FDA.reportPublic FDA data

NDC 68094-037-01 - Childrens 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
68094-037
Requested NDC
68094-037-01
Package NDCs from labels
68094-037-01, 68094-037-58
Manufacturer
Precision Dose Inc.
Effective date
2025-08-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CHILDREN'S IBUPROFEN ORAL SUSPENSIONPrecision Dose Inc.2025-08-01HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-037-01Childrens Ibuprofen5 mL in 1 SYRINGESUSPENSION516
68094-037-58Childrens Ibuprofen50 in 1 CASESUSPENSION5016
68094-037-58Childrens Ibuprofen1 in 1 BAGSUSPENSION116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-037CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]15Legacy NDC, 3 package rows20250226_1984374e-7639-4a4f-bf96-a614e663e0c4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-037-01ML - Milliliter68094-0378955527b-147e-4228-84ca-3b0eead548a712021-07-15
68094-037-58ML - Milliliter68094-03706b90cc6-db86-41a8-bed5-f9dee1093ac512021-07-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QMCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]3
IbuprofenACTIVE MOIETYWK2XYI10QMCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]3
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]3
D&C yellow NO. 10INACTIVE INGREDIENT35SW5USQ3GCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]3
FD&C red NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]3
high fructose corn syrupINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]3
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]3
sorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]3
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]3
xanthan gumINACTIVE INGREDIENTTTV12P4NEECHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.]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 86 · 1,713 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
AdvilIBUPROFENHaleon US Holdings LLC1f01c10a-9434-91a4-2ee4-352315a6b6102026-07-29WarningsExact identifier
unii: WK2XYI10QM
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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