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 37 of 71 · 1,411 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-37ALUMINUM OXIDE, BRYONIA ALBA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MERCURIC CHLORIDE, STRYCHNOS NUX-VOMICA SEED, LEAD ACETATE ANHYDROUS, AND SULFURDNA Labs, Inc.3b408532-b84b-4398-ab8d-64d5a9c8d0922025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-68CROTON OIL, DAPHNE MEZEREUM BARK, SODIUM CHLORIDE, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.01ae098b-aadd-4edc-bf73-6bc60903e7792025-01-13WarningsExact identifier
unii: 6IO182RP7A
D-31ARANEUS DIADEMATUS, ARSENIC TRIIODIDE, CEANOTHUS AMERICANUS LEAF, CINCHONA OFFICINALIS BARK, FERRIC CHLORIDE HEXAHYDRATE, LYCOPODIUM CLAVATUM SPORE, AND SULFURDNA Labs, Inc.7405648a-c6f9-4f40-a0b5-7f505becf0432025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-49ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MERCURIC SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, ANEMONE PRATENSIS, SEPIA OFFICINALIS JUICE, AND SULFURDNA Labs, Inc.26800b04-81c7-4094-afe8-4db6ca878f6d2025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-53AMMONIUM BROMIDE, BROMINE, CALCIUM SULFIDE, POTASSIUM BROMIDE, RHODODENDRON TOMENTOSUM LEAFY TWIG, SODIUM BROMIDE, SODIUM CHLORIDE, AND BOS TAURUS PLACENTADNA Labs, Inc.3787d569-ee4d-41de-9519-73c11b626b382025-01-13WarningsExact identifier
unii: 1MBW07J51Q
D-55COMFREY ROOT, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ATROPA BELLADONNA, RUTA GRAVEOLENS FLOWERING TOP, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.1a316983-a023-4174-9aef-9e268a5799c12025-01-13WarningsExact identifier
unii: 6IO182RP7A
D-103ALUMINUM OXIDE, SILVER, GOLD, BERYLLIUM, CADMIUM, COPPER, CALCIUM SULFIDE, MERCURIC SULFATE, MOLYBDENUM, NICKEL, PLANTAGO MAJOR, PLATINUM, LEAD, ANEMONE PRATENSIS, SELENIUM, AND TINDNA Labs, Inc.f4efd03d-3f80-4694-9a02-b71b7e3e3f0d2025-01-13WarningsExact identifier
unii: 1MBW07J51Q
D-107ACTAEA SPICATA ROOT, ARNICA MONTANA, CAULOPHYLLUM THALICTROIDES ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, OXALIC ACID, SEPIA OFFICINALIS JUICE, COLA ACUMINATA SEED, STELLARIA MEDIA, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.e12a693d-cf0b-48d6-9317-a54d146005e02025-01-13WarningsExact identifier
unii: 6IO182RP7A
D-61TOBACCO LEAF, SALIX NIGRA BARK, CAMPHOR (NATURAL), TURPENTINE OIL, BERBERIS VULGARIS ROOT BARK, SOLANUM DULCAMARA WHOLE, STRYCHNOS NUX-VOMICA SEED, RHODODENDRON AUREUM LEAF, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.5582d3d0-cf33-45d8-b3fb-5bf85e15bdfa2025-01-13WarningsExact identifier
unii: 6IO182RP7A
D-102GARLIC, ALOE, MYCOBACTERIUM TUBERCULOSIS, EUCALYPTUS GLOBULUS LEAF, CANIS LUPUS FAMILIARIS MILK, COW MILK, RANCID BEEF, DELPHINIUM STAPHISAGRIA SEED, STAPHYLOCOCCUS EPIDERMIDIS, STAPHYLOCOCCUS HAEMOLYTICUS, STAPHYLOCOCCUS SIMULANS, STREPTOCOCCUS PYOGENES, AND SULFURDNA Labs, Inc.d64022f6-e3e1-459b-b896-843c2a92d9da2025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-118TOXICODENDRON PUBESCENS LEAF, PUNICA GRANATUM ROOT BARK, ARISAEMA TRIPHYLLUM ROOT, AND KEROSENEDNA Labs, Inc.697add39-8767-43cd-bcd1-16a961160f702025-01-13WarningsExact identifier
unii: 6IO182RP7A
D-84MILK THISTLE, BOS TAURUS BILE, SULFUR, THALLOUS ACETATE, AND ACTIVATED CHARCOALDNA Labs, Inc.d33c34b1-6121-4875-8974-f074d88f212f2025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-120CALCIUM FLUORIDE, BISMUTH SUBNITRATE, ZINC, MERCURIC CHLORIDE, TOXICODENDRON PUBESCENS LEAF, ANTIMONY TRISULFIDE, BARIUM CARBONATE, ECHINACEA ANGUSTIFOLIA, IODINE, PHOSPHORIC ACID, POTASSIUM CARBONATE, DIBASIC POTASSIUM PHOSPHATE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.9525c016-f0dd-43fd-a4e9-062075107eec2025-01-13WarningsExact identifier
unii: 6IO182RP7A
D-105BOS TAURUS ADRENAL GLAND, APIS MELLIFERA, ARSENIC TRIOXIDE, LYTTA VESICATORIA, BOS TAURUS LYMPH VESSEL, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, URTICA URENS, PYRIDOXINE HYDROCHLORIDE, AND ASCORBIC ACIDDNA Labs, Inc.1535cb47-b155-4ac4-af7d-b22ac83254032025-01-13WarningsExact identifier
unii: 3Q034RO3BT
unii: 6IO182RP7A
D-137APIS MELLIFERA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, ATROPA BELLADONNA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, CALCIUM SULFIDE, RANCID BEEF, SULFUR, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.240d03c0-957b-48e4-9bab-43f9e6b8fb422025-01-13WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
D-154ANAMIRTA COCCULUS, ARABICA COFFEE BEAN, ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITE, NUX VOMICA, PHOSPHORUS, POTASSIUM CARBONATE, SULFURDNA Labsf53e05de-043c-4eb4-e053-2995a90ad9cf2025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-115CAUSTICUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, IODINE, ARSENIC TRIOXIDE, BARIUM CARBONATE, ECHINACEA ANGUSTIFOLIA, ALUMINUM, ANTIMONY TRISULFIDE, STRYCHNOS NUX-VOMICA SEED, DELPHINIUM STAPHISAGRIA SEED, SULFURIC ACID, CALCIUM SULFIDE, AND SILVER NITRATEDNA Labs, Inc.247a9133-fe4b-42a0-b3f3-7cb62eaec8c42025-01-13WarningsExact identifier
unii: 1MBW07J51Q
D-152ARSENIC TRIOXIDE, STRYCHNOS NUX-VOMICA SEED, ACONITUM NAPELLUS, GOLD, CAUSTICUM, HYOSCYAMUS NIGER LEAF, LACHESIS MUTA WHOLE, DAPHNE MEZEREUM WHOLE, ANEMONE PULSATILLA, SULFUR, AND VERATRUM VIRIDE WHOLEDNA Labs, Inc.e8968153-24c0-474d-8f4d-493481f442062025-01-13WarningsExact identifier
unii: 70FD1KFU70
EradiKate ACNE TREATMENTSULFURKate Somerville Skincare, LLC713093d9-29c3-44c9-b90f-ee7448c5063e2025-01-12WarningsExact identifier
unii: 70FD1KFU70
EradiKate Daily Foaming Cleanser Acne TreatmentSULFURKate Somerville Skincare, LLCbebe3042-b80c-41ca-b8df-48093573c0822025-01-12WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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