FDA.reportPublic FDA data

Extra Strength Pain Reliever

Product NDC
0363-0531
Requested package NDC
0363-0531-12
11-digit product format
003630531
Labeler code
0363
Product ID
0363-0531_026e53b6-1003-49ac-aabd-97ac7a6d6b61
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2005-12-11
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage0363-05310363-0531-12DDiscontinued by firm2026-10-05

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 · 11 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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0531-12EA - Each0363-0531061bc919-42f8-4445-b432-83d24259d95f12013-06-04
0363-0531-15EA - Each0363-05313d752e2b-129e-4d34-a150-653aff78a6ef12013-06-04
0363-0531-29EA - Each0363-053150adcb36-f7c4-4f53-b8ec-73c33b5fbc8412014-07-02
0363-0531-37EA - Each0363-0531a2f43c63-5f72-4380-bcc8-425e1a7dc1fc12017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET, COATED [WALGREEN CO.]6
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET, COATED [WALGREEN CO.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET, COATED [WALGREEN CO.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET, COATED [WALGREEN CO.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET, COATED [WALGREEN CO.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET, COATED [WALGREEN CO.]6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0531-12003630531121 BOTTLE, PLASTIC in 1 CARTON (0363-0531-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2005-12-110000-00-00NoNoCurrent