Ibuprofen

Product NDC: 41226-700
11-digit product format: 412260700
Labeler code: 41226
Product ID: 41226-700_15f91da6-8763-c2f5-e063-6394a90a0042
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: KROGER COMPANY
Application: ANDA079205
Marketing category: ANDA
Marketing start: 2024-04-15
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079205-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2009-06-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`f41ea6bd6efb…`

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
310964	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
0fbe42d0-b5f0-0780-e063-6394a90a4ecb	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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	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
41226-700-80	Ibuprofen	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	2
41226-700-80	Ibuprofen	80 in 1 BOTTLE	CAPSULE, LIQUID FILLED	80	2
41226-700-87	Ibuprofen	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2	2
41226-700-87	Ibuprofen	160 in 1 BOTTLE	CAPSULE, LIQUID FILLED	160	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41226-700	IBUPROFEN CAPSULE, LIQUID FILLED [KROGER COMPANY]	2	Current NDC, 4 package rows	20240415_0fbe42d0-b5f0-0780-e063-6394a90a4ecb.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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	TIME CAP LABORATORIES, INC.	059cb22f-f6db-5d03-e063-6294a90a9ec1	2023-10-27	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen	IBUPROFEN CAPSULES 200 MG	TIME CAP LABORATORIES, INC.	c7c51cf3-9e95-f8d0-e053-2995a90a7371	2023-09-18	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	403ec259-3be1-4e0b-ab7b-fee213b7eabe	2023-04-03	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen	IBUPROFEN	DOLGENCORP, INC.	df321783-73cb-55bf-e053-2a95a90a4ce2	2022-07-07	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen 200 mg	IBUPROFEN	Allegiant Health	8ba06ba0-bfe9-4626-af65-dae4d6a3a2ad	2021-12-06	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Sound Body Ibuprofen	IBUPROFEN 200 MG	Allegiant Health	73af6385-3081-49cc-83de-f872a47c31dc	2017-11-15	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205

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
310964	ibuprofen 200 MG Oral Capsule	PSN	0fbe42d0-b5f0-0780-e063-6394a90a4ecb	2
310964	ibuprofen 200 MG Oral Capsule	SCD	0fbe42d0-b5f0-0780-e063-6394a90a4ecb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
41226-700-80	41226070080	1 BOTTLE in 1 CARTON (41226-700-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2024-04-15	No	No	Current
41226-700-87	41226070087	2 BOTTLE in 1 CARTON (41226-700-87) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE	2 bottle	2024-04-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Kroger Ibuprofen 200 mg capsules minis	KROGER COMPANY \| TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LIMITED	2024-04-13	HUMAN OTC DRUG LABEL	2