FDA.reportPublic FDA data

NDC 64616-047-01 - Bye Bye Diaper Rash

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
64616-047
Requested NDC
64616-047-01
Package NDCs from labels
64616-047-01, 64616-047-02
Manufacturer
Vitality Works, Inc.
Effective date
2017-12-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bye Bye Diaper RashVitality Works, Inc.2017-12-04HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64616-047-022021-01-29C16284748780-1ba0f9c33-18a1-a910-e053-dadaa90a0b85Bye Bye Diaper Rash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-047-01Bye Bye Diaper Rash59 mL in 1 BOTTLE, SPRAYLIQUID593
64616-047-02Bye Bye Diaper Rash1 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-047BYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]3Legacy NDC, 2 package rows20171207_7d699efc-9aac-43f3-8b06-74520e7f0984.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51QBYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BTBYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
SULFURACTIVE INGREDIENT70FD1KFU70BYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7ABYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
CALCIUM SULFIDEACTIVE MOIETY1MBW07J51QBYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BTBYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
SULFURACTIVE MOIETY70FD1KFU70BYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7ABYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1BYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LBYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EBYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
SHARK LIVER OILINACTIVE INGREDIENT4B24275HEUBYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2

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 49 of 71 · 1,411 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Skin InfectionsECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HEPAR SULPHURIS CALCAREUM, MERCURIUS SOLUBILIS, MEZEREUM, AILANTHUS GLANDULOSUS, ARSENICUM ALBUM, LACHESIS MUTUS, HERPES SIMPLEX I AND II NOSODE, HERPES ZOSTER NOSODEDeseret Biologials, Inc.43eb02e6-723c-4ab5-81cf-4ab18da8d3ea2024-02-02WarningsExact identifier
unii: 1MBW07J51Q
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.34b2924f-d220-4344-8cdd-e7dda54061c22024-02-02WarningsExact identifier
unii: H4N855PNZ1
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.768502e2-541f-4de8-ac68-3ab47c1f436d2024-02-01WarningsExact identifier
unii: H4N855PNZ1
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.3d5fbe3a-a95b-4688-a96e-b34e6e1e868a2024-02-01WarningsExact identifier
unii: H4N855PNZ1
Rhus ToxicodendronTOXICODENDRON PUBESCENS LEAFSEVENE USA6c54293b-7b4c-46d9-a3e2-bf308549481c2024-01-30WarningsExact identifier
unii: 6IO182RP7A
SULPHURSULFURSEVENE USAa727addd-575c-4c46-ad1d-cd9f8d11152d2024-01-30WarningsExact identifier
unii: 70FD1KFU70
Calm Eczema Therapy WashSULPHUR 12XKamedis38a3495e-6872-4cb8-bab7-1c93e1470e2c2024-01-30WarningsExact identifier
unii: 70FD1KFU70
Hepar Sulphuris Calcareum 30cCALCIUM SULFIDESEVENE USAfdf6a2c6-28d6-43ca-9b1f-05169de6bbd72024-01-29WarningsExact identifier
unii: 1MBW07J51Q
SULFACETAMIDE SODIUM, SULFURSULFACETAMIDE SODIUM, SULFURCintex Services, LLC0d1efaac-d62b-41b9-e063-6394a90a94ad2024-01-23Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SULFACETAMIDE SODIUM, SULFURSULFACETAMIDE SODIUM, SULFURCintex Services, LLC0d1f8666-95ff-7844-e063-6394a90af4122024-01-23Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SULFACETAMIDE SODIUM, SULFURSULFACETAMIDE SODIUM, SULFURCintex Services, LLC0e128306-1357-daad-e063-6294a90a760a2024-01-23Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SULFACETAMIDE SODIUM, SULFURSULFACETAMIDE SODIUM, SULFURCintex Services, LLC0fa2c52d-5d4a-4b83-e063-6394a90a54062024-01-23Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
MenotoneANGELICA ARCHANGELICA, CIMICIFUGA RACEMOSA, BELLADONNA, LACHESIS MUTUS, PULSATILLA (PRATENSIS), SABINA, SANGUINARIA CANADENSIS, SEPIA, SULPHUREnergique, Inc.0921be57-44b4-4d1c-a50a-7886fc807d002024-01-23WarningsExact identifier
unii: 70FD1KFU70
Derma Rash HPARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITES, MERCURIUS SOLUBILIS, MEZEREUM, PETROLEUM, RHUS TOX, SEPIA, SULPHUREnergique, Inc.7d3b8655-f1f3-4389-8c0d-7e4fb0b004342024-01-23WarningsExact identifier
unii: 6IO182RP7A
unii: 70FD1KFU70
DERMA SCALE HPARSENICUM IODATUM, BORAX, GRAPHITES, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PETROLEUM, SEPIA, SULPHUREnergique, Inc.64961787-7e9a-4e6f-98ce-0f51934155cf2024-01-23WarningsExact identifier
unii: 70FD1KFU70
Detox ComplexCARDUUS MARIANUS, CYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA (ALBA), CANTHARIS, CARDUUS BENEDICTUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, NUX VOMICA, PTELEA TRIFOLIATA, URICUM ACIDUMHealth Masters LLCef0a4a08-8522-45b0-bb21-7c6845f68a182024-01-22WarningsExact identifier
unii: 3Q034RO3BT
Energy ComplexECHINACEA (ANGUSTIFOLIA), LAPPA MAJOR, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ADRENALINUM, ALOE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, BRYONIA (ALBA), CHELIDONIUM MAJUS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, FERRUM METALLICUM, GLONOINUM, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, IODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, RHUS TOX, RUTA GRAVEOLENS, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Health Masters LLC9286ca29-8190-4867-9231-b0d68180cb102024-01-22WarningsExact identifier
unii: 6IO182RP7A
Naturasil Mite B GoneSULFURNature's Innovation, Inc.d15c2ac6-f323-41af-adfe-f4c88427ffdb2024-01-18WarningsExact identifier
unii: 70FD1KFU70
D1 Organ SupportCARDUUS MARIANUS, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, TARAXACUM OFFICINALE, AVENA SATIVA, CYNARA SCOLYMUS, METHYLCOBALAMIN, MENADIONE, ALPHA-LIPOICUM ACIDUM, CINCHONA OFFICINALIS, HEPAR SUIS, VERATRUM ALBUM, COLON (SUIS), DUODENUM (SUIS), GALLBLADDER (SUIS), INTESTINE (SUIS), LYMPH NODE (SUIS), PANCREAS SUIS, THYMUS (SUIS), THYMUS (SUIS), ALPHA-KETOGLUTARICUM ACIDUM, CHOLESTERINUM, FORMICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, MALICUM ACIDUM, NATRUM OXALACETICUM, SULPHUR, CALCAREA CARBONICA,Dr. Donna Restivo DCe295c5a0-82ca-4fe9-a2e2-9407d81b780e2024-01-18WarningsExact identifier
unii: 70FD1KFU70
D3 Organ SupportDULCAMARA, ECHINACEA (ANGUSTIFOLIA), AESCULUS HIPPOCASTANUM, ANTIMONIUM TARTARICUM, ASCORBICUM ACIDUM, COCCUS CACTI, GALIUM APARINE, GENTIANA LUTEA, GERANIUM ROBERTIANUM, PULSATILLA (PRATENSIS), SARCOLACTICUM ACIDUM, CONIUM MACULATUM, LYMPH NODE (SUIS), SULPHUR, GLANDULA SUPRARENALIS SUIS, L-PHENYLALANINE, CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, HEPAR SUIS, HYPOTHALAMUS SUIS, SPLEEN (SUIS), CORTISONE ACETICUM, MERCURIUS SOLUBILIS, BARYTA CARBONICA, GLYPHOSATE, FUNICULUS UMBILICALIS SUIS, TONSIL (SUIS),Dr. Donna Restivo DC8ad3b8b7-a946-44a5-9d92-aaaf411e7bab2024-01-18WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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