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 firm2026-10-16
excluded packagepackage0363-05190363-0519-20DDiscontinued by firm2026-10-16
excluded packagepackage0363-05190363-0519-29DDiscontinued by firm2026-10-16
excluded packagepackage0363-05190363-0519-54DDiscontinued 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 · 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 27 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREENS CO.d92d97a8-0ee3-1206-e053-2a95a90a72a82025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSAM'S WEST INC0c8e7095-0806-4501-e063-6394a90a89aa2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREEN CO.b3763182-2428-155a-e053-2995a90ab5782025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREENSe467b78e-9f23-5563-e053-2a95a90a586e2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWalgreensfd7c3250-35d4-494a-e053-6394a90a2db52025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INC1ddb8a2b-3081-3eda-e063-6294a90ab82b2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCb1307d52-10e6-46e1-e053-2995a90a03b62025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCc2c6d6a1-b492-506d-e053-2995a90aac232025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENFAMILY DOLLARf8383108-0970-9f1e-e053-6294a90ad38f2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC591ee107-e953-4982-b75f-13a0afd7c4ae2025-12-19WarningsExact identifier
application number: M013
Nuvicare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENUVICARE LLC3ede0fb6-c089-4253-9878-2b01c39e9c872025-12-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINNUVICARE LLC3a4aa3c7-b726-4303-8803-74196fa5637a2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e2025-12-19WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINENUVICARE LLC32a5611b-9bf6-4850-a7ff-fa240da04f452025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e96d0-746e-fb42-e053-2a95a90a19572025-12-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e5dc0-96eb-47b2-e053-2995a90add0e2025-12-18WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.ac0f8d5c-d200-1156-e053-2a95a90aece62025-12-18WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe55645ab-66f9-4160-8247-395bc5b027112025-12-18WarningsExact identifier
application number: M013
Dolex ForteACETAMINOPHEN, ASPIRIN, CAFFEINEPharmadel LLC3c2d90fc-130d-476c-e063-6294a90a8c152025-12-17WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company07bc6632-fabb-427d-81f3-c27c54caa6a02025-12-17WarningsExact 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