FDA.reportPublic FDA data

Headache Relief

Product NDC
63941-159
11-digit product format
639410159
Labeler code
63941
Product ID
63941-159_f39e7afc-b353-4e52-8d80-b454f29aafdb
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin and caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Valu Merchandisers Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1992-11-17
Marketing end
2027-03-31
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

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
99de2c41-59b0-42e7-847e-e51229c6164fAvailable 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
63941-159-12Headache ReliefExtra Strength1 in 1 CARTONTABLET, FILM COATED118
63941-159-12Headache ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10018

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.]3
ASPIRINACTIVE INGREDIENTR16CO5Y76EEXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.]3
CAFFEINEACTIVE INGREDIENT3G6A5W338EEXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.]3
ASPIRINACTIVE MOIETYR16CO5Y76EEXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.]3
CAFFEINEACTIVE MOIETY3G6A5W338EEXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKEXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JEXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2EXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJEXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-159HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [VALU MERCHANDISERS COMPANY]16Current NDC, Legacy NDC, 2 package rows20240825_99de2c41-59b0-42e7-847e-e51229c6164f.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 1 of 85 · 1,692 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
application number: M013
equate aspirinASPIRINWal-Mart Stores Incea3f8eed-7b70-4156-9586-125d27bf29a82026-08-19WarningsExact identifier
application number: M013
CARDIASPIRIN PROTECTASPIRINOPMX LLC03774690-662b-1c30-e063-6294a90a34882026-08-19WarningsExact identifier
application number: M013
aspirin chewable, low doseASPIRINUnited Natural Foods, Inc. dba UNFI6a6ac7fe-91a4-4b55-979a-b53b51505d8b2026-08-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSam's West Inc1098d0e7-8202-4018-a2d2-b0c80ee58b562026-08-19WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINESafeway, Inc.5e77dca4-2ff8-4a8c-94bd-f224b680ca232026-08-19WarningsExact identifier
application number: M013
dg health pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLDolgencorp Inc4d1eddf0-eff7-4c47-b312-30dee08d9e5f2026-08-19WarningsExact identifier
application number: M013
Headache Formula Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEARMY AND AIR FORCE EXCHANGE SERVICEee8d0961-7572-471f-8c96-b4c0bd354de22026-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRugby Laboratories76f10ee2-1d6a-097c-e053-2991aa0af5262026-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMajor Pharmaceuticals780aad35-d0f1-44b1-e053-2991aa0af9a72026-08-18WarningsExact identifier
application number: M013
CHILDRENS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC5eacbc4f-d20a-4c22-9680-4a648e24de432026-08-18WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENWinCo Foods, LLC15921c3f-e8d4-4794-983f-63bb926f6f862026-08-15WarningsExact identifier
application number: M013
Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACYe4cbfb06-d826-4d08-95d6-60305c4176252026-08-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENCVS Pharmacy,Inc.3738d35c-1e83-40df-9292-c54e6b2c83532026-08-14WarningsExact identifier
application number: M013
CVS Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACY22a48a33-995b-481e-9e4e-1ad7ec346f442026-08-14WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECVS Pharmacy31ccc867-ca83-70a9-f3d5-5644030047b82026-08-13WarningsExact 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 TabletPSN99de2c41-59b0-42e7-847e-e51229c6164f18
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD99de2c41-59b0-42e7-847e-e51229c6164f18
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY99de2c41-59b0-42e7-847e-e51229c6164f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63941-159-12639410159121 BOTTLE, PLASTIC in 1 CARTON (63941-159-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1992-11-172027-03-31NoNoCurrent