FDA.reportPublic FDA data

Tylenol Extra Strength

Product NDC
73097-012
Requested package NDC
73097-012-40
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 2 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAX relief juniorACETAMINOPHENAkron Pharma Inc.0e43b885-3843-4f11-9a53-02a38c2283132026-08-31WarningsExact identifier
application number: M013
MAX relief juniorCHILDREN ACETAMINOPHENAkron Pharma Inc.d7874e4d-0b38-4bb1-9a62-aa4f66d9baf92026-08-31WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDREN ACETAMINOPHENAkron Pharma Inc.3c7a7f40-4963-4fd1-942e-93fa08a458302026-08-31WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5a615118-33c9-1520-e063-6394a90a21a62026-08-31WarningsExact identifier
application number: M013
acetaminophen extra strengthACETAMINOPHENSam's West Incdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d2026-08-28WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINHAWAII REPACK, INC.ac94cce3-9a39-41de-bb8b-10a5e5b8e83b2026-08-28WarningsExact identifier
application number: M013
AspirinASPIRINWinCo Foods, LLCa0a19cd1-eb8a-4773-be00-78de90d2a3c32026-08-28WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENFSA STORE INC.5502ef15-9f40-db56-e063-6394a90a2de42026-08-26WarningsExact identifier
application number: M013
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreens3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d2026-08-26WarningsExact identifier
application number: M013
HyVee Extra Strength Headache Relief CAPLETACETAMINOPHEN, ASPIRIN, CAFFEINEHyVee Inc495c75bf-c09a-accd-e063-6294a90a75ec2026-08-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
application number: M013
equate aspirinASPIRINWal-Mart Stores Incea3f8eed-7b70-4156-9586-125d27bf29a82026-08-19WarningsExact identifier
application number: M013
aspirin chewable, low doseASPIRINUnited Natural Foods, Inc. dba UNFI6a6ac7fe-91a4-4b55-979a-b53b51505d8b2026-08-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSam's West Inc1098d0e7-8202-4018-a2d2-b0c80ee58b562026-08-19WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINESafeway, Inc.5e77dca4-2ff8-4a8c-94bd-f224b680ca232026-08-19WarningsExact identifier
application number: M013
dg health pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLDolgencorp Inc4d1eddf0-eff7-4c47-b312-30dee08d9e5f2026-08-19WarningsExact 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
73097-012-407309700124020 POUCH in 1 CARTON (73097-012-40) / 2 TABLET, FILM COATED in 1 POUCH20 pouch2019-07-220000-00-00NoNoCurrent