FDA.reportPublic FDA data

Pain Reliever

Product NDC
0363-0519
11-digit product format
003630519
Labeler code
0363
Product ID
0363-0519_47a1e1b6-6aea-4562-8c40-bcf5bfe79e4c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Walgreen Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-05-10
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0363-05190363-0519-19DDiscontinued by firm2026-10-12
excluded packagepackage0363-05190363-0519-20DDiscontinued by firm2026-10-12
excluded packagepackage0363-05190363-0519-29DDiscontinued by firm2026-10-12
excluded packagepackage0363-05190363-0519-54DDiscontinued by firm2026-10-12

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 · 48 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050363-0519-54d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050363-0519-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050363-0519-19d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050363-0519-29d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260363-0519-54f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260363-0519-29f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260363-0519-19f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260363-0519-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310363-0519-542ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310363-0519-292ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310363-0519-192ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310363-0519-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280363-0519-54a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280363-0519-29a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280363-0519-19a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280363-0519-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210363-0519-54cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210363-0519-29cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210363-0519-19cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210363-0519-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100363-0519-54cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100363-0519-29cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100363-0519-19cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100363-0519-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310363-0519-54302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310363-0519-29302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310363-0519-19302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310363-0519-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200363-0519-54ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200363-0519-29ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200363-0519-19ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200363-0519-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100363-0519-540efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100363-0519-290efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100363-0519-190efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100363-0519-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080363-0519-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080363-0519-29ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080363-0519-54ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080363-0519-19ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030363-0519-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030363-0519-29367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030363-0519-54367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030363-0519-19367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090363-0519-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090363-0519-29557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090363-0519-54557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090363-0519-19557ba5c1ecfa…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
Pain Reliever
Brand name suffix
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fa33f6ef-522b-4630-9716-92371d9cd24aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0519-08Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED124
0363-0519-08Pain RelieverExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED2424
0363-0519-12Pain RelieverExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED10024
0363-0519-12Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED124
0363-0519-15Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED124
0363-0519-15Pain RelieverExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED5024
0363-0519-19Pain RelieverExtra Strength8 in 1 VIALTABLET, COATED824
0363-0519-19Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED124
0363-0519-20Pain RelieverExtra Strength225 in 1 BOTTLE, PLASTICTABLET, COATED22524
0363-0519-20Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED124
0363-0519-29Pain RelieverExtra Strength150 in 1 BOTTLE, PLASTICTABLET, COATED15024
0363-0519-37Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED124
0363-0519-37Pain RelieverExtra Strength75 in 1 BOTTLE, PLASTICTABLET, COATED7524
0363-0519-54Pain RelieverExtra Strength375 in 1 BOTTLE, PLASTICTABLET, COATED37524
0363-0519-92Pain RelieverExtra Strength150 in 1 BOTTLE, PLASTICTABLET, COATED15024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0519-08EA - Each0363-05199a69870d-fdb2-4bc4-8a04-1bf8f981ae4212012-07-24
0363-0519-12EA - Each0363-05193e513c0c-aedd-48d9-bcf5-603984d6f23812012-07-24
0363-0519-15EA - Each0363-0519beabd538-bc4f-4d80-a59a-8a7884e4992412012-07-24
0363-0519-19EA - Each0363-05194dd1144b-a6a2-44da-a280-f0e95c92346612012-07-24
0363-0519-20EA - Each0363-0519ca07599c-a398-4321-be29-e16da39195a112012-07-24
0363-0519-29EA - Each0363-05193b4f0f1a-ebe6-4702-ba0b-70a0324c373a12012-07-24
0363-0519-54EA - Each0363-051968c192ff-03d2-4c02-a129-310a1134b99a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9
GELATININACTIVE INGREDIENT2G86QN327LPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0519PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [WALGREEN COMPANY]23Current NDC, Legacy NDC, 15 package rows20250104_fa33f6ef-522b-4630-9716-92371d9cd24a.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 7 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFANTS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC112076c4-cac2-45ab-9c77-5573edae71802026-07-10WarningsExact identifier
application number: M013
AspirinASPIRINWal-Mart Stores Inc8ae16aa2-54bc-4c1a-aa36-93524199a67b2026-07-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWildman Business Group943c8f49-e65e-40bc-b364-3274df4d21a22026-07-09WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINFOODHOLD U.S.A., LLC9e09b4fb-e015-45ea-8b1c-27faf65572aa2026-07-09WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEWalgreen Companyf13fb7e9-50ea-4e2c-a442-38b1b5b315d72026-07-09WarningsExact identifier
application number: M013
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETSHealth Pharma USA LLC34eb8a9b-d0ee-13e8-e063-6294a90a2fef2026-07-08WarningsExact identifier
application number: M013
Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mgACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MGHealth Pharma USA LLC3590d417-272b-ae4d-e063-6394a90a5dc62026-07-08WarningsExact identifier
application number: M013
GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHENACETAMINOPHENCabinet Health P.B.C.88884253-5a79-4ac1-b8ce-03966d8b509d2026-07-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHealth Pharma USA LLC671adabe-5f82-4599-a133-3f67ccb340792026-07-07WarningsExact identifier
application number: M013
Pain Reliever PlusACETAMINOPHEN, ASPIRIN, CAFFEINERugby Laboratoriesc3df1652-96a8-6043-e053-2995a90a2d262026-07-07WarningsExact identifier
application number: M013
Rapidol AspirinASPIRINPharmadel LLC00d9ab0d-ff25-784f-e063-6294a90a84972026-07-06WarningsExact identifier
application number: M013
AspirinASPIRINTrifecta Pharmaceuticals USA LLC227cefca-acc4-41d0-e063-6394a90a35b92026-07-06WarningsExact identifier
application number: M013
Extra Strength Pain AidACETAMINOPHEN, ASPIRIN, CAFFEINEHi-Tech Nutaceuticals, LLCa39e4b99-700d-0f5c-e053-2a95a90a6bd32026-07-06WarningsExact identifier
application number: M013
Nighttime Sleep AidACETAMINOPHEN, DIPHENHYDRAMINEHi-Tech Nutraceuticals, LLCa39e2bd6-3d0a-642b-e053-2995a90a42a02026-07-06WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa36be487-7a36-550f-e053-2a95a90a95c12026-07-06WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa39c524e-c131-d7fb-e053-2995a90a785b2026-07-06WarningsExact identifier
application number: M013
PAIN RELIEVERASPIRIN 81 MGHealth Pharma USA, LLCd60aed37-3a9e-46d1-e053-2995a90a1d1f2026-07-06WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESelect Consumer Group55d0dceb-c9a9-778e-e063-6294a90a2ad72026-07-04WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINSelect Consumer Group3ca776c2-47ed-5107-e063-6394a90ac5df2026-07-03WarningsExact identifier
application number: M013
AspirinASPIRINRugby Laboratoriesf7ca9f4a-f8ef-46d2-9536-b69541e6653d2026-07-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNfa33f6ef-522b-4630-9716-92371d9cd24a24
198440acetaminophen 500 MG Oral TabletSCDfa33f6ef-522b-4630-9716-92371d9cd24a24
198440APAP 500 MG Oral TabletSYfa33f6ef-522b-4630-9716-92371d9cd24a24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0519-08003630519081 BOTTLE, PLASTIC in 1 CARTON (0363-0519-08) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent
0363-0519-12003630519121 BOTTLE, PLASTIC in 1 CARTON (0363-0519-12) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent
0363-0519-15003630519151 BOTTLE, PLASTIC in 1 CARTON (0363-0519-15) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent
0363-0519-19003630519198 in 1 VIALHistorical
0363-0519-20003630519201 BOTTLE, PLASTIC in 1 CARTON (0363-0519-20) > 225 TABLET in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent
0363-0519-2900363051929150 TABLET in 1 BOTTLE (0363-0519-29) 150 tablet2004-05-100000-00-00NoNoCurrent
0363-0519-37003630519371 BOTTLE, PLASTIC in 1 CARTON (0363-0519-37) / 75 TABLET, COATED in 1 BOTTLE, PLASTIC2024-12-30NoNoCurrent
0363-0519-5400363051954375 TABLET in 1 BOTTLE, PLASTIC (0363-0519-54) 375 tablet2004-05-100000-00-00NoNoCurrent
0363-0519-9200363051992150 TABLET, COATED in 1 BOTTLE, PLASTIC (0363-0519-92) 2004-05-100000-00-00NoNoCurrent