FDA.reportPublic FDA data

Excedrin

Product NDC
0067-2000
11-digit product format
000672000
Labeler code
0067
Product ID
0067-2000_c6b4c367-7ec3-4005-be16-765f9e1a3f0b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin (NSAID), and Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-09-27
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0067-20000067-2000-07DDiscontinued by firm2026-10-05
excluded packagepackage0067-20000067-2000-94DDiscontinued by firm2026-10-05

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 · 35 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0067-2000-07DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0067-2000-94DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0067-2000-07DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0067-2000-94DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0067-2000-07DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0067-2000-94DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0067-2000-07DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0067-2000-94DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0067-2000-07DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0067-2000-94DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0067-2000-07DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0067-2000-94DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0067-2000-07DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0067-2000-94DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0067-2000-07DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0067-2000-94DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0067-2000-07DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0067-2000-94DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0067-2000-07DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0067-2000-94DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0067-2000-07DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0067-2000-94DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0067-2000-07DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0067-2000-94DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0067-2000-91IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0067-2000-33IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0067-2000-24IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0067-2000-50IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0067-2000-20IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0067-2000-77IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0067-2000-30IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0067-2000-83IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0067-2000-10IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0067-2000-02IInactivated by FDAfb8cb913e6d1…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
Brand name suffix
Extra Strength Pain Reliever
Listing expiration
2026-12-31

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
a71074a6-cc19-4bb3-8c84-4e82a8906801Available 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, Related label table
NDCEffectiveRelated label
0067-2000-022023-05-15Drug Facts
0067-2000-072023-05-15Drug Facts
0067-2000-102023-05-15Drug Facts
0067-2000-202023-05-15Drug Facts
0067-2000-242023-05-15Drug Facts
0067-2000-302023-05-15Drug Facts
0067-2000-332023-05-15Drug Facts
0067-2000-502023-05-15Drug Facts
0067-2000-772023-05-15Drug Facts
0067-2000-832023-05-15Drug Facts
0067-2000-912023-05-15Drug Facts
0067-2000-942023-05-15Drug Facts
0067-2000-022022-07-29Drug Facts
0067-2000-072022-07-29Drug Facts
0067-2000-102022-07-29Drug Facts
0067-2000-202022-07-29Drug Facts
0067-2000-242022-07-29Drug Facts
0067-2000-302022-07-29Drug Facts
0067-2000-332022-07-29Drug Facts
0067-2000-502022-07-29Drug Facts
0067-2000-772022-07-29Drug Facts
0067-2000-832022-07-29Drug Facts
0067-2000-912022-07-29Drug Facts
0067-2000-942022-07-29Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-2000-02ExcedrinExtra Strength Pain Reliever2 in 1 POUCHTABLET, FILM COATED212
0067-2000-07ExcedrinExtra Strength Pain Reliever250 in 1 BOTTLETABLET, FILM COATED25012
0067-2000-10ExcedrinExtra Strength Pain Reliever10 in 1 BOTTLETABLET, FILM COATED1012
0067-2000-10ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED112
0067-2000-20ExcedrinExtra Strength Pain Reliever200 in 1 BOTTLETABLET, FILM COATED20012
0067-2000-20ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED112
0067-2000-24ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED112
0067-2000-24ExcedrinExtra Strength Pain Reliever24 in 1 BOTTLETABLET, FILM COATED2412
0067-2000-30ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED112
0067-2000-30ExcedrinExtra Strength Pain Reliever30 in 1 BOTTLETABLET, FILM COATED3012
0067-2000-33ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED112
0067-2000-33ExcedrinExtra Strength Pain Reliever300 in 1 BOTTLETABLET, FILM COATED30012
0067-2000-50ExcedrinExtra Strength Pain Reliever50 in 1 BOTTLETABLET, FILM COATED5012
0067-2000-50ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED112
0067-2000-77ExcedrinExtra Strength Pain Reliever250 in 1 BOTTLETABLET, FILM COATED25012
0067-2000-77ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED112
0067-2000-83ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED112
0067-2000-83ExcedrinExtra Strength Pain Reliever125 in 1 BOTTLETABLET, FILM COATED12512
0067-2000-91ExcedrinExtra Strength Pain Reliever100 in 1 BOTTLETABLET, FILM COATED10012
0067-2000-91ExcedrinExtra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED112
0067-2000-94ExcedrinExtra Strength Pain Reliever100 in 1 BOTTLETABLET, FILM COATED10012
0067-2000-91Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED65 mg6
0067-2000-91Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever100 in 1 BOTTLETABLET, FILM COATED100250 mg6
0067-2000-91Excedrin Extra Strength and Excedrin Tension Headache1 in 1 CARTONTABLET, FILM COATED65 mg5
0067-2000-91Excedrin Extra Strength and Excedrin Tension Headache100 in 1 BOTTLETABLET, FILM COATED10065 mg5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-2000-10EA - Each0067-2000adfcd816-2ed6-4c72-8c5d-908c9756ab3f12015-11-12
0067-2000-20EA - Each0067-2000cbff9d6a-ce12-4fbb-ac40-512a94ce514a12014-11-05
0067-2000-24EA - Each0067-20003de1f192-e5db-479d-84d8-19456b94640212012-07-24
0067-2000-30EA - Each0067-20001f7e4f47-6c08-41f8-861c-981a7184f7a412025-05-14
0067-2000-33EA - Each0067-2000dcae665d-7d8d-4cfb-a2f9-93b577535a3e12015-10-02
0067-2000-50EA - Each0067-20009b6938a9-715c-431b-bada-71e78baeda0312012-07-24
0067-2000-77EA - Each0067-20007d621095-87ef-450a-891e-06781177125112012-07-24
0067-2000-91EA - Each0067-200051e263ed-40ca-4508-82dd-ccf0854b9b2112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
ASPIRINACTIVE INGREDIENTR16CO5Y76EEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
CAFFEINEACTIVE INGREDIENT3G6A5W338EEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
ASPIRINACTIVE MOIETYR16CO5Y76EEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
CAFFEINEACTIVE MOIETY3G6A5W338EEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
SORBITAN MONOLAURATEINACTIVE INGREDIENT6W9PS8B71JEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-2000EXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) TABLET, FILM COATED [HALEON US HOLDINGS LLC]12Current NDC, Legacy NDC, 21 package rows20240423_a71074a6-cc19-4bb3-8c84-4e82a8906801.zip
0067-2000EXCEDRIN 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 NDC20240316_444fa225-c204-45d1-b3b3-aa5650ee5d07.zip
0067-2000EXCEDRIN EXTRA STRENGTH AND EXCEDRIN TENSION HEADACHE (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) KIT [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC20240315_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 16 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACYaf6fe4a9-2d18-4fed-b952-0a7866f652512026-04-20WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINPreferred Pharmaceuticals Inc.ac7f11d2-cbfd-4610-a652-fc2f1ea41d7e2026-04-20WarningsExact identifier
application number: M013
Parry-500mg AcetaminophenACETAMINOPHENMDC PHARMACEUTICALS LIMITEDfb07ba10-3210-41bc-9310-c952118fdcf32026-04-17WarningsExact identifier
application number: M013
Aspirin NSAIDASPIRINValu Merchandisers Company0cc46a81-54c9-44b7-b384-79d25255eff22026-04-17WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEValu Merchandisers Company99de2c41-59b0-42e7-847e-e51229c6164f2026-04-17WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENWalgreen Company1f3e2895-5ef7-4e6a-8d2e-b805d148f9802026-04-16WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCb297aff8-a08b-4d37-b168-800a56564cbd2026-04-16WarningsExact identifier
application number: M013
Childrens TylenolACETAMINOPHENKenvue Brands LLC9782fe86-d72a-4231-b1ba-d3f3b4ee49e32026-04-16WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLDOLGENCORP, LLC8e65478b-7a7b-416c-b8e3-23dad79f8cc12026-04-16WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINValu Merchandisers Companyc9e384e5-fa9b-4c75-b5e3-16eb8db662ef2026-04-16WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.b6abfbbb-9826-4cd6-940f-3a314480a5a52026-04-15WarningsExact identifier
application number: M013
Good Sense Pain and FeverACETAMINOPHENL. Perrigo Companyf7137fe6-582e-43a4-8302-90ca54cd1de32026-04-14WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCardinal Health 107, LLCe13656eb-513e-411e-bdae-35ff1ba7cfc12026-04-13WarningsExact identifier
application number: M013
CareOne AcetaminophenACETAMINOPHENAmerican Sales Companyb4f54465-3232-4685-9570-90be008765772026-04-12WarningsExact identifier
application number: M013
Childrens Pain Relief Dye freeACTEMINOPHENBETTER LIVING BRANDS LLC.41f504d1-29c4-f075-e063-6394a90ad64c2026-04-11WarningsExact identifier
application number: M013
Dr. Simi Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLFarmacias De Similares TX LLC4f1e1f1a-44f4-2356-e063-6294a90a8cdd2026-04-10WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINAkron Pharma Inc.e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed2026-04-10WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.28413cb3-22c4-40e2-ad6b-42beb438dea32026-04-10WarningsExact identifier
application number: M013
Pain Reliever ChildrensACETAMINOPHENH E B7e43de11-d20b-4920-a04d-3c1b5d35e0052026-04-09WarningsExact identifier
application number: M013
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINENavajo Manufacturing Company Inc.f7e572e9-82a7-2127-e053-6394a90ab01a2026-04-08WarningsExact 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 TabletPSNa71074a6-cc19-4bb3-8c84-4e82a890680112
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSNa71074a6-cc19-4bb3-8c84-4e82a890680112
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBDa71074a6-cc19-4bb3-8c84-4e82a890680112
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCDa71074a6-cc19-4bb3-8c84-4e82a890680112
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSYa71074a6-cc19-4bb3-8c84-4e82a890680112
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SYa71074a6-cc19-4bb3-8c84-4e82a890680112
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYa71074a6-cc19-4bb3-8c84-4e82a890680112
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYa71074a6-cc19-4bb3-8c84-4e82a890680112
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYa71074a6-cc19-4bb3-8c84-4e82a890680112
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
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
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
0067-2000-02000672000022 TABLET, FILM COATED in 1 POUCH (0067-2000-02) 2006-09-270000-00-00NoNoCurrent
0067-2000-0700067200007250 in 1 BOTTLEHistorical
0067-2000-10000672000101 BOTTLE in 1 CARTON (0067-2000-10) / 10 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-09-270000-00-00NoNoCurrent
0067-2000-20000672000201 BOTTLE in 1 CARTON (0067-2000-20) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-09-270000-00-00NoNoCurrent
0067-2000-24000672000241 BOTTLE in 1 CARTON (0067-2000-24) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-09-270000-00-00NoNoCurrent
0067-2000-30000672000301 BOTTLE in 1 CARTON (0067-2000-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-09-270000-00-00NoNoCurrent
0067-2000-33000672000331 BOTTLE in 1 CARTON (0067-2000-33) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-09-270000-00-00NoNoCurrent
0067-2000-50000672000501 BOTTLE in 1 CARTON (0067-2000-50) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-09-270000-00-00NoNoCurrent
0067-2000-77000672000771 BOTTLE in 1 CARTON (0067-2000-77) / 250 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-09-270000-00-00NoNoCurrent
0067-2000-83000672000831 BOTTLE in 1 CARTON (0067-2000-83) / 125 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-09-270000-00-00NoNoCurrent
0067-2000-91000672000911 BOTTLE in 1 CARTON (0067-2000-91) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-09-270000-00-00NoNoCurrent
0067-2000-9400067200094100 in 1 BOTTLEHistorical