Night Time Cold And Flu Capsule, Liquid Filled
NDC Package 72476-998-14
Package Information
Night Time Cold And Flu (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride) capsules is do not take more than directed (see Overdose warning)do not take more than 12 softgels in any 24-hour periodadults and children 12 years of age and older: take 2 softgels every 4 hourschildren under 12 years of age: do not use. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Retail Business Services, Llc, this product is identified by NDC 72476-998 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
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Antihistamine - [EPC] (Established Pharmacologic Class)
- Histamine Receptor Antagonists - [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
- 72476 - Retail Business Services, Llc
- 72476-998 - Night Time Cold And Flu
- 72476-998-14 - 2 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
- 72476-998 - Night Time Cold And Flu
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 72476-998-14 identifies a specific commercial package of 2 blister pack in 1 carton / 8 capsule, liquid filled in 1 blister pack of Night Time Cold And Flu, a human over the counter drug labeled by Retail Business Services, Llc. This capsule, liquid filled is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; doxylamine succinate; 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 Retail Business Services, Llc on March 18, 2019. The current certification is valid through December 31, 2026.
How is this Retail Business Services, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 72476099814. 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.