Home NDC 69618-011 ACETAMINOPHEN 500 MG
Product NDC 69618-011
11-digit product format 696180011
Labeler code 69618
Product ID 69618-011_2bc81112-204d-2514-e063-6394a90a80ed
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form TABLET
Route ORAL
Labeler Reliable 1 Laboratories LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-11-01
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 500 MG
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69618-011-01 ACETAMINOPHEN 500 MG 100 in 1 BOTTLE, PLASTIC TABLET 100 8 69618-011-10 ACETAMINOPHEN 500 MG 1000 in 1 BOTTLE, PLASTIC TABLET 1000 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69618-011 ACETAMINOPHEN 500 MG (ACETAMINOPHEN) TABLET [RELIABLE 1 LABORATORIES LLC] 8 Current NDC, Legacy NDC, 2 package rows 20250117_2651bf11-4d66-43ba-e054-00144ff88e88.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 Marketing end Sample Exclude flag Status 69618-011-01 69618001101 100 TABLET in 1 BOTTLE, PLASTIC (69618-011-01) 100 tablet 2015-11-01 0000-00-00 No No Current 69618-011-10 69618001110 1000 TABLET in 1 BOTTLE, PLASTIC (69618-011-10) 1000 tablet 2015-11-01 0000-00-00 No No Current