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 63 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Talbots Mucus Cold ReliefEUPATORIUM PERF, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MARRUBIUM VULGARE, PHOSPHORUS, PULSATILLA, RUMEX CRISPUS, SAMBUCUS NIGRA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUMTalbot's Pharmaceuticals Family Products, LLC.91c311b2-a22c-0db0-e053-2995a90af3ef2021-10-05WarningsExact identifier
unii: 1MBW07J51Q
SULPHURSULPHURRxhomeo Private Limited d.b.a. Rxhomeo, Inc61a36a56-4e62-4721-81fb-ee8dcd08b4d82021-09-02WarningsExact identifier
unii: 70FD1KFU70
HEPAR SULPHURIS CALCAREUMHEPAR SULPHURIS CALCAREUMRxhomeo Private Limited d.b.a. Rxhomeo, Ince35ab095-c0c3-423a-9ba3-3d26b74bf3222021-09-02WarningsExact identifier
unii: 1MBW07J51Q
CANTHARISCANTHARISRxhomeo Private Limited d.b.a. Rxhomeo, Inc642a1b2d-05cf-4711-b121-487e62eabf622021-09-02WarningsExact identifier
unii: 3Q034RO3BT
RHUS TOXICODENDRONRHUS TOXICODENDRONRxhomeo Private Limited d.b.a. Rxhomeo, Inc05bf00bd-c16a-4631-9b1b-7b683749cff72021-08-16WarningsExact identifier
unii: 6IO182RP7A
FungisodeARSENICUM ALBUM, BERBERIS VULGARIS, CALCAREA CARBONICA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NITRICUM ACIDUM, OXALICUM ACIDUM, SEPIA OFFICINALIS, SULPHURSeroyal USA55c5dfc4-3757-6ac2-e054-00144ff88e882021-07-22WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
HLU PNEUMO DROPSARSENICUM IODATUM, CALCAREA PHOSPHORICA, CARBO VEGETABILIS, ORYCTOLAGUS CUNICULUS LUNG, PHELLANDRIUM AQUATICUM, SILICEA, STANNUM METALLICUM, SULPHUR, THYMUS VULGARISSeroyal USA2f0acce5-aad5-1dd3-e054-00144ff88e882021-07-22WarningsExact identifier
unii: 70FD1KFU70
UNDA 210BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALISSeroyal USA205b68ed-ff41-3559-e054-00144ff88e882021-07-15WarningsExact identifier
unii: 70FD1KFU70
Post - VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.c67b3a39-ef78-5e81-e053-2a95a90a47862021-07-06WarningsExact identifier
unii: 6IO182RP7A
unii: 70FD1KFU70
OHM-INMAACONITUM NAPELLUS, ARANEA DIADEMA, ARNICA MONTANA, ASCLEPIAS VINCETOXICUM, BAPTISIA TINCTORIA, BRYONIA ALBA, ECHINACEA ANGUSTIFOLIA, EQUISETUM HYEMALE, EUPATORIUM PERFORLIATUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, JUGLANS REGIA, PHYTOLACCA DECANDRA, SANGUINARIA CANADENSIS, SARSAPARILLA, SULPHUR, ZINCUM METALLICUMOHM PHARMA INC.bc8e72c7-b7e6-4d5d-bd37-75202244d4402021-03-25WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
OHM-OSTARNICA MONTANA, CALCAREA PHOSPHORICA, CAUSTICUM, CHINA OFFICINALIS, COLCHICUM AUTUMNALE, DULCAMARA, LEDUM PALUSTRE, RHUS TOXICODENDRON, SYMPHYTUM OFFICINALEOHM PHARMA INC.773c7d64-387b-4232-9b4f-93b7ea026efe2021-03-25WarningsExact identifier
unii: 6IO182RP7A
GUNA SINUS PLUSALTHAEA OFFICINALIS LEAF - CALCIUM SULFIDE - COPPER - DRIMIA MARITIMA BULB - ECHINACEA ANGUSTIFOLIA - HYDRASTIS CANADENSIS WHOLE - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR WHOLE - POTASSIUM DICHROMATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA -Guna spab48c5634-24cf-343e-e053-2995a90a3a9a2021-02-17WarningsExact identifier
unii: 1MBW07J51Q
GUNA THROAT AND GUMSACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - WITCH HAZEL -Guna spaba484531-ef7a-17ed-e053-2995a90a50b32021-02-17WarningsExact identifier
unii: 1MBW07J51Q
GUNA KIDNEY PLUSCALCIUM SULFIDE - CHONDRODENDRON TOMENTOSUM ROOT - EQUISETUM HYEMALE - SUS SCROFA PITUITARY GLAND - APIS MELLIFERA - URTICA URENS - SODIUM CHLORIDE - LOBARIA PULMONARIA - HORSE CHESTNUT - BERBERIS VULGARIS FRUIT - SOLIDAGO VIRAGAUREA FLOWERING TOP -Guna spab8dacd94-8da1-4a8d-e053-2995a90acb672021-02-04WarningsExact identifier
unii: 1MBW07J51Q
SODIUM SULFACETAMIDE, SULFURSODIUM SULFACETAMIDE, SULFURKMM Pharmaceuticals, LLCba0fc821-1fc2-20f9-e053-2a95a90ad9772021-01-29Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
AllergyALLIUM SAT, ANACARDIUM, APIS MEL, GAMBOGIA, MERC SOLUB, NAT CARB, NITRICUM AC, NUX VOM, PHOSPHORUS, PULSATILLA, SULPHURNet Remedies0b7129bf-c0de-496c-81f5-286d5ce8d82c2021-01-21WarningsExact identifier
unii: 70FD1KFU70
ER 911ACONITUM NAP, APIS MEL, ARNICA, ARSENICUM ALB, BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, CLEMATIS ERECTA, FERRUM PHOS, HISTAMINUM, HYPERICUM, IGNATIA, IMPATIENS GLAN FLOS, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS CERASIFERA, RHUS TOX, SULPHUR, SYMPHYTUM, VERTARUM ALBNet Remedies9daa0b2f-cfca-4a40-ae88-c38c7cd2db322021-01-21WarningsExact identifier
unii: 6IO182RP7A
unii: 70FD1KFU70
Scars-AdhesionsCALC FLUOR, CAUSTICUM, GRAPHITES, HYDROFLUORICUM AC, LACHESIS, PLUMB MET, RHUS TOX, SEPIA, SILICEA, THIOSINAMINUMNET Remediesb6bae38b-90c3-47bc-9d6f-8ce6640bbedc2021-01-21WarningsExact identifier
unii: 6IO182RP7A
TOTAL PRO-JESADRENAL,BELLADONNA,CHELIDONIUM,DIOSCOREAVILLOSA,FOLLICULINUM,HYPOTHALAMUS,ARGININE,LILIUMTIGRINIUM,LIVER,OOPHORINUM,PINEAL,PITUITARINUM,PLACENTANIUM,PROGESTERONEWhite Manufacturing Inc. BDA Micro-Westb26953f8-7b56-432c-958c-d80c528fbb6a2021-01-21WarningsExact identifier
unii: 70FD1KFU70
Met-ToxARSENICUM ALBUM, AVENA SATIVA,LYCOPODIUM CLAVATUM,NATRUM MURIATICUM,NUX VOMICA,PHYTOLACCA DECANDRARHAMNUS FRANGULA,SOLIDAGO VIRGAUREA,TRIFOLIUM PRATENSE,HEAVY METAL NOSODESwHITE mANUFACTURING INC DBA MICRO-WESTe65db4c2-0bc7-4c50-8f18-b36ee004c4f52021-01-21WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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