CHILDRENS IBUPROFEN

Product NDC: 58602-200
Requested package NDC: 58602-200-20
11-digit product format: 586020200
Labeler code: 58602
Product ID: 58602-200_a5e55642-8e21-4274-98b2-a49637fadbf8
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA209179
Marketing category: ANDA
Marketing start: 2018-04-17
Marketing end: 2023-09-30
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: 0000-00-00
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	58602-200	58602-200-20	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A209179-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			2018-04-17

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	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`cb3db0bc1861…`

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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHILDRENS IBUPROFEN	IBUPROFEN	Aurohealth LLC	7461e50d-bfa1-4627-b691-089636b979d2	2026-05-22	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	Better Living Brands, LLC	fab39a0a-882b-bf96-e053-6294a90a2932	2025-09-02	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	WALGREEN CO.	fea3c4b2-cf96-2425-e053-6394a90ac697	2025-09-02	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	7-Eleven	af0ec23c-cefc-40a9-ab9a-03b8528d4e13	2025-09-01	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	Aurohealth LLC	0e1bcb06-be48-4efc-82e2-516582e02348	2025-09-01	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	KROGER COMPANY	15e72384-3a04-242d-e063-6294a90aa0fa	2025-09-01	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	7-Eleven	cf7b38fc-0590-126a-e053-2a95a90a3e78	2025-09-01	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	Chalkboard Health	c63eb5c6-adac-4d23-9661-1081ba4591ba	2025-09-01	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	Randob Labs., Ltd.	50d6bf9d-ae37-4af3-bfeb-cc0abf8cb094	2025-09-01	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	Aurohealth LLC	ad55d9b1-17b3-4a17-a4a3-d95ba2943959	2025-09-01	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
Childrens FLANAX ORAL	IBUPROFEN	Belmora LLC	9b9318cb-3bc7-40ca-bf8a-7495d93869b3	2024-01-30	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	BluePoint Laboratories	d71acfe2-4643-f50b-e053-2a95a90add8b	2023-05-31	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179

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
58602-200-20	58602020020	1 BOTTLE in 1 CARTON (58602-200-20) > 240 mL in 1 BOTTLE	1 bottle	2018-04-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CHILDRENS IBUPROFEN - Aurohealth LLC \| Aurobindo Pharma Limited	Aurohealth LLC \| Aurobindo Pharma Limited	2022-05-20	Human OTC Drug Label	5