robitussin nighttime cough dm soft chews

Generic: dextromethorphan hydrobromide, doxylamine succinate

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

Drug Facts

Product Profile

Brand Name robitussin nighttime cough dm soft chews
Generic Name dextromethorphan hydrobromide, doxylamine succinate
Labeler haleon us holdings llc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 15 mg/1, doxylamine succinate 6.25 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-9311
Product ID 0031-9311_4472847f-6aad-ca49-e063-6394a90a7ff3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-06-19

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 00319311
Hyphenated Format 0031-9311

Supplemental Identifiers

RxCUI
2685210
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 nighttime cough dm soft chews (source: ndc)
Generic Name dextromethorphan hydrobromide, doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • 20 TABLET, CHEWABLE in 1 BOTTLE (0031-9311-20)
source: ndc

Packages (1)

0031-9311-20 20 TABLET, CHEWABLE in 1 BOTTLE (0031-9311-20)

Ingredients (2)

dextromethorphan hydrobromide (15 mg/1) doxylamine succinate (6.25 mg/1)

Linked Drug Pages (1)

ROBITUSSIN Nighttime Cough DM Soft CHEWS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4472847f-6aad-ca49-e063-6394a90a7ff3", "openfda": {"unii": ["9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["2685210"], "spl_set_id": ["39468746-e06d-4849-9d06-9af4d14351b0"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, CHEWABLE in 1 BOTTLE (0031-9311-20)", "package_ndc": "0031-9311-20", "marketing_start_date": "20240619"}], "brand_name": "ROBITUSSIN Nighttime Cough DM Soft CHEWS", "product_id": "0031-9311_4472847f-6aad-ca49-e063-6394a90a7ff3", "dosage_form": "TABLET, CHEWABLE", "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": "0031-9311", "generic_name": "dextromethorphan hydrobromide, doxylamine succinate", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ROBITUSSIN Nighttime Cough DM Soft CHEWS", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240619", "listing_expiration_date": "20261231"}