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 62 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens pain reliefACETAMINOPHENPublix Super Markets Incde7dd4dc-c5df-4cac-a83a-b21a7637f3392024-10-02WarningsExact identifier
application number: M013
Good Neighbor Pharmacy childrens pain and feverACETAMINOPHENAmerisource Bergen6ba153b7-9dc9-4e42-9176-13b3922268bd2024-10-02WarningsExact identifier
application number: M013
equaline acetaminophenACETAMINOPHENUnited Natural Foods, Inc. dba UNFId418c676-03c3-4031-bbf4-8bf908d10e4c2024-10-02WarningsExact identifier
application number: M013
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporationf6e51c4b-2941-4862-8262-bd97163248412024-10-02WarningsExact identifier
application number: M013
Extra Strength PM Pain MedicineACETAMINOPHEN, DIPHENHYDRAMINE HCLAmerisource Bergen23fbda2b-885b-ce00-e063-6294a90a586e2024-10-01WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINProficient Rx LPe839bff7-779a-446d-8486-c0e0a1b6d6652024-10-01WarningsExact identifier
application number: M013
Aspirin Low Dose Chewable OrangeASPIRINProficient Rx LP9e08b91c-b067-4ccd-ae0d-01f48f992f202024-10-01WarningsExact identifier
application number: M013
Good Sense Pain ReliefACETAMINOPHENA-S Medication Solutionsd9bebb47-6ff4-4ddc-b48f-18f9423734842024-09-30WarningsExact identifier
application number: M013
basic care acetaminophenACETAMINOPHENAmazon.com Services LLC24fca5f8-1c08-4d1f-8e2c-dc274c4bcd792024-09-29WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENMeijer Distribution Inceef2fef5-34b3-4ac2-94cb-5bd6b4c5ab1c2024-09-27WarningsExact identifier
application number: M013
good sense childrens pain and feverACETAMINOPHENA-S Medication Solutionsce4ae43b-4ec2-42d1-b665-9114aaeb857e2024-09-26WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCd8aa3b1a-5f63-49db-998c-35cd11bd733f2024-09-25WarningsExact identifier
application number: M013
meijer LOW DOSE AspirinASPIRINMeijer, Inc.1bf12831-5d50-c1b4-e063-6394a90a69702024-09-24WarningsExact identifier
application number: M013
Good Sense Pain ReliefACETAMINOPHENL. Perrigo Company7f2038d3-9c95-4d83-b459-49ba8a3cd0ad2024-09-23WarningsExact identifier
application number: M013
pain relief extra strengthACETAMINOPHENPublix Super Markets Incdd01adcd-26a1-416e-92fc-8b6c0cc5512e2024-09-23WarningsExact identifier
application number: M013
Signature Care Pain ReliefACETAMINOPHENSafeway917bcd06-6dc6-42b3-80b4-c6746b3472612024-09-22WarningsExact identifier
application number: M013
equaline childrens acetaminophenACETAMINOPHENUnited Natural Foods, Inc. dba UNFI1e0cbb47-08f6-4afb-ad5a-6ce1b262ab972024-09-19WarningsExact identifier
application number: M013
ASPIRINASPIRINTARGET CORPORATION8ed252be-8fdb-3809-e053-2995a90a4b4f2024-09-19WarningsExact identifier
application number: M013
DoloDent Toothache For adultsACETAMINOPHEN, CAFFEINEPharmadel LLC1e7a0c06-ad3c-b94f-e063-6394a90abab12024-09-19WarningsExact identifier
application number: M013
foster and thrive childrens pain and feverACETAMINOPHENStrategic Sourcing Services LLC0a4b10e3-29df-40a5-a3fa-0e9beeadfbb42024-09-19WarningsExact 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