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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 application applno (NDA): 020802 application number: NDA020802 ndc (product): 69168-285

Additional Listing Data#

Finished product: Yes
Brand name base: Headache Relief
Brand name suffix: Extra Strength
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
362O9ITL9D	Internal UNII lookup
R16CO5Y76E	Internal UNII lookup
3G6A5W338E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69168-285-24	2020-03-13	C162847	48780-1	9d75b9d0-1cb4-f424-e053-dadaa90a57ce	Drug Facts
69168-285-24	2020-01-31	C162847	48780-1	9d75b9d0-1cb4-f424-e053-dadaa90a57ce	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

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
69168-285-37	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