robitussin honey maximum strength nighttime cough dm

Generic: dextromethorphan hbr, doxylamine succinate

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

Drug Facts

Product Profile

Brand Name robitussin honey maximum strength nighttime cough dm
Generic Name dextromethorphan hbr, doxylamine succinate
Labeler haleon us holdings llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 30 mg/20mL, doxylamine succinate 12.5 mg/20mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-8758
Product ID 0031-8758_176b9197-54b8-217e-e063-6394a90add78
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-06-25

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa] 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 00318758
Hyphenated Format 0031-8758

Supplemental Identifiers

RxCUI
1115329
UNII
9D2RTI9KYH V9BI9B5YI2

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 honey maximum strength nighttime cough dm (source: ndc)
Generic Name dextromethorphan hbr, doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/20mL
  • 12.5 mg/20mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0031-8758-12) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0031-8758-18) / 237 mL in 1 BOTTLE
source: ndc

Packages (2)

0031-8758-12 1 BOTTLE in 1 CARTON (0031-8758-12) / 118 mL in 1 BOTTLE 0031-8758-18 1 BOTTLE in 1 CARTON (0031-8758-18) / 237 mL in 1 BOTTLE

Ingredients (2)

dextromethorphan hydrobromide (30 mg/20mL) doxylamine succinate (12.5 mg/20mL)

Linked Drug Pages (1)

Robitussin Honey Maximum Strength Nighttime Cough DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "176b9197-54b8-217e-e063-6394a90add78", "openfda": {"unii": ["9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1115329"], "spl_set_id": ["0b41da13-18a1-4987-ae43-1319bfa27484"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-8758-12)  / 118 mL in 1 BOTTLE", "package_ndc": "0031-8758-12", "marketing_start_date": "20180625"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-8758-18)  / 237 mL in 1 BOTTLE", "package_ndc": "0031-8758-18", "marketing_start_date": "20180625"}], "brand_name": "Robitussin Honey Maximum Strength Nighttime Cough DM", "product_id": "0031-8758_176b9197-54b8-217e-e063-6394a90add78", "dosage_form": "SOLUTION", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "0031-8758", "generic_name": "dextromethorphan HBr, doxylamine succinate", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robitussin Honey Maximum Strength Nighttime Cough DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/20mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180625", "listing_expiration_date": "20261231"}