Robitussin Maximum Strength Severe Multi-symptom 7 In 1 Relief Nighttime Capsule, Liquid Filled
NDC Package 0031-8744-10
Package Information
Robitussin Maximum Strength Severe Multi-symptom 7 In 1 Relief Nighttime (acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate) capsules is usestemporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies:headachesore throatcoughminor aches and painsrunny nosesneezingitchy, watery eyesitching of the nose or throattemporarily reduces fever. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0031-8744 and is authorized under FDA application M012.
Identification & Billing
- 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
- RxCUI: 1094549 - APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule
Clinical Specifications
- 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)
Regulatory & Marketing
Hierarchy Structure
- 0031 - Haleon Us Holdings Llc
- 0031-8744 - Robitussin Maximum Strength Severe Multi-symptom 7 In 1 Relief Nighttime
- 0031-8744-10 - 5 BLISTER PACK in 1 CARTON / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
- 0031-8744 - Robitussin Maximum Strength Severe Multi-symptom 7 In 1 Relief Nighttime
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 0031-8744-10 identifies a specific commercial package of 5 blister pack in 1 carton / 2 capsule, liquid filled in 1 blister pack of Robitussin Maximum Strength Severe Multi-symptom 7 In 1 Relief Nighttime, a human over the counter drug labeled by Haleon Us Holdings Llc. This capsule, liquid filled is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; doxylamine succinate 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 Haleon Us Holdings Llc on July 01, 2015. The current certification is valid through December 31, 2026.
How is this Haleon Us Holdings Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00031874410. 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 Labeler segment to maintain the 5-4-2 structure.