FDA.reportPublic FDA data

sunmark ibuprofen

Product NDC
49348-374
Requested package NDC
49348-374-69
11-digit product format
493480374
Labeler code
49348
Product ID
49348-374_557e6ae7-b2bb-47b2-9eea-d8769e2ab6ba
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA075217
Marketing category
ANDA
Marketing start
2003-08-28
Marketing end
0000-00-00
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49348-37449348-374-69DDiscontinued by firm2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49348-37449348-374-69DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49348-37449348-374-69DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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…

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-374-69ML - Milliliter49348-374ab7aaea5-6e87-449d-9afb-0e64afbe7bce12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMSUNMARK IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MCKESSON]3
IBUPROFENACTIVE MOIETYWK2XYI10QMSUNMARK IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MCKESSON]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSUNMARK IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MCKESSON]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASUNMARK IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MCKESSON]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUNMARK IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MCKESSON]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUNMARK IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MCKESSON]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSUNMARK IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MCKESSON]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSUNMARK IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MCKESSON]3
SORBITOLINACTIVE INGREDIENT506T60A25RSUNMARK IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MCKESSON]3
SUCROSEINACTIVE INGREDIENTC151H8M554SUNMARK IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MCKESSON]3
WATERINACTIVE INGREDIENT059QF0KO0RSUNMARK IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MCKESSON]3
Xanthan GumINACTIVE INGREDIENTTTV12P4NEESUNMARK IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MCKESSON]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-374SUNMARK IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [STRATEGIC SOURCING SERVICES LLC]8Legacy NDC20241225_f208ae37-01f8-4ff3-8c54-a776d158cc96.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204442ibuprofen 50 MG in 1.25 mL Oral SuspensionPSN06e681b1-6816-438f-9694-7592c8d5ab4a2
204442ibuprofen 40 MG/ML Oral SuspensionSCD06e681b1-6816-438f-9694-7592c8d5ab4a2
204442ibuprofen 50 MG per 1.25 ML Oral SuspensionSY06e681b1-6816-438f-9694-7592c8d5ab4a2
204442ibuprofen 50 MG per 1.25 ML Oral Suspension DropsSY06e681b1-6816-438f-9694-7592c8d5ab4a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-374-69493480374691 BOTTLE in 1 CARTON (49348-374-69) > 15 mL in 1 BOTTLE1 bottle2003-08-280000-00-00NoNoCurrent