Home NDC 85237-1946 TYLENOL Extra Strength
Product NDC 85237-1946
11-digit product format 852371946
Labeler code 85237
Product ID 85237-1946_5543ed1a-4081-afdd-e063-6394a90aa77b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Select Consumer Group LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 1984-08-19
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 TYLENOL Extra Strength
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup 209459 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 9 of 83 · 1,657 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr Kids Pain and Fever ACETAMINOPHEN CalmCo LLC 5534a784-a7b1-5599-e063-6294a90a7961 2026-06-27 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Select Consumer Group LLC 529d3a51-a248-7c02-e063-6294a90a10ae 2026-06-27 Warnings Exact identifier application number: M013 ndc (product): 85237-1946 Acetaminophen ACETAMINOPHEN Sportpharm LLC 830ffcaa-7ff8-4732-bc84-6a8c5e78722d 2026-06-25 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Strategic Sourcing Services LLC ea2ef485-429e-4c63-ba7b-0a6b32892ad2 2026-06-25 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Chain Drug Marketing Association, Inc. 055d8420-c189-4a9e-acdc-21627935c8eb 2026-06-25 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Topco Associates, LLC 5f32cf74-dbea-496c-ba23-2040ea354f40 2026-06-25 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Salado Sales, Inc. cf3139a5-e36e-48e3-bb6c-e102b0cec555 2026-06-25 Warnings Exact identifier application number: M013 Pain Relief Aspirin ASPIRIN Rite Aid Corporation bd69d3d2-5d38-47c6-98a6-124f7a43b8b0 2026-06-25 Warnings Exact identifier application number: M013 Aspirin Regular Strength ASPIRIN Walgreen Company 0b27c0fd-7ea8-4588-9169-5ad4e8df77ef 2026-06-25 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN ARMY AND AIR FORCE EXCHANGE SERVICE e273ead7-7cbc-4fd5-a136-9d3558a35360 2026-06-24 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN CVS PHARMACY 5e35df92-6282-4ca6-902b-bb6bd326b487 2026-06-23 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN Orelli Inc. 4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d 2026-06-22 Warnings Exact identifier application number: M013 Pain Relief Aspirin Chewable, Low Dose ASPIRIN Rite Aid Corporation 65cdce0f-be04-43ba-8c68-bdce7983cfa1 2026-06-22 Warnings Exact identifier application number: M013 Aspirin Regimen ASPIRIN Cardinal Health 110, LLC. DBA Leader 88f425df-712d-4911-824b-94085c7190b6 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Meijer Distribution, Inc. 3716a7d4-a555-4e54-aa0a-7b8f3e32addb 2026-06-19 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DOLGENCORP, LLC acc94a3e-21b6-4375-9881-38cf9bab8692 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN L.N.K. International, Inc. 2f6ec676-3832-420e-be91-fce83f6586c8 2026-06-19 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE DOLGENCORP, LLC e1e24d52-0b4d-400b-8181-e3f6ab75c4f6 2026-06-18 Warnings Exact identifier application number: M013 Neo-Lubrina Children ACETAMINOPHEN OPMX LLC 5476f4cf-4a5d-2287-e063-6394a90a5ed5 2026-06-17 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Oncor Pharmaceuticals 4c396d0e-aa93-4f9e-b065-2e606f7f05cd 2026-06-17 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 85237-1946-1 85237194601 1 POUCH in 1 BLISTER PACK (85237-1946-1) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 1 pouch 2025-06-04 No No Current 85237-1946-2 85237194602 2 POUCH in 1 BLISTER PACK (85237-1946-2) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 2 pouch 2025-06-04 No No Current 85237-1946-3 85237194603 20 POUCH in 1 CARTON (85237-1946-3) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 20 pouch 2025-06-04 No No Current 85237-1946-4 85237194604 25 POUCH in 1 CARTON (85237-1946-4) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 25 pouch 2025-06-04 No No Current 85237-1946-5 85237194605 30 POUCH in 1 CARTON (85237-1946-5) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 30 pouch 2025-06-04 No No Current 85237-1946-6 85237194606 50 POUCH in 1 CARTON (85237-1946-6) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 50 pouch 2025-06-04 No No Current 85237-1946-7 85237194607 3 POUCH in 1 BLISTER PACK (85237-1946-7) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 3 pouch 2025-06-04 No No Current