CHILDRENS ADVIL

Product NDC
0573-0207
11-digit product format
005730207
Labeler code
0573
Product ID
0573-0207_88972802-d04c-4fe3-8c56-3c3d1e3b4218
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA020589
Marketing category
NDA
Marketing start
2012-09-04
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020589-001CHILDREN'S ADVILIBUPROFEN100MG/5MLSUSPENSION / ORAL1996-06-27
N020589-002CHILDREN'S ADVIL-FLAVOREDIBUPROFEN100MG/5MLSUSPENSION / ORAL1997-11-07

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020589-001CHILDREN'S ADVIL100MG/5MLSUSPENSION / ORAL1996-06-27782e0a99824c…
2021-12-28 21:50 UTC2021-12N020589-002CHILDREN'S ADVIL-FLAVORED100MG/5MLSUSPENSION / ORAL1997-11-07782e0a99824c…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020589-002102386402024-05-25Drug product2019-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020589-002102386402024-05-25Drug product2019-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020589-002102386402024-05-25Drug product2019-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020589-002102386402024-05-25Drug product2019-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020589-002102386402024-05-25Drug product2019-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020589-002102386402024-05-25Drug product2019-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020589-002102386402024-05-25Drug product2019-04-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020589-002102386402024-05-25Drug product2019-04-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020589-002102386402024-05-25Drug product2019-04-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020589-002102386402024-05-25Drug product2019-04-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020589-002102386402024-05-25Drug product2019-04-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020589-002102386402024-05-25Drug product2019-04-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020589-002102386402024-05-25Drug product2019-04-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020589-002102386402024-05-25Drug product2019-04-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020589-002102386402024-05-25Drug product2019-04-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020589-002102386402024-05-25Drug product2019-04-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N020589-002102386402024-05-25Drug product2019-04-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020589-002102386402024-05-25Drug product2019-04-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020589-002102386402024-05-25Drug product2019-04-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020589-002102386402024-05-25Drug product2019-04-243f01610625f2…
2019-09-15 20:21 UTC2019-09N020589-002102386402024-05-25Drug product2019-04-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N020589-002102386402024-05-25Drug product2019-04-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020589-002102386402024-05-25Drug product2019-04-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020589-002102386402024-05-25Drug product2019-04-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020589-002102386402024-05-25Drug product2019-04-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020589-002102386402024-05-25Drug product2019-04-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020589-002102386402024-05-25Drug product2019-04-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020589-002102386402024-05-25Drug product2019-04-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020589-002102386402024-05-25Drug product2019-04-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N020589-002102386402024-05-25Drug product2019-04-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N020589-002102386402024-05-25Drug product2019-04-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020589-002102386402024-05-25Drug product2019-04-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020589-002102386402024-05-25Drug product2019-04-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020589-002102386402024-05-25Drug product2019-04-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020589-002102386402024-05-25Drug product2019-04-24cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
CHILDRENS ADVIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197803Internal RxNorm lookup
206878Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3079d932-afb2-94fe-f4ba-a3d8b5198fceAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0207-30CHILDRENS ADVIL1 in 1 CARTONSUSPENSION120
0573-0207-30CHILDRENS ADVIL120 mL in 1 BOTTLESUSPENSION12020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0207-30ML - Milliliter0573-02076e079f5d-a80c-4049-80fa-5e546966824612019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
IBUPROFENACTIVE MOIETYWK2XYI10QMCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311CHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
PROPYLENE GLYCOL, (R)-INACTIVE INGREDIENT602HN5L69HCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
SUCROSEINACTIVE INGREDIENTC151H8M554CHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS ADVIL (IBUPROFEN) SUSPENSION [PFIZER CONSUMER HEALTHCARE]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0207CHILDRENS ADVIL (IBUPROFEN) SUSPENSION [HALEON US HOLDINGS LLC]20Current NDC, Legacy NDC, 2 package rows20240209_3079d932-afb2-94fe-f4ba-a3d8b5198fce.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHILDRENS ADVILIBUPROFENHaleon US Holdings LLC3079d932-afb2-94fe-f4ba-a3d8b5198fce2024-02-08WarningsExact identifier
application applno (NDA): 020589
application number: NDA020589
ndc (product): 0573-0207
CHILDRENS ADVILIBUPROFENHaleon US Holdings LLC4eba2795-e826-480d-afdc-d62004e95f362024-02-08WarningsExact identifier
application applno (NDA): 020589
application number: NDA020589

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206878Advil Children 100 MG in 5 mL Oral SuspensionPSN3079d932-afb2-94fe-f4ba-a3d8b5198fce20
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN3079d932-afb2-94fe-f4ba-a3d8b5198fce20
206878ibuprofen 20 MG/ML Oral Suspension [Advil]SBD3079d932-afb2-94fe-f4ba-a3d8b5198fce20
197803ibuprofen 20 MG/ML Oral SuspensionSCD3079d932-afb2-94fe-f4ba-a3d8b5198fce20
206878Advil 100 MG per 5 ML Oral SuspensionSY3079d932-afb2-94fe-f4ba-a3d8b5198fce20
206878Advil 20 MG/ML Oral SuspensionSY3079d932-afb2-94fe-f4ba-a3d8b5198fce20
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY3079d932-afb2-94fe-f4ba-a3d8b5198fce20
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY3079d932-afb2-94fe-f4ba-a3d8b5198fce20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0207-30005730207301 BOTTLE in 1 CARTON (0573-0207-30) / 120 mL in 1 BOTTLE1 bottle2012-09-040000-00-00NoNoCurrent