robitussin 12 hour cough relief

Generic: dextromethorphan polistirex

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

Drug Facts

Product Profile

Brand Name robitussin 12 hour cough relief
Generic Name dextromethorphan polistirex
Labeler haleon us holdings llc
Dosage Form SUSPENSION, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 30 mg/5mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-8755
Product ID 0031-8755_159a0a07-055f-e1e2-e063-6394a90a9a37
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091135
Listing Expiration 2026-12-31
Marketing Start 2016-07-05

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 00318755
Hyphenated Format 0031-8755

Supplemental Identifiers

RxCUI
1373045
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 robitussin 12 hour cough relief (source: ndc)
Generic Name dextromethorphan polistirex (source: ndc)
Application Number ANDA091135 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0031-8755-15) / 148 mL in 1 BOTTLE
source: ndc

Packages (1)

0031-8755-15 1 BOTTLE in 1 CARTON (0031-8755-15) / 148 mL in 1 BOTTLE

Ingredients (1)

dextromethorphan hydrobromide (30 mg/5mL)

Linked Drug Pages (1)

Robitussin 12 Hour Cough Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "159a0a07-055f-e1e2-e063-6394a90a9a37", "openfda": {"unii": ["9D2RTI9KYH"], "rxcui": ["1373045"], "spl_set_id": ["5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-8755-15)  / 148 mL in 1 BOTTLE", "package_ndc": "0031-8755-15", "marketing_start_date": "20160705"}], "brand_name": "Robitussin 12 Hour Cough Relief", "product_id": "0031-8755_159a0a07-055f-e1e2-e063-6394a90a9a37", "dosage_form": "SUSPENSION, EXTENDED RELEASE", "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": "0031-8755", "generic_name": "dextromethorphan polistirex", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robitussin 12 Hour Cough Relief", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/5mL"}], "application_number": "ANDA091135", "marketing_category": "ANDA", "marketing_start_date": "20160705", "listing_expiration_date": "20261231"}