acetaminophen

Generic: acetaminophen

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler topco associates llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1

Manufacturer
TOPCO ASSOCIATES LLC

Identifiers & Regulatory

Product NDC 36800-665
Product ID 36800-665_4651f3b4-2e3a-fc6f-e063-6294a90adbba
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2024-10-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800665
Hyphenated Format 36800-665

Supplemental Identifiers

RxCUI
198440
UNII
362O9ITL9D

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 (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (36800-665-10)
  • 225 TABLET in 1 BOTTLE (36800-665-21)
  • 400 TABLET in 1 BOTTLE (36800-665-40)
source: ndc

Packages (3)

36800-665-10 100 TABLET in 1 BOTTLE (36800-665-10) 36800-665-21 225 TABLET in 1 BOTTLE (36800-665-21) 36800-665-40 400 TABLET in 1 BOTTLE (36800-665-40)

Ingredients (1)

acetaminophen (500 mg/1)

Linked Drug Pages (1)

Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4651f3b4-2e3a-fc6f-e063-6294a90adbba", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["198440"], "spl_set_id": ["1a00a49e-f9ff-b928-e063-6394a90a4cb5"], "manufacturer_name": ["TOPCO ASSOCIATES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (36800-665-10)", "package_ndc": "36800-665-10", "marketing_start_date": "20241014"}, {"sample": false, "description": "225 TABLET in 1 BOTTLE (36800-665-21)", "package_ndc": "36800-665-21", "marketing_start_date": "20241014"}, {"sample": false, "description": "400 TABLET in 1 BOTTLE (36800-665-40)", "package_ndc": "36800-665-40", "marketing_start_date": "20241014"}], "brand_name": "Acetaminophen", "product_id": "36800-665_4651f3b4-2e3a-fc6f-e063-6294a90adbba", "dosage_form": "TABLET", "product_ndc": "36800-665", "generic_name": "Acetaminophen", "labeler_name": "TOPCO ASSOCIATES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241014", "listing_expiration_date": "20261231"}