000 CAPSULE, LIQUID FILLED in 1 POUCH
Product Code:
35916-0185
Proprietary Name:
Acetaminophen, Dextromethorphan Hbr And Doxylamine Succinate
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hbr And Doxylamine Succinate
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate
Usage Information:
Take only as directeddo not exceed 8 softgels per 24 hrsadults & children 12 yrs & over2 softgels with water every 4 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use
11-Digit NDC Billing Format:
35916018502
NDC to 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
Product Type:
Human Otc Drug
Labeler Name:
Softgel Healthcare Private Limited
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
M012
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
05-17-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 35916-0185-2?

The NDC Packaged Code 35916-0185-2 is assigned to a package of 3000 capsule, liquid filled in 1 pouch of Acetaminophen, Dextromethorphan Hbr And Doxylamine Succinate, a human over the counter drug labeled by Softgel Healthcare Private Limited. The product's dosage form is capsule, liquid filled and is administered via oral form.

Is NDC 35916-0185 included in the NDC Directory?

Yes, Acetaminophen, Dextromethorphan Hbr And Doxylamine Succinate with product code 35916-0185 is active and included in the NDC Directory. The product was first marketed by Softgel Healthcare Private Limited on May 17, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 35916-0185-2?

The 11-digit format is 35916018502. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-135916-0185-25-4-235916-0185-02