Ibuprofen Oral

Product NDC: 63629-8540
11-digit product format: 636298540
Labeler code: 63629
Product ID: 63629-8540_2ae0c738-b6de-4b5a-83ba-c6ce09f1a065
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen Oral
Dosage form: SUSPENSION
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA210602
Marketing category: ANDA
Marketing start: 2018-11-23
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 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
A210602-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			2018-11-23

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	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`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 Oral
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
cf22da7e-fcf1-49da-8314-277d31199c1c	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
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-8540-1	Ibuprofen Oral	1 in 1 CARTON	SUSPENSION	1		105
63629-8540-1	Ibuprofen Oral	118 mL in 1 BOTTLE	SUSPENSION	118		105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8540-1	ML - Milliliter	63629-8540	c7a7870c-1b46-4da0-a501-084eca1704e7	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8540	IBUPROFEN ORAL (IBUPROFEN ORAL) SUSPENSION [BRYANT RANCH PREPACK]	105	Current NDC, Legacy NDC, 2 package rows	20240315_cf22da7e-fcf1-49da-8314-277d31199c1c.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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen Oral	IBUPROFEN ORAL	Bryant Ranch Prepack	6dc47070-4185-404f-94b0-5252a78ea6fe	2024-01-18	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Ibuprofen Oral	IBUPROFEN ORAL	Bryant Ranch Prepack	e4e778f3-97f9-4fd7-8eb8-9ceb5bc9ee7d	2024-01-18	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Ibuprofen Oral	IBUPROFEN ORAL	Bryant Ranch Prepack	3762ee9b-5811-46e2-83df-db5f6863e055	2024-01-18	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Childrens Ibuprofen Oral Suspension	IBUPROFEN	DEMOULAS SUPERMARKETS INC.	4ca54293-9e81-4b24-8112-734f28cd2c55	2023-12-29	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Ibuprofen Oral	IBUPROFEN ORAL	A-S Medication Solutions	a8672e5a-61f2-46d8-9401-432a978d2fd3	2023-12-15	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Childrens Ibuprofen	IBUPROFEN	American Health Packaging	bc69d88b-d9af-4010-8e8f-e761a9e295a9	2023-12-05	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Pediacare Childrens Ibuprofen Berry	IBUPROFEN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	347d081f-068c-4173-9b4b-001ab2b891f5	2022-12-20	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Ibuprofen Oral	IBUPROFEN ORAL	Strategic Sourcing Services	a3062142-db0e-4758-a762-2b2bb05670b1	2022-08-10	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Dolex Children	IBUPROFEN	Pharmadel LLC	ac3c264f-da37-a474-e053-2a95a90abdad	2020-08-06	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602

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	cf22da7e-fcf1-49da-8314-277d31199c1c	105
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	cf22da7e-fcf1-49da-8314-277d31199c1c	105
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	cf22da7e-fcf1-49da-8314-277d31199c1c	105
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	cf22da7e-fcf1-49da-8314-277d31199c1c	105

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8540-1	63629854001	1 BOTTLE in 1 CARTON (63629-8540-1) / 118 mL in 1 BOTTLE	1 bottle	2018-11-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Oral Suspension USP, 100 mg/5 mL (OTC)	Bryant Ranch Prepack	2024-03-13	HUMAN OTC DRUG LABEL	105