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 66 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne - Cystic AcneECHINACEA, JUGLANS REGIA, LAPPA MAJOR, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, AURUM METALLICUM, BERBERIS AQUIFOLIUM, BOVISTA, CARBO VEGETABILIS, CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, LEDUM PALUSTRE, LYCOPDIUM CLAVATUM, NUX VOMICA, SULPHUR IODATUM, ZINCUM METALLICUM, SILICEANewton Laboratories, Inc92afe017-74c7-16c6-e053-2995a90a5c7d2020-12-02WarningsExact identifier
unii: 1MBW07J51Q
Appetite - Craving ControlCHAMOMILLA, PASSIFLORA, VALERIANA, ANACARDIUM, ANTIMON. CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJ., DIGITALIS, GRAPHITES, HUMULUS, IRIS VERS., KALI CARB., LYCOPODIUM, NAT. CARB., NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS TOX., SCUTELLARIA, SEPIA, STRAMONIUMNewton Laboratories, Inc.98cf5293-2a47-5e15-e053-2995a90a9c3b2020-12-02WarningsExact identifier
unii: 6IO182RP7A
Bact-InECHINACEA, HYDRASTIS CANADENSIS, IRIS VERSICOLOR, URTICA URENS, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, HYDRASTIS CANADENSIS, IODIUM, LACHESIS MUTUS, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, ANTHRACINUM, PYROGENIUMNewton Laboratories, Inc.9a9f61c8-1913-1e6d-e053-2a95a90a83562020-12-02WarningsExact identifier
unii: 6IO182RP7A
Blad-RAPIS MEL., BERBER. VULG., BRYONIA, CANTHARIS, CINCHONA, EQUISETUM HYEMALE, FERRUM PHOSPHORICUM, GELSEMIUM, JUNIPERUS COM., PAREIRA, PHOSPHORUS, PLANTAGO, PULSATILLA, SABAL, TEREBINTHINA, UVA-URSI, ECHINACEA, HYDRASTIS, LAPPA, SOLIDAGONewton Laboratories, Inc.98cf954f-4b9e-c4ce-e053-2995a90a31d22020-12-02WarningsExact identifier
unii: 3Q034RO3BT
BronCareECHINACEA, LAPPA, RUMEX CRISP., ANTIMON. TART., ARSENICUM ALB., BRYONIA, CAMPHORA, CHELIDONIUM MAJ., CINCHONA, DROSERA, EUCALYPTUS, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, IPECAC., KALI BIC., KALI CARB., KALI IOD., LYCOPODIUM, MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOS., PULSATILLA, SAINGUINARIA, SPONGIA, STANNUM MET., TUSSILAGO FAR., VERBASCUM, INFLUENZINUMNewton Laboratories, Inc.98d0c6e4-5825-0361-e053-2a95a90aaddd2020-12-02WarningsExact identifier
unii: 1MBW07J51Q
DiabaseCYNARA, ECHINACEA, IRIS VERS., THUJA OCC., URTICA UR., ARG. MET., ARSENICUM ALB., AUR. MET., BOVISTA, BRYONIA, CHELIDONIUM MAJ., CHIONANTHUS, GAULTHERIA, HELONIAS, IRIS VERS., LYCOPODIUM, NUX VOM., PHOS., RHUS TOX., SABAL, SYZYGIUMNewton Laboratories, Inc.9948bd7a-2ca2-272c-e053-2a95a90a4dc02020-12-02WarningsExact identifier
unii: 6IO182RP7A
DrainerCYNARA 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.Newton Laboratories, Inc.9a008b9f-5db5-fac0-e053-2995a90a17c62020-12-02WarningsExact identifier
unii: 3Q034RO3BT
Eczema - Skin CareANTIMON. CRUD., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SEPIA, SULPHUR IOD., ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.Newton Laboratories, Inc.98fb65dc-6c97-3b9d-e053-2995a90ade262020-12-02WarningsExact identifier
unii: 3Q034RO3BT
unii: 6IO182RP7A
unii: 1MBW07J51Q
Thyroid-AdrenalADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEANewton Laboratories, Inc.b56f2ffc-4637-1f23-e053-2a95a90aa3af2020-12-01WarningsExact identifier
unii: 6IO182RP7A
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9aefc830-329c-5e35-e053-2a95a90a6ffe2020-11-30WarningsExact identifier
unii: 6IO182RP7A
unii: 70FD1KFU70
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9af2d6f4-baa8-5da9-e053-2995a90a3dac2020-11-30WarningsExact identifier
unii: 6IO182RP7A
unii: 70FD1KFU70
Hair-ScalpAPIS MEL., ARSENICUM ALB., CALC. CARB., DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDRASTIS, HYDROFLUORICUM ACIDUM, KALI CARB., LYCOPODIUM, MEZEREUM, OLEANDER, PETROLEUM, PHOSPHORICUM AC., PHOSPHORUS, RHUS TOXICODENDRON, SELENIUM, SEPIA, SILICEA, SULPHUR, THUJA OCC.Newton Laboratories, Inc.9ab3b944-443c-74a1-e053-2a95a90aa0e52020-11-30WarningsExact identifier
unii: 6IO182RP7A
unii: 70FD1KFU70
unii: 1MBW07J51Q
Fatigue FighterACONITUM NAP., ADRENALINUM, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., BAPTISIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA, IODIUM, KALI CARB., KALI IOD., LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABAL, THYROIDINUM, ECHINACEA, GINGKO, PHYTOLACCA.Newton Laboratories, Inc.9aa3c692-fbe0-debe-e053-2995a90add502020-11-25WarningsExact identifier
unii: 3Q034RO3BT
unii: 6IO182RP7A
Eye CareACONITUM NAP., ALLIUM CEPA, ARSENICUM ALB., BRYONIA, CALENDULA, CHELIDONIUM MAJUS, CINERARIA, EUPHRASIA, GRAPHITES, LYCOPODIUM, MERC. CORROS., NUX VOM., PHOSPHORUS, PHYTOLACCA, PICRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SULPHUR, ECHINACEANewton Laboratories, Inc.924e15f1-92af-7fc9-e053-2995a90a1fcc2020-11-25WarningsExact identifier
unii: 6IO182RP7A
unii: 70FD1KFU70
Eye CareACONITUM NAP., ALLIUM CEPA, ARSENICUM ALB., BRYONIA, CALENDULA, CHELIDONIUM MAJUS, CINERARIA, EUPHRASIA, GRAPHITES, LYCOPODIUM, MERC. CORROS., NUX VOM., PHOSPHORUS, PHYTOLACCA, PICRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SULPHUR, ECHINACEANewton Laboratories, Inc.924e562a-d9ae-5cae-e053-2995a90ace382020-11-25WarningsExact identifier
unii: 6IO182RP7A
unii: 70FD1KFU70
Fatigue FighterACONITUM NAP., ADRENALINUM, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., BAPTISIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA, IODIUM, KALI CARB., KALI IOD., LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABAL, THYROIDINUM, ECHINACEA, GINGKO, PHYTOLACCA.Newton Laboratories, Inc.9ab1c9ba-a90e-7f55-e053-2a95a90a94512020-11-25WarningsExact identifier
unii: 3Q034RO3BT
unii: 6IO182RP7A
Feminine ComfortAGARICUS MUSC., ARSENICUM ALB., AUR. MET., BERBER. AQUI., CALADIUM SEGUINUM, CANDIDA ALBICANS, CANTHARIS, CONIUM, GRAPHITES, HELONIAS DIOICA, HYDRASTIS, KALI CARB., KREOSOTUM, LYCOPODIUM, MERC. VIV., MUREX PURPUREA, NAT. MUR., NITRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SEPIA, SULPHUR, TARENTULA HISPANA, THUJA OCC., ZINC. MET., APIS MEL., HAMAMELISNewton Laboratories, Inc.9ab4520d-1dd3-7b9f-e053-2a95a90a274f2020-11-25WarningsExact identifier
unii: 3Q034RO3BT
unii: 6IO182RP7A
unii: 70FD1KFU70
Eczema - Skin CareANTIMON. CRUD., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SEPIA, SULPHUR IOD., ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.Newton Laboratories, Inc.91d5a49e-3994-39ec-e053-2a95a90ac6902020-11-25WarningsExact identifier
unii: 3Q034RO3BT
unii: 6IO182RP7A
unii: 1MBW07J51Q
Aches - PainsACONITUM NAP., ARG. NIT., ARNICA, BRYONIA, COLCHICUM, GUAIACUM, HYPERICUM, KALMIA, PHOSPHORUS, PHYTOLACCA, PULSATILLA, RHUS TOXICODENDRON, RUTA, SARCOLACTICUM AC., STICTA, STRAMONIUM, HAMAMELIS, TARAXACUM,Newton Laboratories, Inc.7923c9ad-6078-f496-e053-2991aa0a15c42020-11-24WarningsExact identifier
unii: 6IO182RP7A
Accident - Injury RescueACONITUM NAP, ARNICA, BELLIS, CALENDULA, ECHINACEA, GELSEMIUM, HAMAMELIS, HYPERICUM, LEDUM, PHOSPHORUS, RHUS TOXICODENDRON, RUTA, STAPHYSAG., SYMPHYTUM, HYDRASTIS CANADENSIS.Newton Laboratories, Inc.785fd0ec-efe7-790e-e053-2991aa0afd912020-11-24WarningsExact identifier
unii: 6IO182RP7A

Reported adverse events (FAERS/openFDA)#

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