Daytime Nighttime Cold And Flu Relief Combo Pack Kit
NDC Package 69168-438-15
Package Information
Daytime Nighttime Cold And Flu Relief Combo Pack (daytime nighttime cold and flu) kits is dAYTIME ONLY Take only as directed Do not exceed 4 doses in 24 hrs adults and children 12 yrs & over: 2 softgels with water every 4 hrschildren 4 to under 12 yrs: ask a doctorchildren under 4 yrs: do not use NIGHTTIME ONLYTake only as directed Do not exceed 4 doses in 24 hrs adults and children 12 yrs & over: 2 softgels with water every 6 hrschildren 4 to under 12 yrs: ask a doctorchildren under 4 yrs: do not use. This formulation utilizes a kit delivery system. Marketed by Allegiant Health, this product is identified by NDC 69168-438 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
- RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
- RxCUI: 1086997 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
- RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule
- RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 69168 - Allegiant Health
- 69168-438 - Daytime Nighttime Cold And Flu Relief Combo Pack
- 69168-438-15 - 1 KIT in 1 CARTON * 2 BLISTER PACK in 1 CARTON (69168-417-93) / 12 CAPSULE in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (69168-418-86) / 12 CAPSULE in 1 BLISTER PACK
- 69168-438 - Daytime Nighttime Cold And Flu Relief Combo Pack
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 69168-438-15 identifies a specific commercial package of 1 kit in 1 carton * 2 blister pack in 1 carton (69168-417-93) / 12 capsule in 1 blister pack * 1 blister pack in 1 carton (69168-418-86) / 12 capsule in 1 blister pack of Daytime Nighttime Cold And Flu Relief Combo Pack, a human over the counter drug labeled by Allegiant Health. This kit is formulated for use and contains 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 Allegiant Health on May 20, 2022. The current certification is valid through December 31, 2026.
How is this Allegiant Health product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 69168043815. 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.
