EXTRA STRENGTH HEADACHE RELIEF

Product NDC: 0363-7214
11-digit product format: 003637214
Labeler code: 0363
Product ID: 0363-7214_4886bd53-5aba-e648-e063-6294a90aeceb
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, ASPIRIN, CAFFEINE
Dosage form: TABLET
Route: ORAL
Labeler: WALGREENS
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-11-17
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: 2027-12-31
Current FDA listing: Yes

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: EXTRA STRENGTH HEADACHE RELIEF
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 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
7d8f8389-730d-494e-a0af-5a91a3c99e17	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-7214-25	EXTRA STRENGTH HEADACHE RELIEF	250 in 1 BOTTLE	TABLET	250		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-7214	EXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WALGREENS]	6	Current NDC, Legacy NDC, 1 package rows	20250101_7d8f8389-730d-494e-a0af-5a91a3c99e17.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 66 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Acetaminophen	ACETAMINOPHEN	Padagis Israel Pharmaceuticals Ltd	a426dd82-b2d6-405e-b0af-cfb1310a6e19	2024-06-26	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	WALMART INC. (see also Equate)	7d86a03f-74f4-4b24-b6a6-8747acfe905e	2024-06-26	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	5bcc5da9-7e64-4308-a5be-2f47a8ca774d	2024-06-25	Warnings	Exact identifier application number: M013
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	NuCare Pharmaceuticals,Inc.	9e691264-d48a-6b48-e053-2995a90a9352	2024-06-20	Warnings	Exact identifier application number: M013
Aspirin	REGULAR STRENGTH ENTERIC COATED ASPIRIN	NuCare Pharmceuticals,Inc.	a0705f4f-55cb-214a-e053-2995a90aa680	2024-06-20	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN 500 MG	Lil' Drug Store Products, Inc.	ee8e0e79-4da4-101f-e053-2a95a90a30a4	2024-06-19	Warnings	Exact identifier application number: M013
Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Lil' Drug Store Products, Inc.	b3a06e4b-0b31-4e2a-8dd1-9de85760477b	2024-06-19	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Meijer Distribution Inc	43c3fe72-a4ef-48a6-bc22-a644919c0c5c	2024-06-17	Warnings	Exact identifier application number: M013
Aspirin Regular Strength	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	093182a6-3ed8-5a3f-e063-6294a90a354a	2024-06-14	Warnings	Exact identifier application number: M013
ACETAMINOPHEN PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	093199be-e92a-6f60-e063-6294a90a8533	2024-06-14	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES , LLC.	09315a3d-bb2d-4f06-e063-6294a90a3bd3	2024-06-14	Warnings	Exact identifier application number: M013
Pain Relief Regular Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	613bc633-0426-41a7-aea9-9ff56311b607	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	cfaf9495-e654-4dfc-ba23-d2358c3720c4	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin 81 mg Low Dose	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	18ff2df8-ee65-4219-ad93-cf5090bfac2d	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	9fdbaf5e-f88b-4d18-97df-0b2e8dddf377	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin 81 mg Low dose	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	bfb9af64-3195-44bf-bcf3-6b36b40d3cc7	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	1ac7ed71-5afe-d09c-e063-6294a90a3b88	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	3ce5bbf2-d449-464e-abeb-5c26866d1ab5	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	AAA Pharmaceutical, Inc.	609948d6-0f20-4d0c-adc0-6ae72a4f2b7a	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	AAA Pharmaceutical, Inc.	3f73a359-59d7-47bb-872e-914b0db719af	2024-06-13	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
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	7d8f8389-730d-494e-a0af-5a91a3c99e17	7
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	SCD	7d8f8389-730d-494e-a0af-5a91a3c99e17	7
308297	APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet	SY	7d8f8389-730d-494e-a0af-5a91a3c99e17	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-7214-25	00363721425	250 TABLET in 1 BOTTLE (0363-7214-25)	250 tablet	2020-11-17	0000-00-00	No	No	Current