childrens robitussin cough long-acting

Generic: 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 cough long-acting
Generic Name dextromethorphan hydrobromide
Labeler haleon us holdings llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 7.5 mg/5mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-8694
Product ID 0031-8694_13de389a-3701-8e4c-e063-6294a90a2587
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2004-01-01

Pharmacologic Class

Classes
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 00318694
Hyphenated Format 0031-8694

Supplemental Identifiers

RxCUI
1370211
UNII
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 cough long-acting (source: ndc)
Generic Name dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0031-8694-12) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

0031-8694-12 1 BOTTLE in 1 CARTON (0031-8694-12) / 118 mL in 1 BOTTLE

Ingredients (1)

dextromethorphan hydrobromide (7.5 mg/5mL)

Linked Drug Pages (1)

Childrens Robitussin Cough Long-Acting ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "13de389a-3701-8e4c-e063-6294a90a2587", "openfda": {"unii": ["9D2RTI9KYH"], "rxcui": ["1370211"], "spl_set_id": ["75bc7827-4439-e6a8-a65c-7154d5592e58"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-8694-12)  / 118 mL in 1 BOTTLE", "package_ndc": "0031-8694-12", "marketing_start_date": "20150701"}], "brand_name": "Childrens Robitussin Cough Long-Acting", "product_id": "0031-8694_13de389a-3701-8e4c-e063-6294a90a2587", "dosage_form": "LIQUID", "pharm_class": ["Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "0031-8694", "generic_name": "dextromethorphan hydrobromide", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Robitussin Cough Long-Acting", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "7.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20040101", "listing_expiration_date": "20261231"}