Gencare Daytime Cold And Flu Softgel Capsule, Liquid Filled
NDC Package 72090-005-01
Package Information
Gencare Daytime Cold And Flu Softgel (acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride) capsules is ■ take only as directed■ do not exceed 4 doses per 24 hrs. Adults and children 12 yrs and overtake 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 capsule, liquid filled delivery system. Marketed by Pioneer Life Sciences, Llc, this product is identified by NDC 72090-005 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
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 72090 - Pioneer Life Sciences, Llc
- 72090-005 - Gencare Daytime Cold And Flu Softgel
- 72090-005-01 - 48 CAPSULE, LIQUID FILLED in 1 BOTTLE
- 72090-005 - Gencare Daytime Cold And Flu Softgel
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 72090-005-01 identifies a specific commercial package of 48 capsule, liquid filled in 1 bottle of Gencare Daytime Cold And Flu Softgel, a human over the counter drug labeled by Pioneer Life Sciences, Llc. This capsule, liquid filled is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; 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 Pioneer Life Sciences, Llc on December 08, 2023. The current certification is valid through December 31, 2026.
How is this Pioneer Life Sciences, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 72090000501. 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.