CHILDRENS IBUPROFEN

Product NDC: 79395-003
11-digit product format: 793950003
Labeler code: 79395
Product ID: 79395-003_9808ec56-25ae-44d6-9253-4498450020a2
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Chalkboard Health
Application: ANDA209179
Marketing category: ANDA
Marketing start: 2020-08-01
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
A209179-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			2018-04-17

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	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209179-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-04-17	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: CHILDRENS 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
c63eb5c6-adac-4d23-9661-1081ba4591ba	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
79395-003-92	CHILDRENS IBUPROFEN	120 mL in 1 BOTTLE	SUSPENSION	120		4
79395-003-92	CHILDRENS IBUPROFEN	1 in 1 CARTON	SUSPENSION	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79395-003	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CHALKBOARD HEALTH]	3	Current NDC, Legacy NDC, 2 package rows	20200825_c63eb5c6-adac-4d23-9661-1081ba4591ba.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHILDRENS IBUPROFEN	IBUPROFEN	Aurohealth LLC	7461e50d-bfa1-4627-b691-089636b979d2	2026-05-22	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	Better Living Brands, LLC	fab39a0a-882b-bf96-e053-6294a90a2932	2025-09-02	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	WALGREEN CO.	fea3c4b2-cf96-2425-e053-6394a90ac697	2025-09-02	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	7-Eleven	af0ec23c-cefc-40a9-ab9a-03b8528d4e13	2025-09-01	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	Aurohealth LLC	0e1bcb06-be48-4efc-82e2-516582e02348	2025-09-01	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	KROGER COMPANY	15e72384-3a04-242d-e063-6294a90aa0fa	2025-09-01	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	7-Eleven	cf7b38fc-0590-126a-e053-2a95a90a3e78	2025-09-01	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	Chalkboard Health	c63eb5c6-adac-4d23-9661-1081ba4591ba	2025-09-01	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179 ndc (product): 79395-003
CHILDRENS IBUPROFEN	IBUPROFEN	Randob Labs., Ltd.	50d6bf9d-ae37-4af3-bfeb-cc0abf8cb094	2025-09-01	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	Aurohealth LLC	ad55d9b1-17b3-4a17-a4a3-d95ba2943959	2025-09-01	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
Childrens FLANAX ORAL	IBUPROFEN	Belmora LLC	9b9318cb-3bc7-40ca-bf8a-7495d93869b3	2024-01-30	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179
CHILDRENS IBUPROFEN	IBUPROFEN	BluePoint Laboratories	d71acfe2-4643-f50b-e053-2a95a90add8b	2023-05-31	Warnings	Exact identifier application applno (ANDA): 209179 application number: ANDA209179

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	c63eb5c6-adac-4d23-9661-1081ba4591ba	4
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	c63eb5c6-adac-4d23-9661-1081ba4591ba	4
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	c63eb5c6-adac-4d23-9661-1081ba4591ba	4
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	c63eb5c6-adac-4d23-9661-1081ba4591ba	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79395-003-92	79395000392	1 BOTTLE in 1 CARTON (79395-003-92) / 120 mL in 1 BOTTLE	1 bottle	2020-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CHILDRENS IBUPROFEN - Chalkboard Health \| Aurohealth LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	Chalkboard Health \| Aurohealth LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-09-01	Human OTC Drug Label	4