Extra Strength Pain Reliever

Product NDC
0363-0684
11-digit product format
003630684
Labeler code
0363
Product ID
0363-0684_5d4d0228-36e7-15ac-e063-6294a90af9db
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
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0684-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0684-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0684-050efc9e666f02…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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0684-05Extra Strength Pain Reliever1 in 1 CARTONTABLET14
0363-0684-05Extra Strength Pain Reliever50 in 1 BOTTLETABLET504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0684EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN TABLETS 500 MG) TABLET [WALGREENS]4Current NDC, Legacy NDC, 2 package rows20250210_c25bcfdc-3119-0e8e-e053-2995a90a9e49.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 57 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
foster and thrive pain relieverACETAMINOPHENStrategic Sourcing Services LLC338021bd-b92b-45eb-a4b8-bc4a100ab7182024-11-06WarningsExact identifier
application number: M013
basic care headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmazon.com Services LLCf85d2f4c-8184-4555-a310-3979722e860b2024-11-05WarningsExact identifier
application number: M013
MENSTRUAL COMPLETEMENSTRUAL COMPLETEAllegiant Healthd197b886-67e4-4aba-8582-305576c076042024-11-05WarningsExact identifier
application number: M013
dg health headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp Incddf40cc4-d73f-4460-be72-9486134329a72024-11-05WarningsExact identifier
application number: M013
DOLO- NeuroBion Acetaminophen 500mgACETAMINOPHENBENARD INDUSTRIES INC16f8415d-8190-4212-b487-c0caf7d3bee22024-11-04WarningsExact identifier
application number: M013
basic care acetaminophenACETAMINOPHENAmazon.com Services LLC8c3343ee-d7b6-496d-9702-6736539a72702024-11-02WarningsExact identifier
application number: M013
dg health pain reliefACETAMINOPHENDolgencorp, LLC382fa2cc-1c39-4bee-b528-08b11ec945af2024-11-02WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENBryant Ranch Prepackf7e20527-1d4b-434c-997b-3eb8211fdaa12024-11-01WarningsExact identifier
application number: M013
Aspirin Enteric Safety CoatedASPIRINPublix Supermarkets, Inc.a661a9ed-9b31-46b1-aafb-61d1ba8a49182024-11-01WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENBryant Ranch Prepack614e69c7-d3cb-4d47-9603-c1c14b87544c2024-11-01WarningsExact identifier
application number: M013
infants fever reducer and pain relieverACETAMINOPHENRite Aid Corporationbaee03b8-fcfd-440e-90ea-1ee2a18516ef2024-11-01WarningsExact identifier
application number: M013
good neighbor pharmacy infants pain and feverACETAMINOPHENAmerisource Bergenbfb954b7-3a79-4bca-95e8-d39e1074b07f2024-11-01WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEVERACETAMINOPHEN, ASPIRIN AND CAFFEINEProficient Rx LPbf365bfc-35cc-47f9-a50b-ff2b38d7316b2024-11-01WarningsExact identifier
application number: M013
Infants Pain ReliefACETAMINOPHENPublix Super Markets Inc0bc33897-afc2-4d11-be6c-a26480f448bf2024-10-31WarningsExact identifier
application number: M013
equate infants pain and feverACETAMINOPHENWALMART INC.34b2512e-743b-45db-92cb-ea05e2f47b3d2024-10-31WarningsExact identifier
application number: M013
foster and thrive infants pain and feverACETAMINOPHENStrategic Sourcing Services LLC45770ad6-9bf7-41bd-a724-e5260cd31fa12024-10-31WarningsExact identifier
application number: M013
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLETLil' Drug Store Products, Inc.d20425a4-f074-4154-e053-2995a90ae9fd2024-10-30WarningsExact identifier
application number: M013
up and up infants acetaminophenACETAMINOPHENTarget Corporation31104956-04d7-41b5-82be-219ded5c02a92024-10-30WarningsExact identifier
application number: M013
Sunmark AspirinASPIRINStrategic Sourcing Services LLCa7139686-b351-47dc-a395-832429aaa5692024-10-30WarningsExact identifier
application number: M013
Good Neighbor Pharmacy Pain ReliefACETAMINOPHENAmerisource Bergen5101125d-4819-4e4b-a0ee-a0ff8d5a0ab12024-10-30WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNc25bcfdc-3119-0e8e-e053-2995a90a9e494
198440acetaminophen 500 MG Oral TabletSCDc25bcfdc-3119-0e8e-e053-2995a90a9e494
198440APAP 500 MG Oral TabletSYc25bcfdc-3119-0e8e-e053-2995a90a9e494

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0684-05003630684051 BOTTLE in 1 CARTON (0363-0684-05) / 50 TABLET in 1 BOTTLE1 bottle2021-10-130000-00-00NoNoCurrent