robitussin maximum strength severe multi-symptom cough cold flu nighttime

Generic: acetaminophen, diphenhydramine hcl

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 cough cold flu nighttime
Generic Name acetaminophen, diphenhydramine hcl
Labeler haleon us holdings llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/20mL, diphenhydramine hydrochloride 25 mg/20mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-0101
Product ID 0031-0101_0f9df094-b106-76fc-e063-6294a90a6a18
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-02-15

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00310101
Hyphenated Format 0031-0101

Supplemental Identifiers

RxCUI
2374554
UNII
362O9ITL9D TC2D6JAD40

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 cough cold flu nighttime (source: ndc)
Generic Name acetaminophen, diphenhydramine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/20mL
  • 25 mg/20mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0031-0101-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

0031-0101-04 1 BOTTLE in 1 CARTON (0031-0101-04) / 118 mL in 1 BOTTLE

Ingredients (2)

acetaminophen (650 mg/20mL) diphenhydramine hydrochloride (25 mg/20mL)

Linked Drug Pages (1)

Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0f9df094-b106-76fc-e063-6294a90a6a18", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["2374554"], "spl_set_id": ["721bfee2-0d3d-4d8b-beee-1ea83064d1c8"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-0101-04)  / 118 mL in 1 BOTTLE", "package_ndc": "0031-0101-04", "marketing_start_date": "20240215"}], "brand_name": "Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime", "product_id": "0031-0101_0f9df094-b106-76fc-e063-6294a90a6a18", "dosage_form": "LIQUID", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0031-0101", "generic_name": "acetaminophen, diphenhydramine hcl", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240215", "listing_expiration_date": "20261231"}