Splizz Pain Reliever - Orange-flavored
NDC Package 78612-110-20

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Splizz Pain Reliever - Orange-flavored is do not use more than directedFully dissolve 2 tablets in a glass of water and drinkAdults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours.Children under 12 years: do not use. Marketed by Marga Labs, Llc, this product is identified by NDC 78612-110 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
78612-110-20
Package Description
10 POUCH in 1 CARTON / 2 TABLET, EFFERVESCENT in 1 POUCH
Product Code
78612-110
11-Digit Billing Format
78612011020
RxNorm Crosswalk
  • RxCUI: 2474495 - acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Effervescent Oral Tablet
  • RxCUI: 2474495 - APAP 250 MG / ASA 250 MG / caffeine 65 MG Effervescent Oral Tablet

Clinical Specifications

Proprietary Name
Splizz Pain Reliever - Orange-flavored
Dosage Form
-
Usage Information
Do not use more than directedFully dissolve 2 tablets in a glass of water and drinkAdults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours.Children under 12 years: do not use.

Regulatory & Marketing

Labeler Name
Marga Labs, Llc
FDA Application #
part343
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
01-01-2021
Listing Expiration
12-31-2022
Exclude Flag
I
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 78612-110-20 identifies a specific commercial package of 10 pouch in 1 carton / 2 tablet, effervescent in 1 pouch of Splizz Pain Reliever - Orange-flavored, labeled by Marga Labs, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Marga Labs, Llc on January 01, 2021. The current certification is valid through December 31, 2022.

How is this Marga Labs, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78612011020. 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)
78612-110-20
11-Digit CMS (5-4-2)
78612-0110-20

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