robitussin severe multi-symptom cough cold flu nighttime

Generic: acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name robitussin severe multi-symptom cough cold flu nighttime
Generic Name acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
Labeler haleon us holdings llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/20mL, diphenhydramine hydrochloride 25 mg/20mL, phenylephrine hydrochloride 10 mg/20mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-8752
Product ID 0031-8752_156ef02d-2284-6dc7-e063-6294a90a3be9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M0012
Listing Expiration 2026-12-31
Marketing Start 2015-07-01

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00318752
Hyphenated Format 0031-8752

Supplemental Identifiers

RxCUI
1375932
UNII
362O9ITL9D TC2D6JAD40 04JA59TNSJ

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 severe multi-symptom cough cold flu nighttime (source: ndc)
Generic Name acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride (source: ndc)
Application Number M0012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/20mL
  • 25 mg/20mL
  • 10 mg/20mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0031-8752-12) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0031-8752-18) / 237 mL in 1 BOTTLE
source: ndc

Packages (2)

0031-8752-12 1 BOTTLE in 1 CARTON (0031-8752-12) / 118 mL in 1 BOTTLE 0031-8752-18 1 BOTTLE in 1 CARTON (0031-8752-18) / 237 mL in 1 BOTTLE

Ingredients (3)

acetaminophen (650 mg/20mL) diphenhydramine hydrochloride (25 mg/20mL) phenylephrine hydrochloride (10 mg/20mL)

Linked Drug Pages (1)

Robitussin 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": "156ef02d-2284-6dc7-e063-6294a90a3be9", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1375932"], "spl_set_id": ["89360fa8-014d-4da8-bb1c-197e3aa52256"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-8752-12)  / 118 mL in 1 BOTTLE", "package_ndc": "0031-8752-12", "marketing_start_date": "20150701"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-8752-18)  / 237 mL in 1 BOTTLE", "package_ndc": "0031-8752-18", "marketing_start_date": "20150701"}], "brand_name": "Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime", "product_id": "0031-8752_156ef02d-2284-6dc7-e063-6294a90a3be9", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0031-8752", "generic_name": "acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/20mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/20mL"}], "application_number": "M0012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150701", "listing_expiration_date": "20261231"}