FDA.reportPublic FDA data

Headache Relief

Product NDC
70000-0777
11-digit product format
700000777
Labeler code
70000
Product ID
70000-0777_5f102573-49e1-79ba-e063-6394a90a7735
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin, Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
LEADER/ Cardinal Health 110, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-10-30
Substance
ASPIRIN; ACETAMINOPHEN; 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

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN250 mg/1
ACETAMINOPHEN250 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
3G6A5W338EInternal UNII lookup
R16CO5Y76EInternal UNII lookup
362O9ITL9DInternal 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
b3773f02-02a9-33c8-e053-2995a90a2235Available 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

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 77 · 1,530 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
INFANTS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC112076c4-cac2-45ab-9c77-5573edae71802026-07-10WarningsExact identifier
application number: M013
AspirinASPIRINWal-Mart Stores Inc8ae16aa2-54bc-4c1a-aa36-93524199a67b2026-07-09WarningsExact 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 TabletPSNb3773f02-02a9-33c8-e053-2995a90a22354
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCDb3773f02-02a9-33c8-e053-2995a90a22354
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSYb3773f02-02a9-33c8-e053-2995a90a22354

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSNb3773f02-02a9-33c8-e053-2995a90a22354
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCDb3773f02-02a9-33c8-e053-2995a90a22354
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSYb3773f02-02a9-33c8-e053-2995a90a22354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0777-1700000777011 BOTTLE in 1 CARTON (70000-0777-1) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2026-10-30NoNoCurrent