FDA.reportPublic FDA data

Excedrin Extra Strength

Product NDC
66715-9810
11-digit product format
667159810
Labeler code
66715
Product ID
66715-9810_458c59d3-e231-99ac-e063-6394a90ac131
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin, and Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lil Drug Store Products, Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-05-10
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
2026-12-31
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
Excedrin Extra Strength
Listing expiration
2026-12-31

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
3G6A5W338EInternal UNII lookup
R16CO5Y76EInternal UNII lookup
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
209468Internal RxNorm lookup
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
7f0f8b3c-c226-4a3a-af46-a708f345e4f5Available 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
66715-9810-2Excedrin Extra Strength2 in 1 POUCHTABLET, FILM COATED210
66715-9810-2Excedrin Extra Strength2 in 1 CARTONTABLET, FILM COATED210
66715-9810-3Excedrin Extra Strength3 in 1 CARTONTABLET, FILM COATED310
66715-9810-3Excedrin Extra Strength2 in 1 POUCHTABLET, FILM COATED210
66715-9810-7Excedrin Extra Strength25 in 1 BOX, UNIT-DOSETABLET, FILM COATED2510
66715-9810-7Excedrin Extra Strength2 in 1 POUCHTABLET, FILM COATED210
66715-9810-8Excedrin Extra Strength30 in 1 CARTONTABLET, FILM COATED3010
66715-9810-8Excedrin Extra Strength2 in 1 POUCHTABLET, FILM COATED210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9810EXCEDRIN EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) TABLET, FILM COATED EXCEDRIN EXTRA STRENGTH, TRAVEL BASIX (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) TABLET, FILM COATED EXCEDRIN EXTRA STRENGTH, CVP HEALTH (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) TABLET, FILM COATED [LIL DRUG STORE PRODUCTS, INC]9Current NDC, Legacy NDC, 8 package rows20241127_7f0f8b3c-c226-4a3a-af46-a708f345e4f5.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 47 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AeroTab Non-AspirinACETAMINOPHEN 500MG ESAero Healthcarefaa3a4ef-3c70-06ca-e053-6394a90a512d2025-02-26WarningsExact identifier
application number: M013
Bufferin Regular Strength Pain ReliefASPIRINGenomma Lab USA3543b2bf-1062-468a-a5dc-eabb2408af8c2025-02-25WarningsExact identifier
application number: M013
Calmour Childrens Acetaminophen Strips ChewableACETAMINOPHEN ORAL CHEWABLE 80 MGCalmourae47b027-4f29-45bb-a8bd-8129789328352025-02-22WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLCf9de7c2f-016b-4f40-8b5e-141ad194be972025-02-20WarningsExact identifier
application number: M013
Genexa Acetaminophen PM Extra StrengthACETAMINOPHENGenexa Inc.d82cf6f3-a291-ca2b-e053-2a95a90a6de12025-02-20WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENAdvagen Pharma Limited8b9456c9-a56b-4748-adb8-c66d6bf072e82025-02-19WarningsExact identifier
application number: M013
Genexa Childrens AcetaminophenACETAMINOPHENGenexa Inc.d89fd9d8-d88e-3968-e053-2a95a90afc5f2025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.debfa787-7a48-48b5-94b0-6128205240322025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.b16e5dcf-b290-4ff2-a150-4b875647ec9a2025-02-19WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCbb6533e5-e6a9-488c-b8ab-a6a06e87ede92025-02-18WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCc830320e-72ba-48ff-a4cd-250ac5650bf02025-02-18WarningsExact identifier
application number: M013
Aspirina CapletsASPIRINBayer HealthCare LLC.2e6f5ba8-8e8b-6059-e063-6394a90adcd52025-02-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.da7d95af-6583-429d-8d04-e0424f32e9ad2025-02-17WarningsExact identifier
application number: M013
GOODYS Mental AlertASPIRIN AND CAFFEINEMedtech Products Inc.31ef6d07-d314-4d09-abcd-389ba66cbcc52025-02-17WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINAsclemed USA, Inc.878dab20-668b-4d7a-a5f8-794a587564d52025-02-13WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENCVS HEALTH CORPbbc48c9e-7eb8-2c67-e053-2a95a90a85522025-02-13WarningsExact identifier
application number: M013
Dye Free Infants Pain and FeverACETAMINOPHENCVS1fde0f7c-4b5b-ae9c-e063-6394a90afa412025-02-13WarningsExact identifier
application number: M013
NOTTS - Extra Strength 500 mgACETAMINOPHENVIVUNT PHARMA LLCe677f43d-b4ce-e5b0-e053-2a95a90ad67e2025-02-12WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINELEADER/ Cardinal Health 110, Inc.b3773f02-02a9-33c8-e053-2995a90a22352025-02-11WarningsExact identifier
application number: M013
EXTRA STRENGTH ACETAMINOPHENACETAMINOPHENTIME CAP LABORATORIES, INC.c9f80d24-bd05-e1ce-e053-2995a90aa6462025-02-10WarningsExact 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 TabletPSN7f0f8b3c-c226-4a3a-af46-a708f345e4f510
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSN7f0f8b3c-c226-4a3a-af46-a708f345e4f510
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBD7f0f8b3c-c226-4a3a-af46-a708f345e4f510
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD7f0f8b3c-c226-4a3a-af46-a708f345e4f510
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY7f0f8b3c-c226-4a3a-af46-a708f345e4f510
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SY7f0f8b3c-c226-4a3a-af46-a708f345e4f510
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY7f0f8b3c-c226-4a3a-af46-a708f345e4f510
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY7f0f8b3c-c226-4a3a-af46-a708f345e4f510
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY7f0f8b3c-c226-4a3a-af46-a708f345e4f510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9810-2667159810022 POUCH in 1 CARTON (66715-9810-2) / 2 TABLET, FILM COATED in 1 POUCH2 pouch2016-02-040000-00-00NoNoCurrent
66715-9810-3667159810033 POUCH in 1 CARTON (66715-9810-3) / 2 TABLET, FILM COATED in 1 POUCH3 pouch2017-05-120000-00-00NoNoCurrent
66715-9810-76671598100725 POUCH in 1 BOX, UNIT-DOSE (66715-9810-7) / 2 TABLET, FILM COATED in 1 POUCH25 pouch2022-04-192028-09-11NoNoHistorical
66715-9810-86671598100830 POUCH in 1 CARTON (66715-9810-8) / 2 TABLET, FILM COATED in 1 POUCH30 pouch2022-04-19NoNoCurrent