TYLENOL EXTRA STRENGTH

Product NDC
66715-9747
11-digit product format
667159747
Labeler code
66715
Product ID
66715-9747_460387da-80ba-42ee-e063-6394a90a5957
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-09
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage66715-974766715-9747-1DDiscontinued by firm2026-10-16

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 · 12 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…

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
2026-12-31

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
fa951d50-b79c-4161-8c81-fcf386b0964eAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-9747-1TYLENOL EXTRA STRENGTH1 in 1 CARTONTABLET, COATED111
66715-9747-1TYLENOL EXTRA STRENGTH2 in 1 POUCHTABLET, COATED211
66715-9747-2TYLENOL EXTRA STRENGTH2 in 1 CARTONTABLET, COATED211
66715-9747-2TYLENOL EXTRA STRENGTH2 in 1 POUCHTABLET, COATED211
66715-9747-3TYLENOL EXTRA STRENGTH2 in 1 POUCHTABLET, COATED211
66715-9747-3TYLENOL EXTRA STRENGTH3 in 1 CARTONTABLET, COATED311
66715-9747-7TYLENOL EXTRA STRENGTH30 in 1 CARTONTABLET, COATED3011
66715-9747-7TYLENOL EXTRA STRENGTH2 in 1 POUCHTABLET, COATED211
66715-9747-8TYLENOL EXTRA STRENGTH2 in 1 POUCHTABLET, COATED211
66715-9747-8TYLENOL EXTRA STRENGTH25 in 1 BOX, UNIT-DOSETABLET, COATED2511
66715-9747-9TYLENOL EXTRA STRENGTH2 in 1 POUCHTABLET, COATED211
66715-9747-9TYLENOL EXTRA STRENGTH30 in 1 BOX, UNIT-DOSETABLET, COATED3011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
AcetaminophenACTIVE MOIETY362O9ITL9DTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
castor oilINACTIVE INGREDIENTD5340Y2I9GTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOATYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ATYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
powdered celluloseINACTIVE INGREDIENTSMD1X3XO9MTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
shellacINACTIVE INGREDIENT46N107B71OTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9747TYLENOL EXTRA STRENGTH, TRAVEL BASIX (ACETAMINOPHEN) TABLET, COATED TYLENOL EXTRA STRENGTH, CVP HEALTH (ACETAMINOPHEN) TABLET, COATED TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]10Current NDC, Legacy NDC, 12 package rows20240120_fa951d50-b79c-4161-8c81-fcf386b0964e.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 22 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC01f41fae-4abb-4b96-ab09-a7d3dfc286cd2026-01-26WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENMeijer Distribution Incec4dbb71-b507-42a3-9b68-14d4b6621ec12026-01-23WarningsExact identifier
application number: M013
Adult Low Dose AspirinASPIRINNCS HealthCare of KY, LLC dba Vangard Labs9105eff0-1c22-4298-8ee5-9fb7a1de12f12026-01-23WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENPreferred Pharmaceuticals Inc.c70e3b8e-071d-4b9a-9393-ad8aa09c6b6e2026-01-22WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC17cfa99d-abb2-4d77-9e0e-e77109fbb61a2026-01-21WarningsExact identifier
application number: M013
Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mgACETAMINOPHEN 250 MG, ASPIRIN 250 MG, AND CAFFEINE 65 MGFarmacias De Similares TX LLC48ea0a2c-511b-4805-e063-6394a90a12252026-01-21WarningsExact identifier
application number: M013
childrens mapapACETAMINOPHENMajor Pharmaceuticalsa1b0ccf0-cf24-4b34-b42a-aa1cc1e57f602026-01-20WarningsExact identifier
application number: M013
EXTRA STRENGTH ACETAMINOPHENACETAMINOPHENWALGREENS CO.9b756e4e-6c56-43aa-a5bc-5b649440e7592026-01-20WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEVER PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWALGREENS CO.5a58d620-a0ec-48d7-92dd-3f3f78ec10ea2026-01-20WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWal-Mart Stores Incd4e438c6-80dd-4531-91e6-bc4ca7a8570f2026-01-20WarningsExact identifier
application number: M013
Unishield Extra Strength Non-AspirinACETAMINOPHENUnishieldba0ec1eb-db85-6a7f-e053-2995a90aafe52026-01-19WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENHyVee Inc24acd62f-72b1-418a-b733-7e4888f3c0a32026-01-16WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCardinal Health 110, LLC. DBA Leaderdd8b13a5-07df-4cec-92c3-1a662b1e1a562026-01-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS7d8f8389-730d-494e-a0af-5a91a3c99e172026-01-16WarningsExact identifier
application number: M013
TENSION HEADACHE RELIEFACETAMINOPHEN AND CAFFEINEWALGREENS54aff6a0-2778-472f-90ba-375d6bce6ee82026-01-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS097fbab7-3886-4e75-b037-f03adcf3859f2026-01-16WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS CO.bdb09e15-8e17-4987-99d0-bab8856a21092026-01-16WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst4870ff00-f727-814d-e063-6394a90a6c8e2026-01-15WarningsExact identifier
application number: M013
AspirinASPIRINHyVee Inc957b13a4-4086-459f-8fa0-9708b317fabe2026-01-15WarningsExact identifier
application number: M013
Unisom PM Pain Nighttime Sleep Aid and Pain RelieverACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEChattem, Inc.451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb2026-01-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNfa951d50-b79c-4161-8c81-fcf386b0964e11
209459Tylenol Extra Strength 500 MG Oral TabletPSNfa951d50-b79c-4161-8c81-fcf386b0964e11
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBDfa951d50-b79c-4161-8c81-fcf386b0964e11
198440acetaminophen 500 MG Oral TabletSCDfa951d50-b79c-4161-8c81-fcf386b0964e11
198440APAP 500 MG Oral TabletSYfa951d50-b79c-4161-8c81-fcf386b0964e11
209459APAP 500 MG Oral Tablet [Tylenol]SYfa951d50-b79c-4161-8c81-fcf386b0964e11
209459Tylenol 500 MG Oral TabletSYfa951d50-b79c-4161-8c81-fcf386b0964e11
209459Tylenol Extra Strength 500 MG Oral TabletSYfa951d50-b79c-4161-8c81-fcf386b0964e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9747-1667159747011 POUCH in 1 CARTON (66715-9747-1) > 2 TABLET, COATED in 1 POUCH1 pouch2018-04-160000-00-00NoNoCurrent
66715-9747-2667159747022 POUCH in 1 CARTON (66715-9747-2) / 2 TABLET, COATED in 1 POUCH2 pouch2019-04-130000-00-00NoNoCurrent
66715-9747-3667159747033 POUCH in 1 CARTON (66715-9747-3) / 2 TABLET, COATED in 1 POUCH3 pouch2018-06-290000-00-00NoNoCurrent
66715-9747-76671597470730 POUCH in 1 CARTON (66715-9747-7) / 2 TABLET, COATED in 1 POUCH30 pouch2018-04-090000-00-00NoNoCurrent
66715-9747-86671597470825 POUCH in 1 BOX, UNIT-DOSE (66715-9747-8) / 2 TABLET, COATED in 1 POUCH25 pouch2022-04-192028-08-12NoNoHistorical
66715-9747-96671597470930 POUCH in 1 BOX, UNIT-DOSE (66715-9747-9) / 2 TABLET, COATED in 1 POUCH30 pouch2022-04-19NoNoCurrent