robitussin direct cough

Generic: dextromethorphan hydrobromide

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

Drug Facts

Product Profile

Brand Name robitussin direct cough
Generic Name dextromethorphan hydrobromide
Labeler haleon us holdings llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 15 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-9302
Product ID 0031-9302_13f2a432-de15-26a7-e063-6294a90a43e6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-07-15

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 00319302
Hyphenated Format 0031-9302

Supplemental Identifiers

RxCUI
1090487
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 direct cough (source: ndc)
Generic Name dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 18 CAPSULE, LIQUID FILLED in 1 BOTTLE (0031-9302-01)
source: ndc

Packages (1)

0031-9302-01 18 CAPSULE, LIQUID FILLED in 1 BOTTLE (0031-9302-01)

Ingredients (1)

dextromethorphan hydrobromide (15 mg/1)

Linked Drug Pages (1)

Robitussin Direct Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "13f2a432-de15-26a7-e063-6294a90a43e6", "openfda": {"unii": ["9D2RTI9KYH"], "rxcui": ["1090487"], "spl_set_id": ["70c9556b-063a-4fb3-96f6-1d4ffa495ed4"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "18 CAPSULE, LIQUID FILLED in 1 BOTTLE (0031-9302-01)", "package_ndc": "0031-9302-01", "marketing_start_date": "20220715"}], "brand_name": "Robitussin Direct Cough", "product_id": "0031-9302_13f2a432-de15-26a7-e063-6294a90a43e6", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "0031-9302", "generic_name": "dextromethorphan hydrobromide", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robitussin Direct Cough", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220715", "listing_expiration_date": "20261231"}