FDA.reportPublic FDA data

Excedrin Extra Strength and Excedrin Tension Headache

Product NDC
0067-8151
11-digit product format
000678151
Labeler code
0067
Product ID
0067-8151_4b80ea7d-b5ef-e06c-e063-6294a90aafac
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin (NSAID), and Caffeine
Dosage form
KIT
Labeler
Haleon US Holdings LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-30
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproduct0067-8151IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0067-81510067-8151-01IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…

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 Extra Strength and Excedrin Tension Headache
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
209468Internal RxNorm lookup
307686Internal RxNorm lookup
308297Internal 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
2c8df1c7-7864-48df-939c-d9ae22e0f52cAvailable 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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0067-8151-012023-03-28C16284748780-1e4f33bdf-b2f2-d8a0-e053-dadaa90a6e4eDrug Facts
0067-8151-012022-07-29C16284748780-1e4f33bdf-b2f2-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-2000-91Excedrin Extra Strength and Excedrin Tension Headache100 in 1 BOTTLETABLET, FILM COATED10065 mg5
0067-2000-91Excedrin Extra Strength and Excedrin Tension Headache1 in 1 CARTONTABLET, FILM COATED65 mg5
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
0067-8151-01Excedrin Extra Strength and Excedrin Tension Headache1 in 1 PACKAGE, COMBINATIONKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-8151EXCEDRIN EXTRA STRENGTH AND EXCEDRIN TENSION HEADACHE (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) KIT [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 5 package rows20240315_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 42 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens AcetaminophenACETAMINOPHENBryant Ranch Prepack190bb2dc-92b4-4b59-a47f-a0251df8261c2025-07-29WarningsExact identifier
application number: M013
Extra Strength NiteTime Pain ReliefACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLETWALGREENSc25c75c7-157f-1c0d-e053-2995a90a2e3c2025-07-25WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWalmart Inc.21ab3d58-bb0e-3e51-e063-6294a90ad4152025-07-25WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC3a935584-6045-0a58-e063-6394a90a40c42025-07-23WarningsExact identifier
application number: M013
DR. SANA PAIN AND FEVER FOR ChildrenACETAMINOPHENGADAL Laboratories, Inc8a22a5ba-8623-4cca-8723-52b4954034612025-07-23WarningsExact identifier
application number: M013
DuralginaACETAMINOPHENMenper Distributors Inc.bb31f66c-80a9-4bdb-983b-cef5d21de5ff2025-07-22WarningsExact identifier
application number: M013
GesteiraACETAMINOPHENMenper Distributors, Inc.5a907289-564c-491b-98d5-d7f43eaaa1b22025-07-22WarningsExact identifier
application number: M013
Extra strength Acetaminophen PMACETAMINOPHEN 500MG/ DIPHENHYDRAMINE HCL 25MGTIME CAP LABS INC010c5c98-fc67-a9c3-e063-6394a90aa6402025-07-21WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENMeijer Distribution Inc44d50d79-6e47-429f-8cbe-6fcac46677322025-07-18WarningsExact identifier
application number: M013
ADWE Childrens Pain FeverACETAMINOPHENRARITAN PHARMACEUTICALS INC79a3232f-0211-4c8a-acee-4f87e06ffc262025-07-17WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalmart Inc.24d191ca-a0c4-e1a8-e063-6394a90a7a2a2025-07-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN ASPIRIN CAFFEINEWAL-MART STORES INCd97073cd-b5d7-8c09-e053-2a95a90a89382025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENBETTER LIVING BRANDS LLC.f3005d0c-424e-0ab3-e053-2995a90a1c102025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc397fa6e1-37b2-8f51-e063-6394a90a7b942025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc39800c27-f39f-cd60-e063-6394a90acd552025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc397f2b63-733e-5b44-e063-6394a90a97182025-07-16WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEBETTER LIVING BRANDS, LLCeb6026d5-d88a-f6b3-e053-2a95a90a5b202025-07-15WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESafewayf9597abc-3f01-4b94-8078-228e0b74677e2025-07-15WarningsExact identifier
application number: M013
Berkley and Jensen Pain ReliefACETAMINOPHENBJWCd3ee3341-93b8-487c-921e-2892d213efbb2025-07-15WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINECVS Pharmacy9e459853-5951-4ae7-88a6-85b502e9dd412025-07-14WarningsExact 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 TabletPSN2c8df1c7-7864-48df-939c-d9ae22e0f52c5
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
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
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
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD2c8df1c7-7864-48df-939c-d9ae22e0f52c5
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
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
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
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
0067-2000-9100067200091100 in 1 BOTTLEHistorical
0067-8139-010006781390124 in 1 BOTTLEHistorical
0067-8151-01000678151011 KIT in 1 PACKAGE, COMBINATION (0067-8151-01) * 1 BOTTLE in 1 CARTON (0067-8139-01) / 24 TABLET, FILM COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0067-2000-91) / 100 TABLET, FILM COATED in 1 BOTTLE1 kit2018-09-300000-00-00NoNoCurrent