FDA.reportPublic FDA data

Excedrin

Product NDC
0067-2002
Requested package NDC
0067-2002-02
11-digit product format
000672002
Labeler code
0067
Product ID
0067-2002_1005a911-f3ad-23c9-e063-6294a90abb9f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin (NSAID), Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
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
Brand name suffix
Extra Strength Headache
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
61802b27-c9ec-4386-9d44-45e8b1e558b7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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
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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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-2002-01ExcedrinExtra Strength Headache1 in 1 CARTONTABLET, FILM COATED12
0067-2002-01ExcedrinExtra Strength Headache24 in 1 BOTTLETABLET, FILM COATED242
0067-2002-02ExcedrinExtra Strength Headache1 in 1 CARTONTABLET, FILM COATED12
0067-2002-02ExcedrinExtra Strength Headache30 in 1 BOTTLETABLET, FILM COATED302
0067-2002-03ExcedrinExtra Strength Headache50 in 1 BOTTLETABLET, FILM COATED502
0067-2002-03ExcedrinExtra Strength Headache1 in 1 CARTONTABLET, FILM COATED12
0067-2002-04ExcedrinExtra Strength Headache1 in 1 CARTONTABLET, FILM COATED12
0067-2002-04ExcedrinExtra Strength Headache100 in 1 BOTTLETABLET, FILM COATED1002
0067-2002-05ExcedrinExtra Strength Headache1 in 1 CARTONTABLET, FILM COATED12
0067-2002-05ExcedrinExtra Strength Headache125 in 1 BOTTLETABLET, FILM COATED1252
0067-2002-06ExcedrinExtra Strength Headache1 in 1 CARTONTABLET, FILM COATED12
0067-2002-06ExcedrinExtra Strength Headache200 in 1 BOTTLETABLET, FILM COATED2002
0067-2002-07ExcedrinExtra Strength Headache250 in 1 BOTTLETABLET, FILM COATED2502
0067-2002-07ExcedrinExtra Strength Headache1 in 1 CARTONTABLET, FILM COATED12
0067-2002-08ExcedrinExtra Strength Headache300 in 1 BOTTLETABLET, FILM COATED3002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-2002EXCEDRIN EXTRA STRENGTH HEADACHE (ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE) TABLET, FILM COATED [HALEON US HOLDINGS LLC]2Current NDC, 15 package rows20240129_61802b27-c9ec-4386-9d44-45e8b1e558b7.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 77 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINEProficient Rx LPaf8b30a0-7a56-4557-8404-cc8059fcd6bc2023-11-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAMERIFOODS TRADING COMPANYf6dd387d-c768-9443-e053-6394a90aca142023-10-31WarningsExact identifier
application number: M013
ASPIRINASPIRINAMERIFOODS TRADING COMPANYf6cec280-17a5-5c5d-e053-6394a90a81aa2023-10-31WarningsExact identifier
application number: M013
Regular Strength AspirinASPIRINCARDINAL HEALTH, INC.8aaa82c6-b46b-25c5-e053-2a95a90a37932023-10-30WarningsExact identifier
application number: M013
SafeTynadolACETAMINOPHENSinew Pharma Inc.b956d527-7ea7-e084-e053-2a95a90a866d2023-10-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMagno-Humphries, Inc.9d2275c8-0c3d-d2b3-e053-2995a90a368e2023-10-27WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENMagno-Humphries, Inc.9d22bedb-9fb3-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENMagno-Humphries, Inc.9d22d642-8aaf-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M013
ENTERIC COATED ASPIRINASPIRINMagno-Humphries, Inc.a7c02378-4213-4e57-aca2-2437ad02f7862023-10-27WarningsExact identifier
application number: M013
ExtraprinACETAMINOPHEN, ASPIRIN, CAFFEINEMagno-Humphries, Inc.9d22cdc8-29c5-4273-e053-2a95a90ad0bf2023-10-27WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINGeri-Care Pharmaceutical Corpc321208c-f192-42c5-9454-e0df5d02d6852023-10-26WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENSf3c69974-7f51-2227-e053-2995a90a55702023-10-21WarningsExact identifier
application number: M013
Menstrual CompleteMENSTRUAL COMPLETEHealthlife of USAc7e89b01-a8eb-4487-8f0b-a4b9ae6d9f332023-10-21WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corpe65dbd01-2d5e-4067-ad98-98d879cfb5ee2023-10-19WarningsExact identifier
application number: M013
Regular Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.f06fe167-8a16-14d9-e053-2a95a90a1a0f2023-10-17WarningsExact identifier
application number: M013
Childrens Chewable AcetaminophenACETAMINOPHENBLESSINGS INTERNATIONALee8ba190-2c42-7ca2-e053-2a95a90a01a02023-10-17WarningsExact identifier
application number: M013
AphenACETAMINOPHENAsclemed USA, Inc.fe3c0a2b-316b-4620-b6bc-378dbaf7ed572023-10-16WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENWalgreensb4b06d32-6a09-4c43-980b-377b617ba7392023-10-09WarningsExact identifier
application number: M013
FLO PMS CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEO Positiv, Inc.cce62d9f-adb1-4473-8258-910dff6b13782023-10-09WarningsExact identifier
application number: M013
childrens mapapACETAMINOPHENProficient Rx LP88c4183a-3032-46de-bf18-f700055f617b2023-10-01WarningsExact 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 TabletPSN907c89e7-2482-465f-9f85-2381ecab1b862
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN29b764c7-3d07-5191-e063-6294a90a9c302
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN61802b27-c9ec-4386-9d44-45e8b1e558b72
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSN29b764c7-3d07-5191-e063-6294a90a9c302
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSN907c89e7-2482-465f-9f85-2381ecab1b862
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSN61802b27-c9ec-4386-9d44-45e8b1e558b72
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBD61802b27-c9ec-4386-9d44-45e8b1e558b72
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBD907c89e7-2482-465f-9f85-2381ecab1b862
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBD29b764c7-3d07-5191-e063-6294a90a9c302
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD29b764c7-3d07-5191-e063-6294a90a9c302
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD907c89e7-2482-465f-9f85-2381ecab1b862
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD61802b27-c9ec-4386-9d44-45e8b1e558b72
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY907c89e7-2482-465f-9f85-2381ecab1b862
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY29b764c7-3d07-5191-e063-6294a90a9c302
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY61802b27-c9ec-4386-9d44-45e8b1e558b72
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SY29b764c7-3d07-5191-e063-6294a90a9c302
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SY907c89e7-2482-465f-9f85-2381ecab1b862
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SY61802b27-c9ec-4386-9d44-45e8b1e558b72
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY61802b27-c9ec-4386-9d44-45e8b1e558b72
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY29b764c7-3d07-5191-e063-6294a90a9c302
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY907c89e7-2482-465f-9f85-2381ecab1b862
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY907c89e7-2482-465f-9f85-2381ecab1b862
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY61802b27-c9ec-4386-9d44-45e8b1e558b72
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY29b764c7-3d07-5191-e063-6294a90a9c302
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY29b764c7-3d07-5191-e063-6294a90a9c302
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY907c89e7-2482-465f-9f85-2381ecab1b862
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY61802b27-c9ec-4386-9d44-45e8b1e558b72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0067-2002-02000672002021 BOTTLE in 1 CARTON (0067-2002-02) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-01-01NoNoCurrent