topcare ibuprofen

Product NDC: 36800-897
Requested package NDC: 36800-897-26
11-digit product format: 368000897
Labeler code: 36800
Product ID: 36800-897_425d20bf-3122-45aa-b83d-2a68ce57ef9e
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Topco Associates LLC
Application: ANDA074937
Marketing category: ANDA
Marketing start: 1998-12-31
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 100 mg/5mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-897	36800-897-26	I	Inactivated by FDA		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`cb3db0bc1861…`

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
36800-897-26	topcare ibuprofen	1 in 1 CARTON	SUSPENSION	1	9
36800-897-26	topcare ibuprofen	120 mL in 1 BOTTLE	SUSPENSION	120	9
36800-897-28	topcare ibuprofen	1 in 1 CARTON	SUSPENSION	1	9
36800-897-28	topcare ibuprofen	150 mL in 1 BOTTLE	SUSPENSION	150	9
36800-897-34	topcare ibuprofen	120 mL in 1 BOTTLE	SUSPENSION	120	9
36800-897-34	topcare ibuprofen	2 in 1 CARTON	SUSPENSION	2	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-897-26	ML - Milliliter	36800-897	1a1b5c4b-7b93-47b3-ae89-c52471d569f1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	TOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	TOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	TOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	TOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	TOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	TOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	TOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-897	TOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]	9	Legacy NDC, 6 package rows	20220819_2a8ba703-587f-4717-a9d5-ee142e36a4d9.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 1 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
childrens ibuprofen	IBUPROFEN	Rite Aid Corporation	26bccfc1-bc8d-4241-a078-c760048951c9	2026-07-24	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Ibuprofen	IBUPROFEN	ATLANTIC BIOLOGICALS CORP.	3ce7549f-e4db-9f89-e063-6294a90a126d	2026-07-10	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Rite Aid Corporation	1da544eb-ed4e-4124-bea3-f827f1322270	2026-05-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	52d3e633-13a2-cdcd-e063-6394a90ac189	2026-05-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen	IBUPROFEN	Rite Aid Corporation	69ca781a-202e-4579-91e6-f32a22ccc22c	2026-05-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen childrens	IBUPROFEN	Walgreen Company	f67612e8-38f3-4d1c-889b-57995a2f9f66	2026-05-15	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
care one ibuprofen	IBUPROFEN	American Sales Company	d26d2766-6d4c-462b-ae8b-ef8d87acd633	2026-04-16	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	9291857c-30b3-414b-99e1-9c127e72c0d4	2026-04-16	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Ibuprofen childrens	IBUPROFEN	HyVee Inc	55f8def6-f7de-4b3e-a92a-5cd9e68a46a1	2026-04-15	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
CHILDRENS Ibuprofen	IBUPROFEN	Kesin Pharma Corporation	436c0126-4ff3-c082-e063-6294a90a3d72	2026-04-13	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen childrens	IBUPROFEN	HyVee Inc	3d8497c6-1c46-4248-b75c-b086591529cc	2026-04-10	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Ibuprofen	IBUPROFEN	CVS Pharmacy	ef204cc0-4009-4dd0-83e2-2b5ad6f98409	2026-02-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
equate ibuprofen childrens	IBUPROFEN	Wal-Mart Stores Inc	7817923f-4c21-4943-a7e2-dad4e2915fc4	2026-02-23	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen	IBUPROFEN	HyVee Inc	c20a9bc5-e481-4fb2-ad10-d01e83e43ca0	2026-02-21	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Ibuprofen Childrens	IBUPROFEN	Major Pharmaceuticals	9d56e64d-7860-4fd1-88d2-c537e50079d8	2026-02-13	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
childrens ibuprofen	IBUPROFEN	HyVee Inc	d522a3ac-dd43-4faa-b3f8-69313be1c829	2026-02-11	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Ibuprofen	IBUPROFEN	Major Pharmaceuticals	847758ed-66fc-4db9-8fdb-78f3c3291a03	2026-01-26	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
good sense ibuprofen childrens	IBUPROFEN	Preferred Pharmaceuticals Inc.	7ac61180-d668-4eec-b04f-d14f7b552a4d	2025-12-23	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
topcare childrens ibuprofen	IBUPROFEN	Topco Associates LLC	d1bb68a6-3a29-4a4e-b4e9-413cc8d16191	2025-12-12	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	a1a5a9c7-c727-4e41-a8f0-2982f796a3ca	2025-09-29	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	2a8ba703-587f-4717-a9d5-ee142e36a4d9	9
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	2a8ba703-587f-4717-a9d5-ee142e36a4d9	9
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	2a8ba703-587f-4717-a9d5-ee142e36a4d9	9
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	2a8ba703-587f-4717-a9d5-ee142e36a4d9	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-897-26	36800089726	1 BOTTLE in 1 CARTON (36800-897-26) > 120 mL in 1 BOTTLE	1 bottle	1998-12-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Children's Ibuprofen Oral Suspension Drug Facts	Topco Associates LLC	2022-08-16	HUMAN OTC DRUG LABEL	9