up and up dye free infants concentrated ibuprofen

Product NDC
11673-255
11-digit product format
116730255
Labeler code
11673
Product ID
11673-255_5fce3ec0-d8a0-40a5-a33b-0a890cefd621
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
Target Corporation
Application
ANDA075217
Marketing category
ANDA
Marketing start
2009-07-08
Substance
IBUPROFEN
Active strength
50 mg/1.25mL
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075217-001IBUPROFENIBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16

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 UTC2026-02A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
up and up dye free infants concentrated ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN50 mg/1.25mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204442Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6cfdcd94-95cb-4447-a14b-cdb49a1e3114Available 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-255-10up and up dye free infants concentrated ibuprofen30 mL in 1 BOTTLESUSPENSION/ DROPS305
11673-255-10up and up dye free infants concentrated ibuprofen1 in 1 CARTONSUSPENSION/ DROPS15
11673-255-16up and up dye free infants concentrated ibuprofen30 mL in 1 BOTTLESUSPENSION/ DROPS305
11673-255-16up and up dye free infants concentrated ibuprofen2 in 1 CARTONSUSPENSION/ DROPS25

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMUP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN (IBUPROFEN) SUSPENSION/ DROPS [TARGET CORPORATION]2
IBUPROFENACTIVE MOIETYWK2XYI10QMUP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN (IBUPROFEN) SUSPENSION/ DROPS [TARGET CORPORATION]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLUP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN (IBUPROFEN) SUSPENSION/ DROPS [TARGET CORPORATION]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXUP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN (IBUPROFEN) SUSPENSION/ DROPS [TARGET CORPORATION]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOUP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN (IBUPROFEN) SUSPENSION/ DROPS [TARGET CORPORATION]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HUP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN (IBUPROFEN) SUSPENSION/ DROPS [TARGET CORPORATION]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUUP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN (IBUPROFEN) SUSPENSION/ DROPS [TARGET CORPORATION]2
SORBITOLINACTIVE INGREDIENT506T60A25RUP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN (IBUPROFEN) SUSPENSION/ DROPS [TARGET CORPORATION]2
SUCROSEINACTIVE INGREDIENTC151H8M554UP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN (IBUPROFEN) SUSPENSION/ DROPS [TARGET CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RUP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN (IBUPROFEN) SUSPENSION/ DROPS [TARGET CORPORATION]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEUP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN (IBUPROFEN) SUSPENSION/ DROPS [TARGET CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-255UP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN (IBUPROFEN) SUSPENSION/ DROPS [TARGET CORPORATION]5Current NDC, Legacy NDC, 4 package rows20250409_6cfdcd94-95cb-4447-a14b-cdb49a1e3114.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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofenIBUPROFENRite Aid Corporation99a76de3-166a-4902-b400-b262a4fa0ae82026-05-27WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
Good Sense Infants IbuprofenIBUPROFENL. Perrigo Company3d2fa7ad-1574-4c79-959d-3ee284468a992026-05-11WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
ibuprofen infantsIBUPROFENH E Be353bc69-c03e-4bae-a357-f7f3fab916952026-05-07WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
infants dye free ibuprofenIBUPROFENKroger Company6dc009c8-5b44-4d53-b053-eaed2223d9752026-05-05WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
Good Sense ibuprofen infantsIBUPROFENL. Perrigo Companyc79e65e7-149b-450f-b083-99e16ff717292026-04-14WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
care one ibuprofenIBUPROFENAmerican Sales Company15f63d40-276c-4c02-9f8c-0354e47799162026-04-09WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
ibuprofenIBUPROFENCVS Pharmacye28d0916-8165-431c-a19c-ef7d4bb6b8e62026-02-26WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
ibuprofen infantsIBUPROFENHyVee Ince8fcaf17-234a-4d64-b621-9ca505884b0a2026-01-12WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
Foster and Thrive IbuprofenIBUPROFENStrategic Sourcing Services LLCbcfa45ac-63d6-49a7-aa1c-b9f1d6c571f32025-10-22WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
ibuprofenIBUPROFENMeijer Distribution Ince28e64dc-5f4e-4260-953a-3de38a5eaa762025-09-15WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
INFANTS IBUPROFENIBUPROFENSafeway6fed7c65-69a3-4899-a85d-23ea95f571a42025-07-21WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
profen ib infantsIBUPROFENPublix Super Markets Inc84aea3fc-4f3b-4a76-a3a6-94ed6549dbea2025-07-17WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
Dg Health IbuprofenIBUPROFENDolgencorp, LLC9022e393-084e-499b-ac84-f35360d795922025-07-17WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
dg health ibuprofenIBUPROFENDolgencorp, LLCd6dcbdee-7c0d-4b5c-b0c1-1e8f357f7f592025-05-15WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
Equaline IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFIc611afc0-5cde-4f01-908a-de52cb61ab022025-05-08WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
ibuprofenIBUPROFENMajor Pharmaceuticalsb4962985-47e6-4389-874f-76742b086e2f2025-05-03WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
Topcare Infants IbuprofenIBUPROFENTopco Associates LLC00d33273-e8c7-4d40-8e6f-a980f746fff22025-05-03WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
profen ibIBUPROFENPublix Super Markets Incbee4b754-c476-4d0e-a1b4-4db8861af84a2025-05-01WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
parents choice infants ibuprofenIBUPROFENWal-Mart Stores Inca826d6cc-f582-4508-897d-0d637de0666c2025-04-07WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
up and up dye free infants concentrated ibuprofenIBUPROFENTarget Corporation6cfdcd94-95cb-4447-a14b-cdb49a1e31142025-04-07WarningsExact identifier
application applno (ANDA): 075217
application number: ANDA075217
ndc (product): 11673-255

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204442ibuprofen 50 MG in 1.25 mL Oral SuspensionPSN6cfdcd94-95cb-4447-a14b-cdb49a1e31145
204442ibuprofen 40 MG/ML Oral SuspensionSCD6cfdcd94-95cb-4447-a14b-cdb49a1e31145
204442ibuprofen 50 MG per 1.25 ML Oral SuspensionSY6cfdcd94-95cb-4447-a14b-cdb49a1e31145
204442ibuprofen 50 MG per 1.25 ML Oral Suspension DropsSY6cfdcd94-95cb-4447-a14b-cdb49a1e31145

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-255-10116730255101 BOTTLE in 1 CARTON (11673-255-10) / 30 mL in 1 BOTTLE1 bottle2009-07-080000-00-00NoNoCurrent
11673-255-16116730255162 BOTTLE in 1 CARTON (11673-255-16) / 30 mL in 1 BOTTLE2 bottle2018-08-230000-00-00NoNoCurrent