Pain, Headache And Congestion Tablet, Film Coated
NDC Package 51316-809-09

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

Package Information

Pain, Headache And Congestion (acetaminophen, guaifenesin) tablets is do not take more than directeddo not take more than 12 caplets in any 24-hour periodadults and children 12 years and over: take 2 caplets every 4 hourschildren under 12 years: do not use. This formulation utilizes a tablet, film coated delivery system. Marketed by Cvs Woonsocket Prescription Center, Incorporated, this product is identified by NDC 51316-809 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
51316-809-09
Package Description
2 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
51316-809
11-Digit Billing Format
51316080909
RxNorm Crosswalk
  • RxCUI: 602617 - acetaminophen 325 MG / guaiFENesin 200 MG Oral Tablet
  • RxCUI: 602617 - acetaminophen 325 MG / guaifenesin 200 MG Oral Tablet
  • RxCUI: 602617 - APAP 325 MG / guaifenesin 200 MG Oral Tablet

Clinical Specifications

Proprietary Name
Pain, Headache And Congestion
Non-Proprietary Name
Acetaminophen, Guaifenesin
Substance Name
Acetaminophen; Guaifenesin
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 take more than directeddo not take more than 12 caplets in any 24-hour periodadults and children 12 years and over: take 2 caplets every 4 hourschildren under 12 years: do not use

Regulatory & Marketing

Labeler Name
Cvs Woonsocket Prescription Center, Incorporated
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-29-2026
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51316-809-09 identifies a specific commercial package of 2 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack of Pain, Headache And Congestion, a human over the counter drug labeled by Cvs Woonsocket Prescription Center, Incorporated. This tablet, film coated is formulated for oral use and contains acetaminophen; guaifenesin 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 Woonsocket Prescription Center, Incorporated on April 29, 2026. The current certification is valid through December 31, 2027.

How is this Cvs Woonsocket Prescription Center, Incorporated product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316080909. 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)
51316-809-09
11-Digit CMS (5-4-2)
51316-0809-09

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