Ibuprofen

Product NDC: 49035-693
11-digit product format: 490350693
Labeler code: 49035
Product ID: 49035-693_3bb4a859-a353-e550-e063-6394a90a7645
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: EQUATE (WAL-MART STORES, INC.)
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: 2026-12-31
Current FDA listing: Yes

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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209207-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2017-06-27	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
Listing expiration: 2026-12-31

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
104b5ac1-9c5e-40f8-a9b1-1761b495bb1c	Available on FDA.report

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
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
49035-693-08	2025-08-06	Ibuprofen
49035-693-09	2025-08-06	Ibuprofen
49035-693-08	2025-07-29	Ibuprofen
49035-693-09	2025-07-29	Ibuprofen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49035-693-08	Ibuprofen	1 in 1 CARTON	SUSPENSION	1	3
49035-693-08	Ibuprofen	120 mL in 1 BOTTLE	SUSPENSION	120	3
49035-693-09	Ibuprofen	120 mL in 1 BOTTLE	SUSPENSION	120	3
49035-693-09	Ibuprofen	1 in 1 CARTON	SUSPENSION	1	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49035-693-09	ML - Milliliter	49035-693	bb4f336a-150e-4b3b-9166-b3d8eaa568dc	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-693	IBUPROFEN SUSPENSION [EQUATE (WAL-MART STORES, INC.)]	2	Current NDC, Legacy NDC, 4 package rows	20210417_104b5ac1-9c5e-40f8-a9b1-1761b495bb1c.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 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
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 ndc (product): 49035-693
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

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	104b5ac1-9c5e-40f8-a9b1-1761b495bb1c	3
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	104b5ac1-9c5e-40f8-a9b1-1761b495bb1c	3
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	104b5ac1-9c5e-40f8-a9b1-1761b495bb1c	3
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	104b5ac1-9c5e-40f8-a9b1-1761b495bb1c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-693-08	49035069308	1 BOTTLE in 1 CARTON (49035-693-08) / 120 mL in 1 BOTTLE	1 bottle	2019-02-14	0000-00-00	No	No	Current
49035-693-09	49035069309	1 BOTTLE in 1 CARTON (49035-693-09) / 120 mL in 1 BOTTLE	1 bottle	2021-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen	EQUATE (WAL-MART STORES, INC.) \| Sun Pharma Canada Inc.	2025-08-06	HUMAN OTC DRUG LABEL	3