Home NDC 53209-1002-01 NDC 53209-1002-01 - Tylenol PM Extra Strength This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
Product NDC 53209-1002
Requested NDC 53209-1002-01
Package NDCs from labels 53209-1002-1, 53209-1002-2, 53209-1002-01
Manufacturer Morning Star OTC
Effective date 2025-06-19
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53209-1002-1 Tylenol PMExtra Strength 2 in 1 BLISTER PACK TABLET, FILM COATED 2 1 53209-1002-2 Tylenol PMExtra Strength 25 in 1 POUCH TABLET, FILM COATED 25 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 101 of 315 · 6,294 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen ACETAMINOPHEN Granules USA, Inc a1255f60-b9c6-9a95-e053-2995a90a9e80 2025-12-22 Warnings Exact identifier application number: M013 unii: 362O9ITL9D Acetaminophen ACETAMINOPHEN Granules USA, Inc a51395ea-e038-dc9c-e053-2a95a90a287d 2025-12-22 Warnings Exact identifier application number: M013 unii: 362O9ITL9D CareALL Acetaminophen ACETAMINOPHEN New World Imports, Inc 1148b4d9-fa6a-49e6-9663-17b2c8373846 2025-12-22 Warnings Exact identifier application number: M013 unii: 362O9ITL9D CAREALL Aspirin ASPIRIN New World Imports, Inc f4aa0de9-ffcc-4140-91a3-fd9e7a55f2ac 2025-12-22 Warnings Exact identifier application number: M013 CAREALL Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE New World Imports, Inc f3b177ef-55d5-4525-bf33-99205c414a5b 2025-12-22 Warnings Exact identifier unii: TC2D6JAD40 CAREALL Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE New World Imports, Inc af2f8389-d696-4060-8abd-6eda04e73009 2025-12-22 Warnings Exact identifier unii: TC2D6JAD40 Vitapirena ACETAMINOPHEN Pharmadel LLC 0547bc1f-d000-f5a6-e063-6294a90ac73d 2025-12-22 Warnings Exact identifier application number: M013 unii: 362O9ITL9D CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc f818417e-0b31-4fe7-8313-4160a00b248a 2025-12-22 Warnings Exact identifier application number: M013 unii: 362O9ITL9D CareALL Acetaminophen ACETAMINOPHEN New World Imports, Inc c4f82ed8-b82c-47bb-9ab9-108a13d29cf7 2025-12-22 Warnings Exact identifier application number: M013 unii: 362O9ITL9D CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc 5103450a-3095-49cc-9823-4fb4c1d258ff 2025-12-22 Warnings Exact identifier application number: M013 unii: 362O9ITL9D CAREALL Non-Aspirin PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL New World Imports, Inc 499b2bf8-72fb-4500-b16e-517cab09a8ae 2025-12-22 Warnings Exact identifier application number: M013 rxcui: 1092189 unii: TC2D6JAD40 unii: 362O9ITL9D CAREALL Pain Relief PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL New World Imports, Inc 933154b9-c9d6-4260-8775-1c83631c74e4 2025-12-22 Warnings Exact identifier application number: M013 rxcui: 1092189 unii: TC2D6JAD40 unii: 362O9ITL9D CAREALL Pain Relief PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL New World Imports, Inc c93aa5e4-3994-439f-8f14-4e81773ed4e2 2025-12-22 Warnings Exact identifier application number: M013 rxcui: 1092189 unii: TC2D6JAD40 unii: 362O9ITL9D Acetaminophen ACETAMINOPHEN Granules USA, Inc. 96131c7b-bdff-0642-e053-2a95a90a4f32 2025-12-22 Warnings Exact identifier unii: 362O9ITL9D Acetaminophen Diphenhydramine HCl ACETAMINOPHEN DIPHENHYDRAMINE HCL Granules USA, Inc. 8c9f68e3-fedc-6457-e053-2995a90a045a 2025-12-22 Warnings Exact identifier application number: M013 rxcui: 1092189 unii: TC2D6JAD40 unii: 362O9ITL9D Nighttime Cold and Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Harris Teeter, LLC 89fd57d2-fe49-41cb-b02e-9643e526cf47 2025-12-22 Warnings Exact identifier unii: 362O9ITL9D Aspirin ASPIRIN L.N.K. International, Inc. 35005045-57b2-4ffe-ab70-22d570c1b161 2025-12-22 Warnings Exact identifier application number: M013 THE MELT MIST Sheerest Mineral Mist Suncare for Body TITANIUM DIOXIDE, ZINC OXIDE Dune Suncare, Inc. 465d3277-7798-512a-e063-6294a90a2065 2025-12-20 Warnings Exact identifier unii: 15FIX9V2JP SleepAid Softgels DIPHENHYDRAMINE HYDROCHLORIDE NUVICARE LLC 963c6925-dfbf-4cdc-8d13-5e10b499c4a9 2025-12-19 Warnings Exact identifier unii: TC2D6JAD40 Cold and Flu severe ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL Wal-Mart Stores Inc 9fca25dc-f63e-487a-8b7c-84d65ea51cb5 2025-12-19 Warnings Exact identifier unii: 362O9ITL9D
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.