FDA.reportPublic FDA data

Extra Strength Pain Reliever

Product NDC
0363-0669
Requested package NDC
0363-0669-01
11-digit product format
003630669
Labeler code
0363
Product ID
0363-0669_2ce99cb7-fea1-5da2-e063-6294a90afc4e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen tablets 500 mg
Dosage form
TABLET
Route
ORAL
Labeler
WALGREENS
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-13
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-06690363-0669-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-06690363-0669-01UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-06690363-0669-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Extra Strength Pain Reliever
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
c25bfe92-0196-0489-e053-2995a90abea1Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0669-012025-02-11C16284748780-12cef2736-5a69-d83d-e063-dadaa90ab31f342R 0363 0669 Walgreens Acetaminophen 500 mg 100s
0363-0669-012025-01-30C16284748780-12cef2736-5a69-d83d-e063-dadaa90ab31f342R 0363 0669 Walgreens Acetaminophen 500 mg 100s

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0669-01Extra Strength Pain Reliever100 in 1 BOTTLETABLET1004
0363-0669-01Extra Strength Pain Reliever1 in 1 CARTONTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0669EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN TABLETS 500 MG) TABLET [WALGREENS]4Current NDC, Legacy NDC, 2 package rows20250213_c25bfe92-0196-0489-e053-2995a90abea1.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 53 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
St. Joseph Chewable Low Dose AspirinASPIRINFoundation Consumer Healthcare LLC248cd302-e380-4837-bdae-9df620b67e8a2024-12-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAAA Pharmaceutical, Inc.2d98e390-4f2a-41cc-b307-3d2f6a3700dd2024-12-02WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.409b5fcd-5880-4dda-85d8-26aeceb4f8ab2024-12-02WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.c0c31523-c4c5-43c2-8d72-4d1456c720e92024-12-02WarningsExact identifier
application number: M013
NOTTS - Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLCe6754f62-e3b2-773f-e053-2a95a90ad36a2024-12-02WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.a891896d-c9fa-4448-915a-e6b531157d222024-12-02WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENSAFEWAYd2d15e06-e9eb-3d2b-e053-2995a90a1cec2024-12-02WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENTopCo Associates LLCc2d33352-431c-4683-a4fa-a54437e7b8d22024-12-02WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENTopCo Associates LLCbdb01b3e-ad34-4003-9b9a-e83a2c0e90bb2024-12-02WarningsExact identifier
application number: M013
Aspirin 81mg Adult Low DoseASPIRINTopCare14d010fb-c4a1-4c3d-942f-58719727bfc02024-12-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS Pharmacy, Incc4473ee6-4e01-1ec2-e053-2995a90ac5132024-12-02WarningsExact identifier
application number: M013
AspirinASPIRINProficient Rx LP9c186289-e309-45e8-8934-1d0eae0375c22024-12-01WarningsExact identifier
application number: M013
Childrens Chewable AcetaminophenACETAMINOPHENGERI-CARE PHARMACEUTICAL CORP22f63d62-c941-5b8f-e063-6394a90aeecd2024-11-28WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp7a7b6318-b7d6-31b1-e053-2991aa0abf252024-11-28WarningsExact identifier
application number: M013
Extra Strength Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLINGLES MARKETS, INC.27fd288e-c07a-617f-e063-6394a90a17a42024-11-28WarningsExact identifier
application number: M013
BAYER Aspirin Original, TRAVEL BASIXASPIRINLil' Drug Store Products, Inc.7f5d9ebe-8119-49a2-9380-eca18a5e5e852024-11-27WarningsExact identifier
application number: M013
EXCEDRIN MIGRAINEACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINEJones Healthcare Group - Packaging Services, Incc4168e4d-3dfc-4e51-a32e-14704cb59c662024-11-27WarningsExact identifier
application number: M013
TYLENOL Extra Strength / TYLENOL Precise Cooling Pain ReliefACETAMINOPHEN, LIDOCAINE, MENTHOLKenvue Brands LLC2611e984-0dd5-bda1-e063-6394a90a559a2024-11-26WarningsExact identifier
application number: M013
First Aid Only Extra-Strength Non-AspirinACETAMINOPHENAcme United Corporation6891d57a-10a6-53de-e053-2a91aa0ac7c22024-11-26WarningsExact identifier
application number: M013
Chewable AspirinASPIRINMARC GLASSMAN, INC.c8314910-71ff-5a55-e053-2995a90aafc72024-11-26WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNc25bfe92-0196-0489-e053-2995a90abea14
198440acetaminophen 500 MG Oral TabletSCDc25bfe92-0196-0489-e053-2995a90abea14
198440APAP 500 MG Oral TabletSYc25bfe92-0196-0489-e053-2995a90abea14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0669-01003630669011 BOTTLE in 1 CARTON (0363-0669-01) / 100 TABLET in 1 BOTTLE1 bottle2021-10-130000-00-00NoNoCurrent