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 9 of 40 · 788 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LMNOOP Wound CareWOUND CARE OINTMENTHunan Xiong Shi Pharmaceutical Co., Ltd193009cf-02bd-a187-e063-6294a90a5d752026-02-13WarningsExact identifier
unii: P0M7O4Y7YD
LMNOOP Seborrheic Dermatitis TreatmentLMNOOP SEBORRHEIC DERMATITIS TREATMENTShenzhen Ishan Technology Co., Ltd1a0eb78f-e915-b4fe-e063-6394a90a7fe02026-02-13WarningsExact identifier
unii: 8PI54V663Y
ishancare wound careISHANCARE WOUND CARE OINTMENTHunan Xiong Shi Pharmaceutical Co., Ltd1aed8fef-e456-e6b6-e063-6294a90a57872026-02-13WarningsExact identifier
unii: P0M7O4Y7YD
LMNOOP Urticaria CreamLMNOOP URTICARIA CREAMShenzhen Ishan Technology Co., Ltd1a1d92c5-f59f-667c-e063-6294a90ae2bf2026-02-13WarningsExact identifier
unii: 8PI54V663Y
LMNOOP Wound CareWOUND CARE OINTMENTHunan Xiong Shi Pharmaceutical Co., Ltd8f096f20-b5b6-4b6c-e053-2a95a90a5cc42026-02-13WarningsExact identifier
unii: P0M7O4Y7YD
ishancare bed and pressure soreISHANCARE BED AND PRESSURE SOREHunan Xiong Shi Pharmaceutical Co., Ltde8a28671-194a-69b5-e053-2995a90a49ab2026-02-13WarningsExact identifier
unii: P0M7O4Y7YD
iShancare Diabetic Wounds and Sores CreamISHANCARE DIABETIC WOUND AND SORES CREAMHunan Xiong Shi Pharmaceutical Co., Ltd19bb986c-7797-9542-e063-6394a90a97542026-02-13WarningsExact identifier
unii: P0M7O4Y7YD
perianal careLMNOOP PERIANAL CARE OINTMENTHunan Xiong Shi Pharmaceutical Co., Ltd192ee5a6-0023-71a1-e063-6294a90ab1232026-02-13WarningsExact identifier
unii: P0M7O4Y7YD
LMNOOP Tinea TreatmentLMNOOP TINEA TREATMENTShenzhen Ishan Technology Co., Ltd1d1bfa7c-19af-ced6-e063-6394a90aa2f72026-02-13WarningsExact identifier
unii: 8PI54V663Y
LMNOOP Jock Itch CreamLMNOOP JOCK ITCH CREAMShenzhen Ishan Technology Co., Ltd1d1bf590-76d2-bca1-e063-6294a90ab9b02026-02-13WarningsExact identifier
unii: 8PI54V663Y
iShancare Folliculitis CreamFOLLICULITIS CREAMShenzhen Ishan Technology Co., Ltd0c85c8e9-f50f-1b72-e063-6394a90a88c42026-02-13WarningsExact identifier
unii: 8PI54V663Y
iShanCare Jock Itch TreatmentISHANCARE JOCK ITCH TREATMENTShenzhen Ishan Technology Co., Ltd1d1c2951-a786-3ef1-e063-6294a90a50962026-02-13WarningsExact identifier
unii: 8PI54V663Y
Baby Eczema TherapyCOLLOIDAL OATMEALTopco Associates LLC4f6af42c-f41e-455f-b94b-3793bf0b9a3f2026-02-13Warnings, Adverse reactionsExact identifier
unii: 8PI54V663Y
BM CalendulaCALENDULA OFFICINALISBM Private Limited388ca53f-be13-b8d1-e063-6294a90a12342026-02-12WarningsExact identifier
unii: ZY81Z83H0X
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
HOMWIS Eczame Relief CreamECZAME RELIEF CREAMShenzhen Ishan Technology Co., Ltd3653bef6-b3a3-75bb-e063-6294a90a02eb2026-02-12WarningsExact identifier
unii: 8PI54V663Y
LMNOOP Vaginal Antifungal CreamLMNOOP VAGINAL ANTIFUNGAL CREAMShenzhen Ishan Technology Co., Ltd24cdc8e9-837c-0e6b-e063-6394a90ac3322026-02-12WarningsExact identifier
unii: 8PI54V663Y
Natouch Eczema WipesECZEMA WIPESNatouch LLC0a9756a4-2fa9-cd19-e063-6294a90a93ad2026-02-10WarningsExact identifier
unii: 8PI54V663Y
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX
EARTHS CARE Eczema CreamECZEMADLC Laboratories, Inc.17436fa0-d6c7-1052-e063-6294a90adae42026-02-09WarningsExact identifier
unii: 8PI54V663Y

Reported adverse events (FAERS/openFDA)#

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