Headache Relief

Product NDC: 69168-285
11-digit product format: 691680285
Labeler code: 69168
Product ID: 69168-285_62d55418-7d3d-4708-af3a-2969be915e4a
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Aspirin and Caffeine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Allegiant Health
Application: NDA020802
Marketing category: NDA
Marketing start: 2010-02-15
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69168-285	69168-285-24	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020802-001	EXCEDRIN (MIGRAINE RELIEF)	ACETAMINOPHEN; ASPIRIN; CAFFEINE	250MG;250MG;65MG	TABLET / ORAL		RLD, RS	1998-01-14

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Headache Relief
Brand name suffix: Extra Strength
Listing expiration: 2027-12-31

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
362O9ITL9D	Internal UNII lookup
R16CO5Y76E	Internal UNII lookup
3G6A5W338E	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
6197eff5-0351-42ef-bb3f-cbc26e6d0d14	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
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
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
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	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#

Effective, Related label table
Effective	Related label
2020-03-13	Drug Facts
2020-03-13	Drug Facts
2020-03-13	Drug Facts
2020-01-31	Drug Facts
2020-01-31	Drug Facts
2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69168-285-24	Headache ReliefExtra Strength	24 in 1 BOTTLE	TABLET, FILM COATED	24	4
69168-285-24	Headache ReliefExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	4
69168-285-37	Headache ReliefExtra Strength	16 in 1 BOTTLE	TABLET, FILM COATED	16	4
69168-285-37	Headache ReliefExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-285	HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [ALLEGIANT HEALTH]	4	Current NDC, Legacy NDC, 4 package rows	20220910_6197eff5-0351-42ef-bb3f-cbc26e6d0d14.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 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Excedrin Migraine	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Select Consumer Group	3caa4adf-abe3-67c3-e063-6294a90a87a4	2026-07-03	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802
Excedrin Migraine	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Navajo Manufacturing Company Inc.	4efbd21b-92fe-96a7-e063-6294a90ac4ad	2026-04-08	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802
EXCEDRIN MIGRAINE	ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE	Haleon US Holdings LLC	7ed841fb-a61c-4868-b4e5-4f2311a5e79c	2025-06-25	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802
Excedrin Migraine Relief	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE	Haleon US Holdings LLC	dd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d8	2025-03-11	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802
Excedrin Migraine	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Haleon US Holdings LLC	910d7254-d0f4-4c5c-a26e-7f8acecbe02d	2025-03-11	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802
Excedrin Extra Strength Headache	ACETAMINOPHEN, ASPIRIN, CAFFEINE	JC World Bell Wholesale Co., Inc	29b764c7-3d07-5191-e063-6294a90a9c30	2024-12-23	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802
Excedrin Migraine, TRAVEL BASIX	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Lil' Drug Store Products, Inc.	40aeb2c5-a37b-446d-9918-8378a75ff327	2024-12-13	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802
Excedrin Migraine	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	A-S Medication Solutions	d012ed1d-b256-48ec-b988-f226c2c5ae9e	2024-05-29	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802
EXCEDRIN MIGRAINE	ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE	Haleon US Holdings LLC	920c8898-e222-4b91-afc5-04d25317ade7	2024-03-14	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802
Excedrin Migraine Geltabs	ACETAMINOPHEN, ASPRIN, CAFFEINE	Haleon US Holdings LLC	cc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff8	2024-01-28	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Allegiant Health	6197eff5-0351-42ef-bb3f-cbc26e6d0d14	2018-12-28	Warnings	Exact identifier ndc (product): 69168-285

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	6197eff5-0351-42ef-bb3f-cbc26e6d0d14	4
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	SCD	6197eff5-0351-42ef-bb3f-cbc26e6d0d14	4
308297	APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet	SY	6197eff5-0351-42ef-bb3f-cbc26e6d0d14	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-285-24	69168028524	1 BOTTLE in 1 CARTON (69168-285-24) > 24 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2010-02-15	2024-03-31	No	No	Current
69168-285-26	69168028526	1 BOTTLE in 1 CARTON (69168-285-26) / 20 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2020-03-06		0		Current
69168-285-37	69168028537	1 BOTTLE in 1 CARTON (69168-285-37) / 16 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2022-09-08	0000-00-00	No	No	Current