FDA.reportPublic FDA data

Excedrin PM Triple Action Caplets and Excedrin Tension Headache

Product NDC
0067-8147
Requested package NDC
0067-8147-01
11-digit product format
000678147
Labeler code
0067
Product ID
0067-8147_5b0f5eff-6fa1-4334-a51c-fd79e54e209b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin (NSAID), Caffeine, and Diphenhydramine Citrate
Dosage form
KIT
Labeler
Haleon US Holdings LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-06-01
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 1 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
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0067-81470067-8147-01IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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 PM Triple Action Caplets and Excedrin Tension Headache
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307686Internal RxNorm lookup
404172Internal RxNorm lookup
1593110Internal RxNorm lookup
1593116Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
978a9d27-6d41-42cb-a193-11314923d2acAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0067-8147-012020-12-01C16284748780-19d75b9d0-c6f4-f424-e053-dadaa90a57ceDrug Facts
0067-8147-012020-01-31C16284748780-19d75b9d0-c6f4-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-2056-24Excedrin PM Triple Action Caplets and Excedrin Tension Headache1 in 1 CARTONTABLET, COATED250 mg5
0067-2056-24Excedrin PM Triple Action Caplets and Excedrin Tension Headache24 in 1 BOTTLETABLET, COATED2438 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
0067-8147-01Excedrin PM Triple Action Caplets and Excedrin Tension Headache1 in 1 PACKAGE, COMBINATIONKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-8147EXCEDRIN PM TRIPLE ACTION CAPLETS AND EXCEDRIN TENSION HEADACHE (ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE) KIT [HALEON US HOLDINGS LLC]5Current NDC, Legacy NDC, 5 package rows20240316_978a9d27-6d41-42cb-a193-11314923d2ac.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 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLC03d42892-4465-4089-90a7-cd5f00c356022023-11-29WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLC57bb1acc-b9a0-48cd-8e5c-33712441ce812023-11-29WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENAurohealth LLCcc0ab7a1-e535-4dc8-962f-c58949fc17372023-11-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAurohealth LLCa4ff94b9-c248-4cd3-8491-38e9555cc22e2023-11-29WarningsExact identifier
application number: M013
Aurophen Extra Strength for AdultsACETAMINOPHENAurohealth LLCd59c5f04-4bcc-4a52-a42f-e049506f00de2023-11-29WarningsExact identifier
application number: M013
Aurophen Extra Strength for AdultsACETAMINOPHENAurohealth LLCa769094b-1e91-4ca7-ba67-21aa7e3129102023-11-29WarningsExact identifier
application number: M013
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
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
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
1593110acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral TabletSCD978a9d27-6d41-42cb-a193-11314923d2ac5
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD978a9d27-6d41-42cb-a193-11314923d2ac5
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
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-8147-01000678147011 KIT in 1 PACKAGE, COMBINATION (0067-8147-01) * 1 BOTTLE in 1 CARTON (0067-2056-24) / 24 TABLET, COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0067-8139-02) / 100 TABLET, FILM COATED in 1 BOTTLE1 kit2017-06-010000-00-00NoNoCurrent