FDA.reportPublic FDA data

Headache Relief

Product NDC
0363-0586
11-digit product format
003630586
Labeler code
0363
Product ID
0363-0586_72d96ec0-72fe-4dba-8e8c-dda6a9864aae
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin, Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-31
Marketing end
2026-12-31
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
250; 250; 65 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
Current FDA listing
Yes

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
Headache Relief
Brand name suffix
Extra Strength

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN250 mg/1
ASPIRIN250 mg/1
CAFFEINE65 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
R16CO5Y76EInternal UNII lookup
3G6A5W338EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308297Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2eb9575-d527-44c7-aa5e-efabfd9a0278Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0586-20Headache ReliefExtra Strength20 in 1 BOTTLE, PLASTICTABLET2010
0363-0586-20Headache ReliefExtra Strength1 in 1 BOXTABLET110
0363-0586-80Headache ReliefExtra Strength80 in 1 BOTTLE, PLASTICTABLET8010
0363-0586-80Headache ReliefExtra Strength1 in 1 BOXTABLET110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0586HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WALGREENS]9Current NDC, Legacy NDC, 4 package rows20240302_f2eb9575-d527-44c7-aa5e-efabfd9a0278.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 77 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINEProficient Rx LPaf8b30a0-7a56-4557-8404-cc8059fcd6bc2023-11-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAMERIFOODS TRADING COMPANYf6dd387d-c768-9443-e053-6394a90aca142023-10-31WarningsExact identifier
application number: M013
ASPIRINASPIRINAMERIFOODS TRADING COMPANYf6cec280-17a5-5c5d-e053-6394a90a81aa2023-10-31WarningsExact identifier
application number: M013
Regular Strength AspirinASPIRINCARDINAL HEALTH, INC.8aaa82c6-b46b-25c5-e053-2a95a90a37932023-10-30WarningsExact identifier
application number: M013
SafeTynadolACETAMINOPHENSinew Pharma Inc.b956d527-7ea7-e084-e053-2a95a90a866d2023-10-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMagno-Humphries, Inc.9d2275c8-0c3d-d2b3-e053-2995a90a368e2023-10-27WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENMagno-Humphries, Inc.9d22bedb-9fb3-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENMagno-Humphries, Inc.9d22d642-8aaf-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M013
ENTERIC COATED ASPIRINASPIRINMagno-Humphries, Inc.a7c02378-4213-4e57-aca2-2437ad02f7862023-10-27WarningsExact identifier
application number: M013
ExtraprinACETAMINOPHEN, ASPIRIN, CAFFEINEMagno-Humphries, Inc.9d22cdc8-29c5-4273-e053-2a95a90ad0bf2023-10-27WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINGeri-Care Pharmaceutical Corpc321208c-f192-42c5-9454-e0df5d02d6852023-10-26WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENSf3c69974-7f51-2227-e053-2995a90a55702023-10-21WarningsExact identifier
application number: M013
Menstrual CompleteMENSTRUAL COMPLETEHealthlife of USAc7e89b01-a8eb-4487-8f0b-a4b9ae6d9f332023-10-21WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corpe65dbd01-2d5e-4067-ad98-98d879cfb5ee2023-10-19WarningsExact identifier
application number: M013
Regular Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.f06fe167-8a16-14d9-e053-2a95a90a1a0f2023-10-17WarningsExact identifier
application number: M013
Childrens Chewable AcetaminophenACETAMINOPHENBLESSINGS INTERNATIONALee8ba190-2c42-7ca2-e053-2a95a90a01a02023-10-17WarningsExact identifier
application number: M013
AphenACETAMINOPHENAsclemed USA, Inc.fe3c0a2b-316b-4620-b6bc-378dbaf7ed572023-10-16WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENWalgreensb4b06d32-6a09-4c43-980b-377b617ba7392023-10-09WarningsExact identifier
application number: M013
FLO PMS CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEO Positiv, Inc.cce62d9f-adb1-4473-8258-910dff6b13782023-10-09WarningsExact identifier
application number: M013
childrens mapapACETAMINOPHENProficient Rx LP88c4183a-3032-46de-bf18-f700055f617b2023-10-01WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSNf2eb9575-d527-44c7-aa5e-efabfd9a027810
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCDf2eb9575-d527-44c7-aa5e-efabfd9a027810
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSYf2eb9575-d527-44c7-aa5e-efabfd9a027810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0586-20003630586201 BOTTLE, PLASTIC in 1 BOX (0363-0586-20) / 20 TABLET in 1 BOTTLE, PLASTIC2019-03-312026-12-31NoNoCurrent
0363-0586-80003630586801 BOTTLE, PLASTIC in 1 BOX (0363-0586-80) / 80 TABLET in 1 BOTTLE, PLASTIC2019-03-312026-12-31NoNoCurrent