Quality Choice Severe Cold And Cough Nighttime Powder, For Solution
NDC Package 63868-291-06
Package Information
Quality Choice Severe Cold And Cough Nighttime (acetaminophen, diphenhydramine, phenylephrine) powders is •do not use more than directed•take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctorAgeDosechildren under 12 years of agedo not use unless directed by a doctor adults and children 12 years of age and overone packet•dissolve contents of one packet into 8 oz. This formulation utilizes a powder, for solution delivery system. Marketed by Chain Drug Manufacturing Assn, this product is identified by NDC 63868-291 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1659960 - acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution
- RxCUI: 1659960 - acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution
- RxCUI: 1659960 - acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution
- RxCUI: 1659960 - acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
- RxCUI: 1659960 - APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 63868 - Chain Drug Manufacturing Assn
- 63868-291 - Quality Choice Severe Cold And Cough Nighttime
- 63868-291-06 - 6 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET
- 63868-291 - Quality Choice Severe Cold And Cough Nighttime
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 63868-291-06 identifies a specific commercial package of 6 packet in 1 carton / 1 powder, for solution in 1 packet of Quality Choice Severe Cold And Cough Nighttime, a human over the counter drug labeled by Chain Drug Manufacturing Assn. This powder, for solution is formulated for oral use and contains acetaminophen; diphenhydramine hydrochloride; phenylephrine hydrochloride 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 Manufacturing Assn on July 16, 2018. The current certification is valid through December 31, 2026.
How is this Chain Drug Manufacturing Assn product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 63868029106. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 6 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.
