Tension Headache Relief

Product NDC: 0363-0572
11-digit product format: 003630572
Labeler code: 0363
Product ID: 0363-0572_ec169872-a3fb-4903-bdf2-b2e121e707f7
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Caffeine
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Walgreen Company
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-02-09
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: 2027-12-31
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	0363-0572	0363-0572-09	D	Discontinued by firm		2026-10-16

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…`

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: Tension Headache Relief
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
307686	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
f13fb7e9-50ea-4e2c-a442-38b1b5b315d7	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
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
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0572-09	Tension Headache Relief	20 in 1 BOTTLE	TABLET, COATED	20	19
0363-0572-09	Tension Headache Relief	1 in 1 CARTON	TABLET, COATED	1	19
0363-0572-31	Tension Headache Relief	1 in 1 CARTON	TABLET, COATED	1	19
0363-0572-31	Tension Headache Relief	80 in 1 BOTTLE, PLASTIC	TABLET, COATED	80	19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [WALGREEN CO.]	3
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [WALGREEN CO.]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [WALGREEN CO.]	3
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [WALGREEN CO.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [WALGREEN CO.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [WALGREEN CO.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [WALGREEN CO.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [WALGREEN CO.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0572	TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, COATED [WALGREEN COMPANY]	18	Current NDC, Legacy NDC, 4 package rows	20240702_f13fb7e9-50ea-4e2c-a442-38b1b5b315d7.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 16 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Pain Relief Dye free	ACTEMINOPHEN	BETTER LIVING BRANDS LLC.	41f504d1-29c4-f075-e063-6394a90ad64c	2026-04-11	Warnings	Exact identifier application number: M013
Dr. Simi Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Farmacias De Similares TX LLC	4f1e1f1a-44f4-2356-e063-6294a90a8cdd	2026-04-10	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	Akron Pharma Inc.	e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed	2026-04-10	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	Akron Pharma Inc.	28413cb3-22c4-40e2-ad6b-42beb438dea3	2026-04-10	Warnings	Exact identifier application number: M013
Pain Reliever Childrens	ACETAMINOPHEN	H E B	7e43de11-d20b-4920-a04d-3c1b5d35e005	2026-04-09	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Navajo Manufacturing Company Inc.	f7e572e9-82a7-2127-e053-6394a90ab01a	2026-04-08	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	ASPIRIN	Navajo Manufacturing Company Inc.	f6f2ce71-5728-aefb-e053-6394a90a20e4	2026-04-08	Warnings	Exact identifier application number: M013
Midol	ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE	Navajo Manufacturing Company Inc.	cabd10f2-a91e-4406-9249-915e306c867b	2026-04-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	HyVee Inc	3730ee46-b241-44eb-94fa-52b9d12a9c35	2026-04-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Walgreen Company	82cc404b-fcf5-4e48-ab1a-09d8c47f9e04	2026-04-08	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Cardinal Health 107, LLC	9efcce86-dd57-4ea2-ad31-d2038eb61bf1	2026-04-07	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	1b164780-ec84-4187-8afa-6f8a0da550fc	2026-04-07	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	201b860d-dc3c-4380-affa-e757bf2103cf	2026-04-07	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Walgreens	6e7475e2-81a9-43b5-9b81-b58ab761a6f4	2026-04-07	Warnings	Exact identifier application number: M013
Pain Relief Aspirin Low Dose	ASPIRIN	Rite Aid Corporation	503408ed-e799-48a0-8d38-3034f4a0ead5	2026-04-02	Warnings	Exact identifier application number: M013
Aspirin 81 mg	ASPIRIN	Lidl US LLC	468f4a2f-60f7-4808-95d7-a00be1bb112f	2026-04-02	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Grocery Outlet, Inc.	44de6f5a-0b5c-6c28-e063-6394a90a7e0b	2026-04-02	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	ARMY AND AIR FORCE EXCHANGE SERVICE	26ae0d0a-34c0-4d16-951a-8d5a463c808b	2026-04-02	Warnings	Exact identifier application number: M013
Pain Reliever plus Sleep Aid NightTime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Kroger Company	286ca3b3-2ecc-4f90-adb5-d7bc0ba0b4d0	2026-04-02	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	COSTCO WHOLESALE CORPORATION	c8a8986b-1ab4-9da0-71da-42595db08b44	2026-04-02	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	f13fb7e9-50ea-4e2c-a442-38b1b5b315d7	19
307686	acetaminophen 500 MG / caffeine 65 MG Oral Tablet	SCD	f13fb7e9-50ea-4e2c-a442-38b1b5b315d7	19
307686	APAP 500 MG / Caffeine 65 MG Oral Tablet	SY	f13fb7e9-50ea-4e2c-a442-38b1b5b315d7	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0572-09	00363057209	20 in 1 BOTTLE					Historical
0363-0572-31	00363057231	1 BOTTLE, PLASTIC in 1 CARTON (0363-0572-31) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC	2009-02-09	0000-00-00	No	No	Current