robitussin honey severe cough, flu plus sore throat nighttime

Generic: acetaminophen and diphenhydramine hydrochloride

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

Drug Facts

Product Profile

Brand Name robitussin honey severe cough, flu plus sore throat nighttime
Generic Name acetaminophen and diphenhydramine hydrochloride
Labeler haleon us holdings llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-8770
Product ID 0031-8770_e1aff09c-8c75-45af-b83c-71be0cb7309b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-06-15

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 00318770
Hyphenated Format 0031-8770

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 honey severe cough, flu plus sore throat nighttime (source: ndc)
Generic Name acetaminophen and diphenhydramine hydrochloride (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 (0031-8770-12) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0031-8770-18) / 237 mL in 1 BOTTLE
source: ndc

Packages (2)

0031-8770-12 1 BOTTLE in 1 CARTON (0031-8770-12) / 118 mL in 1 BOTTLE 0031-8770-18 1 BOTTLE in 1 CARTON (0031-8770-18) / 237 mL in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e1aff09c-8c75-45af-b83c-71be0cb7309b", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["2374554"], "spl_set_id": ["7decc168-e847-4bbe-910b-26081469406f"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-8770-12)  / 118 mL in 1 BOTTLE", "package_ndc": "0031-8770-12", "marketing_start_date": "20200615"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-8770-18)  / 237 mL in 1 BOTTLE", "package_ndc": "0031-8770-18", "marketing_start_date": "20200615"}], "brand_name": "Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime", "product_id": "0031-8770_e1aff09c-8c75-45af-b83c-71be0cb7309b", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0031-8770", "generic_name": "acetaminophen and diphenhydramine hydrochloride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robitussin Honey Severe Cough, Flu Plus Sore Throat 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": "20200615", "listing_expiration_date": "20261231"}