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 17 of 40 · 788 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foot CareCALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OILSpry Life LLC480e32e4-42d1-606c-e054-00144ff8d46c2025-12-15WarningsExact identifier
unii: DG4F8T839X
unii: P0M7O4Y7YD
Citrus Zest Lip BalmCALENDULA OFFICIALS FLOWERSSpry Life LLC48c02d94-faad-110c-e054-00144ff8d46c2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Free to BreatheCALENDULA, EUCALYPTUS,PEPPERMINTSpry Life LLC8d437d62-2cbc-5b17-e053-2a95a90ad5cb2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Belly BalmROSEHIP SEED OILSpry Life LLC7c03ade4-7e84-7f5e-e053-2a91aa0a6fd22025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Poison Ivy CareCALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OILSpry Life LLC480ee4ba-a92c-07ee-e054-00144ff8d46c2025-12-15WarningsExact identifier
unii: DG4F8T839X
unii: P0M7O4Y7YD
Dry Skin CareCALENDULA OFFICIALS FLOWERS, CHAMOLLIA RECUTITA FLOWERS, VIOLA TRICOLOR LEAF, SAMBUCUS NIGRA FLOWERS, TRIFOLIUM PRATENSE FLOWERS, ARCHILLEA MILLEFOLIUMSpry Life LLC48329ee2-d8df-2179-e054-00144ff8d46c2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Sweet Honey Lip BalmZINC OXIDE, CALENDULA OFFICIALS FLOWERSSpry Life LLC48c1c11d-296b-5e48-e054-00144ff8d46c2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Baby BalmCALENDULA OFFICINALIS, CHAMOMILLA RECUTITA, ARCHILLEA MILLEFOLIUM, SYMPHYTUM OFFICINALIS, HELIANTHUS ANNUUSSpry Life LLC48313e43-245f-5257-e054-00144ff8d46c2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Eczema Face and Body WashCALENDULA, YARROW, CHAMOMILE, ELDERSpry Life LLCe068aedb-04b7-1c17-e053-2995a90a4fcc2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Acne Face WashCALENDULA, YARROW, CHAMOMILESpry Life LLCdbd6d26d-ceb5-c214-e053-2a95a90a70c22025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Hydrating Face WashCALENDULASpry Life LLCe0648212-f843-902a-e053-2995a90a5e5d2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
SalvacineCALENDULA OFFICIALS, PLANTAGO MAJOR, OLEA EUROPAEA, ACHILLEA MILLEFOLIUMSpry Life LLCe76594d6-7397-5d57-e053-2a95a90a99af2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Tattoo CareCALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OILSpry Life LLC480f0858-1f69-057c-e054-00144ff88e882025-12-15WarningsExact identifier
unii: DG4F8T839X
unii: P0M7O4Y7YD
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: PDC6A3C0OX
Prequel Barrier Therapy Rich Skin Protectant CreamSKIN PROTECTANT CREAMThe Center Brands, LLC39945806-8f29-020b-e063-6294a90a9fc62025-12-13WarningsExact identifier
unii: 8PI54V663Y
ElixirLidoFast Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEELIXIR HEALTHCARE USA, LLC.45de9dfa-6c89-1eae-e063-6294a90a4dac2025-12-13WarningsExact identifier
unii: PDC6A3C0OX
ECZEMACOLLOIDAL OATMEALSmith Amish, LLC20c4bc16-ba20-47ec-e063-6394a90a8b4e2025-12-12WarningsExact identifier
unii: 8PI54V663Y
Kroger HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLKroger Company45b2dd86-7fb0-07bf-e063-6394a90a18842025-12-11WarningsExact identifier
unii: PDC6A3C0OX
AL0043600 Alba Botanica VE Herbal Healing BodyCOLLOIDAL OATMEALThe Hain Celestial Group, Inc.60672feb-141f-651e-e053-2a91aa0af41d2025-12-10WarningsExact identifier
unii: 8PI54V663Y
Soteri Skin Baby Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc41d88ff2-22aa-8447-e063-6294a90aea0e2025-12-10WarningsExact identifier
unii: 8PI54V663Y

Reported adverse events (FAERS/openFDA)#

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