Headache Relief Tablet, Film Coated
NDC Package 63868-485-01

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

Package Information

Headache Relief (acetaminophen, aspirin and caffeine) tablets is do not use more than directeddrink a full glass of water with each doseadults and children 12 years and overtake 2 tablets every 6 hoursdo not take more than 8 tablets in 24 hourschildren under 12 years: ask a doctor. This formulation utilizes a tablet, film coated delivery system. Marketed by Chain Drug Marketing Association Inc, this product is identified by NDC 63868-485 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
63868-485-01
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
63868-485
11-Digit Billing Format
63868048501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 308297 - acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet
  • RxCUI: 308297 - APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet

Clinical Specifications

Proprietary Name
Headache Relief Extra Strength
Non-Proprietary Name
Acetaminophen, Aspirin And Caffeine
Substance Name
Acetaminophen; Aspirin; Caffeine
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Do not use more than directeddrink a full glass of water with each doseadults and children 12 years and overtake 2 tablets every 6 hoursdo not take more than 8 tablets in 24 hourschildren under 12 years: ask a doctor

Regulatory & Marketing

Labeler Name
Chain Drug Marketing Association Inc
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-17-1992
End Marketing Date
03-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63868-485). Click a package code to view its specific billing and regulatory data.

63868-485-02
1 BOTTLE, PLASTIC in 1 CARTON / 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
63868-485-24
1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
63868-485-50
1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* 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 63868-485-01 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 100 tablet, film coated in 1 bottle, plastic of Headache Relief Extra Strength, a human over the counter drug labeled by Chain Drug Marketing Association Inc. This tablet, film coated is formulated for oral use and contains acetaminophen; aspirin; caffeine 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 Chain Drug Marketing Association Inc on November 17, 1992.

How is this Chain Drug Marketing Association Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63868048501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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:

10-Digit Format (5-3-2)
63868-485-01
11-Digit CMS (5-4-2)
63868-0485-01

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