Childrens Ibuprofen

Product NDC: 63868-795
11-digit product format: 638680795
Labeler code: 63868
Product ID: 63868-795_e30f7f75-b812-4dcb-9239-d26dd411ac08
Type: HUMAN OTC DRUG
Nonproprietary name: IBUPROFEN
Dosage form: SUSPENSION
Route: ORAL
Labeler: Chain Drug Marketing Association, Inc.
Application: ANDA210602
Marketing category: ANDA
Marketing start: 2020-12-15
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 100 mg/5mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63868-795		D	Discontinued by firm	2026-08-07
excluded package	package	63868-795	63868-795-04	D	Discontinued by firm	2026-08-07
excluded package	package	63868-795	63868-795-08	D	Discontinued by firm	2026-08-07

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 · 27 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63868-795-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63868-795-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63868-795-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63868-795-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63868-795-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63868-795-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63868-795-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63868-795-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63868-795-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63868-795-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63868-795-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63868-795-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63868-795-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63868-795-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63868-795-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63868-795-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63868-795-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63868-795-04	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-795-04	ML - Milliliter	63868-795	14c79a9a-d229-44c3-8370-e3e47ba36244	1	2022-09-12
63868-795-08	ML - Milliliter	63868-795	d60d5af0-8eaa-4f0f-bdf4-3ca92cb4d8aa	1	2022-09-12

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

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
63868-795-04	63868079504	1 BOTTLE in 1 CARTON (63868-795-04) > 118 mL in 1 BOTTLE	1 bottle	2020-12-15	0000-00-00	No	No	Current
63868-795-08	63868079508	1 BOTTLE in 1 CARTON (63868-795-08) > 237 mL in 1 BOTTLE	1 bottle	2020-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children's Ibuprofen Oral Suspension	Chain Drug Marketing Association, Inc. \| AptaPharma Inc.	2023-12-30	HUMAN OTC DRUG LABEL	4