HEADACHE RELIEF

Product NDC: 0363-0770
11-digit product format: 003630770
Labeler code: 0363
Product ID: 0363-0770_2ceb0700-f9ba-7e4a-e063-6294a90ac679
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, ASPIRIN, CAFFEINE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: WALGREENS
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-03-31
Substance: ASPIRIN; ACETAMINOPHEN; 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

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 · 9 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0363-0770-42	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0363-0770-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0363-0770-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0363-0770-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0363-0770-42	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0363-0770-01	`0efc9e666f02…`	`f202fb6c5f17…`

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: HEADACHE RELIEF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ASPIRIN	250 mg/1
ACETAMINOPHEN	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
R16CO5Y76E	Internal UNII lookup
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
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
b5a45daa-05b1-4d6d-e053-2995a90a8444	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, Related label table
NDC	Effective	Related label
0363-0770-01	2025-02-10	370R WALGREENS 0363-0770 Acetaminophen, Aspirin and Caffeine tablets
0363-0770-42	2025-02-10	370R WALGREENS 0363-0770 Acetaminophen, Aspirin and Caffeine tablets
0363-0770-01	2025-01-30	370R WALGREENS 0363-0770 Acetaminophen, Aspirin and Caffeine tablets
0363-0770-42	2025-01-30	370R WALGREENS 0363-0770 Acetaminophen, Aspirin and Caffeine tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0770-01	HEADACHE RELIEF	100 in 1 BOTTLE	TABLET, COATED	100	5
0363-0770-01	HEADACHE RELIEF	1 in 1 CARTON	TABLET, COATED	1	5
0363-0770-42	HEADACHE RELIEF	1 in 1 CARTON	TABLET, COATED	1	5
0363-0770-42	HEADACHE RELIEF	24 in 1 BOTTLE	TABLET, COATED	24	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0770	HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [WALGREENS]	5	Current NDC, Legacy NDC, 4 package rows	20250212_b5a45daa-05b1-4d6d-e053-2995a90a8444.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 58 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	PAIN RELIEVER	McKesson	9d620700-5d00-475f-e053-2995a90a9a3f	2024-10-28	Warnings	Exact identifier application number: M013
Junior Acetaminophen Ages 6-11	ACETAMINOPHEN	Chain Drug Consortium	d356bc9c-66f1-45c3-a455-98c0b8890f78	2024-10-28	Warnings	Exact identifier application number: M013
leader Acetaminophen	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	36bdcac9-eed4-40f9-a6f2-4c1e773a6b50	2024-10-25	Warnings	Exact identifier application number: M013
GOODYS PM	ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE	Medtech Products Inc.	db5d6c2b-688e-4e88-a42d-0fa2b0d8140b	2024-10-25	Warnings	Exact identifier application number: M013
Goodys Extra Strength	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Medtech Products Inc.	16d774cc-4247-4bf8-9b5a-c338ffebda3d	2024-10-25	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	PUBLIX SUPER MARKETS INC	9e77ab7a-07e8-42aa-e053-2995a90a0d0e	2024-10-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Kroger Company	5bfd9841-c781-43be-b823-d334893ae6ed	2024-10-24	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	H E B	add6952e-9dd5-487c-93e6-337e9d6a4872	2024-10-24	Warnings	Exact identifier application number: M013
Dye Free Pain Reliever Childrens	ACETAMINOPHEN	Safeway, Inc.	7d55cb42-295f-473a-941d-71825b44a3c0	2024-10-24	Warnings	Exact identifier application number: M013
rapid release pain relief	ACETAMINOPHEN	Publix Super Markets Inc	d0b34133-d69d-47db-bf51-be942769c612	2024-10-24	Warnings	Exact identifier application number: M013
basic care acetaminophen	ACETAMINOPHEN	Amazon.com Services LLC	00146b91-008d-4b16-95b0-6077f98821be	2024-10-24	Warnings	Exact identifier application number: M013
equate pain reliever	ACETAMINOPHEN	WALMART INC.	9a20273e-a4d1-4c38-9efb-e6347f8dc14e	2024-10-24	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	MARC GLASSMAN, INC.	e221905b-a795-c067-e053-2a95a90a02e7	2024-10-23	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e221bbce-83de-0f03-e053-2995a90abca5	2024-10-23	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	MARC GLASSMAN, INC.	e231c2f6-927c-1ab0-e053-2995a90a6121	2024-10-23	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	MARC GLASSMAN, INC.	e23703bb-6087-7985-e053-2995a90aa5ec	2024-10-23	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e237550d-711d-5d87-e053-2995a90affce	2024-10-23	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	HARRIS TEETER	a6f15f71-1327-4b71-b9d6-e3e9f0243801	2024-10-22	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	HARRIS TEETER	43308b23-7d4f-4e4f-a497-af71920d86aa	2024-10-22	Warnings	Exact identifier application number: M013
Pain Relief Regular Strength	ACETAMINOPHEN	MARC GLASSMAN, INC.	e21e821c-9694-5db0-e053-2995a90ad034	2024-10-22	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN
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
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	PSN	b5a45daa-05b1-4d6d-e053-2995a90a8444	5
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	SCD	b5a45daa-05b1-4d6d-e053-2995a90a8444	5
308297	APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet	SY	b5a45daa-05b1-4d6d-e053-2995a90a8444	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0770-01	00363077001	1 BOTTLE in 1 CARTON (0363-0770-01) / 100 TABLET, COATED in 1 BOTTLE	1 bottle	2021-03-31	0000-00-00	No	No	Current
0363-0770-42	00363077042	1 BOTTLE in 1 CARTON (0363-0770-42) / 24 TABLET, COATED in 1 BOTTLE	1 bottle	2021-08-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
370R WALGREENS 0363-0770 Acetaminophen, Aspirin and Caffeine tablets	WALGREENS \| TIME CAP LABORATORIES, INC.	2025-01-30	HUMAN OTC DRUG LABEL	5