acetaminophen and diphenhydramine hcl

Generic: acetaminophen and diphenhydramine hcl

Labeler: publix supermarkets, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen and diphenhydramine hcl
Generic Name acetaminophen and diphenhydramine hcl
Labeler publix supermarkets, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, diphenhydramine 25 mg/1

Manufacturer
PUBLIX SUPERMARKETS, INC

Identifiers & Regulatory

Product NDC 41415-661
Product ID 41415-661_465302f5-b590-5105-e063-6394a90aa9d0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2024-08-02

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 41415661
Hyphenated Format 41415-661

Supplemental Identifiers

RxCUI
1092189
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 and diphenhydramine hcl (source: ndc)
Generic Name acetaminophen and diphenhydramine hcl (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 50 TABLET in 1 BOTTLE (41415-661-05)
  • 100 TABLET in 1 BOTTLE (41415-661-10)
source: ndc

Packages (2)

41415-661-05 50 TABLET in 1 BOTTLE (41415-661-05) 41415-661-10 100 TABLET in 1 BOTTLE (41415-661-10)

Ingredients (2)

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

Linked Drug Pages (1)

Acetaminophen and Diphenhydramine HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "465302f5-b590-5105-e063-6394a90aa9d0", "openfda": {"nui": ["N0000000190", "N0000175587"], "unii": ["362O9ITL9D", "8GTS82S83M"], "rxcui": ["1092189"], "spl_set_id": ["08f549cf-042a-7bf2-e063-6394a90a83ef"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["PUBLIX SUPERMARKETS, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET in 1 BOTTLE (41415-661-05)", "package_ndc": "41415-661-05", "marketing_start_date": "20240802"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (41415-661-10)", "package_ndc": "41415-661-10", "marketing_start_date": "20240802"}], "brand_name": "Acetaminophen and Diphenhydramine HCL", "product_id": "41415-661_465302f5-b590-5105-e063-6394a90aa9d0", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "41415-661", "generic_name": "Acetaminophen and Diphenhydramine HCL", "labeler_name": "PUBLIX SUPERMARKETS, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen and Diphenhydramine HCL", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DIPHENHYDRAMINE", "strength": "25 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240802", "listing_expiration_date": "20261231"}