Ibuprofen Oral

Product NDC: 68071-1628
11-digit product format: 680711628
Labeler code: 68071
Product ID: 68071-1628_1d4dcfbd-9377-6426-e063-6394a90aa935
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen Oral
Dosage form: SUSPENSION
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
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

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1628-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-1628-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-1628-4	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-1628-4	`1332a3947898…`	`d4bfe170f9cd…`

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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`cb3db0bc1861…`

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
84764eda-7446-5b16-e053-2991aa0abd7c	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-07-15	Ibuprofen Oral Suspension USP, 100 mg/5 mL (OTC)
2023-01-30	Ibuprofen Oral Suspension USP, 100 mg/5 mL (OTC)
2021-02-11	Ibuprofen Oral Suspension USP, 100 mg/5 mL (OTC)
2021-01-29	Ibuprofen Oral Suspension USP, 100 mg/5 mL (OTC)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-1628-4	Ibuprofen Oral	118 mL in 1 BOTTLE	SUSPENSION	118		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-1628	IBUPROFEN ORAL SUSPENSION [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240716_84764eda-7446-5b16-e053-2991aa0abd7c.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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Ibuprofen Oral Suspension Dye free	IBUPROFEN	AptaPharma Inc.	bb995c57-a2cc-4bc7-9c7d-f885c425be64	2026-05-10	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Ibuprofen Oral	IBUPROFEN ORAL	Camber Consumer Care Inc	b2dd4863-613e-4a41-98c1-3191e41b8463	2026-03-26	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Childrens Ibuprofen Oral Suspension Original Berry Flavor	IBUPROFEN	Puro Pharma Inc.	6b993b25-9c81-4d75-b332-6de3f6c3b4c9	2025-12-27	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Childrens Ibuprofen Oral Suspension	IBUPROFEN	AptaPharma Inc.	40936019-74ab-4b25-a502-7bbc6e12034a	2025-12-26	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Childrens Ibuprofen Grape	IBUPROFEN	AptaPharma Inc.	7caca7e2-6652-45fc-9538-275b43a1594e	2025-12-26	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Childrens Ibuprofen Oral Suspension	IBUPROFEN	Marc Glassman, Inc.	0ef3f4b3-9af5-4243-8d45-dd68f7285229	2025-12-19	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Childrens Ibuprofen Oral Suspension	IBUPROFEN	Discount Drug Mart	7b7954b7-e4c8-4284-a649-31a4eb6ba73e	2025-12-19	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
KOSHER MEDS	IBUPROFEN	Mollec Inc	c9c31326-6a19-9a9c-e053-2a95a90aed06	2025-10-29	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Kosher Meds Dye-Free Ibuprofen	IBUPROFEN	Mollec Inc	ba1a0bc2-0a28-4d73-9667-5a220b806e87	2025-10-29	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Childrens Ibuprofen Oral Suspension Dye Free	IBUPROFEN	FSA Store Inc. (Caring Mill)	099e374b-49c2-4d56-a047-d4f0c4af34ba	2025-09-18	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Ibuprofen Oral	IBUPROFEN ORAL	Bryant Ranch Prepack	34f88afb-5c56-ca2c-e063-6394a90a9072	2025-05-12	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Ibuprofen Oral	IBUPROFEN ORAL	Strategic Sourcing Services	863f7ce3-b7b9-4c66-b351-5b95dd23dcb4	2025-02-20	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Dye Free Childrens Ibuprofen	IBUPROFEN	PAI Holdings, LLC dba PAI Pharma	a616a7cd-4814-478e-8c58-7fbc2454d992	2025-01-31	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Childrens Ibuprofen Oral Suspension, Dye Free	IBUPROFEN	Best Choice	55fd05c7-b902-4c82-ab9a-8054d880dfbd	2025-01-20	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Childrens Ibuprofen Oral Suspension, Bubble Gum	IBUPROFEN	Best Choice	d27ca801-d4d3-4fd0-a22b-db5ada5fcb9f	2025-01-20	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Ibuprofen Oral	IBUPROFEN ORAL	Bryant Ranch Prepack	9b98fc28-6cba-4b22-8d4a-9c7735d346b4	2025-01-03	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Ibuprofen Oral	IBUPROFEN ORAL	Bryant Ranch Prepack	b9968d61-bd5d-4573-825a-7630f86eb7c6	2025-01-03	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Ibuprofen Oral	IBUPROFEN ORAL	Bryant Ranch Prepack	5c817d24-2dd3-468e-9678-311d038c7b4a	2025-01-03	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Childrens Ibuprofen Oral Suspension	IBUPROFEN	Chain Drug Marketing Association, Inc.	f0959369-890e-403e-8a98-4eda340a0783	2024-12-23	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Ibuprofen Oral	IBUPROFEN ORAL	NuCare Pharmaceuticals,Inc.	84764eda-7446-5b16-e053-2991aa0abd7c	2024-07-15	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602 ndc (product): 68071-1628

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	84764eda-7446-5b16-e053-2991aa0abd7c	3
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	84764eda-7446-5b16-e053-2991aa0abd7c	3
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	84764eda-7446-5b16-e053-2991aa0abd7c	3
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	84764eda-7446-5b16-e053-2991aa0abd7c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1628-4	68071162804	118 mL in 1 BOTTLE (68071-1628-4)	118 ml	2019-03-19	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)	NuCare Pharmaceuticals,Inc.	2024-07-15	HUMAN OTC DRUG LABEL	3