CHILDRENS ADVIL

Product NDC: 0573-1174
11-digit product format: 005731174
Labeler code: 0573
Product ID: 0573-1174_e78c4482-deac-46a8-8774-856e1fe5054c
Type: HUMAN OTC DRUG
Nonproprietary name: ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: NDA020589
Marketing category: NDA
Marketing start: 1996-06-27
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020589-001	CHILDREN'S ADVIL	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1996-06-27
N020589-002	CHILDREN'S ADVIL-FLAVORED	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1997-11-07

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`bb7c543d1eb4…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: CHILDRENS ADVIL
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197803	Internal RxNorm lookup
206878	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
4eba2795-e826-480d-afdc-d62004e95f36	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
0573-1174-12	CHILDRENS ADVIL	120 mL in 1 BOTTLE	SUSPENSION	120		5
0573-1174-12	CHILDRENS ADVIL	1 in 1 CARTON	SUSPENSION	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-1174-12	ML - Milliliter	0573-1174	8832558f-1e2f-4c5c-85ec-f94661da7f02	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0573-1174	CHILDRENS ADVIL (IBUPROFEN) SUSPENSION [HALEON US HOLDINGS LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240209_4eba2795-e826-480d-afdc-d62004e95f36.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHILDRENS ADVIL	IBUPROFEN	Haleon US Holdings LLC	3079d932-afb2-94fe-f4ba-a3d8b5198fce	2024-02-08	Warnings	Exact identifier application applno (NDA): 020589 application number: NDA020589
CHILDRENS ADVIL	IBUPROFEN	Haleon US Holdings LLC	4eba2795-e826-480d-afdc-d62004e95f36	2024-02-08	Warnings	Exact identifier application applno (NDA): 020589 application number: NDA020589 ndc (product): 0573-1174

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
206878	Advil Children 100 MG in 5 mL Oral Suspension	PSN	4eba2795-e826-480d-afdc-d62004e95f36	5
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	4eba2795-e826-480d-afdc-d62004e95f36	5
206878	ibuprofen 20 MG/ML Oral Suspension [Advil]	SBD	4eba2795-e826-480d-afdc-d62004e95f36	5
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	4eba2795-e826-480d-afdc-d62004e95f36	5
206878	Advil 100 MG per 5 ML Oral Suspension	SY	4eba2795-e826-480d-afdc-d62004e95f36	5
206878	Advil 20 MG/ML Oral Suspension	SY	4eba2795-e826-480d-afdc-d62004e95f36	5
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	4eba2795-e826-480d-afdc-d62004e95f36	5
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	4eba2795-e826-480d-afdc-d62004e95f36	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0573-1174-12	00573117412	1 BOTTLE in 1 CARTON (0573-1174-12) / 120 mL in 1 BOTTLE	1 bottle	2019-09-30	0000-00-00	No	No	Current