Childrens Robitussin Nighttime Cough Long-acting Dm Solution
NDC Package 0031-8692-13
Package Information
Childrens Robitussin Nighttime Cough Long-acting Dm (chlorpheniramine maleate, dextromethorphan hydrobromide) solution is do not take more than 6 doses in any 24-hour periodmeasure only with dosing cup providedkeep dosing cup with productmL = milliliteragedosechildren under 4 yearsdo not usechildren 4 to under 6 years5 mL every 4 hourschildren 6 to under 12 years10 mL every 4 hoursadults and children 12 years and over20 mL every 4 hours. This formulation utilizes a solution delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0031-8692 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1111440 - chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral Solution
- RxCUI: 1111440 - chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Solution
- RxCUI: 1111440 - chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral Solution
- RxCUI: 1111440 - chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Solution
- RxCUI: 1790650 - dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral Solution
Clinical Specifications
- Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
- Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- 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
- 0031-8692 - Childrens Robitussin Nighttime Cough Long-acting Dm
- 0031-8692-13 - 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
- 0031-8692 - Childrens Robitussin Nighttime Cough Long-acting Dm
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 0031-8692-13 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Childrens Robitussin Nighttime Cough Long-acting Dm, a human over the counter drug labeled by Haleon Us Holdings Llc. This solution is formulated for oral use and contains chlorpheniramine maleate; dextromethorphan hydrobromide 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, 2014. 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: 00031869213. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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.