Tylenol Extra Strength

Product NDC
73097-012
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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage73097-012-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage73097-012-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage73097-012-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73097-012-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73097-012-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73097-012-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73097-012-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73097-012-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73097-012-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73097-012-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73097-012-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73097-012-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73097-012-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73097-012-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73097-012-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73097-012-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73097-012-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73097-012-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage73097-012-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage73097-012-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage73097-012-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73097-012-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73097-012-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73097-012-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73097-012-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73097-012-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73097-012-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage73097-012-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage73097-012-40ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage73097-012-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage73097-012-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage73097-012-40367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage73097-012-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage73097-012-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage73097-012-40557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage73097-012-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage73097-012-508af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage73097-012-408af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage73097-012-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage73097-012-50834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage73097-012-40834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage73097-012-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage73097-012-501332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage73097-012-401332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage73097-012-021332a3947898…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 9 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Kids Pain and FeverACETAMINOPHENCalmCo LLC5534a784-a7b1-5599-e063-6294a90a79612026-06-27WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENSelect Consumer Group LLC529d3a51-a248-7c02-e063-6294a90a10ae2026-06-27WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSportpharm LLC830ffcaa-7ff8-4732-bc84-6a8c5e78722d2026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINStrategic Sourcing Services LLCea2ef485-429e-4c63-ba7b-0a6b32892ad22026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINChain Drug Marketing Association, Inc.055d8420-c189-4a9e-acdc-21627935c8eb2026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINTopco Associates, LLC5f32cf74-dbea-496c-ba23-2040ea354f402026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINSalado Sales, Inc.cf3139a5-e36e-48e3-bb6c-e102b0cec5552026-06-25WarningsExact identifier
application number: M013
Pain Relief AspirinASPIRINRite Aid Corporationbd69d3d2-5d38-47c6-98a6-124f7a43b8b02026-06-25WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINWalgreen Company0b27c0fd-7ea8-4588-9169-5ad4e8df77ef2026-06-25WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINARMY AND AIR FORCE EXCHANGE SERVICEe273ead7-7cbc-4fd5-a136-9d3558a353602026-06-24WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENCVS PHARMACY5e35df92-6282-4ca6-902b-bb6bd326b4872026-06-23WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENOrelli Inc.4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d2026-06-22WarningsExact identifier
application number: M013
Pain Relief Aspirin Chewable, Low DoseASPIRINRite Aid Corporation65cdce0f-be04-43ba-8c68-bdce7983cfa12026-06-22WarningsExact identifier
application number: M013
Aspirin RegimenASPIRINCardinal Health 110, LLC. DBA Leader88f425df-712d-4911-824b-94085c7190b62026-06-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINMeijer Distribution, Inc.3716a7d4-a555-4e54-aa0a-7b8f3e32addb2026-06-19WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDOLGENCORP, LLCacc94a3e-21b6-4375-9881-38cf9bab86922026-06-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINL.N.K. International, Inc.2f6ec676-3832-420e-be91-fce83f6586c82026-06-19WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEDOLGENCORP, LLCe1e24d52-0b4d-400b-8181-e3f6ab75c4f62026-06-18WarningsExact identifier
application number: M013
Neo-Lubrina ChildrenACETAMINOPHENOPMX LLC5476f4cf-4a5d-2287-e063-6394a90a5ed52026-06-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENOncor Pharmaceuticals4c396d0e-aa93-4f9e-b065-2e606f7f05cd2026-06-17WarningsExact 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
73097-012-02730970012021 POUCH in 1 CARTON (73097-012-02) / 2 TABLET, FILM COATED in 1 POUCH1 pouch2019-07-220000-00-00NoNoCurrent
73097-012-407309700124020 POUCH in 1 CARTON (73097-012-40) / 2 TABLET, FILM COATED in 1 POUCH20 pouch2019-07-220000-00-00NoNoCurrent
73097-012-507309700125025 POUCH in 1 BOX (73097-012-50) / 2 TABLET, FILM COATED in 1 POUCH25 pouch2019-07-220000-00-00NoNoCurrent