sunmark ibuprofen

Product NDC: 49348-196
11-digit product format: 493480196
Labeler code: 49348
Product ID: 49348-196_dbc8bf08-a838-462a-80ae-d7a3155e6679
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: ANDA072096
Marketing category: ANDA
Marketing start: 2003-06-24
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49348-196		D	Discontinued by firm	2026-10-05
excluded package	package	49348-196	49348-196-09	D	Discontinued by firm	2026-10-05
excluded package	package	49348-196	49348-196-10	D	Discontinued by firm	2026-10-05
excluded package	package	49348-196	49348-196-19	D	Discontinued by firm	2026-10-05
excluded package	package	49348-196	49348-196-35	D	Discontinued by firm	2026-10-05

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 · 24 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-196-35	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-196-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-196-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-196-19	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-196-35	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-196-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-196-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-196-19	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-196-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-196-19	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-196-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-196-19	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-196-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-196-19	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-196-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-196-19	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-196-19	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-196-19	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49348-196-19	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49348-196-19	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49348-196-19	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49348-196-19	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A072096-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			1987-12-08

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	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-196-09	EA - Each	49348-196	81633555-eb10-403c-9abd-9e065022ddae	1	2012-07-24
49348-196-10	EA - Each	49348-196	d537237a-fcc4-419d-a6ef-bf7d18eeab05	1	2012-07-24
49348-196-19	EA - Each	49348-196	7a9804e2-3dce-4af4-9540-0c8c0a1d0190	1	2012-07-24
49348-196-35	EA - Each	49348-196	424fa47a-603b-4aba-a1c8-1101f5269c4e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SUNMARK IBUPROFEN (IBUPROFEN) TABLET, COATED [MCKESSON]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-196	SUNMARK IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC]	6	Legacy NDC	20241225_a8507ff0-b9ab-415d-acbc-ea424e35d12c.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 4 · 65 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
careone ibuprofen	IBUPROFEN	American Sales Company	2720b8aa-4361-4cd4-be26-aa6dd1692d12	2025-10-01	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
pain relief	IBUPROFEN	Meijer, Inc.	ae39917e-1998-4298-8686-919c0d3c2b07	2025-09-19	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	Walgreen Company	37c9b887-190a-4daf-8199-f406913132f0	2025-09-03	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
foster and thrive ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	cfa8578c-2bcc-4aa7-bb8c-0d0e193020ed	2025-08-28	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	Bryant Ranch Prepack	230fd746-92e0-40b6-9a90-595812bd8a18	2025-08-20	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
Leader Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	63b8d389-7feb-41d2-8970-b7d5660ccb4a	2025-08-14	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
Topcare Ibuprofen	IBUPROFEN	Topco Associates LLC	8be375b0-c729-49de-abc5-2e7d37144b89	2025-06-16	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
good neighbor pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	08d9477e-3033-4b74-8f81-934f39e37e55	2025-06-16	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
equaline ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	9bf3546a-9f94-47b5-9b01-aed93e69d5aa	2025-06-16	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	CVS Pharmacy	e655bd64-dd82-46d8-87cc-2674beaffe20	2025-06-16	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	Major Pharmaceuticals	03993008-7bd2-465f-b5a9-1cbc3c1fff02	2025-06-16	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	Publix Super Markets Inc	032decc5-9f7a-4f12-8ca4-a95a79a426c6	2025-06-16	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
care one ibuprofen	IBUPROFEN	American Sales Company	006adf23-21ab-4a4e-aae9-c4e587777165	2025-06-03	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	Meijer Distribution Inc	66b19ed1-6cf9-4705-82cd-02f23c6379e7	2025-05-06	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
kirkland signature ibuprofen	IBUPROFEN	Costco Wholesale Company	65d8d650-9afc-44f7-9409-a3aa3014d4ab	2025-04-24	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	A-S Medication Solutions	504c7e5d-e721-4df8-865b-8ea17559831d	2025-04-24	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
up and up ibuprofen	IBUPROFEN	Target Corporation	2919fe8b-9c76-4ef6-851e-3247782cef44	2025-04-11	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
equaline ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	e18f4ce6-d7d3-4b53-b87a-5900ac3397f1	2025-04-11	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
TopCare Ibuprofen	IBUPROFEN	Topco Associates LLC	66097f19-227c-4f9c-a7f3-ab8476e1bb6e	2025-04-08	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	Major Pharmaceuticals	14f43c32-0895-4ef2-aa54-52b952d058fd	2025-04-08	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-196-09	49348019609	1 BOTTLE in 1 CARTON (49348-196-09) > 50 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2003-06-24	0000-00-00	No	No	Current
49348-196-10	49348019610	1 BOTTLE in 1 CARTON (49348-196-10) > 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2003-08-11	0000-00-00	No	No	Current
49348-196-35	49348019635	500 TABLET, FILM COATED in 1 BOTTLE (49348-196-35)		2003-08-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
McKesson Ibuprofen Tablets 200 mg Drug Facts	Strategic Sourcing Services LLC	2024-12-23	HUMAN OTC DRUG LABEL	6