Headache Relief

Product NDC
0363-0443
Requested package NDC
0363-0443-12
11-digit product format
003630443
Labeler code
0363
Product ID
0363-0443_c011d2e4-d4f7-4416-9ea5-6e75448f23e2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin and Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2008-03-13
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
250 mg/1; mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage0363-04430363-0443-12DDiscontinued by firm2026-10-15

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 · 12 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…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
0363-0443-08EA - Each0363-0443eacc5a6d-87e6-4d4c-8b40-83ff1b35575712015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [WALGREEN CO.]3
ASPIRINACTIVE INGREDIENTR16CO5Y76EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [WALGREEN CO.]3
CAFFEINEACTIVE INGREDIENT3G6A5W338EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [WALGREEN CO.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [WALGREEN CO.]3
ASPIRINACTIVE MOIETYR16CO5Y76EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [WALGREEN CO.]3
CAFFEINEACTIVE MOIETY3G6A5W338EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [WALGREEN CO.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [WALGREEN CO.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [WALGREEN CO.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [WALGREEN CO.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [WALGREEN CO.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [WALGREEN CO.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [WALGREEN CO.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [WALGREEN CO.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [WALGREEN CO.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0443-12003630443121 BOTTLE, PLASTIC in 1 CARTON (0363-0443-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2008-03-130000-00-00NoNoCurrent