Dye Free Childrens Ibuprofen Suspension
NDC Package 51316-914-03

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

Package Information

Dye Free Childrens Ibuprofen (ibuprofen) suspension is ibuprofen is used to help relieve mild to moderate pain. This formulation utilizes a suspension delivery system. Marketed by Cvs, this product is identified by NDC 51316-914 and is authorized under FDA application ANDA210149.

Identification & Billing

NDC Package Code
51316-914-03
Package Description
1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE
Product Code
51316-914
11-Digit Billing Format
51316091403
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dye Free Childrens Ibuprofen
Non-Proprietary Name
Ibuprofen
Substance Name
Ibuprofen
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
IBUPROFEN 100 mg/5mL
Pharmacologic Class
Usage Information
Ibuprofen is used to help relieve mild to moderate pain. When used with an opioid (such as morphine), it may be used to relieve moderate to severe pain. It is also used to reduce fever. Ibuprofen is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

Regulatory & Marketing

Labeler Name
Cvs
Product Type
Human Otc Drug
FDA Application #
ANDA210149
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2025
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 51316-914-03 identifies a specific commercial package of 1 bottle in 1 carton / 120 ml in 1 bottle of Dye Free Childrens Ibuprofen, a human over the counter drug labeled by Cvs. This suspension is formulated for oral use and contains ibuprofen 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 Cvs on May 01, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ibuprofen is used to help relieve mild to moderate pain. When used with an opioid (such as morphine), it may be used to relieve moderate to severe pain. It is also used to reduce fever. Ibuprofen is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

How is this Cvs product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316091403. 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)
51316-914-03
11-Digit CMS (5-4-2)
51316-0914-03

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