FDA.reportPublic FDA data

NDC 42957-002-01 - BabySpa Calming Relief Eczema

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
42957-002
Requested NDC
42957-002-01
Package NDCs from labels
42957-002-01, 42957-002-02, 42957-002-03
Manufacturer
Expro3, LLC | EL Erman Manufacturing, Ltd.
Effective date
2013-03-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BabySpa Calming Relief Eczema - Expro3, LLC | EL Erman Manufacturing, Ltd.Expro3, LLC | EL Erman Manufacturing, Ltd.2013-03-07HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42957-002-022019-11-27C16284748780-19855d018-da21-cd31-e053-dbdaa90ab51a4999358e-e799-4267-9a0f-336a948d9d87
42957-002-032019-11-27C16284748780-19855d018-da21-cd31-e053-dbdaa90ab51a4999358e-e799-4267-9a0f-336a948d9d87

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42957-002-01BabySpa Calming Relief Eczema125 g in 1 TUBECREAM1251
42957-002-02BabySpa Calming Relief Eczema1 in 1 BOXCREAM11
42957-002-03BabySpa Calming Relief Eczema4 g in 1 POUCHCREAM41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42957-002BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1Legacy NDC, 3 package rows20130325_4999358e-e799-4267-9a0f-336a948d9d87.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OATMEALACTIVE INGREDIENT8PI54V663YBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1
OATMEALACTIVE MOIETY8PI54V663YBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1
CHAMAEMELUM NOBILE FLOWERINACTIVE INGREDIENTO2T154T6OGBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839XBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEBABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]1

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 24 of 40 · 788 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OKeeffes Skin Repair Body Cream Eczema ReliefCOLLOIDAL OATMEALThe Gorilla Glue Company/O'Keeffe's Company39e9ca98-d0e6-6b8f-e063-6394a90aa3662025-09-01WarningsExact identifier
unii: 8PI54V663Y
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Foaming Facial CleanserGLYCERIN, NIACINAMIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd396c1db9-a5d3-cc82-e063-6294a90a90bb2025-08-23WarningsExact identifier
unii: PDC6A3C0OX
Refresh RELIEVA PFCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.d5d3df4a-a311-4f2d-9a24-edfec1a6c9f92025-08-22WarningsExact identifier
unii: PDC6A3C0OX
Refresh OptiveCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.37e99aa8-02d6-4efb-a862-90bc7fcd5ca52025-08-22WarningsExact identifier
unii: PDC6A3C0OX
Upside Down Pain ReliefBENZOCAINE, GLYCERINFridababy, LLC31c2cd25-1fec-5ec5-e063-6394a90a24b42025-08-15WarningsExact identifier
unii: PDC6A3C0OX
SmoflipidSMOFLIPIDFresenius Kabi USA, LLCe0e9d917-ff6f-488e-a6a8-0ad59dd17d802025-08-15Warnings, Adverse reactionsExact identifier
unii: C9H2L21V7U
Earth Mama Eczema CreamCOLLOIDAL OATMEALEarth Mama Angel Baby, LLCbd30b525-f68c-4786-9fbc-745e2634c6bb2025-08-12WarningsExact identifier
unii: 8PI54V663Y
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
unii: PDC6A3C0OX
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINUnimed3bcd8394-f486-d306-e063-6294a90a4e9a2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINKC Pharmaceuticals, Inc.3bc03d54-6b31-5921-e063-6294a90af5992025-08-01WarningsExact identifier
unii: PDC6A3C0OX
Aveeno Baby Eczema Therapy Soothing Bath TreatmentOATMEALKenvue Brands LLCe7eb10b7-3950-49cb-ba73-11e7581b6be92025-07-25WarningsExact identifier
unii: 8PI54V663Y
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
unii: PDC6A3C0OX
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
unii: PDC6A3C0OX
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
unii: PDC6A3C0OX
Mountain Ice EczemaCOLLOIDAL OATMEALMountainside Medical Equipment, Inc.1a91f33e-dd85-4d5a-b61c-e460a507e2922025-07-21WarningsExact identifier
rxcui: 240651
unii: 8PI54V663Y
Our Eczema RemedyCOLLOIDAL OATMEALFewer Better Things3a755b4c-47c8-9ca5-e063-6394a90af84a2025-07-21WarningsExact identifier
unii: 8PI54V663Y
GoodSense Hemorrhoidal Pain ReliefGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPerrigo Direct, Inc2e5f699d-45e8-6451-e063-6394a90a8ad82025-07-20WarningsExact identifier
unii: PDC6A3C0OX
SilkTearsGLYCERIN OPHTHALMIC SOLUTIONSilkTears3866e2c1-051b-0b01-e063-6394a90af5cf2025-07-16WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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