care one ibuprofen

Product NDC
41520-660
11-digit product format
415200660
Labeler code
41520
Product ID
41520-660_bb9cb0af-884c-4855-87c7-ca9ed68dab7f
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
American Sales Company
Application
ANDA074937
Marketing category
ANDA
Marketing start
2004-05-04
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct41520-660DDiscontinued by firm2026-10-05
excluded packagepackage41520-66041520-660-26DDiscontinued by firm2026-10-05
excluded packagepackage41520-66041520-660-28DDiscontinued by firm2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2284e616aacf4f…
2026-08-18 06:07:402026-07A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMCARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]3
IBUPROFENACTIVE MOIETYWK2XYI10QMCARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]3
SORBITOLINACTIVE INGREDIENT506T60A25RCARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RCARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-660CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]8Legacy NDC20190119_ab65bbbd-5141-4f3e-884d-4b52d9171003.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 3 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
profen ibIBUPROFENPublix Super Markets Inc51fbfd25-3c4d-4de1-8fa2-e5b4b24022f22025-05-13WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
IbuprofenIBUPROFENATLANTIC BIOLOGICALS CORP.230914e6-fe0c-45be-8b2e-e066c71d004c2025-05-12WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
good sense ibuprofen childrensIBUPROFENL. Perrigo Companyb8e3ad4f-3212-4674-bcdf-a60a6b23d7bb2025-05-12WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Childrens IbuprofenIBUPROFENMeijer Distribution Inc3b15dc44-ae1d-43c6-b6c5-05fa31beb5542025-05-12WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Up and Up childrens ibuprofenIBUPROFENTarget Corporation28911692-882b-4e30-ba1d-5c10f847be802025-05-12WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Equaline ibuprofen childrensIBUPROFENUnited Natural Foods, Inc. dba UNFI811d4360-7468-4ef8-a60e-6e9a6e169de02025-05-08WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
up and up ibuprofenIBUPROFENTarget Corporation6e0330ac-a111-4574-9197-d7aab33b86082025-05-07WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
equaline ibuprofen childrensIBUPROFENUnited Natural Foods, Inc. dba UNFI835c3bc8-fb55-4b7e-98ad-3d84d089c8cb2025-05-06WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
good sense ibuprofen childrensIBUPROFENL. Perrigo Company6127469c-143f-4dd2-bd37-6630291fcd5a2025-04-30WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofen childrensIBUPROFENCVS Pharmacy4459298c-e0bf-4a10-b68c-6f83fefde7e92025-04-29WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofenIBUPROFENH E Bbbcfea51-4c57-4a2c-a0ac-2a189c5ff38a2025-04-28WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
DG Health IbuprofenIBUPROFENDolgencorp Inc0c0cf516-b3e7-474d-885c-897574365be32025-04-28WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofen childrensIBUPROFENMeijer Distribution Incc5e1d74d-99a3-4b3d-86c4-03f5c4c22f772025-04-27WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Equaline IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI5e860059-afc8-419e-9451-b1c2265f5ce62025-04-18WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leadera5701486-0a5f-4645-91ef-1fbf525c84dd2025-04-18WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
childrens ibuprofenIBUPROFENMeijer Distribution Inc02681a10-eb8a-457f-8aff-12e6f29079de2025-04-18WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Good Neighbor Pharmacy ibuprofen childrensIBUPROFENAmerisource Bergen43b8e61b-3ac4-4a41-b682-67d08b212cc62025-04-18WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Good Sense IbuprofenIBUPROFENL. Perrigo Company1a6b42be-c0c2-48f8-9ba3-22d1f0c0b18d2025-04-18WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Childrens IbuprofenIBUPROFENBryant Ranch Prepackb303b554-c457-4f2b-9931-48f30943178b2025-04-03WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Childrens IbuprofenIBUPROFENBryant Ranch Prepack87c9f15f-1196-477c-b5d2-3b875bea61d02025-04-03WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-660-26415200660261 BOTTLE in 1 CARTON (41520-660-26) > 118 mL in 1 BOTTLE1 bottle2004-05-040000-00-00NoNoCurrent
41520-660-28415200660281 BOTTLE in 1 CARTON (41520-660-28) > 147 mL in 1 BOTTLE1 bottle2013-08-030000-00-00NoNoCurrent