FDA.reportPublic FDA data

Excedrin Extra Strength

Product NDC
52904-868
Requested package NDC
52904-868-25
11-digit product format
529040868
Labeler code
52904
Product ID
52904-868_055e2c6d-5d40-4f69-a5f7-9f96df4894d2
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, aspirin (nsaid), and caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Select Corporation
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-01-23
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
250 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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52904-86852904-868-25IInactivated by FDA2026-10-12

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product 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, Related label table
NDCRelated label
52904-868-04Excedrin® Extra Strength
52904-868-05Excedrin® Extra Strength
52904-868-25Excedrin® Extra Strength
52904-868-50Excedrin® Extra Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-868-04Excedrin Extra Strength2 in 1 POUCHTABLET, FILM COATED21
52904-868-04Excedrin Extra Strength1 in 1 BLISTER PACKTABLET, FILM COATED11
52904-868-05Excedrin Extra Strength2 in 1 BLISTER PACKTABLET, FILM COATED21
52904-868-05Excedrin Extra Strength2 in 1 POUCHTABLET, FILM COATED21
52904-868-25Excedrin Extra Strength2 in 1 POUCHTABLET, FILM COATED21
52904-868-25Excedrin Extra Strength25 in 1 CARTONTABLET, FILM COATED251
52904-868-50Excedrin Extra Strength2 in 1 POUCHTABLET, FILM COATED21
52904-868-50Excedrin Extra Strength50 in 1 CARTONTABLET, FILM COATED501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-868EXCEDRIN EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [SELECT CORPORATION]1Legacy NDC, 8 package rows20220412_60af6b21-9dc2-461e-a9bd-28d8e75cecb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN60af6b21-9dc2-461e-a9bd-28d8e75cecb51
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSN60af6b21-9dc2-461e-a9bd-28d8e75cecb51
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBD60af6b21-9dc2-461e-a9bd-28d8e75cecb51
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD60af6b21-9dc2-461e-a9bd-28d8e75cecb51
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY60af6b21-9dc2-461e-a9bd-28d8e75cecb51
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SY60af6b21-9dc2-461e-a9bd-28d8e75cecb51
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY60af6b21-9dc2-461e-a9bd-28d8e75cecb51
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY60af6b21-9dc2-461e-a9bd-28d8e75cecb51
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY60af6b21-9dc2-461e-a9bd-28d8e75cecb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52904-868-255290408682525 POUCH in 1 CARTON (52904-868-25) > 2 TABLET, FILM COATED in 1 POUCH25 pouch2016-01-230000-00-00NoNoCurrent