FDA.reportPublic FDA data

Headache Relief

Product NDC
41250-334
11-digit product format
412500334
Labeler code
41250
Product ID
41250-334_746072ad-79e2-4d14-939d-d3c4396b47f2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin, Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Meijer Distribution Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-03-13
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
Listing certified through
2027-12-31
Current FDA listing
Yes

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 packagepackage41250-33441250-334-08DDiscontinued 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 · 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.

Additional Listing Data#

Finished product
Yes
Brand name base
Headache Relief
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
377068df-225f-7318-a910-a1987cdfa361Product name320170608
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-334-08Headache ReliefExtra Strength1 in 1 CARTONTABLET, FILM COATED118
41250-334-08Headache ReliefExtra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2418
41250-334-12Headache ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10018
41250-334-12Headache ReliefExtra Strength1 in 1 CARTONTABLET, FILM COATED118
41250-334-15Headache ReliefExtra Strength50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5018
41250-334-15Headache ReliefExtra Strength1 in 1 CARTONTABLET, FILM COATED118
41250-334-98Headache ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10018
41250-334-98Headache ReliefExtra Strength2 in 1 CARTONTABLET, FILM COATED218

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN-NSAID, CAFFEINE) TABLET, FILM COATED [MEIJER]2
ASPIRINACTIVE INGREDIENTR16CO5Y76EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN-NSAID, CAFFEINE) TABLET, FILM COATED [MEIJER]2
CAFFEINEACTIVE INGREDIENT3G6A5W338EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN-NSAID, CAFFEINE) TABLET, FILM COATED [MEIJER]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN-NSAID, CAFFEINE) TABLET, FILM COATED [MEIJER]2
ASPIRINACTIVE MOIETYR16CO5Y76EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN-NSAID, CAFFEINE) TABLET, FILM COATED [MEIJER]2
CAFFEINEACTIVE MOIETY3G6A5W338EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN-NSAID, CAFFEINE) TABLET, FILM COATED [MEIJER]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN-NSAID, CAFFEINE) TABLET, FILM COATED [MEIJER]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN-NSAID, CAFFEINE) TABLET, FILM COATED [MEIJER]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN-NSAID, CAFFEINE) TABLET, FILM COATED [MEIJER]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN-NSAID, CAFFEINE) TABLET, FILM COATED [MEIJER]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN-NSAID, CAFFEINE) TABLET, FILM COATED [MEIJER]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN-NSAID, CAFFEINE) TABLET, FILM COATED [MEIJER]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN-NSAID, CAFFEINE) TABLET, FILM COATED [MEIJER]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN-NSAID, CAFFEINE) TABLET, FILM COATED [MEIJER]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN-NSAID, CAFFEINE) TABLET, FILM COATED [MEIJER]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-334HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]17Current NDC, Legacy NDC, 8 package rows20241211_04f2c3ed-4bcf-4b6a-b8fb-0aa6ecb3dca2.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 6 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporationa63727c3-64d8-4ae9-8da3-974cae6beed22026-07-24WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCe4a2566e-48ec-4602-87e3-143398d15f332026-07-24WarningsExact identifier
application number: M013
infants fever reducer and pain relieverACETAMINOPHENRite Aid Corporation920e7055-7ed1-4db4-9215-f8933078bb7b2026-07-24WarningsExact identifier
application number: M013
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreensc6665c11-9a01-4472-a444-acadb1de0b692026-07-23WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC103d109d-f520-409c-8da2-eb6b0fbec8912026-07-22WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCce58105b-f010-47af-8f31-6dd4ce4e9cba2026-07-22WarningsExact identifier
application number: M013
GOOD SENSE INFANTS PAIN AND FEVERACETAMINOPHENL. Perrigo Companya7cc3964-e8fa-41da-89ca-b0d2aa80f2a72026-07-22WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENCardinal Health 107, LLC7562f4e4-54fa-488c-a199-48ad2632e2a12026-07-21WarningsExact identifier
application number: M013
MedlineACETAMINOPHENMedline Industries, LP4b1d7243-b943-4e2b-e063-6294a90a2c4e2026-07-20WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENLEADER/ Cardinal Health 110, Inc.7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d2026-07-16WarningsExact identifier
application number: M013
Rapidol 500 Extra StrengthACETAMINOPHENPharmadel LLC1d9fa7ec-a509-28b2-e063-6294a90a78312026-07-16WarningsExact identifier
application number: M013
equate pain reliefACETAMINOPHENWALMART INC.2f9b2550-5476-49ae-b741-54416a40bc292026-07-16WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLHyVee Inc4f45a750-1220-4a81-801e-bf08c9d117d62026-07-16WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENDr. Reddy's Laboratories Inc.9d34abc2-3a9a-b68f-80d4-4ede1eb1e45f2026-07-15WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENFamily Dollar, Inc.3f182571-3212-eb29-e063-6294a90a9fa02026-07-15WarningsExact identifier
application number: M013
AspirinASPIRINDOLGENCORP, LLC955484a6-2a7a-4b15-a9b4-e888ed5de04c2026-07-15WarningsExact identifier
application number: M013
AspirinASPIRINGeri-Care Pharmaceuticals, Corp58941782-362d-4436-b365-e909bdbd29a22026-07-15WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINMajor Pharmaceuticals44730dfb-5062-4015-924b-c30b6c2b19c22026-07-13WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINECardinal Health 110, LLC. DBA Leaderf1cd0d59-12a8-4ff2-942a-6faa6907ef052026-07-13WarningsExact identifier
application number: M013
AspirinASPIRINAmerisource Bergen2c5e80e8-a979-45fb-9297-8ff294280c252026-07-13WarningsExact 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 TabletPSN04f2c3ed-4bcf-4b6a-b8fb-0aa6ecb3dca218
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD04f2c3ed-4bcf-4b6a-b8fb-0aa6ecb3dca218
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY04f2c3ed-4bcf-4b6a-b8fb-0aa6ecb3dca218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41250-334-08412500334081 BOTTLE, PLASTIC in 1 CARTON (41250-334-08) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2008-03-130000-00-00NoNoCurrent
41250-334-12412500334121 BOTTLE, PLASTIC in 1 CARTON (41250-334-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2008-03-130000-00-00NoNoCurrent
41250-334-15412500334151 BOTTLE, PLASTIC in 1 CARTON (41250-334-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2008-03-130000-00-00NoNoCurrent
41250-334-98412500334982 BOTTLE, PLASTIC in 1 CARTON (41250-334-98) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2008-03-130000-00-00NoNoCurrent