FDA.reportPublic FDA data

Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever

Product NDC
0067-8148
11-digit product format
000678148
Labeler code
0067
Product ID
0067-8148_4b80de14-ddcc-e314-e063-6394a90aaa0f
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
2018-05-01
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 productproduct0067-8148IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0067-81480067-8148-01IInactivated 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 PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
209468Internal RxNorm lookup
308297Internal RxNorm lookup
1593110Internal RxNorm lookup
1593116Internal RxNorm lookup
2047427Internal RxNorm lookup
2047428Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
444fa225-c204-45d1-b3b3-aa5650ee5d07Available 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0067-8148-012023-11-13C16284748780-1e4f33bdf-aa52-d8a0-e053-dadaa90a6e4eDrug Facts
0067-8148-012022-07-29C16284748780-1e4f33bdf-aa52-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-2000-91Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever100 in 1 BOTTLETABLET, FILM COATED100250 mg6
0067-2000-91Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED65 mg6
0067-2056-24Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever24 in 1 BOTTLETABLET, COATED24250 mg6
0067-2056-24Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever1 in 1 CARTONTABLET, COATED38 mg6
0067-8148-01Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever1 in 1 PACKAGE, COMBINATIONKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-8148EXCEDRIN PM TRIPLE ACTION CAPLETS AND EXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE) KIT [HALEON US HOLDINGS LLC]5Current NDC, Legacy NDC, 5 package rows20240316_444fa225-c204-45d1-b3b3-aa5650ee5d07.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 73 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANADOL ExtraACETAMINOPHEN AND CAFFEINEHaleon US Holdings LLCe5c2d88a-d903-4ca0-b895-f27e791dfc4e2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLCb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLC9d384e88-5c11-4600-ac6c-a383715701382024-02-06WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLC95801755-db54-4ad7-bec1-52671914f6ca2024-02-06WarningsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLC01e7dddb-755c-4745-b701-edcdb62090642024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLCfe7cd1f2-9b00-4ded-99c2-8a152c71093c2024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.9064943f-836f-4853-b6f2-2c4879941eeb2024-02-02WarningsExact identifier
application number: M013
Quality Choice Effervescent Pain ReliefASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.079af5d7-1be8-2a93-e063-6294a90a496d2024-02-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-AspirinACETAMINOPHENProficient Rx LP4c84948d-3a95-4c53-8529-7e7b9d8bb6df2024-02-01WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENProficient Rx LP9c7d65e4-df2f-47c1-a185-66aaf19aad2b2024-02-01WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENProficient Rx LP57e4820c-b4eb-442e-9c49-93eedfbc5e5e2024-02-01WarningsExact identifier
application number: M013
good sense aspirinASPIRINProficient Rx LP73013074-9c6e-43c7-acde-4d9d8ed0133d2024-02-01WarningsExact identifier
application number: M013
MEDIQUE APAP Extra StrengthACETAMINOPHENProficient Rx LPc466a07f-2339-4cf5-8377-e0f109649c522024-02-01WarningsExact identifier
application number: M013
Percogesic Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINEMedtech Products Inc.2c5f1140-fb83-42c9-b0b1-5e2bd69340bb2024-02-01WarningsExact identifier
application number: M013
aspirinASPIRINProficient Rx LP3c7783a7-2b28-4968-b766-0a49dc70ce6d2024-02-01WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.102bdcde-cb90-f248-e063-6394a90aac792024-01-30WarningsExact identifier
application number: M013
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINEHaleon US Holdings LLC61802b27-c9ec-4386-9d44-45e8b1e558b72024-01-28WarningsExact identifier
application number: M013
AGRIFENACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLC0fde22da-cdfc-36cc-e063-6294a90a38852024-01-26WarningsExact identifier
application number: M013
DOLODOLACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe80536f1-92cc-5bb3-e053-2995a90a95402024-01-26WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINBryant Ranch Prepackd913d11f-c7a1-49d2-a2d3-9a29fc0328062024-01-18WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047428{100 (acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]) / 24 (acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet [Excedrin PM Triple Action]) } Pack [Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever]BPCK444fa225-c204-45d1-b3b3-aa5650ee5d076
2047427{100 (acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet) / 24 (acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet) } PackGPCK444fa225-c204-45d1-b3b3-aa5650ee5d076
2047427100 daytime (acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet) / 24 nighttime (acetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet) KitPSN444fa225-c204-45d1-b3b3-aa5650ee5d076
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN444fa225-c204-45d1-b3b3-aa5650ee5d076
1593110acetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN444fa225-c204-45d1-b3b3-aa5650ee5d076
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSN444fa225-c204-45d1-b3b3-aa5650ee5d076
1593116Excedrin PM Triple Action (250 MG / 250 MG / 38 MG) Oral TabletPSN444fa225-c204-45d1-b3b3-aa5650ee5d076
2047428Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever KitPSN444fa225-c204-45d1-b3b3-aa5650ee5d076
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBD444fa225-c204-45d1-b3b3-aa5650ee5d076
1593116acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet [Excedrin PM Triple Action]SBD444fa225-c204-45d1-b3b3-aa5650ee5d076
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD444fa225-c204-45d1-b3b3-aa5650ee5d076
1593110acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral TabletSCD444fa225-c204-45d1-b3b3-aa5650ee5d076
2047427100 daytime (acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet) / 24 nighttime (acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet) KitSY444fa225-c204-45d1-b3b3-aa5650ee5d076
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY444fa225-c204-45d1-b3b3-aa5650ee5d076
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SY444fa225-c204-45d1-b3b3-aa5650ee5d076
1593110APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral TabletSY444fa225-c204-45d1-b3b3-aa5650ee5d076
1593116APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet [Excedrin PM Triple Action]SY444fa225-c204-45d1-b3b3-aa5650ee5d076
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY444fa225-c204-45d1-b3b3-aa5650ee5d076
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY444fa225-c204-45d1-b3b3-aa5650ee5d076
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY444fa225-c204-45d1-b3b3-aa5650ee5d076
1593116Excedrin PM Triple Action (acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG) Oral TabletSY444fa225-c204-45d1-b3b3-aa5650ee5d076
2047428Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever KitSY444fa225-c204-45d1-b3b3-aa5650ee5d076

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-2000-9100067200091100 in 1 BOTTLEHistorical
0067-2056-240006720562424 in 1 BOTTLEHistorical
0067-8148-01000678148011 KIT in 1 PACKAGE, COMBINATION (0067-8148-01) * 1 BOTTLE in 1 CARTON (0067-2056-24) / 24 TABLET, COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0067-2000-91) / 100 TABLET, FILM COATED in 1 BOTTLE1 kit2018-05-010000-00-00NoNoCurrent