FDA.reportPublic FDA data

Excedrin

Product NDC
0067-2001
Requested package NDC
0067-2001-14
11-digit product format
000672001
Labeler code
0067
Product ID
0067-2001_155eb367-99df-1f50-e063-6294a90a21d6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin (NSAID), and Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-15
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 Pain Reliever
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
362O9ITL9DInternal UNII lookup
R16CO5Y76EInternal UNII lookup
3G6A5W338EInternal 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
1b5ff867-5442-4cf8-bd1e-530093cc88f8Available 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
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, Related label table
NDCEffectiveRelated label
0067-2001-012024-02-05Drug Facts
0067-2001-022024-02-05Drug Facts
0067-2001-032024-02-05Drug Facts
0067-2001-042024-02-05Drug Facts
0067-2001-052024-02-05Drug Facts
0067-2001-062024-02-05Drug Facts
0067-2001-072024-02-05Drug Facts
0067-2001-082024-02-05Drug Facts
0067-2001-092024-02-05Drug Facts
0067-2001-142024-02-05Drug Facts
0067-2001-012024-01-30Drug Facts
0067-2001-022024-01-30Drug Facts
0067-2001-032024-01-30Drug Facts
0067-2001-042024-01-30Drug Facts
0067-2001-052024-01-30Drug Facts
0067-2001-062024-01-30Drug Facts
0067-2001-072024-01-30Drug Facts
0067-2001-082024-01-30Drug Facts
0067-2001-092024-01-30Drug Facts
0067-2001-142024-01-30Drug Facts
0067-2001-012023-02-13Drug Facts
0067-2001-022023-02-13Drug Facts
0067-2001-032023-02-13Drug Facts
0067-2001-042023-02-13Drug Facts
0067-2001-052023-02-13Drug Facts
0067-2001-062023-02-13Drug Facts
0067-2001-072023-02-13Drug Facts
0067-2001-082023-02-13Drug Facts
0067-2001-092023-02-13Drug Facts
0067-2001-012022-07-29Drug Facts
0067-2001-022022-07-29Drug Facts
0067-2001-032022-07-29Drug Facts
0067-2001-042022-07-29Drug Facts
0067-2001-052022-07-29Drug Facts
0067-2001-062022-07-29Drug Facts
0067-2001-072022-07-29Drug Facts
0067-2001-082022-07-29Drug Facts
0067-2001-092022-07-29Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-2001-01ExcedrinExtra Strength Pain Reliever2 in 1 POUCHTABLET, FILM COATED210
0067-2001-02ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-02ExcedrinExtra Strength Pain Reliever24 in 1 BOTTLETABLET, FILM COATED2410
0067-2001-03ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-03ExcedrinExtra Strength Pain Reliever30 in 1 BOTTLETABLET, FILM COATED3010
0067-2001-04ExcedrinExtra Strength Pain Reliever50 in 1 BOTTLETABLET, FILM COATED5010
0067-2001-04ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-05ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-05ExcedrinExtra Strength Pain Reliever100 in 1 BOTTLETABLET, FILM COATED10010
0067-2001-06ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-06ExcedrinExtra Strength Pain Reliever125 in 1 BOTTLETABLET, FILM COATED12510
0067-2001-07ExcedrinExtra Strength Pain Reliever200 in 1 BOTTLETABLET, FILM COATED20010
0067-2001-07ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-08ExcedrinExtra Strength Pain Reliever300 in 1 BOTTLETABLET, FILM COATED30010
0067-2001-08ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-09ExcedrinExtra Strength Pain Reliever250 in 1 BOTTLETABLET, FILM COATED25010
0067-2001-09ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED110
0067-2001-14ExcedrinExtra Strength Pain Reliever8 in 1 VIALTABLET, FILM COATED810
0067-2001-14ExcedrinExtra Strength Pain Reliever1 in 1 BLISTER PACKTABLET, FILM COATED110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-2001EXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [HALEON US HOLDINGS LLC]10Current NDC, Legacy NDC, 19 package rows20240407_1b5ff867-5442-4cf8-bd1e-530093cc88f8.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 76 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENAurohealth LLC30756257-f748-4a5d-b031-dd267d0f91ad2023-11-29WarningsExact identifier
application number: M013
Aurophen Regular StrengthACETAMINOPHENAurohealth LLC8eda893f-5266-4b7a-95b9-2e194973cf062023-11-29WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENAurohealth LLC00ec6518-b5e3-49d1-a342-139381c3bfd22023-11-29WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEFACETAMINOPHENBetter Living Brands, LLCfadb4c09-071f-56c0-e053-6294a90ae6c12023-11-28WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEBetter Living Brands, LLCfc07d516-9ffe-9989-e053-6294a90ae1a52023-11-28WarningsExact identifier
application number: M013
NOTTS - Tension HeadacheACETAMINOPHEN, CAFFEINEVIVUNT PHARMA LLC08f2ae03-967b-ad7e-e063-6294a90a84842023-11-24WarningsExact identifier
application number: M013
Sanatos Multi Symptoms NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0a60326a-a17b-e843-e063-6394a90ac2112023-11-22WarningsExact identifier
application number: M013
Sanatos Nighttime Multi SymptomsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0ab188f3-f7f9-d665-e063-6294a90a198a2023-11-22WarningsExact identifier
application number: M013
ASPIRINASPIRINTIME CAP LABS INCfe12519c-3e5f-4592-bd34-2d6b81b981f42023-11-22WarningsExact identifier
application number: M013
Rugby Regular Strength AcetaminophenACETAMINOPHENA-S Medication Solutions400d4a29-9e39-4e74-8272-37be5d7899242023-11-22WarningsExact identifier
application number: M013
RIGHT REMEDIES Pain Relief Extra Strength CapletACETAMINOPHENStrive Pharmaceuticals Inc.dcce28d9-8528-489e-b995-1d98e9d0e6ad2023-11-21WarningsExact identifier
application number: M013
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCIPharmadel LLC0ab11691-5b29-55fc-e063-6394a90aa3282023-11-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions1e223faa-f6d0-4235-bc4c-6cfca84a5b0a2023-11-17WarningsExact identifier
application number: M013
SanaTos XACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC85b8ef3d-7318-7f3b-e053-2991aa0a07772023-11-14WarningsExact identifier
application number: M013
RIGHT REMEDIES EXTRA STRENGTH PM Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.8badbaad-eb35-4251-a779-00474819360d2023-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC09935a74-34b0-0e7c-e063-6294a90a7c832023-11-07WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6dd6396-93e9-1096-e053-6394a90af06d2023-11-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.eb644e9e-36dc-5f84-e053-2a95a90affa52023-11-02WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENProficient Rx LP46527b1f-7515-44ce-b5cb-9d24223b9af12023-11-01WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions12feb32b-4b8c-4b17-9e86-cb286457b0882023-11-01WarningsExact 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 TabletPSN1b5ff867-5442-4cf8-bd1e-530093cc88f810
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSN1b5ff867-5442-4cf8-bd1e-530093cc88f810
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBD1b5ff867-5442-4cf8-bd1e-530093cc88f810
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD1b5ff867-5442-4cf8-bd1e-530093cc88f810
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY1b5ff867-5442-4cf8-bd1e-530093cc88f810
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SY1b5ff867-5442-4cf8-bd1e-530093cc88f810
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY1b5ff867-5442-4cf8-bd1e-530093cc88f810
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY1b5ff867-5442-4cf8-bd1e-530093cc88f810
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY1b5ff867-5442-4cf8-bd1e-530093cc88f810
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSNf7e572e9-82a7-2127-e053-6394a90ab01a3
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSNf7e572e9-82a7-2127-e053-6394a90ab01a3
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBDf7e572e9-82a7-2127-e053-6394a90ab01a3
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCDf7e572e9-82a7-2127-e053-6394a90ab01a3
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSYf7e572e9-82a7-2127-e053-6394a90ab01a3
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SYf7e572e9-82a7-2127-e053-6394a90ab01a3
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYf7e572e9-82a7-2127-e053-6394a90ab01a3
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYf7e572e9-82a7-2127-e053-6394a90ab01a3
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYf7e572e9-82a7-2127-e053-6394a90ab01a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0067-2001-14000672001141 VIAL in 1 BLISTER PACK (0067-2001-14) / 8 TABLET, FILM COATED in 1 VIAL1 vial2021-01-31NoNoCurrent