CHILDRENS IBUPROFEN

Product NDC
50090-3227
11-digit product format
500903227
Labeler code
50090
Product ID
50090-3227_f51b0f71-5531-4967-9078-9498ea36e99a
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074937
Marketing category
ANDA
Marketing start
1999-02-07
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/5mL
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3227IInactivated by FDA2026-08-03
excluded packagepackage50090-322750090-3227-0IInactivated by FDA2026-08-03

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3227-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3227-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3227-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3227-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3227-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3227-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3227-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3227-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3227-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3227-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3227-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3227-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-3227-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-3227-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-3227-01332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50090-3227-0fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50090-3227-086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50090-3227-0bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50090-3227-08dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-3227-0e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50090-3227-09bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074937-001CHILDREN'S IBUPROFENIBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22cb3db0bc1861…

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
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3227-02020-01-31C16284748780-19d75b9d0-36f1-f424-e053-dadaa90a57ceCHILDRENS IBUPROFEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3227-0CHILDRENS IBUPROFEN10 in 1 CASESUSPENSION105
50090-3227-0CHILDRENS IBUPROFEN10 mL in 1 TRAYSUSPENSION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3227-0ML - Milliliter50090-3227a6cafede-00f9-4f70-bb65-98c30a6ce65012019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3227CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20180821_707a0325-fa88-4b3a-a5fd-10696882081e.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 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens ibuprofenIBUPROFENRite Aid Corporation26bccfc1-bc8d-4241-a078-c760048951c92026-07-24WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
IbuprofenIBUPROFENATLANTIC BIOLOGICALS CORP.3ce7549f-e4db-9f89-e063-6294a90a126d2026-07-10WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Childrens IbuprofenIBUPROFENRite Aid Corporation1da544eb-ed4e-4124-bea3-f827f13222702026-05-27WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Childrens IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.52d3e633-13a2-cdcd-e063-6394a90ac1892026-05-27WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofenIBUPROFENRite Aid Corporation69ca781a-202e-4579-91e6-f32a22ccc22c2026-05-27WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofen childrensIBUPROFENWalgreen Companyf67612e8-38f3-4d1c-889b-57995a2f9f662026-05-15WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
care one ibuprofenIBUPROFENAmerican Sales Companyd26d2766-6d4c-462b-ae8b-ef8d87acd6332026-04-16WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Childrens IbuprofenIBUPROFENCardinal Health 107, LLC9291857c-30b3-414b-99e1-9c127e72c0d42026-04-16WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Ibuprofen childrensIBUPROFENHyVee Inc55f8def6-f7de-4b3e-a92a-5cd9e68a46a12026-04-15WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
CHILDRENS IbuprofenIBUPROFENKesin Pharma Corporation436c0126-4ff3-c082-e063-6294a90a3d722026-04-13WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofen childrensIBUPROFENHyVee Inc3d8497c6-1c46-4248-b75c-b086591529cc2026-04-10WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
IbuprofenIBUPROFENCVS Pharmacyef204cc0-4009-4dd0-83e2-2b5ad6f984092026-02-27WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
equate ibuprofen childrensIBUPROFENWal-Mart Stores Inc7817923f-4c21-4943-a7e2-dad4e2915fc42026-02-23WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofenIBUPROFENHyVee Incc20a9bc5-e481-4fb2-ad10-d01e83e43ca02026-02-21WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Ibuprofen ChildrensIBUPROFENMajor Pharmaceuticals9d56e64d-7860-4fd1-88d2-c537e50079d82026-02-13WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
childrens ibuprofenIBUPROFENHyVee Incd522a3ac-dd43-4faa-b3f8-69313be1c8292026-02-11WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
IbuprofenIBUPROFENMajor Pharmaceuticals847758ed-66fc-4db9-8fdb-78f3c3291a032026-01-26WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
good sense ibuprofen childrensIBUPROFENPreferred Pharmaceuticals Inc.7ac61180-d668-4eec-b04f-d14f7b552a4d2025-12-23WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
topcare childrens ibuprofenIBUPROFENTopco Associates LLCd1bb68a6-3a29-4a4e-b4e9-413cc8d161912025-12-12WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Childrens IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.a1a5a9c7-c727-4e41-a8f0-2982f796a3ca2025-09-29WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN707a0325-fa88-4b3a-a5fd-10696882081e5
197803ibuprofen 20 MG/ML Oral SuspensionSCD707a0325-fa88-4b3a-a5fd-10696882081e5
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY707a0325-fa88-4b3a-a5fd-10696882081e5
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY707a0325-fa88-4b3a-a5fd-10696882081e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-3227-05009032270010 in 1 CASEHistorical