Excedrin PM Triple Action Caplets and Excedrin Tension Headache

Product NDC: 0067-8147
Requested package NDC: 0067-8147-01
11-digit product format: 000678147
Labeler code: 0067
Product ID: 0067-8147_5b0f5eff-6fa1-4334-a51c-fd79e54e209b
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Aspirin (NSAID), Caffeine, and Diphenhydramine Citrate
Dosage form: KIT
Labeler: Haleon US Holdings LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-06-01
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0067-8147	0067-8147-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

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 PM Triple Action Caplets and Excedrin Tension Headache
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
307686	Internal RxNorm lookup
404172	Internal RxNorm lookup
1593110	Internal RxNorm lookup
1593116	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
978a9d27-6d41-42cb-a193-11314923d2ac	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
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
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
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
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	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
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0067-8147-01	2020-12-01	C162847	48780-1	9d75b9d0-c6f4-f424-e053-dadaa90a57ce	Drug Facts
0067-8147-01	2020-01-31	C162847	48780-1	9d75b9d0-c6f4-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-2056-24	Excedrin PM Triple Action Caplets and Excedrin Tension Headache	1 in 1 CARTON	TABLET, COATED		250 mg	5
0067-2056-24	Excedrin PM Triple Action Caplets and Excedrin Tension Headache	24 in 1 BOTTLE	TABLET, COATED	24	38 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
0067-8147-01	Excedrin PM Triple Action Caplets and Excedrin Tension Headache	1 in 1 PACKAGE, COMBINATION	KIT	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-8147	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, 5 package rows	20240316_978a9d27-6d41-42cb-a193-11314923d2ac.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 79 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Westminster Pharmaceuticals, LLC	ace5ebac-ec11-4c26-b1e3-954b450ee671	2021-05-04	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN 81 MG	Allegiant Health	8cacf02c-9925-40d4-92bc-78788aa0681a	2020-11-11	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN 500 MG	Allegiant Health	8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7	2020-03-13	Warnings	Exact identifier application number: M013
Acetaminophen 500mg ES	ACETAMINOPHEN 500MG	Allegiant Health	91acc132-01b6-467b-9af5-70f4dc93e087	2019-01-08	Warnings	Exact identifier application number: M013
Acetaminophen 325mg RS	ACETAMINOPHEN 325MG	Allegiant Health	61c6d281-e59b-4277-bbce-f71c12c2a56d	2019-01-07	Warnings	Exact identifier application number: M013
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Allegiant Health	9a4c0c43-a71a-4e22-a3d5-9eb9622689a2	2019-01-02	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG	Allegiant Health	423a8445-964c-4cdb-889a-f391ca5253e7	2018-12-31	Warnings	Exact identifier application number: M013
Cold Multi-Symptom Night-time	ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI	Allegiant Health	3f020cf2-6011-4216-9b39-0b3dc5f0749c	2018-12-26	Warnings	Exact identifier application number: M013
Aspirin Chewable	ASPIRIN 81 MG	Allegiant Health	92b8637b-03a9-461f-b2f6-6eddaa214953	2018-12-21	Warnings	Exact identifier application number: M013
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy	ACETAMINOPHEN AND PHENYLEPHRINE HCL	Allegiant Health	b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f	2018-12-21	Warnings	Exact identifier application number: M013
Clear Choice Regular Strength Pain Reliever	ACETAMINOPHEN	Athlete's Needs, Inc.	d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7	2018-12-11	Warnings	Exact identifier application number: M013
ASPIRIN Enteric Coated	ASPIRIN 81 MG	Allegiant Health	5910a882-eb40-440f-8a30-c21fbce9050e	2018-11-07	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN 325 MG	Allegiant Health	88b54062-8b3d-4024-a957-62b3255184b9	2018-11-07	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN 81 MG	Allegiant Health	3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe5	2018-11-07	Warnings	Exact identifier application number: M013
Tension Headache Relief	TENSION HEADACHE RELIEF	Allegiant Health	b431a1a3-39c4-4d6c-afdc-c8b017ad89da	2017-11-16	Warnings	Exact identifier application number: M013
SED-MAX	ACETAMINOPHEN 500 MG WITH CAFFEINE 65MG	Command Brands, LLC	4920a0e9-6f88-4df0-8657-77c95a3b9617	2017-01-19	Warnings	Exact identifier application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
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
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
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
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	978a9d27-6d41-42cb-a193-11314923d2ac	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
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0067-8147-01	00067814701	1 KIT in 1 PACKAGE, COMBINATION (0067-8147-01) * 1 BOTTLE in 1 CARTON (0067-2056-24) / 24 TABLET, COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0067-8139-02) / 100 TABLET, FILM COATED in 1 BOTTLE	1 kit	2017-06-01	0000-00-00	No	No	Current