Home NDC 55289-880-12 Acetaminophen
Product NDC 55289-880
Requested package NDC 55289-880-12
11-digit product format 552890880
Labeler code 55289
Product ID 55289-880_48390181-cda8-a543-e063-6294a90a5896
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2006-01-10
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 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 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55289-880-01 Acetaminophen 100 in 1 BOTTLE, PLASTIC TABLET 100 17 55289-880-06 Acetaminophen 6 in 1 BOTTLE, PLASTIC TABLET 6 17 55289-880-12 Acetaminophen 12 in 1 BOTTLE, PLASTIC TABLET 12 17 55289-880-20 Acetaminophen 20 in 1 BOTTLE, PLASTIC TABLET 20 17 55289-880-21 Acetaminophen 21 in 1 BOTTLE, PLASTIC TABLET 21 17 55289-880-24 Acetaminophen 24 in 1 BOTTLE, PLASTIC TABLET 24 17 55289-880-30 Acetaminophen 30 in 1 BOTTLE, PLASTIC TABLET 30 17 55289-880-50 Acetaminophen 50 in 1 BOTTLE, PLASTIC TABLET 50 17 55289-880-60 Acetaminophen 60 in 1 BOTTLE, PLASTIC TABLET 60 17 55289-880-97 Acetaminophen 200 in 1 BOTTLE, PLASTIC TABLET 200 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-880 ACETAMINOPHEN TABLET [PD-RX PHARMACEUTICALS, INC.] 14 Current NDC, Legacy NDC, 10 package rows 20250322_64696f65-415e-4ce1-a5b3-70662fbcb002.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 55289-880-12 55289088012 12 TABLET in 1 BOTTLE, PLASTIC (55289-880-12) 12 tablet 2021-03-26 0000-00-00 No No Current