robitussin maximum strength severe cough plus sore throat

Generic: acetaminophen, dextromethorphan hydrobromide

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

Drug Facts

Product Profile

Brand Name robitussin maximum strength severe cough plus sore throat
Generic Name acetaminophen, dextromethorphan hydrobromide
Labeler haleon us holdings llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/20mL, dextromethorphan hydrobromide 20 mg/20mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-8750
Product ID 0031-8750_4380fed9-2211-3875-e063-6394a90ab5ea
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2017-04-10

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 00318750
Hyphenated Format 0031-8750

Supplemental Identifiers

RxCUI
1919076
UNII
362O9ITL9D 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 robitussin maximum strength severe cough plus sore throat (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/20mL
  • 20 mg/20mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0031-8750-12) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0031-8750-18) / 237 mL in 1 BOTTLE
source: ndc

Packages (2)

0031-8750-12 1 BOTTLE in 1 CARTON (0031-8750-12) / 118 mL in 1 BOTTLE 0031-8750-18 1 BOTTLE in 1 CARTON (0031-8750-18) / 237 mL in 1 BOTTLE

Ingredients (2)

acetaminophen (650 mg/20mL) dextromethorphan hydrobromide (20 mg/20mL)

Linked Drug Pages (1)

Robitussin Maximum Strength Severe Cough Plus Sore Throat ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4380fed9-2211-3875-e063-6394a90ab5ea", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH"], "rxcui": ["1919076"], "spl_set_id": ["6a6f5da8-6433-4284-8df7-2d5b099b74dc"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-8750-12)  / 118 mL in 1 BOTTLE", "package_ndc": "0031-8750-12", "marketing_start_date": "20170410"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-8750-18)  / 237 mL in 1 BOTTLE", "package_ndc": "0031-8750-18", "marketing_start_date": "20170410"}], "brand_name": "Robitussin Maximum Strength Severe Cough Plus Sore Throat", "product_id": "0031-8750_4380fed9-2211-3875-e063-6394a90ab5ea", "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": "0031-8750", "generic_name": "acetaminophen, dextromethorphan hydrobromide", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robitussin Maximum Strength Severe Cough Plus Sore Throat", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170410", "listing_expiration_date": "20261231"}