Extra Strength Pain Relief
NDC Package 36800-414-25
Package Information
Extra Strength Pain Relief is do not take more than directed (see Overdose warning)adults and children 12 years and overtake 2 softgels every 6 hours while symptoms lastdo not take more than 6 softgels in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctorchildren under 12 yearsask a doctor. Marketed by Topco Associates Llc, this product is identified by NDC 36800-414 and is authorized under FDA application part343.
Identification & Billing
- RxCUI: 198439 - acetaminophen 500 MG Oral Capsule
- RxCUI: 198439 - APAP 500 MG Oral Capsule
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 36800 - Topco Associates Llc
- 36800-414 - Extra Strength Pain Relief
- 36800-414-25 - 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
- 36800-414 - Extra Strength Pain Relief
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 36800-414-25 identifies a specific commercial package of 40 capsule, liquid filled in 1 bottle of Extra Strength Pain Relief, labeled by Topco Associates Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 40 billable units per package. 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 Topco Associates Llc on July 11, 2016. The current certification is valid through December 31, 2024.
How is this Topco Associates Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800041425. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 40 total billable units per package. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.