IBUPROFEN

Product NDC: 41226-601
11-digit product format: 412260601
Labeler code: 41226
Product ID: 41226-601_3f89772f-94d8-4e14-e063-6294a90a769b
Type: HUMAN OTC DRUG
Nonproprietary name: IBUPROFEN
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Kroger Company
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-04-10
Substance: IBUPROFEN
Active strength: 200 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: IBUPROFEN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310965	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
bbedfc37-913d-8046-e053-2995a90af68a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41226-601-01	IBUPROFEN	1 in 1 CARTON	TABLET, COATED	1	6
41226-601-01	IBUPROFEN	100 in 1 BOTTLE	TABLET, COATED	100	6
41226-601-05	IBUPROFEN	1 in 1 CARTON	TABLET, COATED	1	6
41226-601-05	IBUPROFEN	50 in 1 BOTTLE	TABLET, COATED	50	6
41226-601-10	IBUPROFEN	2 in 1 PACKAGE, COMBINATION	TABLET, COATED	2	6
41226-601-20	IBUPROFEN	200 in 1 BOTTLE	TABLET, COATED	200	6
41226-601-25	IBUPROFEN	250 in 1 BOTTLE	TABLET, COATED	250	6
41226-601-42	IBUPROFEN	24 in 1 BOTTLE	TABLET, COATED	24	6
41226-601-42	IBUPROFEN	1 in 1 CARTON	TABLET, COATED	1	6
41226-601-53	IBUPROFEN	500 in 1 BOTTLE	TABLET, COATED	500	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41226-601	IBUPROFEN TABLET, COATED [KROGER COMPANY]	5	Current NDC, Legacy NDC, 10 package rows	20240823_bbedfc37-913d-8046-e053-2995a90af68a.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 55 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACETAMINOPHEN (RED)	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	a352f588-4a70-42b2-8f9c-a73a0629517d	2024-11-25	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	5c42dd28-820c-4cc5-9016-11ad5e580616	2024-11-25	Warnings	Exact identifier application number: M013
equate pain reliever	ACETAMINOPHEN	WALMART INC.	4518fe82-3ba8-4e9e-a036-776df7fb8d57	2024-11-21	Warnings	Exact identifier application number: M013
Family Wellness Pain Reliever	ASPIRIN	FAMILY WELLNESS SERVICES, INC.	075e19f4-1a58-aedd-e063-6294a90af708	2024-11-20	Warnings	Exact identifier application number: M013
Mejoralito	ACETAMINOPHEN	OPMX Chula Vista	fd2ecde0-296e-060f-e053-6294a90afd98	2024-11-15	Warnings	Exact identifier application number: M013
Temp X	ACETAMINOPHEN	OPMX Chula Vista	fd2edc32-0351-c991-e053-6294a90ab4ce	2024-11-15	Warnings	Exact identifier application number: M013
CVS Health Extra Strength Antacid and Pain Reliever	ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE	CVS Pharmacy	afe9e755-18ba-305f-e053-2995a90aa8d0	2024-11-14	Warnings	Exact identifier application number: M013
Walgreens Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Walgreens	667418fc-a3ab-cbc7-e053-2a91aa0a2023	2024-11-13	Warnings	Exact identifier application number: M013
Up and Up Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Target Corporation	a72eef45-b985-638a-e053-2995a90aa20a	2024-11-13	Warnings	Exact identifier application number: M013
Signature Care Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Safeway, Inc	6e120024-475a-73af-e053-2a91aa0a42a6	2024-11-13	Warnings, Adverse reactions	Exact identifier application number: M013
Kroger Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Kroger Company	6d858b0e-a3c8-2686-e053-2991aa0acc06	2024-11-13	Warnings	Exact identifier application number: M013
TopCare Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Topco Associates LLC	639f9d57-f26a-708a-e053-2a91aa0a6962	2024-11-13	Warnings, Adverse reactions	Exact identifier application number: M013
Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	H. E. Butt Grocery Company	6418cde9-607b-4ca1-e053-2991aa0a9170	2024-11-13	Warnings	Exact identifier application number: M013
Bromo Seltzer	ASPIRIN, SODIUM BICARBONATE, CITRIC ACID	Tower Laboratories Ltd	8ff88ee1-e33e-4051-992f-24e2720c48ce	2024-11-13	Warnings	Exact identifier application number: M013
Care One Original Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Foodhold U.S.A.	8f662c51-d2fa-6458-e053-2995a90ac6fd	2024-11-13	Warnings	Exact identifier application number: M013
Top Value Effervescent Pain Relief	APIRIN, CITRIC ACID, SODIUM BICARBONATE	Tower Laboratories Ltd	43c7f435-735c-3fab-e054-00144ff88e88	2024-11-13	Warnings, Adverse reactions	Exact identifier application number: M013
DG Health Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	DOLGENCORP, INC	8f1343d5-2884-3a14-e053-2a95a90a2f90	2024-11-13	Warnings	Exact identifier application number: M013
Good Sense Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Good Sense	cd25b0c3-0134-beef-e053-2a95a90a092b	2024-11-13	Warnings	Exact identifier application number: M013
Drug Mart Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Discount Drug Mart, Inc	8bc65603-1dbf-30ab-e053-2995a90a7c15	2024-11-13	Warnings	Exact identifier application number: M013
Best Choice Effervescent Antacid Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Valu Merchandisers Company	8aab905b-5fe7-dddb-e053-2995a90a6c6f	2024-11-13	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310965	ibuprofen 200 MG Oral Tablet	PSN	bbedfc37-913d-8046-e053-2995a90af68a	6
310965	ibuprofen 200 MG Oral Tablet	SCD	bbedfc37-913d-8046-e053-2995a90af68a	6
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	bbedfc37-913d-8046-e053-2995a90af68a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41226-601-01	41226060101	1 BOTTLE in 1 CARTON (41226-601-01) / 100 TABLET, COATED in 1 BOTTLE	1 bottle	2021-06-12	0000-00-00	No	No	Current
41226-601-05	41226060105	1 BOTTLE in 1 CARTON (41226-601-05) / 50 TABLET, COATED in 1 BOTTLE	1 bottle	2021-06-12	0000-00-00	No	No	Current
41226-601-10	41226060110	2 BOTTLE in 1 PACKAGE, COMBINATION (41226-601-10) / 500 TABLET, COATED in 1 BOTTLE (41226-601-53)	2 bottle	2024-04-15		No	No	Current
41226-601-20	41226060120	200 TABLET, COATED in 1 BOTTLE (41226-601-20)		2021-06-12	0000-00-00	No	No	Current
41226-601-25	41226060125	250 TABLET, COATED in 1 BOTTLE (41226-601-25)		2021-06-12	0000-00-00	No	No	Current
41226-601-42	41226060142	1 BOTTLE in 1 CARTON (41226-601-42) / 24 TABLET, COATED in 1 BOTTLE	1 bottle	2021-04-10	0000-00-00	No	No	Current
41226-601-53	41226060153	500 TABLET, COATED in 1 BOTTLE (41226-601-53)		2024-04-15		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Kroger Ibuprofen Tablets 200 mg (Brown Round)	Kroger Company \| Time Cap Laboratories, Inc. \| MARKSANS PHARMA LIMITED	2025-09-24	HUMAN OTC DRUG LABEL	6