acetaminophen diphenhydramine hcl

Generic: acetaminophen diphenhydramine hcl

Labeler: chain drug consortium,llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH NOT FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen diphenhydramine hcl
Generic Name acetaminophen diphenhydramine hcl
Labeler chain drug consortium,llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, diphenhydramine 25 mg/1

Manufacturer
Chain Drug Consortium,LLC

Identifiers & Regulatory

Product NDC 68016-654
Product ID 68016-654_47f839b9-ac8b-161c-e054-00144ff8d46c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH NOT FINAL
Application Number part343
Listing Expiration 2026-12-31
Marketing Start 2016-02-25

Pharmacologic Class

Established (EPC)
histamine-1 receptor antagonist [epc]
Mechanism of Action
histamine h1 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68016654
Hyphenated Format 68016-654

Supplemental Identifiers

RxCUI
1092189
UPC
0840986031847 0840986031830
UNII
362O9ITL9D 8GTS82S83M
NUI
N0000000190 N0000175587

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 hcl (source: ndc)
Generic Name acetaminophen diphenhydramine hcl (source: ndc)
Application Number part343 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 50 TABLET in 1 BOTTLE (68016-654-05)
  • 100 TABLET in 1 BOTTLE (68016-654-10)
source: ndc

Packages (2)

68016-654-05 50 TABLET in 1 BOTTLE (68016-654-05) 68016-654-10 100 TABLET in 1 BOTTLE (68016-654-10)

Ingredients (2)

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

Linked Drug Pages (1)

Acetaminophen Diphenhydramine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47f839b9-ac8b-161c-e054-00144ff8d46c", "openfda": {"nui": ["N0000000190", "N0000175587"], "upc": ["0840986031847", "0840986031830"], "unii": ["362O9ITL9D", "8GTS82S83M"], "rxcui": ["1092189"], "spl_set_id": ["47f839b9-ac8a-161c-e054-00144ff8d46c"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["Chain Drug Consortium,LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET in 1 BOTTLE (68016-654-05)", "package_ndc": "68016-654-05", "marketing_start_date": "20160225"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (68016-654-10)", "package_ndc": "68016-654-10", "marketing_start_date": "20160225"}], "brand_name": "Acetaminophen Diphenhydramine HCl", "product_id": "68016-654_47f839b9-ac8b-161c-e054-00144ff8d46c", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68016-654", "generic_name": "Acetaminophen Diphenhydramine HCl", "labeler_name": "Chain Drug Consortium,LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen Diphenhydramine HCl", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DIPHENHYDRAMINE", "strength": "25 mg/1"}], "application_number": "part343", "marketing_category": "OTC MONOGRAPH NOT FINAL", "marketing_start_date": "20160225", "listing_expiration_date": "20261231"}