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 25 of 40 · 788 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nikzon HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDEGenomma Lab USA8f9a9939-2c99-489f-b597-9a51ec2684f92025-07-14WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Pipette EczemaCOLLOIDAL OATMEALPipette LLC39829827-d801-f5a7-e063-6394a90a024c2025-07-09WarningsExact identifier
unii: 8PI54V663Y
Maximum Strength Hemorrhoidal Cream with AloeGLYCERIN, PHENYLEPHINE HCI, PRAMOXINE HCI, PETROLATUMChain Drug Marketing Association396ea654-8be1-591a-e063-6294a90a11e22025-07-08WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc38cf4e43-280b-eb96-e063-6294a90a59492025-07-02WarningsExact identifier
unii: PDC6A3C0OX
SEFUDUN FUNGAL NAIL PATCHESGLYCERINShenzhen Shandian Jingling Technology Co., Ltd.38db97d6-27c8-da99-e063-6294a90aac662025-07-01WarningsExact identifier
unii: PDC6A3C0OX
Glycerin LaxativeGLYCERIN LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cc266a-196f-16ce-e063-6394a90a24af2025-06-20WarningsExact identifier
unii: PDC6A3C0OX
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
CLn Body MoisturizerCOLLOIDAL OAT MOISTURIZERTopMD Skin Care, Inc.2de3d68d-a540-d456-e063-6394a90a4b572025-06-18WarningsExact identifier
unii: 8PI54V663Y
Sunshine YeastReliefVAGINAL YEAST RELIEFApcco Labs, Inc37de3347-7ad2-b9e7-e063-6394a90a90f42025-06-18WarningsExact identifier
unii: P0M7O4Y7YD
Sunshine HemorrhoidReliefHEMORRHOID SUPPOSITORYApcco Labs, Inc37de3cb4-f31e-0da7-e063-6294a90a78bf2025-06-18WarningsExact identifier
unii: P0M7O4Y7YD
THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal OatmealOATMEALTHERAPLEX, LLCe51aa467-ffe7-4c6b-8588-6df8592596d42025-06-16WarningsExact identifier
rxcui: 240651
unii: 8PI54V663Y
Aveeno Calm Plus Restore Skin Therapy BalmCOLLOIDAL OATMEALKenvue Brands LLCdbe7a2cc-9c21-2a48-e053-2a95a90a54e22025-06-04WarningsExact identifier
rxcui: 240651
unii: 8PI54V663Y
Psoriasis Body WashCOLLOIDAL OATMEALRida LLC4b2bba1b-7e7b-4397-9eb4-d94c44b983142025-06-03WarningsExact identifier
unii: 8PI54V663Y
Code Red Eye Drops MicroGLYCERIN AND NAPHAZOLINE HYDROCHLORIDE4 Trees LLC2a15ea9a-ff67-446b-8b83-6517d25ff38a2025-05-29WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SupreH Bee Venom Skin Tag Treatment LiquidSUPREH BEE VENOM SKIN TAG REMOVER LIQUIDShenzhen Xinxin Yunhai Technology Co., Ltd.35ca9836-917a-b0ac-e063-6294a90a28a22025-05-23WarningsExact identifier
unii: P0M7O4Y7YD
Biotrue Hydration BoostGLYCERINBausch & Lomb Incorporatede2621477-e6ee-4275-ba0a-939dca2550c42025-05-19WarningsExact identifier
unii: PDC6A3C0OX
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.3c4c3e7f-0ef9-4de0-b0bf-97fe7f6a527c2025-05-16WarningsExact identifier
unii: PDC6A3C0OX
FEELSHION Lavender MagnesiumLAVENDER MAGNESIUMBeijing JUNGE Technology Co., Ltd.3513964e-dc5a-ab1e-e063-6294a90a993d2025-05-14WarningsExact identifier
unii: K49155WL9Y

Reported adverse events (FAERS/openFDA)#

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