FDA.reportPublic FDA data

Excedrin

Product NDC
85237-1871
Requested package NDC
85237-1871-2
11-digit product format
852371871
Labeler code
85237
Product ID
85237-1871_46f50269-d18b-0be7-e063-6394a90a6fef
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin, and Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Select Consumer Group
Application
NDA020802
Marketing category
NDA
Marketing start
2020-09-30
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
250; 250; 65 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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020802-001EXCEDRIN (MIGRAINE RELIEF)ACETAMINOPHEN; ASPIRIN; CAFFEINE250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINESelect Consumer Group3caa4adf-abe3-67c3-e063-6294a90a87a42026-07-03WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
ndc (package): 85237-1871-2
ndc (product): 85237-1871
ndc11 (package): 85237187102
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINENavajo Manufacturing Company Inc.4efbd21b-92fe-96a7-e063-6294a90ac4ad2026-04-08WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
EXCEDRIN MIGRAINEACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINEHaleon US Holdings LLC7ed841fb-a61c-4868-b4e5-4f2311a5e79c2025-06-25WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
Excedrin Migraine ReliefACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINEHaleon US Holdings LLCdd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d82025-03-11WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINEHaleon US Holdings LLC910d7254-d0f4-4c5c-a26e-7f8acecbe02d2025-03-11WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN, CAFFEINEJC World Bell Wholesale Co., Inc29b764c7-3d07-5191-e063-6294a90a9c302024-12-23WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
Excedrin Migraine, TRAVEL BASIXACETAMINOPHEN, ASPIRIN, AND CAFFEINELil' Drug Store Products, Inc.40aeb2c5-a37b-446d-9918-8378a75ff3272024-12-13WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINEA-S Medication Solutionsd012ed1d-b256-48ec-b988-f226c2c5ae9e2024-05-29WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
EXCEDRIN MIGRAINEACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINEHaleon US Holdings LLC920c8898-e222-4b91-afc5-04d25317ade72024-03-14WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
Excedrin Migraine GeltabsACETAMINOPHEN, ASPRIN, CAFFEINEHaleon US Holdings LLCcc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff82024-01-28WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEAllegiant Health6197eff5-0351-42ef-bb3f-cbc26e6d0d142018-12-28WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802

Additional Listing Data#

Finished product
Yes
Brand name base
Excedrin
Brand name suffix
Migraine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN250 mg/1
ASPIRIN250 mg/1
CAFFEINE65 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
R16CO5Y76EInternal 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
209468Internal RxNorm lookup
308297Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3caa4adf-abe3-67c3-e063-6294a90a87a4Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85237-1871-1ExcedrinMigraine1 in 1 BLISTER PACKTABLET, FILM COATED12
85237-1871-1ExcedrinMigraine2 in 1 POUCHTABLET, FILM COATED22
85237-1871-2ExcedrinMigraine2 in 1 POUCHTABLET, FILM COATED22
85237-1871-2ExcedrinMigraine2 in 1 BLISTER PACKTABLET, FILM COATED22
85237-1871-3ExcedrinMigraine2 in 1 POUCHTABLET, FILM COATED22
85237-1871-3ExcedrinMigraine25 in 1 BOX, UNIT-DOSETABLET, FILM COATED252
85237-1871-4ExcedrinMigraine50 in 1 BOX, UNIT-DOSETABLET, FILM COATED502
85237-1871-4ExcedrinMigraine2 in 1 POUCHTABLET, FILM COATED22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN3caa4adf-abe3-67c3-e063-6294a90a87a42
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSN3caa4adf-abe3-67c3-e063-6294a90a87a42
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBD3caa4adf-abe3-67c3-e063-6294a90a87a42
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD3caa4adf-abe3-67c3-e063-6294a90a87a42
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY3caa4adf-abe3-67c3-e063-6294a90a87a42
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SY3caa4adf-abe3-67c3-e063-6294a90a87a42
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY3caa4adf-abe3-67c3-e063-6294a90a87a42
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY3caa4adf-abe3-67c3-e063-6294a90a87a42
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY3caa4adf-abe3-67c3-e063-6294a90a87a42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85237-1871-2852371871022 POUCH in 1 BLISTER PACK (85237-1871-2) / 2 TABLET, FILM COATED in 1 POUCH2 pouch2025-12-24NoNoCurrent