Home NDC 36800-665 Acetaminophen
Product NDC 36800-665
11-digit product format 368000665
Labeler code 36800
Product ID 36800-665_4651f3b4-2e3a-fc6f-e063-6294a90adbba
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET
Route ORAL
Labeler TOPCO ASSOCIATES LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-14
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-665-10 Acetaminophen 100 in 1 BOTTLE TABLET 100 5 36800-665-21 Acetaminophen 225 in 1 BOTTLE TABLET 225 5 36800-665-40 Acetaminophen 400 in 1 BOTTLE TABLET 400 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-665 ACETAMINOPHEN TABLET [TOPCO ASSOCIATES LLC] 3 Current NDC, 3 package rows 20241120_1a00a49e-f9ff-b928-e063-6394a90a4cb5.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 83 · 1,657 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 36800-665-10 36800066510 100 TABLET in 1 BOTTLE (36800-665-10) 100 tablet 2024-10-14 No No Current 36800-665-21 36800066521 225 TABLET in 1 BOTTLE (36800-665-21) 225 tablet 2024-10-14 No No Current 36800-665-40 36800066540 400 TABLET in 1 BOTTLE (36800-665-40) 400 tablet 2024-10-14 No No Current