Excedrin

Product NDC: 0067-2002
Requested package NDC: 0067-2002-02
11-digit product format: 000672002
Labeler code: 0067
Product ID: 0067-2002_1005a911-f3ad-23c9-e063-6294a90abb9f
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Aspirin (NSAID), Caffeine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-01-01
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

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 Headache
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	250 mg/1
ASPIRIN	250 mg/1
CAFFEINE	65 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3G6A5W338E	Internal UNII lookup
R16CO5Y76E	Internal UNII lookup
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
209468	Internal RxNorm lookup
308297	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
61802b27-c9ec-4386-9d44-45e8b1e558b7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0067-2002-01	ExcedrinExtra Strength Headache	1 in 1 CARTON	TABLET, FILM COATED	1	2
0067-2002-01	ExcedrinExtra Strength Headache	24 in 1 BOTTLE	TABLET, FILM COATED	24	2
0067-2002-02	ExcedrinExtra Strength Headache	1 in 1 CARTON	TABLET, FILM COATED	1	2
0067-2002-02	ExcedrinExtra Strength Headache	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
0067-2002-03	ExcedrinExtra Strength Headache	50 in 1 BOTTLE	TABLET, FILM COATED	50	2
0067-2002-03	ExcedrinExtra Strength Headache	1 in 1 CARTON	TABLET, FILM COATED	1	2
0067-2002-04	ExcedrinExtra Strength Headache	1 in 1 CARTON	TABLET, FILM COATED	1	2
0067-2002-04	ExcedrinExtra Strength Headache	100 in 1 BOTTLE	TABLET, FILM COATED	100	2
0067-2002-05	ExcedrinExtra Strength Headache	1 in 1 CARTON	TABLET, FILM COATED	1	2
0067-2002-05	ExcedrinExtra Strength Headache	125 in 1 BOTTLE	TABLET, FILM COATED	125	2
0067-2002-06	ExcedrinExtra Strength Headache	1 in 1 CARTON	TABLET, FILM COATED	1	2
0067-2002-06	ExcedrinExtra Strength Headache	200 in 1 BOTTLE	TABLET, FILM COATED	200	2
0067-2002-07	ExcedrinExtra Strength Headache	250 in 1 BOTTLE	TABLET, FILM COATED	250	2
0067-2002-07	ExcedrinExtra Strength Headache	1 in 1 CARTON	TABLET, FILM COATED	1	2
0067-2002-08	ExcedrinExtra Strength Headache	300 in 1 BOTTLE	TABLET, FILM COATED	300	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-2002	EXCEDRIN EXTRA STRENGTH HEADACHE (ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE) TABLET, FILM COATED [HALEON US HOLDINGS LLC]	2	Current NDC, 15 package rows	20240129_61802b27-c9ec-4386-9d44-45e8b1e558b7.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 71 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Effervescent Pain Relief	ASPIRIN	Perrigo Direct, Inc.	103027a7-2f0e-8d8c-e063-6294a90aedc7	2024-03-26	Warnings	Exact identifier application number: M013
rugby infants acetaminophen	ACETAMINOPHEN	Rugby Laboratories	8aa9ac68-ca61-4163-a876-52034138c1ea	2024-03-25	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	08a18481-f029-f01f-e063-6294a90aac65	2024-03-21	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	0d106fa2-2a77-deb2-e063-6394a90a2dac	2024-03-21	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	872c5220-a379-4dc1-b99c-f11ebb82db35	2024-03-19	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	79886972-47a4-44c5-a131-1a691a328103	2024-03-19	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	5ffcc78d-9163-4cb4-8811-ae9f0142806a	2024-03-18	Warnings	Exact identifier application number: M013
ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	HF Acquisition Co LLC, DBA HealthFirst	13e621dc-b2b4-98fd-e063-6394a90acc75	2024-03-17	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS PHARMACY, INC	097a9c98-a092-400d-9600-6797b0b9a50c	2024-03-15	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets and Excedrin Tension Headache	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	978a9d27-6d41-42cb-a193-11314923d2ac	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets	ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	b3812d27-40af-40d7-864a-dfa4ae34cb9e	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	691b754c-bafc-47e2-a322-cf56245c01f6	2024-03-14	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS PHARMACY, INC	fdc80b2a-d7c1-4b3d-9a9b-28182c6320de	2024-03-14	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	QUALITY CHOICE (Chain Drug Marketing Association)	2cde052d-22a4-470f-8d6a-7c17061b8ac8	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin Tension Headache	ACETAMINOPHEN, CAFFEINE	Haleon US Holdings LLC	12c074d1-81ac-47d2-8747-b018cda0058a	2024-03-13	Warnings	Exact identifier application number: M013
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Strive Pharmaceuticals Inc.	78c12459-3b27-4ed0-943d-520794eb438d	2024-03-07	Warnings	Exact identifier application number: M013
Pain Reliever fever Reducer Extra Strength	ACETAMINOPHEN	CVS Pharmacy	7b5263ad-01b7-4fc5-9384-4da8efe89e35	2024-03-06	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Geltabs	ACETAMINOPHEN, ASPRIN, CAFFEINE	Haleon US Holdings LLC	11a8439b-0159-4351-b0f5-fe7fad6a33c0	2024-03-05	Warnings	Exact identifier application number: M013
Winco Foods Effervescent Pain Relief	ASPIRIN	Winco Foods, LLC	128afdd7-a9d1-8957-e063-6294a90af569	2024-03-05	Warnings	Exact identifier application number: M013
Aspirin Low Dose Safety Coated	ASPIRIN	Care One (Retail Business Services, LLC.)	6659e103-fa03-4de0-af42-d2fbd548a87c	2024-03-05	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	PSN	907c89e7-2482-465f-9f85-2381ecab1b86	2
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	PSN	29b764c7-3d07-5191-e063-6294a90a9c30	2
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	PSN	61802b27-c9ec-4386-9d44-45e8b1e558b7	2
209468	EXCEDRIN 250 MG / 250 MG / 65 MG Oral Tablet	PSN	29b764c7-3d07-5191-e063-6294a90a9c30	2
209468	EXCEDRIN 250 MG / 250 MG / 65 MG Oral Tablet	PSN	907c89e7-2482-465f-9f85-2381ecab1b86	2
209468	EXCEDRIN 250 MG / 250 MG / 65 MG Oral Tablet	PSN	61802b27-c9ec-4386-9d44-45e8b1e558b7	2
209468	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]	SBD	61802b27-c9ec-4386-9d44-45e8b1e558b7	2
209468	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]	SBD	907c89e7-2482-465f-9f85-2381ecab1b86	2
209468	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]	SBD	29b764c7-3d07-5191-e063-6294a90a9c30	2
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	SCD	29b764c7-3d07-5191-e063-6294a90a9c30	2
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	SCD	907c89e7-2482-465f-9f85-2381ecab1b86	2
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	SCD	61802b27-c9ec-4386-9d44-45e8b1e558b7	2
308297	APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet	SY	907c89e7-2482-465f-9f85-2381ecab1b86	2
308297	APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet	SY	29b764c7-3d07-5191-e063-6294a90a9c30	2
308297	APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet	SY	61802b27-c9ec-4386-9d44-45e8b1e558b7	2
209468	APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]	SY	29b764c7-3d07-5191-e063-6294a90a9c30	2
209468	APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]	SY	907c89e7-2482-465f-9f85-2381ecab1b86	2
209468	APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]	SY	61802b27-c9ec-4386-9d44-45e8b1e558b7	2
209468	Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY	61802b27-c9ec-4386-9d44-45e8b1e558b7	2
209468	Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY	29b764c7-3d07-5191-e063-6294a90a9c30	2
209468	Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY	907c89e7-2482-465f-9f85-2381ecab1b86	2
209468	Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY	907c89e7-2482-465f-9f85-2381ecab1b86	2
209468	Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY	61802b27-c9ec-4386-9d44-45e8b1e558b7	2
209468	Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY	29b764c7-3d07-5191-e063-6294a90a9c30	2
209468	Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY	29b764c7-3d07-5191-e063-6294a90a9c30	2
209468	Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY	907c89e7-2482-465f-9f85-2381ecab1b86	2
209468	Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY	61802b27-c9ec-4386-9d44-45e8b1e558b7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0067-2002-02	00067200202	1 BOTTLE in 1 CARTON (0067-2002-02) / 30 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2024-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Excedrin Extra Strength Headache	R J General Corporation	2025-11-17	HUMAN OTC DRUG LABEL	2
Excedrin Extra Strength Headache	JC World Bell Wholesale Co., Inc \| Haleon US Inc. \| JC World Bell Wholesale Co., Inc.	2024-12-23	HUMAN OTC DRUG LABEL	2
Drug Facts	Haleon US Holdings LLC	2024-01-28	HUMAN OTC DRUG LABEL	2