Combination Pack Topcare Health Daytime Severe And Nitetime Severe Cold And Flu Relief Softgels - 24 Ct Kit
NDC Package 76162-678-24
Package Information
Combination Pack Topcare Health Daytime Severe And Nitetime Severe Cold And Flu Relief Softgels - 24 Ct (acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, phenylephrine hydrochloride) kits is • take only as directed• do not exceed 8 softgels per 24 hrs adults & children 12 yrs and over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use • take only as directed• do not exceed 8 softgels per 24 hours adults & children 12 yrs and over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use . This formulation utilizes a kit delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 76162-678 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule
- RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule
- RxCUI: 1297288 - APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule
- RxCUI: 1656815 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule
- RxCUI: 1656815 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 76162 - Topco Associates Llc
- 76162-678 - Combination Pack Topcare Health Daytime Severe And Nitetime Severe Cold And Flu Relief Softgels - 24 Ct
- 76162-678-24 - 1 KIT in 1 CARTON * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
- 76162-678 - Combination Pack Topcare Health Daytime Severe And Nitetime Severe Cold And Flu Relief Softgels - 24 Ct
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 76162-678-24 identifies a specific commercial package of 1 kit in 1 carton * 12 capsule, liquid filled in 1 blister pack * 12 capsule, liquid filled in 1 blister pack of Combination Pack Topcare Health Daytime Severe And Nitetime Severe Cold And Flu Relief Softgels - 24 Ct, a human over the counter drug labeled by Topco Associates Llc. 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 Topco Associates Llc on December 11, 2025. The current certification is valid through December 31, 2027.
How is this Topco Associates Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 76162067824. 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.
