HEADACHE RELIEF

Product NDC: 41226-370
11-digit product format: 412260370
Labeler code: 41226
Product ID: 41226-370_3992e879-0f22-1e3f-e063-6294a90a67f8
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, ASPIRIN AND CAFFEINE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Kroger Company
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-04-10
Substance: CAFFEINE; ASPIRIN; ACETAMINOPHEN
Active strength: 65; 250; 250 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	41226-370-42	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	41226-370-01	`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	41226-370-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	41226-370-01	`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	41226-370-42	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	41226-370-01	`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
CAFFEINE	65 mg/1
ASPIRIN	250 mg/1
ACETAMINOPHEN	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3G6A5W338E	Internal UNII lookup
R16CO5Y76E	Internal UNII lookup
362O9ITL9D	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
bbed29a1-3c52-3531-e053-2995a90a686c	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
41226-370-01	2025-02-14	370R Headache Relief Caplets KROGER 41226 370
41226-370-42	2025-02-14	370R Headache Relief Caplets KROGER 41226 370
41226-370-01	2025-01-30	370R Headache Relief Caplets KROGER 41226 370
41226-370-42	2025-01-30	370R Headache Relief Caplets KROGER 41226 370

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41226-370-01	HEADACHE RELIEF	100 in 1 BOTTLE	TABLET, COATED	100	4
41226-370-01	HEADACHE RELIEF	1 in 1 CARTON	TABLET, COATED	1	4
41226-370-42	HEADACHE RELIEF	1 in 1 CARTON	TABLET, COATED	1	4
41226-370-42	HEADACHE RELIEF	24 in 1 BOTTLE	TABLET, COATED	24	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41226-370	HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, COATED [KROGER COMPANY]	3	Current NDC, Legacy NDC, 4 package rows	20250216_bbed29a1-3c52-3531-e053-2995a90a686c.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 33 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Childrens Cough and Chest Congestion Mini-Melts Orange Creme	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	66543190-1d3d-4259-ae73-d366ecbf9e52	2026-05-12	Warnings	Exact identifier application number: M012
basic care daytime nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	612719a9-fa2e-4c40-8f35-a399aeaafecc	2026-05-12	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain Daytime Nighttime Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	3cac44ad-1835-487e-b6d0-1483d724bb5e	2026-05-12	Warnings	Exact identifier application number: M012
GUAIFENESIN DM	GUAIFENESIN AND DEXTROMETHORPHAN	Cardinal Health 107, LLC	9cfb1abb-98c4-4e90-8dd7-fcffc112f988	2026-05-12	Warnings	Exact identifier application number: M012
Nasal Decongestant PE and Pain Relief Maximum Strength	ACETAMINOPHEN, PHENYLEPHRINE HCL	WinCo Foods, LLC	fab51b36-1c2e-4c97-932c-dacfaf55935a	2026-05-11	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Walgreen Company	cad5da8c-65a6-44c4-a4c7-38f2c7fe43aa	2026-05-11	Warnings	Exact identifier application number: M012
NebuClear MD	SALINE	Blue Echo Care LLC	3f85fe62-230f-b0f1-e063-6394a90a5cb8	2026-05-11	Warnings	Exact identifier application number: M012
Device - NebuClear MD Hand-held Rubber Bulb Nebulizer	DEVICE - HAND-HELD RUBBER BULB NEBULIZER	Blue Echo Care LLC	43e0a646-be57-1024-e063-6394a90a43e4	2026-05-11	Warnings	Exact identifier application number: M012
Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	1efd1778-7ab1-4797-98c5-4637940ee3ec	2026-05-11	Warnings	Exact identifier application number: M012
DayTime High Blood Pressure Cold and Flu Relief Liquid filled Softgels	ACETAMINOPHEN,DEXTROMETHROPHAN HBR	AptaPharma Inc.	0380035e-44d5-44ea-9d1c-d57a1de65188	2026-05-10	Warnings	Exact identifier application number: M012
Night Time Cold and Flu relief liquid filled softgels	ACETAMINOPHEN,DEXTROMETHROPHAN HBR,DOXYLAMINE SUCCINATE	AptaPharma Inc.	d61e2186-8b59-45f9-96ec-83430a0fe0cb	2026-05-10	Warnings	Exact identifier application number: M012
Maximum Strength Tussin DM Liquid filled Softgels	DEXTROMETHORPHAN HBR, GUAIFENESIN	AptaPharma Inc.	39ad6cc9-d2b0-4b4a-8aa3-977905c9e6f1	2026-05-10	Warnings	Exact identifier application number: M012
Day-Time Cold/Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	AptaPharma Inc.	c0dc613c-7f4e-4733-b2b6-6ba20e8fb83c	2026-05-10	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief Liquid Filled Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	AptaPharma Inc.	c078efb5-d30e-4dd1-a600-6e827390df76	2026-05-10	Warnings	Exact identifier application number: M012
DM Max CONGESTION and COUGH	DEXTROMETHORPHAN HBR, GUAIFENESIN	DeMoulas Market Basket	b12e26b2-79e4-45a5-9a90-4630f92457d0	2026-05-09	Warnings	Exact identifier application number: M012
Flu HBP Maximum Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Walgreen Company	fac55d76-457f-4258-9cc8-6edae539cada	2026-05-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	HyVee Inc	5a0ef8ae-f6d5-4388-b4da-6b7f025160b2	2026-05-08	Warnings	Exact identifier application number: M012
Halls Variety Pack Mentholyptus Honey Lemon Cherry	MENTHOL	Mondelez Global LLC	512a9a2e-6160-80d1-e063-6394a90aeff0	2026-05-08	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5150ff85-85bb-9cd9-e063-6294a90a1144	2026-05-08	Warnings	Exact identifier application number: M012
Dr. Simi Children s Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	Farmacias De Similares TX LLC	5151740a-8270-7bb5-e063-6294a90ae387	2026-05-08	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

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	bbed29a1-3c52-3531-e053-2995a90a686c	4
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	SCD	bbed29a1-3c52-3531-e053-2995a90a686c	4
308297	APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet	SY	bbed29a1-3c52-3531-e053-2995a90a686c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41226-370-01	41226037001	1 BOTTLE in 1 CARTON (41226-370-01) / 100 TABLET, COATED in 1 BOTTLE	1 bottle	2021-04-10	0000-00-00	No	No	Current
41226-370-42	41226037042	1 BOTTLE in 1 CARTON (41226-370-42) / 24 TABLET, COATED in 1 BOTTLE	1 bottle	2021-04-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
370R Headache Relief Caplets KROGER 41226 370	Kroger Company \| Time Cap Laboratories, Inc. \| MARKSANS PHARMA LIMITED	2025-07-10	HUMAN OTC DRUG LABEL	4