FDA.reportPublic FDA data

NDC 17856-5309-08 - Ibuprofen

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
17856-5309
Requested NDC
17856-5309-08
Package NDCs from labels
17856-5309-1, 17856-5309-2, 17856-5309-3, 17856-5309-4, 17856-5309-5, 17856-5309-6, 17856-5309-7, 17856-5309-9, 17856-5309-8, 17856-5309-08
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2025-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug FactsATLANTIC BIOLOGICALS CORP.2025-05-12HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
17856-5309-12025-03-28Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-22025-03-28Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-32025-03-28Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-42025-03-28Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-52025-03-28Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-62025-03-28Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-72025-03-28Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-92025-03-28Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-12025-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-22025-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-32025-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-42025-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-52025-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-62025-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-72025-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-92025-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-12023-12-12Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-22023-12-12Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-32023-12-12Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-42023-12-12Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-52023-12-12Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-62023-12-12Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-72023-12-12Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-92023-12-12Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-12023-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-22023-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-32023-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-42023-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-52023-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-62023-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-72023-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-92023-01-30Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-5309-1Ibuprofen5 mL in 1 SYRINGESUSPENSION512
17856-5309-2Ibuprofen10 mL in 1 SYRINGESUSPENSION1012
17856-5309-3Ibuprofen1 mL in 1 SYRINGESUSPENSION112
17856-5309-4Ibuprofen20 mL in 1 CUPSUSPENSION2012
17856-5309-5Ibuprofen5 mL in 1 CUPSUSPENSION512
17856-5309-6Ibuprofen15 mL in 1 CUPSUSPENSION1512
17856-5309-7Ibuprofen7.5 mL in 1 CUP, UNIT-DOSESUSPENSION7.512
17856-5309-8Ibuprofen10 mL in 1 CUP, UNIT-DOSESUSPENSION1012
17856-5309-8Ibuprofen72 in 1 CASESUSPENSION7212
17856-5309-9Ibuprofen1 mL in 1 SYRINGESUSPENSION112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-5309IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORP.]12Current NDC, Legacy NDC, 10 package rows20250514_230914e6-fe0c-45be-8b2e-e066c71d004c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-5309-5ML - Milliliter17856-53092367354b-add7-439f-ad0e-568dbf9cef4412013-06-04
17856-5309-8ML - Milliliter17856-530957fe7af4-f076-4408-a7bf-96e936366e4212026-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3

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 4 of 87 · 1,723 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.733d0b21-c177-4c60-9243-2f1e7cb5854a2026-08-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPioneer Life Sciences, LLC8abd74a4-ad33-4c10-b677-acb469f815e62026-08-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPioneer Life Sciences, LLC291602fa-8ebe-4200-bba7-9798c90f8a502026-08-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNUVICARE LLCb063d2dc-d579-46e7-8cfc-1596c803c7f92026-08-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNUVICARE LLC7905edc1-2a45-4adc-a7bc-42b1ddb6ba592026-08-03WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEDoc Rx9f5de6af-e555-4efd-a3ed-b72c34c051b62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDERite-Aid483c3bb7-529e-4684-80e1-6646b050988e2026-07-31WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc2b98a62b-bd92-4fb8-ad0f-521cb477b6122026-07-31WarningsExact identifier
unii: WK2XYI10QM
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENAmneal Pharmaceuticals LLC17577b3b-e755-45d1-8b53-775d058578b22026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAmazon.com Services LLCb5a47efe-222f-4cbd-b649-caafd16a08292026-07-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHarris Teeter637210f0-6494-4656-8b2b-14d7476cb1272026-07-29WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENHarris Teeter9d5c994a-8363-4ddb-956c-e12b79a32a582026-07-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHarris Teeter87ffbf01-54de-45a8-b2a3-367d219278822026-07-29WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENHarris Teeter14515409-736f-4119-b6a0-cb19ee2e948e2026-07-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHarris Teeter1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc6332026-07-29WarningsExact identifier
unii: WK2XYI10QM
ADVIL PMDIPHENHYDRAMINE HCL, IBUPROFENHaleon US Holdings LLC405afdb4-c157-1d88-f232-848063ba47142026-07-29WarningsExact identifier
unii: WK2XYI10QM
ADVIL COLD AND SINUSIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEHaleon US Holdings LLC0da9ed22-bfb4-d61b-110b-0c7760332a982026-07-29WarningsExact identifier
unii: WK2XYI10QM
ADVIL MIGRAINEIBUPROFENHaleon US Holdings LLCe4a6219d-4ad4-0119-4cf8-7fc39b4b59792026-07-29WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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