acetaminophen, diphenhydramine hydrochloride

Generic: acetaminophen, diphenhydramine hydrochloride

Labeler: leader/ cardinal health 110, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen, diphenhydramine hydrochloride
Generic Name acetaminophen, diphenhydramine hydrochloride
Labeler leader/ cardinal health 110, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, diphenhydramine hydrochloride 25 mg/1

Manufacturer
LEADER/ Cardinal Health 110, Inc.

Identifiers & Regulatory

Product NDC 70000-0411
Product ID 70000-0411_4bbe57b4-c0c6-c37f-e063-6294a90a7dd7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2027-12-31
Marketing Start 2018-11-29

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 700000411
Hyphenated Format 70000-0411

Supplemental Identifiers

RxCUI
1092189
UPC
0096295135299
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 acetaminophen, diphenhydramine hydrochloride (source: ndc)
Generic Name acetaminophen, diphenhydramine hydrochloride (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70000-0411-1) / 24 TABLET, FILM COATED in 1 BOTTLE
  • 50 TABLET, FILM COATED in 1 BOTTLE (70000-0411-2)
  • 1 BOTTLE in 1 CARTON (70000-0411-3) / 100 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

70000-0411-1 1 BOTTLE in 1 CARTON (70000-0411-1) / 24 TABLET, FILM COATED in 1 BOTTLE 70000-0411-2 50 TABLET, FILM COATED in 1 BOTTLE (70000-0411-2) 70000-0411-3 1 BOTTLE in 1 CARTON (70000-0411-3) / 100 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

acetaminophen (500 mg/1) diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Acetaminophen, Diphenhydramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4bbe57b4-c0c6-c37f-e063-6294a90a7dd7", "openfda": {"upc": ["0096295135299"], "unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189"], "spl_set_id": ["7be4d67e-1af9-f059-e053-2991aa0a382e"], "manufacturer_name": ["LEADER/ Cardinal Health 110, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0411-1)  / 24 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70000-0411-1", "marketing_start_date": "20181210"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (70000-0411-2)", "package_ndc": "70000-0411-2", "marketing_start_date": "20181129"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0411-3)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70000-0411-3", "marketing_start_date": "20181210"}], "brand_name": "Acetaminophen, Diphenhydramine Hydrochloride", "product_id": "70000-0411_4bbe57b4-c0c6-c37f-e063-6294a90a7dd7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "70000-0411", "generic_name": "Acetaminophen, Diphenhydramine Hydrochloride", "labeler_name": "LEADER/ Cardinal Health 110, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen, Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20181129", "listing_expiration_date": "20271231"}