IBUPROFEN

Product NDC: 51662-1582
11-digit product format: 516621582
Labeler code: 51662
Product ID: 51662-1582_574b6f15-70bd-fca7-e063-6294a90a0455
Type: HUMAN OTC DRUG
Nonproprietary name: IBUPROFEN
Dosage form: SUSPENSION
Route: ORAL
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA209207
Marketing category: ANDA
Marketing start: 2017-06-27
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: 2027-12-31
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
A209207-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			2017-06-27

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	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	100 mg/5mL

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
197803	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
574b6f15-70bc-fca7-e063-6294a90a0455	Available on FDA.report

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN	HF Acquisition Co LLC, DBA HealthFirst	574b6f15-70bc-fca7-e063-6294a90a0455	2026-07-23	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207 ndc (product): 51662-1582
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	32edaf34-046e-4ded-8bee-493a0019d6bd	2026-03-25	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207
Ibuprofen	IBUPROFEN	EQUATE (WAL-MART STORES, INC.)	104b5ac1-9c5e-40f8-a9b1-1761b495bb1c	2025-08-06	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207
Childrens Ibuprofen	IBUPROFEN	Kroger Company	91da5b64-db7f-4954-89e8-977b31247f9c	2025-07-11	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207
Childrens Ibuprofen	IBUPROFEN	Rite Aid Corporation	70eb40b8-5862-4eb9-adc8-8a9d6bca7c7d	2025-07-11	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207
Ibuprofen	IBUPROFEN	Sun Pharmaceutical Industries, Inc.	6cf3328b-da8f-4f6b-8237-16a4d6b9c833	2025-07-07	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207
Ibuprofen	IBUPROFEN	Sun Pharmaceutical Industries, Inc.	f4dad3d6-1366-4bdf-99eb-370ab74a6b9e	2025-07-07	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207
Ibuprofen	IBUPROFEN	A-S Medication Solutions	b87cf806-1635-44d5-a9de-383081cb37d8	2024-10-14	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207
Ibuprofen	IBUPROFEN	Proficient Rx LP	b7565aac-a928-4116-b9af-cf636da4537c	2022-07-01	Warnings	Exact identifier application applno (ANDA): 209207 application number: ANDA209207

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	Sample	Exclude flag	Status
51662-1582-1	51662158201	120 mL in 1 BOTTLE (51662-1582-1)	120 ml	2017-06-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IBUPROFEN - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2026-07-23	HUMAN OTC DRUG LABEL	1