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 36 of 71 · 1,411 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Acne Natural Volcanic SulfurSULFURPT. GALENIUM PHARMASIA LABORATORIESa19ac01b-950a-4ddb-9711-17f15bdb40132025-01-23WarningsExact identifier
unii: 70FD1KFU70
Anti Acne Natural Volcanic SulfurSULFURPT. GALENIUM PHARMASIA LABORATORIES4f230abd-5c07-4121-81da-a9fa2d20a2ca2025-01-23WarningsExact identifier
unii: 70FD1KFU70
Uva ursi comp.UVA URSI COMP.Uriel Pharmacy, Inc2c280a05-da87-0480-e063-6294a90a95022025-01-20WarningsExact identifier
unii: 3Q034RO3BT
MetoxALLIUM SATIVUM, ARSENICUM ALBUM, ASCORBICUM ACIDUM, BERBERIS VULGARIS, BORON, CARBOLICUM ACIDUM, CYSTEINUM, FORMALINUM, GLYCYRRHIZA GLABRA, LANTHANUM METALLICUM, LAPPA MAJOR, L-METHIONINE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NIOBIUM METALLICUM, NUX VOMICA, PHYTOLACCA DECANDRA, PLUMBUM METALLICUM, STILLINGIA SYLVATICA, TANTALUM METALLICUM, THYROIDINUM (SUIS), TRIFOLIUM PRATENSE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM,Deseret Biologicals, Inc.deeae030-c266-44ab-8bc7-32c3292c72472025-01-17WarningsExact identifier
unii: 70FD1KFU70
CeleragesicECHINACEA (ANGUSTIFOLIA), CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA PURPUREA, BELLIS PERENNIS, CHAMOMILLA, HYPERICUM PERFORATUM, MILLEFOLIUM, LEDUM PALUSTRE, ARNICA MONTANA, BRYONIA (ALBA), NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALE, RHUS TOX, ACONITUM NAPELLUS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUMDeseret Biologicals, Inc.1a3edb9d-e571-4275-b56e-d2489da11e762025-01-14WarningsExact identifier
unii: 6IO182RP7A
unii: 1MBW07J51Q
SLMD Silver Sulfur Acne CreamSULFUROwen Biosciences Inc.4735a6d6-bf87-404d-a46d-7f29fcff94092025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-4QUININE ARSENITE, PHOSPHORIC ACID, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, MERCURIC CHLORIDE, VERATRUM ALBUM ROOT, BAPTISIA TINCTORIA, FERROSOFERRIC PHOSPHATE, NERIUM OLEANDER LEAF, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.45577059-73f4-4302-b299-3e356aaf959a2025-01-13WarningsExact identifier
unii: 6IO182RP7A
D-8SPONGIA OFFICINALIS SKELETON, ROASTED, CAUSTICUM, LACHESIS MUTA VENOM, CALCIUM SULFIDE, THYMUS SERPYLLUM, ANTIMONY POTASSIUM TARTRATE, ACONITUM NAPELLUS, AND DROSERA ROTUNDIFOLIADNA Labs, Inc.bc817ccf-f11c-4875-9e14-5a249f92c5032025-01-13WarningsExact identifier
unii: 1MBW07J51Q
D-11BERBERIS VULGARIS ROOT BARK, SOLANUM DULCAMARA WHOLE, TOXICODENDRON PUBESCENS LEAF, STRYCHNOS NUX-VOMICA SEED, CAUSTICUM, TRIBASIC CALCIUM PHOSPHATE, AND RHODODENDRON AUREUM LEAFDNA Labs, Inc.6620ef7e-3b89-49cc-bae6-13bad0000ada2025-01-13WarningsExact identifier
unii: 6IO182RP7A
D-13HORSE CHESTNUT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, PAEONIA OFFICINALIS ROOT, STRYCHNOS NUX-VOMICA SEED, GRAPHITE, SULFUR, COLLINSONIA CANADENSIS ROOT, POTASSIUM CARBONATE, LYCOPODIUM CLAVATUM SPORE, AND NITRIC ACIDDNA Labs, Inc.047a2c0e-9b59-45c3-85df-0a26cdc397192025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-18BERBERIS VULGARIS ROOT BARK, LYTTA VESICATORIA, EQUISETUM HYEMALE, EUTROCHIUM PURPUREUM ROOT, AND SOLANUM DULCAMARA STEMDNA Labs, Inc.3418e97b-4713-4570-bf95-70cd584cb5f72025-01-13WarningsExact identifier
unii: 3Q034RO3BT
D-30STRONTIUM SALICYLATE, METHENAMINE, COLCHICUM AUTUMNALE BULB, BLACK COHOSH, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, SOLANUM DULCAMARA WHOLE, HYPERICUM PERFORATUM, STRYCHNOS NUX-VOMICA SEED, ATROPA BELLADONNA, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ACHILLEA MILLEFOLIUM, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.0e74e654-4bda-4969-89be-8ab89014bce22025-01-13WarningsExact identifier
unii: 6IO182RP7A
D-38APIS MELLIFERA, APIS MELLIFERA VENOM, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, AND SULFURDNA Labs, Inc.5fff6e4f-a7a4-4975-a8ad-5a3b4685f4aa2025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-25CHIMAPHILA UMBELLATA, CLEMATIS RECTA FLOWERING TOP, POPULUS TREMULA WHOLE, ANEMONE PRATENSIS, SAW PALMETTO, CHONDRODENDRON TOMENTOSUM ROOT, SULFUR, CONIUM MACULATUM FLOWERING TOP, AND FERRIC PICRATEDNA Labs, Inc.1190f58c-4b20-42e7-a2f8-2942e266dff22025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-78HYPERICUM PERFORATUM, LACHESIS MUTA VENOM, LYTTA VESICATORIA, ECHINACEA ANGUSTIFOLIA, SODIUM CHLORIDE, AND PLANTAGO MAJORDNA Labs, Inc.d62673a9-8a67-4580-a8bf-25f85960a5552025-01-13WarningsExact identifier
unii: 3Q034RO3BT
D-69ARSENIC TRIOXIDE, CITRULLUS COLOCYNTHIS FRUIT PULP, RANUNCULUS BULBOSUS, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.737225d1-dfd7-45a1-90e0-73243004cf052025-01-13WarningsExact identifier
unii: 6IO182RP7A
D-98STRYCHNOS NUX-VOMICA SEED, MATRICARIA CHAMOMILLA, ANEMONE PRATENSIS, SODIUM CHLORIDE, CALCIUM SULFIDE, GOLD, DAPHNE MEZEREUM BARK, PLATINUM, AND BERBERIS VULGARIS ROOT BARKDNA Labs, Inc.9b39b277-9eb2-44c9-9c0c-a8680a50e18d2025-01-13WarningsExact identifier
unii: 1MBW07J51Q
D-23ARSENIC TRIOXIDE, DAPHNE MEZEREUM BARK, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND APIS MELLIFERADNA Labs, Inc.27c2b6e4-275e-4f17-8d31-c7d2c890b93c2025-01-13WarningsExact identifier
unii: 6IO182RP7A
unii: 70FD1KFU70
D-60CALCIUM SULFIDE, JUGLANS REGIA FRUIT RIND, IMMATURE, JUGLANS REGIA LEAF, MYOSOTIS ARVENSIS, SMILAX ORNATA ROOT, FUMARIA OFFICINALIS FLOWERING TOP, ARANEUS DIADEMATUS, SCROPHULARIA NODOSA, CONIUM MACULATUM FLOWERING TOP, AND GALIUM APARINEDNA Labs, Inc.5ff0e58c-d745-4c92-aef6-4f40168a49352025-01-13WarningsExact identifier
unii: 1MBW07J51Q
D-79URTICA URENS, TOXICODENDRON PUBESCENS LEAF, AND ECHINACEA ANGUSTIFOLIADNA Labs, Inc.0dd8244d-4cd4-4fa8-980a-6089278824dc2025-01-13WarningsExact identifier
unii: 6IO182RP7A

Reported adverse events (FAERS/openFDA)#

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