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 12 of 40 · 788 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hemorrhoid, Fissure, ProctalgiaSuppositoriesCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOLWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1d40d16a-ee52-463a-e063-6394a90a60772026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Anal Care GLO packCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOLWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.26612dae-21a0-6f12-e063-6394a90afe932026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Kenkoderm Eczema Honey Intensive Soothing BalmKENKODERM ECZEMA HONEY INTENSIVE SOOTHING BALMGuangzhou Ariel Biotech Co., Ltd.48652b9c-4063-cc16-e063-6394a90a3b862026-01-14WarningsExact identifier
unii: 8PI54V663Y
Hemorrhoid, Fissure, Proctalgia Relief WashCARBON, PANTHENOL, SODIUM HYALURONATEWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1e20de39-45b0-54ec-e063-6294a90a04ed2026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoid, Fissure, Proctalgia OintmentsCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL, GLYCERINWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1efe43d5-a29b-5cb2-e063-6394a90aca662026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Kenkoderm Eczema Honey Soothing BodyKENKODERM ECZEMA HONEY SOOTHING BODY LOTIONGuangzhou Ariel Biotech Co., Ltd.4865c697-05fc-eac8-e063-6294a90ae5412026-01-14WarningsExact identifier
unii: 8PI54V663Y
Gold Bond Medicated eczema reliefCOLLOIDAL OATMEALChattem, Inc.52744c77-278f-40b1-a356-14ae4366389b2026-01-14WarningsExact identifier
unii: 8PI54V663Y
DERMEDIAL Anti-ItchOATMEAL, ZINC OXIDESaje Natural Business Inc385dd757-740b-8324-e063-6294a90afeee2026-01-13WarningsExact identifier
unii: 8PI54V663Y
ECZEMA HAND RELIEFCOLLOIDAL OATMEALSkinfix, Inc.0389bab7-04fb-7cfc-e063-6394a90a22d82026-01-12WarningsExact identifier
rxcui: 240651
unii: 8PI54V663Y
SKINFIX HAND REPAIROATMEALSkinfix, Inc.1b65fc81-1b9e-4260-829a-332cf6891d022026-01-12WarningsExact identifier
rxcui: 240651
unii: 8PI54V663Y
ECZEMA INTENSIVE DAILY RELIEF BODYCOLLOIDAL OATMEAL CREAMSkinfix, Inc.0be3c631-bc9b-00a9-e063-6394a90abcbb2026-01-12WarningsExact identifier
unii: 8PI54V663Y
SarnaCOLLOIDAL OATMEALCrown Laboratories, Inc.2d6b1872-9f4d-9eb3-e063-6394a90ab6752026-01-12WarningsExact identifier
unii: 8PI54V663Y
Hermon bed sore and pressure sore creamCALENDULA OFFICINALIS1X HPUS 1.5%Beautivity LLC48053402-b6c8-0443-e063-6294a90abce72026-01-10WarningsExact identifier
unii: P0M7O4Y7YD
XIMONTH Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.47f1a711-5d6f-c023-e063-6294a90aa8012026-01-09WarningsExact identifier
unii: ZY81Z83H0X
ST MORIZ SUNCARE BODY SUNSCREEN SPF30SUNCARE BODY SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.48026f09-6d15-8fa6-e063-6294a90a17cb2026-01-09WarningsExact identifier
unii: PDC6A3C0OX
Amalgam 6003AMALGAMProfessional Complementary Health Formulas1af74f69-a23a-45a2-a20e-92bf8b0ccb222026-01-08WarningsExact identifier
unii: TTV12P4NEE
Brain Enhancement Liquescence 3006BRAIN ENHANCEMENT LIQUESCENCEProfessional Complementary Health Formulas33bb2104-c16a-49e4-b292-69e10c1f16c02026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC49a93cfc-4ccd-4ef3-928f-901b9926f7942026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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