FDA.reportPublic FDA data

Tylenol Extra Strength

Product NDC
73097-012
Requested package NDC
73097-012-50
11-digit product format
730970012
Labeler code
73097
Product ID
73097-012_518f6c13-a0c6-5f9c-e063-6294a90a74d5
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Savings Distributors LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-22
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
8ed90757-833e-f4d9-e053-2995a90a29dbAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73097-012-022023-01-30C16284748780-1f386c649-c8c6-0266-e053-dadaa90a7c1aTylenol Extra Strength
73097-012-402023-01-30C16284748780-1f386c649-c8c6-0266-e053-dadaa90a7c1aTylenol Extra Strength
73097-012-502023-01-30C16284748780-1f386c649-c8c6-0266-e053-dadaa90a7c1aTylenol Extra Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73097-012-02Tylenol Extra Strength1 in 1 CARTONTABLET, FILM COATED13
73097-012-02Tylenol Extra Strength2 in 1 POUCHTABLET, FILM COATED23
73097-012-40Tylenol Extra Strength2 in 1 POUCHTABLET, FILM COATED23
73097-012-40Tylenol Extra Strength20 in 1 CARTONTABLET, FILM COATED203
73097-012-50Tylenol Extra Strength25 in 1 BOXTABLET, FILM COATED253
73097-012-50Tylenol Extra Strength2 in 1 POUCHTABLET, FILM COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73097-012TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SAVINGS DISTRIBUTORS LLC]1Current NDC, Legacy NDC, 6 package rows20190730_8ed90757-833e-f4d9-e053-2995a90a29db.zip

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 31 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreen Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALGREENSb48d93fe-bb60-493f-8d1a-b2dc864203c42025-12-01WarningsExact identifier
application number: M013
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWALGREEN CO.6c4ab613-a587-4ec4-9986-f1d000bc2d232025-12-01WarningsExact identifier
application number: M013
WAG HBP Daytime and Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEWALGREENS CO.ac2f9ce8-e402-4451-a412-e99248a6ecbe2025-12-01WarningsExact identifier
application number: M013
Walgreen Day Time NightTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE,GUAIFENESINWALGREENS CO.5505217a-9679-4668-bdab-5d4553a47c562025-12-01WarningsExact identifier
application number: M013
CAREALL AspirinASPIRINNew World Imports, Inc58a371d4-1f00-4fda-8e08-80610c58505a2025-12-01WarningsExact identifier
application number: M013
CareALL Non Aspirin Extra StrengthACETAMINOPHENNew World Imports, Incda05a1a1-35b4-4787-8c56-12e369f18ff02025-12-01WarningsExact identifier
application number: M013
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc80a699b9-bf5c-4765-9e20-ccbc7e3ace7a2025-12-01WarningsExact identifier
application number: M013
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc66244cdb-2680-4fa8-890d-32aefd4900382025-12-01WarningsExact identifier
application number: M013
Family Wellness Childrens Pain Reliever 574ACETAMINOPHENFamily Dollar Services, Inc.902c1136-04d2-41f0-81c6-412663cdf3782025-12-01WarningsExact identifier
application number: M013
WalgreenChildrens Pain FeverACETAMINOPHENWALGREENS CO.2f757cde-2604-4ca4-b54e-e444f3757cdd2025-11-26WarningsExact identifier
application number: M013
Walgreen Childrens Pain plus FeverACETAMINOPHENWALGREENS CO.29ca2855-3c07-435d-a8e1-2997fcedd0882025-11-26WarningsExact identifier
application number: M013
Walgreens Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.8714d4e6-3a3b-48c8-8ac1-51b933a2ceac2025-11-26WarningsExact identifier
application number: M013
Pain Reliever, 24/7 Life by 7-ElevenACETAMINOPHEN TABLET, FILM COATEDLil' Drug Store Products, Inc.44828b89-2563-b233-e063-6294a90ab1242025-11-26WarningsExact identifier
application number: M013
MEMBERS MARK ACETAMINOPHENACETAMINOPHENSam's West Inc03e831d4-8060-4633-9d02-e77100063fb42025-11-26WarningsExact identifier
application number: M013
Childrens Pain and Fever Dissolve PacksACETAMINOPHENWALGREENS CO.ea0f265f-7d64-4731-beda-0bb841dd1ad72025-11-25WarningsExact identifier
application number: M013
Sore Throat Logenzes Sore ThroatBENZOCAINE AND MENTHOLATLANTIC BIOLOGICALS CORP.71a80e13-bda3-40fb-b4e7-45e9985e707c2025-11-24WarningsExact identifier
application number: M013
Low Dose AspiriunASPIRINAMERIFOODS TRADING COMPANY3802c96a-5e2a-ba9c-e063-6394a90abb782025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC4227aeb1-dd2c-9ca1-e063-6294a90ad7092025-11-20WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENNuCare Pharamceuticals, Inc.440c13d7-edf0-f611-e063-6394a90af9952025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC4227a2cc-69fa-869d-e063-6294a90a1d412025-11-20WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN8ed90757-833e-f4d9-e053-2995a90a29db3
209459Tylenol Extra Strength 500 MG Oral TabletPSN8ed90757-833e-f4d9-e053-2995a90a29db3
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD8ed90757-833e-f4d9-e053-2995a90a29db3
198440acetaminophen 500 MG Oral TabletSCD8ed90757-833e-f4d9-e053-2995a90a29db3
198440APAP 500 MG Oral TabletSY8ed90757-833e-f4d9-e053-2995a90a29db3
209459APAP 500 MG Oral Tablet [Tylenol]SY8ed90757-833e-f4d9-e053-2995a90a29db3
209459Tylenol 500 MG Oral TabletSY8ed90757-833e-f4d9-e053-2995a90a29db3
209459Tylenol Extra Strength 500 MG Oral TabletSY8ed90757-833e-f4d9-e053-2995a90a29db3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73097-012-507309700125025 POUCH in 1 BOX (73097-012-50) / 2 TABLET, FILM COATED in 1 POUCH25 pouch2019-07-220000-00-00NoNoCurrent