FDA.reportPublic FDA data

Excedrin

Product NDC
0067-8139
11-digit product format
000678139
Labeler code
0067
Product ID
0067-8139_dd87f543-c93b-4204-a601-368db2fec725
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-12-15
Substance
ACETAMINOPHEN; CAFFEINE
Active strength
500; 65 mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [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
Tension Headache
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
CAFFEINE65 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal 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
307686Internal RxNorm lookup
404172Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
12c074d1-81ac-47d2-8747-b018cda0058aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product 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
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-8139-01ExcedrinTension Headache24 in 1 BOTTLETABLET, FILM COATED247
0067-8139-01ExcedrinTension Headache1 in 1 CARTONTABLET, FILM COATED17
0067-8139-02ExcedrinTension Headache100 in 1 BOTTLETABLET, FILM COATED1007
0067-8139-02ExcedrinTension Headache1 in 1 CARTONTABLET, FILM COATED17
0067-8139-01Excedrin Extra Strength and Excedrin Tension Headache24 in 1 BOTTLETABLET, FILM COATED24500 mg5
0067-8139-01Excedrin Extra Strength and Excedrin Tension Headache1 in 1 CARTONTABLET, FILM COATED65 mg5
0067-8139-02Excedrin PM Triple Action Caplets and Excedrin Tension Headache1 in 1 CARTONTABLET, FILM COATED65 mg5
0067-8139-02Excedrin PM Triple Action Caplets and Excedrin Tension Headache100 in 1 BOTTLETABLET, FILM COATED10065 mg5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-8139-01EA - Each0067-8139f7c98859-4508-488d-b72d-51329ba13e7912017-07-07
0067-8139-02EA - Each0067-813909717a78-cbda-4ec5-b388-d04a131c9a6012022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-8139EXCEDRIN TENSION HEADACHE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 4 package rows20240315_12c074d1-81ac-47d2-8747-b018cda0058a.zip
0067-8139EXCEDRIN PM TRIPLE ACTION CAPLETS AND EXCEDRIN TENSION HEADACHE (ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE) KIT [HALEON US HOLDINGS LLC]5Current NDC, Legacy NDC20240316_978a9d27-6d41-42cb-a193-11314923d2ac.zip
0067-8139EXCEDRIN EXTRA STRENGTH AND EXCEDRIN TENSION HEADACHE (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) KIT [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC20240315_2c8df1c7-7864-48df-939c-d9ae22e0f52c.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 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSN12c074d1-81ac-47d2-8747-b018cda0058a7
404172EXCEDRIN TENSION HEADACHE 500 MG / 65 MG Oral TabletPSN12c074d1-81ac-47d2-8747-b018cda0058a7
404172acetaminophen 500 MG / caffeine 65 MG Oral Tablet [Excedrin Tension Headache]SBD12c074d1-81ac-47d2-8747-b018cda0058a7
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD12c074d1-81ac-47d2-8747-b018cda0058a7
307686APAP 500 MG / Caffeine 65 MG Oral TabletSY12c074d1-81ac-47d2-8747-b018cda0058a7
404172APAP 500 MG / Caffeine 65 MG Oral Tablet [Excedrin Tension Headache]SY12c074d1-81ac-47d2-8747-b018cda0058a7
404172Excedrin Aspirin Free (acetaminophen 500 MG / caffeine 65 MG) Oral TabletSY12c074d1-81ac-47d2-8747-b018cda0058a7
404172Excedrin Tension Headache (APAP 500 MG / caffeine 65 MG) Oral TabletSY12c074d1-81ac-47d2-8747-b018cda0058a7
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN2c8df1c7-7864-48df-939c-d9ae22e0f52c5
1593110acetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN978a9d27-6d41-42cb-a193-11314923d2ac5
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSN978a9d27-6d41-42cb-a193-11314923d2ac5
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSN2c8df1c7-7864-48df-939c-d9ae22e0f52c5
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSN2c8df1c7-7864-48df-939c-d9ae22e0f52c5
1593116Excedrin PM Triple Action (250 MG / 250 MG / 38 MG) Oral TabletPSN978a9d27-6d41-42cb-a193-11314923d2ac5
404172EXCEDRIN TENSION HEADACHE 500 MG / 65 MG Oral TabletPSN978a9d27-6d41-42cb-a193-11314923d2ac5
404172EXCEDRIN TENSION HEADACHE 500 MG / 65 MG Oral TabletPSN2c8df1c7-7864-48df-939c-d9ae22e0f52c5
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBD2c8df1c7-7864-48df-939c-d9ae22e0f52c5
1593116acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet [Excedrin PM Triple Action]SBD978a9d27-6d41-42cb-a193-11314923d2ac5
404172acetaminophen 500 MG / caffeine 65 MG Oral Tablet [Excedrin Tension Headache]SBD978a9d27-6d41-42cb-a193-11314923d2ac5
404172acetaminophen 500 MG / caffeine 65 MG Oral Tablet [Excedrin Tension Headache]SBD2c8df1c7-7864-48df-939c-d9ae22e0f52c5
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD2c8df1c7-7864-48df-939c-d9ae22e0f52c5
1593110acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral TabletSCD978a9d27-6d41-42cb-a193-11314923d2ac5
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD2c8df1c7-7864-48df-939c-d9ae22e0f52c5
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD978a9d27-6d41-42cb-a193-11314923d2ac5
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY2c8df1c7-7864-48df-939c-d9ae22e0f52c5
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SY2c8df1c7-7864-48df-939c-d9ae22e0f52c5
1593110APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral TabletSY978a9d27-6d41-42cb-a193-11314923d2ac5
1593116APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet [Excedrin PM Triple Action]SY978a9d27-6d41-42cb-a193-11314923d2ac5
307686APAP 500 MG / Caffeine 65 MG Oral TabletSY978a9d27-6d41-42cb-a193-11314923d2ac5
307686APAP 500 MG / Caffeine 65 MG Oral TabletSY2c8df1c7-7864-48df-939c-d9ae22e0f52c5
404172APAP 500 MG / Caffeine 65 MG Oral Tablet [Excedrin Tension Headache]SY2c8df1c7-7864-48df-939c-d9ae22e0f52c5
404172APAP 500 MG / Caffeine 65 MG Oral Tablet [Excedrin Tension Headache]SY978a9d27-6d41-42cb-a193-11314923d2ac5
404172Excedrin Aspirin Free (acetaminophen 500 MG / caffeine 65 MG) Oral TabletSY978a9d27-6d41-42cb-a193-11314923d2ac5
404172Excedrin Aspirin Free (acetaminophen 500 MG / caffeine 65 MG) Oral TabletSY2c8df1c7-7864-48df-939c-d9ae22e0f52c5
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY2c8df1c7-7864-48df-939c-d9ae22e0f52c5
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY2c8df1c7-7864-48df-939c-d9ae22e0f52c5
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY2c8df1c7-7864-48df-939c-d9ae22e0f52c5
1593116Excedrin PM Triple Action (acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG) Oral TabletSY978a9d27-6d41-42cb-a193-11314923d2ac5
404172Excedrin Tension Headache (APAP 500 MG / caffeine 65 MG) Oral TabletSY978a9d27-6d41-42cb-a193-11314923d2ac5
404172Excedrin Tension Headache (APAP 500 MG / caffeine 65 MG) Oral TabletSY2c8df1c7-7864-48df-939c-d9ae22e0f52c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-8139-01000678139011 BOTTLE in 1 CARTON (0067-8139-01) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-12-150000-00-00NoNoCurrent
0067-8139-02000678139021 BOTTLE in 1 CARTON (0067-8139-02) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-12-150000-00-00NoNoCurrent