Daytime Cold And Flu Multi Symptom Relief Capsule, Liquid Filled
NDC Package 83059-0113-1
Package Information
Daytime Cold And Flu Multi Symptom Relief (acetaminophen, dextromethorphan hbr, phenylephrine hcl) capsules is take only as directed do not exceed 8 softgels per 24 hrsadults & children 12 yrs & over2 Softgels with water every 4 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Shield Pharmaceuticals Corp, this product is identified by NDC 83059-0113 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
- 83059 - Shield Pharmaceuticals Corp
- 83059-0113 - Daytime Cold And Flu Multi Symptom Relief
- 83059-0113-1 - 1 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
- 83059-0113 - Daytime Cold And Flu Multi Symptom Relief
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 83059-0113-1 identifies a specific commercial package of 1 blister pack in 1 carton / 10 capsule, liquid filled in 1 blister pack of Daytime Cold And Flu Multi Symptom Relief, a human over the counter drug labeled by Shield Pharmaceuticals Corp. 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 Shield Pharmaceuticals Corp on April 07, 2024. The current certification is valid through December 31, 2026.
How is this Shield Pharmaceuticals Corp product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 83059011301. 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 Package segment to maintain the 5-4-2 structure.