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 68 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DrainageCYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, NUX VOMICA, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, URICUM.Xymogena526f4ac-1630-c122-e053-2995a90a6a272020-05-08WarningsExact identifier
unii: 3Q034RO3BT
Kids ReliefARSENICUM ALBUM, KALI PHOSPHORICUM, MERCURIS SOLUBILIS, NATRUM SULPHURICUM, HEPAR SULPHURIS CALCAREUM, ARUM TRIPHYLLUMHomeolab International (Canada) inc18a6f6d4-cdfd-4bf7-8cb2-831033c1d9652019-10-23WarningsExact identifier
unii: 1MBW07J51Q
Mercurius Combination 9233MERCURIUS COMBINATIONProfessional Complementary Health Formulas42e1d05d-c0ab-48f3-94d2-1a1d3e1d29442019-08-15WarningsExact identifier
unii: 1MBW07J51Q
Acid Reflux ReliefCAPSICUM, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, STRYCHNOS NUX-VOMICA SEED, ROBINIA PSEUDOACACIA BARK, SULFUR, SEPIA OFFICINALIS JUICEHomeocare Laboratories01ddf3ee-e925-404d-9b41-7876d5fd66342019-03-20WarningsExact identifier
unii: 70FD1KFU70
Bladder Irritation and UTICANTHARIS, CLEMATIS, CUBEBA, ECHINACEA, RANUNCULUS BULBOSUS, SABAL SER, STAPHYSAGRIA, UVA URSIHomeoCare Laboratories, Inc.84796173-945d-c70b-e053-2991aa0a4ee12019-03-19WarningsExact identifier
unii: 3Q034RO3BT
Skin Klear Acne ReliefTRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLORHomeocare Laboratories65afbc20-611b-4bc4-a151-c633bec66a822018-12-31WarningsExact identifier
unii: 70FD1KFU70
Sinus ReliefASAFETIDA, ECHINACEA ANGUSTIFOLIA, CALCIUM SULFIDE, POTASSIUM DICHROMATE, LUFFA OPERCULATA WHOLE, SILICON DIOXIDE, SINUSITISINUMHomeocare Laboratories84483171-df92-47de-9203-ed02d64fb5fb2018-12-31WarningsExact identifier
unii: 1MBW07J51Q
Sciatica ReliefARNICA MONTANA FLOWER, BRYONIA ALBA WHOLE, MATRICARIA RECUTITA, PSEUDOGNAPHALIUM LUTEOALBUM LEAF, KALMIA LATIFOLIA LEAF, TOXICODENDRON PUBESCENS LEAF, VISCUM ALBUM LEAFHomeocare Laboratories5fbffd54-0007-4b9b-922f-1c0e450abd552018-12-31WarningsExact identifier
unii: 6IO182RP7A
Blatrol Bladder ReliefLYTTA VESICATORIA, CAUSTICUM, EQUISETUM HYEMALE, CHONDRODENDRON TOMENTOSUM ROOT, SAW PALMETTO, SEPIA OFFICINALIS JUICE, DELPHINIUM STAPHISAGRIA SEEDHomeocare Laboratories1c26c0b6-6623-417f-8317-eaeb923045e92018-12-31WarningsExact identifier
unii: 3Q034RO3BT
Weight GlossSEMECARPUS ANACARDIUM JUICE,ANTIMONY TRISULFIDE,STRYCHNOS IGNATII SEED,BOS TAURUS HYPOTHALAMUS,SULFUR,COCOA.Homeocare Laboratoriesa228735d-5d26-47d2-a001-c9a9692333af2018-12-31WarningsExact identifier
unii: 70FD1KFU70
GUNA-SINUS NOSEALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR - POTASSIUM CARBONATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - SUS SCROFA THYMUS - SUS SCROFA URINARY BLADDER -Guna spa36fef678-17c6-4d2a-a0f0-ddb298611f252018-12-22WarningsExact identifier
unii: 1MBW07J51Q
Rhus Toxicodendron 200CRHUS TOXICODENDRONNatural Creations, Incff7af922-fcac-43a7-9582-fe70ce9862312018-12-21WarningsExact identifier
unii: 6IO182RP7A
ThroatBAPTISIA, PHYTOLACCA, HYDRASTIS, APIS MEL, ARG NIT, BELLADONNA, HEPAR SULPH CALC, KALI BIC, LAC CAN, LACHESIS, MERC SOLUBNatural Creations, Incdf764380-46e2-46fc-9b5b-a2eca71bbfbf2018-12-21WarningsExact identifier
unii: 1MBW07J51Q
ImucodeASTRAGALUS, HYDRASTIS, ADRENALINUM, THYROIDINUM, PITUITARUM POSTERIUM, ARSENICUM ALB, BAPTISIA, BARYTA CARB, BARYTA MUR, BROMIUM, CANDIDA ALB, CEANOTHUS, CHININUM SULPH, CONIUM, HEPAR SULPH CALC, IGNATIA, INDIUM, IODIUM, MERC SOLUB, PHYTOLACCA, SULPHURNatural Creations, Incbe30901c-0673-4af0-8128-83ed59ff04b12018-12-21WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
Runny Nose CPALLIUM CEPA, CALC CARB, FERRUM PHOS, HEPAR SULPH CALC, LYCOPODIUM, MERC SOLUB, PULSATILLA, SILICEA, SULPHURNatural Creations, Inc868ec0ad-9344-4f94-b2c1-2abb48479b152018-12-21WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
Injure GelARNICA MONTANA, CALENDULA OFFICINALIS, HYPERICUM PERF, SYMPHYTUM OFF, BELLIS PER, LEDUM PALUSTRE, SULPHURICUM AC, CALC FLUOR, FERRUM PHOS, RHUS TOX, NAT SULPHURICUMNatural Creations, Inc8893c906-0dab-44ef-956b-b5427d4dbf7f2018-12-21WarningsExact identifier
unii: 6IO182RP7A
Sulphur 30CSULPHURNatural Creations, Inc32c0d686-0732-47b6-9c05-943651d2814f2018-12-21WarningsExact identifier
unii: 70FD1KFU70
GUNA-ALLERGY-PREVAMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -Guna spaadae93c0-1de9-4e45-ab58-148171f0dc862018-12-21WarningsExact identifier
unii: 70FD1KFU70
GUNA-DERMOALDESLEUKIN - ARSENIC TRIOXIDE - ATROPA BELLADONNA - CANAKINUMAB - ECHINACEA ANGUSTIFOLIA - GRAPHITE - MELATONIN - PLANTAGO MAJOR - SOLANUM DULCAMARA FLOWER - SULFUR -Guna spa8bf717eb-fe46-4066-b124-eb715ffc15422018-12-21WarningsExact identifier
unii: 70FD1KFU70
GUNA-ORALACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - SUS SCROFA TOOTH - WITCH HAZEL -Guna spaf1b8e5ab-8689-4bf2-a6d9-863d02f295792018-12-21WarningsExact identifier
unii: 1MBW07J51Q

Reported adverse events (FAERS/openFDA)#

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