1. Home
  2. Labeler Index
  3. Softgel Healthcare Private Limited
  4. 35916-0188
  5. NDC Package Code: 35916-0188-2 Acetaminophen 325mg, Dextromethorphan Hbr 10mg And Phenyleprine Hcl 5mg

NDC Package 35916-0188-2 Acetaminophen 325mg, Dextromethorphan Hbr 10mg And Phenyleprine Hcl 5mg

Acetaminophen,Dextromethorphan Hbr And Phenylephrine Hcl Capsule, Liquid Filled Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
35916-0188-2
Package Description:
2 POUCH in 1 BOX / 3000 CAPSULE, LIQUID FILLED in 1 POUCH
Product Code:
35916-0188
Proprietary Name:
Acetaminophen 325mg, Dextromethorphan Hbr 10mg And Phenyleprine Hcl 5mg
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hbr And Phenylephrine Hcl
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
Usage Information:
Do not take more than the recommended doseadults 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
11-Digit NDC Billing Format:
35916018802
NDC to RxNorm Crosswalk:
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1086997 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 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:
03-21-2025
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.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
35916-0188-11000 CAPSULE, LIQUID FILLED in 1 BAG

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 35916-0188-2?

The NDC Packaged Code 35916-0188-2 is assigned to a package of 2 pouch in 1 box / 3000 capsule, liquid filled in 1 pouch of Acetaminophen 325mg, Dextromethorphan Hbr 10mg And Phenyleprine Hcl 5mg, 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 35916-0188 included in the NDC Directory?

Yes, Acetaminophen 325mg, Dextromethorphan Hbr 10mg And Phenyleprine Hcl 5mg with product code 35916-0188 is active and included in the NDC Directory. The product was first marketed by Softgel Healthcare Private Limited on March 21, 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 35916-0188-2?

The 11-digit format is 35916018802. 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
5-4-135916-0188-25-4-235916-0188-02