FDA.reportPublic FDA data

Childrens Ibuprofen Oral Suspension

Product NDC
76281-128
11-digit product format
762810128
Labeler code
76281
Product ID
76281-128_f9029942-7f22-4dac-9e80-2d3d995804e6
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
SUSPENSION
Route
ORAL
Labeler
AptaPharma Inc.
Application
ANDA210602
Marketing category
ANDA
Marketing start
2020-09-30
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
2027-12-31
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
A210602-001IBUPROFENIBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23

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 UTC2026-02A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233f01610625f2…
2019-09-15 20:21 UTC2019-09A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Ibuprofen Oral Suspension
Brand name suffix
Dye free
Listing expiration
2027-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb995c57-a2cc-4bc7-9c7d-f885c425be64Available 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
76281-128-24Childrens Ibuprofen Oral SuspensionDye free1 in 1 CARTONSUSPENSION13
76281-128-24Childrens Ibuprofen Oral SuspensionDye free118 mL in 1 BOTTLESUSPENSION1183
76281-128-26Childrens Ibuprofen Oral SuspensionDye free237 mL in 1 BOTTLESUSPENSION2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76281-128CHILDRENS IBUPROFEN ORAL SUSPENSION DYE FREE (IBUPROFEN) SUSPENSION [APTAPHARMA INC.]1Current NDC, 3 package rows20231112_bb995c57-a2cc-4bc7-9c7d-f885c425be64.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
Childrens Ibuprofen Oral Suspension Dye freeIBUPROFENAptaPharma Inc.bb995c57-a2cc-4bc7-9c7d-f885c425be642026-05-10WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
ndc (product): 76281-128
Ibuprofen OralIBUPROFEN ORALCamber Consumer Care Incb2dd4863-613e-4a41-98c1-3191e41b84632026-03-26WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Childrens Ibuprofen Oral Suspension Original Berry FlavorIBUPROFENPuro Pharma Inc.6b993b25-9c81-4d75-b332-6de3f6c3b4c92025-12-27WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Childrens Ibuprofen Oral SuspensionIBUPROFENAptaPharma Inc.40936019-74ab-4b25-a502-7bbc6e12034a2025-12-26WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Childrens Ibuprofen GrapeIBUPROFENAptaPharma Inc.7caca7e2-6652-45fc-9538-275b43a1594e2025-12-26WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Childrens Ibuprofen Oral SuspensionIBUPROFENMarc Glassman, Inc.0ef3f4b3-9af5-4243-8d45-dd68f72852292025-12-19WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Childrens Ibuprofen Oral SuspensionIBUPROFENDiscount Drug Mart7b7954b7-e4c8-4284-a649-31a4eb6ba73e2025-12-19WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
KOSHER MEDSIBUPROFENMollec Incc9c31326-6a19-9a9c-e053-2a95a90aed062025-10-29WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Kosher Meds Dye-Free IbuprofenIBUPROFENMollec Incba1a0bc2-0a28-4d73-9667-5a220b806e872025-10-29WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Childrens Ibuprofen Oral Suspension Dye FreeIBUPROFENFSA Store Inc. (Caring Mill)099e374b-49c2-4d56-a047-d4f0c4af34ba2025-09-18WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepack34f88afb-5c56-ca2c-e063-6394a90a90722025-05-12WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Ibuprofen OralIBUPROFEN ORALStrategic Sourcing Services863f7ce3-b7b9-4c66-b351-5b95dd23dcb42025-02-20WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Dye Free Childrens IbuprofenIBUPROFENPAI Holdings, LLC dba PAI Pharmaa616a7cd-4814-478e-8c58-7fbc2454d9922025-01-31WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Childrens Ibuprofen Oral Suspension, Dye FreeIBUPROFENBest Choice55fd05c7-b902-4c82-ab9a-8054d880dfbd2025-01-20WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Childrens Ibuprofen Oral Suspension, Bubble GumIBUPROFENBest Choiced27ca801-d4d3-4fd0-a22b-db5ada5fcb9f2025-01-20WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepack9b98fc28-6cba-4b22-8d4a-9c7735d346b42025-01-03WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepackb9968d61-bd5d-4573-825a-7630f86eb7c62025-01-03WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepack5c817d24-2dd3-468e-9678-311d038c7b4a2025-01-03WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Childrens Ibuprofen Oral SuspensionIBUPROFENChain Drug Marketing Association, Inc.f0959369-890e-403e-8a98-4eda340a07832024-12-23WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602
Ibuprofen OralIBUPROFEN ORALNuCare Pharmaceuticals,Inc.84764eda-7446-5b16-e053-2991aa0abd7c2024-07-15WarningsExact identifier
application applno (ANDA): 210602
application number: ANDA210602

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNa616a7cd-4814-478e-8c58-7fbc2454d99211
197803ibuprofen 20 MG/ML Oral SuspensionSCDa616a7cd-4814-478e-8c58-7fbc2454d99211
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYa616a7cd-4814-478e-8c58-7fbc2454d99211
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYa616a7cd-4814-478e-8c58-7fbc2454d99211
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNbb995c57-a2cc-4bc7-9c7d-f885c425be643
197803ibuprofen 20 MG/ML Oral SuspensionSCDbb995c57-a2cc-4bc7-9c7d-f885c425be643
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYbb995c57-a2cc-4bc7-9c7d-f885c425be643
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYbb995c57-a2cc-4bc7-9c7d-f885c425be643
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNbc69d88b-d9af-4010-8e8f-e761a9e295a91
197803ibuprofen 20 MG/ML Oral SuspensionSCDbc69d88b-d9af-4010-8e8f-e761a9e295a91
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYbc69d88b-d9af-4010-8e8f-e761a9e295a91
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYbc69d88b-d9af-4010-8e8f-e761a9e295a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76281-128-24762810128241 BOTTLE in 1 CARTON (76281-128-24) / 118 mL in 1 BOTTLE1 bottle2023-11-01NoNoCurrent
76281-128-2676281012826237 mL in 1 BOTTLE (76281-128-26) 237 ml2023-11-01NoNoCurrent