Home NDC 87438-0001 Extra Strength Acetaminophen
Product NDC 87438-0001
11-digit product format 874380001
Labeler code 87438
Product ID 87438-0001_513cf101-7e8d-01e0-e063-6394a90a0b0b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Pinnacle RX LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-05-01
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 Extra Strength Acetaminophen
Listing expiration 2027-12-31 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 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 87438-0001-1 Extra Strength Acetaminophen 100 in 1 BOTTLE CAPSULE, GELATIN COATED 100 1
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 87438-0001-1 87438000101 100 CAPSULE, GELATIN COATED in 1 BOTTLE (87438-0001-1) 2026-05-01 No No Current