rx act ibuprofen

Product NDC: 37808-897
11-digit product format: 378080897
Labeler code: 37808
Product ID: 37808-897_cec6ab78-18da-40cd-b32d-a8f86bee870d
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: H E B
Application: ANDA074937
Marketing category: ANDA
Marketing start: 1999-01-06
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 100 mg/5mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	37808-897		D	Discontinued by firm		2026-10-12
excluded package	package	37808-897	37808-897-26	D	Discontinued by firm		2026-10-12

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 · 4 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	37808-897-26	`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	37808-897-26	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A074937-001	CHILDREN'S IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1998-12-22

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	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`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
37808-897-26	ML - Milliliter	37808-897	1ccf764e-3369-48cf-be33-7d7ecf326d4f	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	RX ACT IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [H E B]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	RX ACT IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [H E B]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	RX ACT IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [H E B]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	RX ACT IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [H E B]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	RX ACT IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [H E B]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	RX ACT IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [H E B]	2
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	RX ACT IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [H E B]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RX ACT IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [H E B]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	RX ACT IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [H E B]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	RX ACT IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [H E B]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	RX ACT IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [H E B]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	RX ACT IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [H E B]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	RX ACT IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [H E B]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-897	RX ACT IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [H E B]	4	Legacy NDC	20191205_dbcf47cc-4dc7-4110-b64d-4e1d52e05d47.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 3 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
profen ib	IBUPROFEN	Publix Super Markets Inc	51fbfd25-3c4d-4de1-8fa2-e5b4b24022f2	2025-05-13	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Ibuprofen	IBUPROFEN	ATLANTIC BIOLOGICALS CORP.	230914e6-fe0c-45be-8b2e-e066c71d004c	2025-05-12	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
good sense ibuprofen childrens	IBUPROFEN	L. Perrigo Company	b8e3ad4f-3212-4674-bcdf-a60a6b23d7bb	2025-05-12	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Meijer Distribution Inc	3b15dc44-ae1d-43c6-b6c5-05fa31beb554	2025-05-12	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Up and Up childrens ibuprofen	IBUPROFEN	Target Corporation	28911692-882b-4e30-ba1d-5c10f847be80	2025-05-12	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Equaline ibuprofen childrens	IBUPROFEN	United Natural Foods, Inc. dba UNFI	811d4360-7468-4ef8-a60e-6e9a6e169de0	2025-05-08	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
up and up ibuprofen	IBUPROFEN	Target Corporation	6e0330ac-a111-4574-9197-d7aab33b8608	2025-05-07	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
equaline ibuprofen childrens	IBUPROFEN	United Natural Foods, Inc. dba UNFI	835c3bc8-fb55-4b7e-98ad-3d84d089c8cb	2025-05-06	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
good sense ibuprofen childrens	IBUPROFEN	L. Perrigo Company	6127469c-143f-4dd2-bd37-6630291fcd5a	2025-04-30	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen childrens	IBUPROFEN	CVS Pharmacy	4459298c-e0bf-4a10-b68c-6f83fefde7e9	2025-04-29	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen	IBUPROFEN	H E B	bbcfea51-4c57-4a2c-a0ac-2a189c5ff38a	2025-04-28	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
DG Health Ibuprofen	IBUPROFEN	Dolgencorp Inc	0c0cf516-b3e7-474d-885c-897574365be3	2025-04-28	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen childrens	IBUPROFEN	Meijer Distribution Inc	c5e1d74d-99a3-4b3d-86c4-03f5c4c22f77	2025-04-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Equaline Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	5e860059-afc8-419e-9451-b1c2265f5ce6	2025-04-18	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Leader Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	a5701486-0a5f-4645-91ef-1fbf525c84dd	2025-04-18	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
childrens ibuprofen	IBUPROFEN	Meijer Distribution Inc	02681a10-eb8a-457f-8aff-12e6f29079de	2025-04-18	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Good Neighbor Pharmacy ibuprofen childrens	IBUPROFEN	Amerisource Bergen	43b8e61b-3ac4-4a41-b682-67d08b212cc6	2025-04-18	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Good Sense Ibuprofen	IBUPROFEN	L. Perrigo Company	1a6b42be-c0c2-48f8-9ba3-22d1f0c0b18d	2025-04-18	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	b303b554-c457-4f2b-9931-48f30943178b	2025-04-03	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	87c9f15f-1196-477c-b5d2-3b875bea61d0	2025-04-03	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937

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
37808-897-26	37808089726	1 BOTTLE in 1 CARTON (37808-897-26) > 120 mL in 1 BOTTLE	1 bottle	1999-01-06	0000-00-00	No	No	Current