FDA.reportPublic FDA data

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
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup
209459Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
529d3a51-a248-7c02-e063-6294a90a10aeAvailable on FDA.report

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 19 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
M-PAPACETAMINOPHENBryant Ranch Prepackc6cec390-004e-45f6-9388-c662a979f37d2026-03-17WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINChain Drug Marketing Association, Inc.b32ada58-a098-47d2-9ed2-4d59186577092026-03-16WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLH E B21a4cc76-a7cb-4d11-bd1b-7d5c6a332f2a2026-03-16WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLTopco Associates, LLCeaa98783-5800-4ae9-832f-f4a1fd1790fd2026-03-16WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINWalgreen Company413b3b95-2867-4534-8290-54f477cccf1e2026-03-16WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGrocery Outlet, Inc.4454d02a-ba49-6c8c-e063-6294a90a47092026-03-12WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRINCVS Pharmacyc55304be-bfc0-46a8-a37e-2e6ba90983942026-03-12WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENAmerisource Bergenc280ac64-920c-4d03-9190-03e0196ed5ef2026-03-11WarningsExact identifier
application number: M013
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLC4cc4b39a-39d5-a2bb-e063-6394a90a2e952026-03-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd79828d8-9279-4ae9-8872-aeca641be5d92026-03-10WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINPreferred Pharmaceuticals Inc.1b5b8bb1-c45d-48f0-b275-9ce1f769fed42026-03-09WarningsExact identifier
application number: M013
foster and thrive childrens pain and feverACETAMINOPHENStrategic Sourcing Services LLCe495a27e-eb64-4c42-8942-43bab99181722026-03-07WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS PHARMACY67a190c3-7de0-4f57-be94-d6b8285e12202026-03-06WarningsExact identifier
application number: M013
Back and Body Pain ReliefASPIRIN, CAFFEINEWinCo Foods, LLCcf5c15e9-c45d-4bd6-a887-fd74de5f81b92026-03-06WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENTopco Associates, LLC87af092c-99e6-475d-81af-b9fd8fc337d72026-03-06WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINRite Aid Corporation879e2258-f61b-47ad-a4b1-7d1e788235702026-03-05WarningsExact identifier
application number: M013
AspirinASPIRINARMY AND AIR FORCE EXCHANGE SERVICE87c580d3-6009-4be9-aea7-13539fbe6e312026-03-05WarningsExact identifier
application number: M013
Aspirin Low Dose Chewable OrangeASPIRINMAJOR PHARMACEUTICALSfb3a8e38-e991-49c9-93dc-1d29c0a97ba32026-03-05WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENKroger41e149df-4140-95cc-e063-6294a90a866b2026-03-03WarningsExact identifier
application number: M013
Medique Pain OffACETAMINOPHEN, ASPIRIN, CAFFEINESportpharm LLC2b35acdc-ff88-46e6-a108-5240aac1d53f2026-03-03WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85237-1946-1852371946011 POUCH in 1 BLISTER PACK (85237-1946-1) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 1 pouch2025-06-04NoNoCurrent
85237-1946-2852371946022 POUCH in 1 BLISTER PACK (85237-1946-2) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 2 pouch2025-06-04NoNoCurrent
85237-1946-38523719460320 POUCH in 1 CARTON (85237-1946-3) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 20 pouch2025-06-04NoNoCurrent
85237-1946-48523719460425 POUCH in 1 CARTON (85237-1946-4) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 25 pouch2025-06-04NoNoCurrent
85237-1946-58523719460530 POUCH in 1 CARTON (85237-1946-5) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 30 pouch2025-06-04NoNoCurrent
85237-1946-68523719460650 POUCH in 1 CARTON (85237-1946-6) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 50 pouch2025-06-04NoNoCurrent
85237-1946-7852371946073 POUCH in 1 BLISTER PACK (85237-1946-7) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 3 pouch2025-06-04NoNoCurrent