childrens robitussin nighttime cough long-acting dm

Generic: chlorpheniramine maleate, dextromethorphan hydrobromide

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens robitussin nighttime cough long-acting dm
Generic Name chlorpheniramine maleate, dextromethorphan hydrobromide
Labeler haleon us holdings llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

chlorpheniramine maleate 2 mg/10mL, dextromethorphan hydrobromide 15 mg/10mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-8692
Product ID 0031-8692_13dfb324-3f9f-0869-e063-6294a90a0770
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-07-01

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00318692
Hyphenated Format 0031-8692

Supplemental Identifiers

RxCUI
1111440
UNII
V1Q0O9OJ9Z 9D2RTI9KYH

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name childrens robitussin nighttime cough long-acting dm (source: ndc)
Generic Name chlorpheniramine maleate, dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/10mL
  • 15 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0031-8692-13) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

Ingredients (2)

chlorpheniramine maleate (2 mg/10mL) dextromethorphan hydrobromide (15 mg/10mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "13dfb324-3f9f-0869-e063-6294a90a0770", "openfda": {"unii": ["V1Q0O9OJ9Z", "9D2RTI9KYH"], "rxcui": ["1111440"], "spl_set_id": ["8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-8692-13)  / 118 mL in 1 BOTTLE", "package_ndc": "0031-8692-13", "marketing_start_date": "20140701"}], "brand_name": "Childrens Robitussin Nighttime Cough Long-Acting DM", "product_id": "0031-8692_13dfb324-3f9f-0869-e063-6294a90a0770", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "0031-8692", "generic_name": "chlorpheniramine maleate, dextromethorphan hydrobromide", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Robitussin Nighttime Cough Long-Acting DM", "active_ingredients": [{"name": "CHLORPHENIRAMINE MALEATE", "strength": "2 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140701", "listing_expiration_date": "20261231"}