Home NDC 53329-604-30 Medline
Product NDC 53329-604
Requested package NDC 53329-604-30
11-digit product format 533290604
Labeler code 53329
Product ID 53329-604_52f5b946-b7ed-be59-e063-6394a90a48f2
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Medline Industries, LP
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-20
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 Medline
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.
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 44 of 79 · 1,570 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirina Cafeina ASPIRIN,CAFFEINE Bayer HealthCare LLC. 2e709acc-325a-baca-e063-6394a90a24be 2025-06-12 Warnings Exact identifier application number: M013 Aspirin ASPIRIN CHAIN DRUG MARKETING ASSOCIATION, INC. 696f55b1-536c-40c4-91f7-b572c39220db 2025-06-11 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS Pharmacy, Inc. 6dea9e11-ff99-63c7-e053-2a91aa0a5b54 2025-06-10 Warnings Exact identifier application number: M013 Children Acetaminophen Oral Solution ACETAMINOPHEN MAJOR PHARMACEUTICALS cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 2025-06-09 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Trifecta Pharmaceuticals USA LLC 372be427-acbd-c10c-e063-6294a90a572d 2025-06-09 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN CVS Pharmacy d6c8118c-bf78-4194-9b14-8de33c3ecdb7 2025-06-06 Warnings Exact identifier application number: M013 Dolo-NeuroBion ACETAMINOPHEN BENARD INDUSTRIES INC b8310770-84d1-4a6f-8e23-9974947f92f1 2025-06-04 Warnings Exact identifier application number: M013 Menstrual Complete Maximum Strength ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE Rite Aid Corporation 69bda7d7-8660-4e8d-b8ac-892a3b1f2124 2025-06-03 Warnings Exact identifier application number: M013 Kids Pain and Fever ACETAMINOPHEN KinderFarms, LLC fb74e8f9-d72f-4681-90bd-df48364405b5 2025-06-01 Warnings Exact identifier application number: M013 Pain and Fever Childrens ACETAMINOPHEN P & L Development, LLC b815fcae-8bba-4737-ac10-29a32fb69275 2025-05-30 Warnings Exact identifier application number: M013 Infants Pain and Fever ACETAMINOPHEN KinderFarms, LLC 81cc4900-226b-4c49-ba9c-5747d2a501b1 2025-05-29 Warnings Exact identifier application number: M013 good sense pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Bryant Ranch Prepack e08a7ab1-4b68-422a-97bd-2c5326633943 2025-05-29 Warnings Exact identifier application number: M013 Acetaminophen Gelcaps ACETAMINOPHEN Kroger 30d3f2d0-da35-7f6f-e063-6294a90a9c22 2025-05-23 Warnings Exact identifier application number: M013 Kids Pain and Fever ACETAMINOPHEN Genexa Inc. fcffa7e6-145c-6bc0-e053-6294a90a4751 2025-05-23 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN CHAIN DRUG MARKETING ASSOCIATION, INC. 1c083e29-8732-4ecd-ab4b-9038acbd0b9d 2025-05-22 Warnings Exact identifier application number: M013 TYLENOL For Children Plus Adults ACETAMINOPHEN Kenvue Brands LLC 5bb8ef99-a94b-49f9-89f9-cd1ce0a47a42 2025-05-21 Warnings Exact identifier application number: M013 Children Acetaminophen ACETAMINOPHEN AARNA USA INC. 25bcb9d5-f388-4ae7-8037-970ffe8d17f0 2025-05-16 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN HF Acquisition Co LLC, DBA HealthFirst 35478de8-50d0-5d0a-e063-6294a90a88ba 2025-05-16 Warnings Exact identifier application number: M013 Extra Strength Acetaminophen ACETAMINOPHEN Preferred Pharmaceuticals Inc. 95f4b628-6d35-4f6b-91f9-b2d117f8e821 2025-05-16 Warnings Exact identifier application number: M013 good neighbor pharmacy childrens pain and fever ACETAMINOPHEN Amerisource Bergen 268a789b-8f31-4739-9777-523249cac326 2025-05-13 Warnings Exact identifier application number: M013
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53329-604-30 53329060430 100 TABLET in 1 BOTTLE (53329-604-30) 100 tablet 2026-07-20 No No Current