Excedrin

Product NDC: 0067-8139
11-digit product format: 000678139
Labeler code: 0067
Product ID: 0067-8139_dd87f543-c93b-4204-a601-368db2fec725
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Caffeine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-12-15
Substance: ACETAMINOPHEN; CAFFEINE
Active strength: 500; 65 mg/1; mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [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: Tension Headache
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1
CAFFEINE	65 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
307686	Internal RxNorm lookup
404172	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
12c074d1-81ac-47d2-8747-b018cda0058a	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
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
3e48c9c4-918d-5d23-2f0b-d2398b06be54	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
865c72dd-0d94-daac-f728-ddd4ded2a79e	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	Strength	SPL version
0067-8139-01	ExcedrinTension Headache	24 in 1 BOTTLE	TABLET, FILM COATED	24		7
0067-8139-01	ExcedrinTension Headache	1 in 1 CARTON	TABLET, FILM COATED	1		7
0067-8139-02	ExcedrinTension Headache	100 in 1 BOTTLE	TABLET, FILM COATED	100		7
0067-8139-02	ExcedrinTension Headache	1 in 1 CARTON	TABLET, FILM COATED	1		7
0067-8139-01	Excedrin Extra Strength and Excedrin Tension Headache	24 in 1 BOTTLE	TABLET, FILM COATED	24	500 mg	5
0067-8139-01	Excedrin Extra Strength and Excedrin Tension Headache	1 in 1 CARTON	TABLET, FILM COATED		65 mg	5
0067-8139-02	Excedrin PM Triple Action Caplets and Excedrin Tension Headache	1 in 1 CARTON	TABLET, FILM COATED		65 mg	5
0067-8139-02	Excedrin PM Triple Action Caplets and Excedrin Tension Headache	100 in 1 BOTTLE	TABLET, FILM COATED	100	65 mg	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0067-8139-01	EA - Each	0067-8139	f7c98859-4508-488d-b72d-51329ba13e79	1	2017-07-07
0067-8139-02	EA - Each	0067-8139	09717a78-cbda-4ec5-b388-d04a131c9a60	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-8139	EXCEDRIN TENSION HEADACHE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [HALEON US HOLDINGS LLC]	7	Current NDC, Legacy NDC, 4 package rows	20240315_12c074d1-81ac-47d2-8747-b018cda0058a.zip
0067-8139	EXCEDRIN PM TRIPLE ACTION CAPLETS AND EXCEDRIN TENSION HEADACHE (ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE) KIT [HALEON US HOLDINGS LLC]	5	Current NDC, Legacy NDC	20240316_978a9d27-6d41-42cb-a193-11314923d2ac.zip
0067-8139	EXCEDRIN EXTRA STRENGTH AND EXCEDRIN TENSION HEADACHE (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) KIT [HALEON US HOLDINGS LLC]	4	Current NDC, Legacy NDC	20240315_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 73 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOLODOL	ACETAMINOPHEN, ASPIRIN, CAFFEINE	OPMX LLC	e80536f1-92cc-5bb3-e053-2995a90a9540	2024-01-26	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	d913d11f-c7a1-49d2-a2d3-9a29fc032806	2024-01-18	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	64c28b38-23bb-4c7e-9c19-1d1f0d597528	2024-01-18	Warnings	Exact identifier application number: M013
Buscapina	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	OPMX LLC	e0dd4c04-6811-38a1-e053-2995a90aa3c9	2024-01-17	Warnings	Exact identifier application number: M013
Regular Strength Acetaminophen	ACETAMINOPHEN	CARDINAL HEALTH	bdf8c511-ce25-0e30-e053-2a95a90a33f6	2024-01-10	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2560126e-a54a-4a47-9631-a1bca42f5277	2024-01-10	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	A-S Medication Solutions	ee4451c9-4d0f-4373-8f64-fcc1f9dd5856	2024-01-05	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN	Proficient Rx LP	51ba690e-d76b-41c6-a083-8bc803e1faa2	2024-01-01	Warnings	Exact identifier application number: M013
MEDI-FIRST Non-Aspirin Extra Strength	ACETAMINOPHEN	Proficient Rx LP	9071b047-5463-4f65-b775-bfb0ce066527	2024-01-01	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	TIME CAP LABORATORIES, INC	1acc8c1a-c746-4635-800c-de1ad758fce0	2023-12-30	Warnings	Exact identifier application number: M013
MAX Cold, Flu, and Sore Throat	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL	H E B	9b09b660-0758-48dc-84c9-26cdd2aacc03	2023-12-29	Warnings	Exact identifier application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU Original	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	DeMoulas Market Basket	eb24323f-82a1-4ba3-9359-fe81571c3fba	2023-12-29	Warnings	Exact identifier application number: M013
Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Salado Sales, Inc.	e6c3e545-b2ad-47f0-8318-c134a8e24f5b	2023-12-29	Warnings	Exact identifier application number: M013
Daytime Non-Drowsy COLD/FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Salado Sales, Inc.	e181b371-78c7-4163-865d-acc064be33ca	2023-12-29	Warnings	Exact identifier application number: M013
Childrens Pain and Fever Cherry flavor	ACETAMINOPHEN	Walgreen Company	64c65244-f7a3-401b-b83a-bf66d45268e2	2023-12-29	Warnings	Exact identifier application number: M013
Nite-Time COLD/FLU ORIGINAL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Salado Sales, Inc.	fcd24753-b42b-4d05-8379-0ec0351ab217	2023-12-29	Warnings	Exact identifier application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU Cherry	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	DeMoulas Market Basket	e772cdf5-d01d-4752-8cfb-7e7f4d7a8dd0	2023-12-29	Warnings	Exact identifier application number: M013
Childrens Pain and Fever, Grape flavor	ACETAMINOPHEN	Walgreen Company	0995d69f-61aa-40b0-b095-bb8595caf773	2023-12-29	Warnings	Exact identifier application number: M013
DAY-TIME Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	ce900e42-d0c8-408d-a1c3-3a9bef1c97ee	2023-12-29	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	DOLGENCORP, INC.	06553550-5685-f3c3-e063-6394a90aef07	2023-12-22	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
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307686	acetaminophen 500 MG / caffeine 65 MG Oral Tablet	PSN	12c074d1-81ac-47d2-8747-b018cda0058a	7
404172	EXCEDRIN TENSION HEADACHE 500 MG / 65 MG Oral Tablet	PSN	12c074d1-81ac-47d2-8747-b018cda0058a	7
404172	acetaminophen 500 MG / caffeine 65 MG Oral Tablet [Excedrin Tension Headache]	SBD	12c074d1-81ac-47d2-8747-b018cda0058a	7
307686	acetaminophen 500 MG / caffeine 65 MG Oral Tablet	SCD	12c074d1-81ac-47d2-8747-b018cda0058a	7
307686	APAP 500 MG / Caffeine 65 MG Oral Tablet	SY	12c074d1-81ac-47d2-8747-b018cda0058a	7
404172	APAP 500 MG / Caffeine 65 MG Oral Tablet [Excedrin Tension Headache]	SY	12c074d1-81ac-47d2-8747-b018cda0058a	7
404172	Excedrin Aspirin Free (acetaminophen 500 MG / caffeine 65 MG) Oral Tablet	SY	12c074d1-81ac-47d2-8747-b018cda0058a	7
404172	Excedrin Tension Headache (APAP 500 MG / caffeine 65 MG) Oral Tablet	SY	12c074d1-81ac-47d2-8747-b018cda0058a	7
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	PSN	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
1593110	acetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet	PSN	978a9d27-6d41-42cb-a193-11314923d2ac	5
307686	acetaminophen 500 MG / caffeine 65 MG Oral Tablet	PSN	978a9d27-6d41-42cb-a193-11314923d2ac	5
307686	acetaminophen 500 MG / caffeine 65 MG Oral Tablet	PSN	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
209468	EXCEDRIN 250 MG / 250 MG / 65 MG Oral Tablet	PSN	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
1593116	Excedrin PM Triple Action (250 MG / 250 MG / 38 MG) Oral Tablet	PSN	978a9d27-6d41-42cb-a193-11314923d2ac	5
404172	EXCEDRIN TENSION HEADACHE 500 MG / 65 MG Oral Tablet	PSN	978a9d27-6d41-42cb-a193-11314923d2ac	5
404172	EXCEDRIN TENSION HEADACHE 500 MG / 65 MG Oral Tablet	PSN	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
209468	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]	SBD	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
1593116	acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet [Excedrin PM Triple Action]	SBD	978a9d27-6d41-42cb-a193-11314923d2ac	5
404172	acetaminophen 500 MG / caffeine 65 MG Oral Tablet [Excedrin Tension Headache]	SBD	978a9d27-6d41-42cb-a193-11314923d2ac	5
404172	acetaminophen 500 MG / caffeine 65 MG Oral Tablet [Excedrin Tension Headache]	SBD	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	SCD	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
1593110	acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet	SCD	978a9d27-6d41-42cb-a193-11314923d2ac	5
307686	acetaminophen 500 MG / caffeine 65 MG Oral Tablet	SCD	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
307686	acetaminophen 500 MG / caffeine 65 MG Oral Tablet	SCD	978a9d27-6d41-42cb-a193-11314923d2ac	5
308297	APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet	SY	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
209468	APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]	SY	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
1593110	APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet	SY	978a9d27-6d41-42cb-a193-11314923d2ac	5
1593116	APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet [Excedrin PM Triple Action]	SY	978a9d27-6d41-42cb-a193-11314923d2ac	5
307686	APAP 500 MG / Caffeine 65 MG Oral Tablet	SY	978a9d27-6d41-42cb-a193-11314923d2ac	5
307686	APAP 500 MG / Caffeine 65 MG Oral Tablet	SY	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
404172	APAP 500 MG / Caffeine 65 MG Oral Tablet [Excedrin Tension Headache]	SY	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
404172	APAP 500 MG / Caffeine 65 MG Oral Tablet [Excedrin Tension Headache]	SY	978a9d27-6d41-42cb-a193-11314923d2ac	5
404172	Excedrin Aspirin Free (acetaminophen 500 MG / caffeine 65 MG) Oral Tablet	SY	978a9d27-6d41-42cb-a193-11314923d2ac	5
404172	Excedrin Aspirin Free (acetaminophen 500 MG / caffeine 65 MG) Oral Tablet	SY	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
209468	Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
209468	Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
209468	Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5
1593116	Excedrin PM Triple Action (acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG) Oral Tablet	SY	978a9d27-6d41-42cb-a193-11314923d2ac	5
404172	Excedrin Tension Headache (APAP 500 MG / caffeine 65 MG) Oral Tablet	SY	978a9d27-6d41-42cb-a193-11314923d2ac	5
404172	Excedrin Tension Headache (APAP 500 MG / caffeine 65 MG) Oral Tablet	SY	2c8df1c7-7864-48df-939c-d9ae22e0f52c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0067-8139-01	00067813901	1 BOTTLE in 1 CARTON (0067-8139-01) / 24 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2016-12-15	0000-00-00	No	No	Current
0067-8139-02	00067813902	1 BOTTLE in 1 CARTON (0067-8139-02) / 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2016-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Haleon US Holdings LLC	2026-02-23	HUMAN OTC DRUG LABEL	5
Drug Facts	Haleon US Holdings LLC	2024-03-14	HUMAN OTC DRUG LABEL	5
Drug Facts	Haleon US Holdings LLC	2024-03-13	HUMAN OTC DRUG LABEL	7