acetaminophen and diphenhydramine citrate

Generic: acetaminophen and diphenhydramine citrate

Labeler: invatech pharma solutions llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen and diphenhydramine citrate
Generic Name acetaminophen and diphenhydramine citrate
Labeler invatech pharma solutions llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, diphenhydramine citrate 38 mg/1

Manufacturer
InvaTech Pharma Solutions LLC

Identifiers & Regulatory

Product NDC 57631-010
Product ID 57631-010_403a87a6-fe92-8e79-e063-6394a90a70ce
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-10-01

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 57631010
Hyphenated Format 57631-010

Supplemental Identifiers

RxCUI
1099872
UNII
362O9ITL9D 4OD433S209

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 citrate (source: ndc)
Generic Name acetaminophen and diphenhydramine citrate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 38 mg/1
source: ndc
Packaging
  • 30000 TABLET in 1 BOX (57631-010-00)
source: ndc

Packages (1)

57631-010-00 30000 TABLET in 1 BOX (57631-010-00)

Ingredients (2)

acetaminophen (500 mg/1) diphenhydramine citrate (38 mg/1)

Linked Drug Pages (1)

Acetaminophen and Diphenhydramine citrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "403a87a6-fe92-8e79-e063-6394a90a70ce", "openfda": {"unii": ["362O9ITL9D", "4OD433S209"], "rxcui": ["1099872"], "spl_set_id": ["403a88fa-e06b-9b6e-e063-6394a90a97b8"], "manufacturer_name": ["InvaTech Pharma Solutions LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30000 TABLET in 1 BOX (57631-010-00)", "package_ndc": "57631-010-00", "marketing_start_date": "20251001"}], "brand_name": "Acetaminophen and Diphenhydramine citrate", "product_id": "57631-010_403a87a6-fe92-8e79-e063-6394a90a70ce", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "57631-010", "generic_name": "Acetaminophen and Diphenhydramine citrate", "labeler_name": "InvaTech Pharma Solutions LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen and Diphenhydramine citrate", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DIPHENHYDRAMINE CITRATE", "strength": "38 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251001", "listing_expiration_date": "20261231"}