robitussin maximum strength severe multi-symptom 7 in 1 relief nighttime

Generic: acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate

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 multi-symptom 7 in 1 relief nighttime
Generic Name acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate
Labeler haleon us holdings llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 15 mg/1, doxylamine succinate 6.25 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-8744
Product ID 0031-8744_156fd078-37b4-ddce-e063-6294a90ae226
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2015-07-01

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 00318744
Hyphenated Format 0031-8744

Supplemental Identifiers

RxCUI
1094549
UNII
362O9ITL9D 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 maximum strength severe multi-symptom 7 in 1 relief nighttime (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 15 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (0031-8744-10) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

0031-8744-10 5 BLISTER PACK in 1 CARTON (0031-8744-10) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (3)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (15 mg/1) doxylamine succinate (6.25 mg/1)

Linked Drug Pages (1)

Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "156fd078-37b4-ddce-e063-6294a90ae226", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1094549"], "spl_set_id": ["e7cf7c5d-5c9a-4201-9e30-1cd616071855"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (0031-8744-10)  / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "0031-8744-10", "marketing_start_date": "20180701"}], "brand_name": "Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime", "product_id": "0031-8744_156fd078-37b4-ddce-e063-6294a90ae226", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "0031-8744", "generic_name": "acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"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": "20150701", "listing_expiration_date": "20261231"}