FDA.reportPublic FDA data

Excedrin

Product NDC
0067-2035
11-digit product format
000672035
Labeler code
0067
Product ID
0067-2035_1006aaaa-a4ed-a80e-e063-6294a90a6bc6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Asprin, Caffeine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA020802
Marketing category
NDA
Marketing start
2011-09-13
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Excedrin
Brand name suffix
Migraine Geltabs
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, R16CO5Y76E, 3G6A5W338E
Rxcui209468, 308297

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
0067-2035-16ExcedrinMigraine Geltabs2 in 1 CARTONTABLET, COATED28
0067-2035-16ExcedrinMigraine Geltabs160 in 1 BOTTLETABLET, COATED1608
0067-2035-20ExcedrinMigraine Geltabs20 in 1 BOTTLETABLET, COATED208
0067-2035-20ExcedrinMigraine Geltabs1 in 1 CARTONTABLET, COATED18
0067-2035-24ExcedrinMigraine Geltabs24 in 1 BOTTLETABLET, COATED248
0067-2035-24ExcedrinMigraine Geltabs1 in 1 CARTONTABLET, COATED18
0067-2035-50ExcedrinMigraine Geltabs1 in 1 CARTONTABLET, COATED18
0067-2035-50ExcedrinMigraine Geltabs50 in 1 BOTTLETABLET, COATED508
0067-2035-80ExcedrinMigraine Geltabs1 in 1 CARTONTABLET, COATED18
0067-2035-80ExcedrinMigraine Geltabs80 in 1 BOTTLETABLET, COATED808
0067-2035-91ExcedrinMigraine Geltabs100 in 1 BOTTLETABLET, COATED1008
0067-2035-91ExcedrinMigraine Geltabs2 in 1 CARTONTABLET, COATED28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-2035-16EA - Each0067-2035f7b73f8f-c033-4e1b-92b5-5cb08865f79b12013-02-13
0067-2035-20EA - Each0067-2035493d95ca-ebab-48f8-b926-0ec4cfee11d712015-11-12
0067-2035-24EA - Each0067-2035b68a9f31-8b32-441d-836a-6825f9c9627c12013-02-13
0067-2035-50EA - Each0067-2035ce883033-a5d0-4dc6-b0ca-9dd7c8fce3b312013-02-13
0067-2035-91EA - Each0067-20351e5b9da2-b570-472b-89ae-f8fce709395112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
ASPIRINACTIVE INGREDIENTR16CO5Y76EEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
CAFFEINEACTIVE INGREDIENT3G6A5W338EEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
ASPIRINACTIVE MOIETYR16CO5Y76EEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
CAFFEINEACTIVE MOIETY3G6A5W338EEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357EXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
GELATININACTIVE INGREDIENT2G86QN327LEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302EXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
MALTITOLINACTIVE INGREDIENTD65DG142WKEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
PEPSININACTIVE INGREDIENTGID333S43JEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92EXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
SORBITAN MONOLAURATEINACTIVE INGREDIENT6W9PS8B71JEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [NOVARTIS CONSUMER HEALTH, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-2035EXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 12 package rows20240129_cc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSNcc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff88
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSNcc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff88
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBDcc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff88
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCDcc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff88
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSYcc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff88
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SYcc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff88
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYcc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff88
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYcc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff88
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYcc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-2035-16000672035162 in 1 CARTONHistorical
0067-2035-20000672035201 BOTTLE in 1 CARTON (0067-2035-20) / 20 TABLET, COATED in 1 BOTTLE1 bottle2011-09-130000-00-00NoNoCurrent
0067-2035-240006720352424 in 1 BOTTLEHistorical
0067-2035-50000672035501 in 1 CARTONHistorical
0067-2035-80000672035801 BOTTLE in 1 CARTON (0067-2035-80) / 80 TABLET, COATED in 1 BOTTLE1 bottle2011-09-130000-00-00NoNoCurrent
0067-2035-9100067203591100 in 1 BOTTLEHistorical