FDA.reportPublic FDA data

Excedrin

Product NDC
0067-2040
11-digit product format
000672040
Labeler code
0067
Product ID
0067-2040_cc2a55d5-3c7f-4c59-a38a-cb51e693649d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin, and Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA020802
Marketing category
NDA
Marketing start
2020-09-30
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
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
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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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0067-2040-012023-02-17C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-022023-02-17C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-032023-02-17C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-042023-02-17C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-052023-02-17C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-062023-02-17C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-072023-02-17C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-082023-02-17C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-092023-02-17C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-012022-07-29C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-022022-07-29C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-032022-07-29C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-042022-07-29C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-052022-07-29C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-062022-07-29C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-072022-07-29C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-082022-07-29C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2040-092022-07-29C16284748780-1e4f33bdf-a2a0-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-2040-01ExcedrinMigraine2 in 1 POUCHTABLET, FILM COATED29
0067-2040-02ExcedrinMigraine24 in 1 BOTTLETABLET, FILM COATED249
0067-2040-02ExcedrinMigraine1 in 1 CARTONTABLET, FILM COATED19
0067-2040-03ExcedrinMigraine1 in 1 CARTONTABLET, FILM COATED19
0067-2040-03ExcedrinMigraine30 in 1 BOTTLETABLET, FILM COATED309
0067-2040-04ExcedrinMigraine50 in 1 BOTTLETABLET, FILM COATED509
0067-2040-04ExcedrinMigraine1 in 1 CARTONTABLET, FILM COATED19
0067-2040-05ExcedrinMigraine1 in 1 CARTONTABLET, FILM COATED19
0067-2040-05ExcedrinMigraine100 in 1 BOTTLETABLET, FILM COATED1009
0067-2040-06ExcedrinMigraine125 in 1 BOTTLETABLET, FILM COATED1259
0067-2040-06ExcedrinMigraine1 in 1 CARTONTABLET, FILM COATED19
0067-2040-07ExcedrinMigraine1 in 1 CARTONTABLET, FILM COATED19
0067-2040-07ExcedrinMigraine200 in 1 BOTTLETABLET, FILM COATED2009
0067-2040-08ExcedrinMigraine250 in 1 BOTTLETABLET, FILM COATED2509
0067-2040-08ExcedrinMigraine1 in 1 CARTONTABLET, FILM COATED19
0067-2040-09ExcedrinMigraine300 in 1 BOTTLETABLET, FILM COATED3009
0067-2040-09ExcedrinMigraine1 in 1 CARTONTABLET, FILM COATED19
0067-2040-11ExcedrinMigraine8 in 1 VIALTABLET, FILM COATED89
0067-2040-11ExcedrinMigraine1 in 1 PACKAGETABLET, FILM COATED19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-2040-02EA - Each0067-2040ec9aa8ea-7220-432a-b26a-6391b4801c7a12023-09-05
0067-2040-03EA - Each0067-204009075a1c-87dd-41f4-8792-791dfc6bf16912025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-2040EXCEDRIN MIGRAINE (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) TABLET, FILM COATED [HALEON US HOLDINGS LLC]9Current NDC, Legacy NDC, 19 package rows20250313_910d7254-d0f4-4c5c-a26e-7f8acecbe02d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN910d7254-d0f4-4c5c-a26e-7f8acecbe02d9
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSN910d7254-d0f4-4c5c-a26e-7f8acecbe02d9
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBD910d7254-d0f4-4c5c-a26e-7f8acecbe02d9
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD910d7254-d0f4-4c5c-a26e-7f8acecbe02d9
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY910d7254-d0f4-4c5c-a26e-7f8acecbe02d9
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SY910d7254-d0f4-4c5c-a26e-7f8acecbe02d9
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY910d7254-d0f4-4c5c-a26e-7f8acecbe02d9
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY910d7254-d0f4-4c5c-a26e-7f8acecbe02d9
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY910d7254-d0f4-4c5c-a26e-7f8acecbe02d9
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSNe935ef7d-a0c8-409e-a59a-51f2b733c5562
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN3caa4adf-abe3-67c3-e063-6294a90a87a42
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSNd012ed1d-b256-48ec-b988-f226c2c5ae9e2
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSNe935ef7d-a0c8-409e-a59a-51f2b733c5562
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSN3caa4adf-abe3-67c3-e063-6294a90a87a42
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSNd012ed1d-b256-48ec-b988-f226c2c5ae9e2
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBDd012ed1d-b256-48ec-b988-f226c2c5ae9e2
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBDe935ef7d-a0c8-409e-a59a-51f2b733c5562
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBD3caa4adf-abe3-67c3-e063-6294a90a87a42
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCDe935ef7d-a0c8-409e-a59a-51f2b733c5562
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCDd012ed1d-b256-48ec-b988-f226c2c5ae9e2
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD3caa4adf-abe3-67c3-e063-6294a90a87a42
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSYe935ef7d-a0c8-409e-a59a-51f2b733c5562
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY3caa4adf-abe3-67c3-e063-6294a90a87a42
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSYd012ed1d-b256-48ec-b988-f226c2c5ae9e2
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SYe935ef7d-a0c8-409e-a59a-51f2b733c5562
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SY3caa4adf-abe3-67c3-e063-6294a90a87a42
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SYd012ed1d-b256-48ec-b988-f226c2c5ae9e2
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYe935ef7d-a0c8-409e-a59a-51f2b733c5562
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY3caa4adf-abe3-67c3-e063-6294a90a87a42
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYd012ed1d-b256-48ec-b988-f226c2c5ae9e2
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY3caa4adf-abe3-67c3-e063-6294a90a87a42
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYe935ef7d-a0c8-409e-a59a-51f2b733c5562
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYd012ed1d-b256-48ec-b988-f226c2c5ae9e2
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYd012ed1d-b256-48ec-b988-f226c2c5ae9e2
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY3caa4adf-abe3-67c3-e063-6294a90a87a42
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYe935ef7d-a0c8-409e-a59a-51f2b733c5562
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN4efbd21b-92fe-96a7-e063-6294a90ac4ad1
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSN4efbd21b-92fe-96a7-e063-6294a90ac4ad1
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBD4efbd21b-92fe-96a7-e063-6294a90ac4ad1
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD4efbd21b-92fe-96a7-e063-6294a90ac4ad1
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY4efbd21b-92fe-96a7-e063-6294a90ac4ad1
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SY4efbd21b-92fe-96a7-e063-6294a90ac4ad1
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY4efbd21b-92fe-96a7-e063-6294a90ac4ad1
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY4efbd21b-92fe-96a7-e063-6294a90ac4ad1
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY4efbd21b-92fe-96a7-e063-6294a90ac4ad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-2040-01000672040012 TABLET, FILM COATED in 1 POUCH (0067-2040-01) 2021-01-310000-00-00NoNoCurrent
0067-2040-02000672040021 BOTTLE in 1 CARTON (0067-2040-02) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-09-300000-00-00NoNoCurrent
0067-2040-03000672040031 BOTTLE in 1 CARTON (0067-2040-03) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-09-300000-00-00NoNoCurrent
0067-2040-04000672040041 BOTTLE in 1 CARTON (0067-2040-04) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-09-300000-00-00NoNoCurrent
0067-2040-05000672040051 BOTTLE in 1 CARTON (0067-2040-05) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-09-300000-00-00NoNoCurrent
0067-2040-06000672040061 BOTTLE in 1 CARTON (0067-2040-06) / 125 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-09-300000-00-00NoNoCurrent
0067-2040-07000672040071 BOTTLE in 1 CARTON (0067-2040-07) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-09-300000-00-00NoNoCurrent
0067-2040-08000672040081 BOTTLE in 1 CARTON (0067-2040-08) / 250 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-09-300000-00-00NoNoCurrent
0067-2040-09000672040091 BOTTLE in 1 CARTON (0067-2040-09) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-09-300000-00-00NoNoCurrent
0067-2040-11000672040111 VIAL in 1 PACKAGE (0067-2040-11) / 8 TABLET, FILM COATED in 1 VIAL1 vial2023-03-06NoNoCurrent