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 57 of 71 · 1,411 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Backache ReliefACONITUM NAPELLUS, BRYONIA ALBA ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, BELLIS PERENNIS, TOXICODENDRON PUBESCENS LEAF AND ARNICA MONTANAHyland's Inc.a51452b3-0aba-6928-e053-2995a90a16192023-05-10WarningsExact identifier
unii: 6IO182RP7A
Pain ReliefDIBASIC POTASSIUM PHOSPHATE,HYPERICUM PERFORATUM,TOXICODENDRON PUBESCENS LEAF,BRYONIA ALBA ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHyland's Inc.a57ac701-c42d-6b2f-e053-2995a90a112d2023-05-08WarningsExact identifier
unii: 6IO182RP7A
Sodium Sulfacetamide 9.8 % and Sulfur 4.8 % CleanserSODIUM SULFACETAMIDE AND SULFURSOHM, Inc67d67324-ff2d-4d5b-8bc5-308c6f4522f52023-05-03Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 10 % and Sulfur 2 % CleanserSODIUM SULFACETAMIDE AND SULFURSOHM, Inc480b4c92-45a1-4ac8-83ee-791abf1b87592023-05-03Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Hepar SulfHEPAR SULFTrue Botanica, LLC5e75952a-f7f1-d2e7-e053-2a91aa0a85d72023-05-01WarningsExact identifier
unii: 1MBW07J51Q
Sodium Sulfacetamide 10 % and Sulfur 5 % CleanserSODIUM SULFACETAMIDE AND SULFURSOHM, Incdc4f3e25-a39d-4965-80e8-4fe2361a67d02023-04-30Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Thyroid SarcodeCALCAREA IODATA, FUCUS VESICULOSUS, GLANDULA SUPRARENALIS (BOVINE), HYPOPHYSIS SUIS, KALI IODATUM, SPLEEN (BOVINE), SPONGIA TOSTA, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, HEPAR SULPHURIS CALCAREUM, LAPIS ALBUSNutritional Specialties, Inc.79f4767a-2b32-4a8a-9af3-109dd86130902023-04-24WarningsExact identifier
unii: 1MBW07J51Q
Histapoll HPALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, APIS MELLFICA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, NUX VOMICA, PHOSPHORUS, PULSATILLA (VULGARIS), SOLIDAGO VIRGAUREA, SULPHUREnergique, Inc.09a75182-6939-4e2b-a61a-9c58c9e9284e2023-04-21WarningsExact identifier
unii: 70FD1KFU70
SystemistatBERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, HYDRASTIS CANADENSIS, HEPAR SULPHURIS CALCAREUM, LYCOPODIUM CLAVATUM, SULPHUR, CALCAREA CARBONICA, MERCURIUS SOLUBILIS, THUJA OCCIDENTALISEnergique, Inc.0d8aa575-3fae-4828-8827-d2561672a91e2023-04-21WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
Boost LiquescenceECHINACEA ANGUSTIFOLIA, POPULUS CANDICANS, HYDRASTIS CANADENSIS, KALI BICHROMICUM, HEPAR SULPHURIS CALCAREUM, MERCURIUS SOLUBILIS.Nutritional Specialties, Inc.206b37a6-0799-4c89-8079-bec570e451432023-04-17WarningsExact identifier
unii: 1MBW07J51Q
CosmestatALFALFA, AVENA SATIVA, IODIUM, BOVISTA, FORMALINUM, HYPOPHYSIS SUIS, MANGANUM ACETICUM, NATRUM MURIATICUM, PETROLEUM, PULSATILLA (PRATENSIS), RHUS TOX, TEREBINTHINA, THYROIDINUM (BOVINE), CORTISONE ACETICUMEnergique, Inc.edc8eb65-84b3-433f-8aad-7a741f5637182023-04-17WarningsExact identifier
unii: 6IO182RP7A
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
BHI Flu PlusACONITUM NAPELLUS, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, BRYONIA ALBA WHOLE, EUPATORIUM PERFOLIATUM FLOWERING TOP, IPECAC, LACHESIS MUTA VENOM,PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, ZINC GLUCONATE, AND ZINCMediNatura Inc8d73082d-a1bc-4e76-9714-49f718b5850b2023-04-13WarningsExact identifier
unii: 70FD1KFU70
SulphurSULPHURNewton Laboratories, Inc.f9142532-84eb-1e4f-e053-6394a90afc152023-04-11WarningsExact identifier
unii: 70FD1KFU70
SulphurSULFURBoiron8697e70b-a99c-8c9a-e053-2991aa0a9b8e2023-04-11Exact identifier
unii: 70FD1KFU70
EnviroforceSARSAPARILLA (SMILAX REGELII), XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, AURUM METALLICUM, CARBO ANIMALIS, CAUSTICUM, IODIUM, SULPHUR, THUJA OCCIDENTALISBioActive Nutritional, Inc.9f364896-8626-49db-aef9-6fbf15e46d8f2023-04-10WarningsExact identifier
unii: 70FD1KFU70
Pancreas LiquescenceCINNAMOMUM, GYMNEMA SYLVESTRE, PHOSPHORICUM ACIDUM, SYZYGIUM JAMBOLANUM, TRIGONELLA FOENUM-GRACEUM, ARGENTUM NITRICUM, CHIONANTHUS VIRGINICA, HEPAR SUIS, PANCREAS SUIS, RHUS AROMATICA, SULPHUR, LYCOPODIUM CLAVATUM, CHROMIUM PICOLINATE, CHROMIUM METALLICUM, PHOSPHORUS, VANADIUM METALLICUM, ZINCUM METALLICUM, MUREX PURPUREA, DNA, INSULINUM (HUMAN), URANIUM NITRICUMNutritional Specialties, Inc.06300339-b068-4685-8475-3765f68288512023-03-27WarningsExact identifier
unii: 70FD1KFU70
Hepar sulphuris calcareumCALCIUM SULFIDEBoiron85b66774-93c2-d76c-e053-2a91aa0a99d32023-03-27Exact identifier
unii: 1MBW07J51Q
Hepar sulphuris calcareumCALCIUM SULFIDEBoiron85b6aeb0-70bb-6940-e053-2a91aa0a818a2023-03-27Exact identifier
unii: 1MBW07J51Q
Hepar sulphuris calcareumCALCIUM SULFIDEBoiron85b63e5f-f475-8fd1-e053-2991aa0a7c102023-03-27Exact identifier
unii: 1MBW07J51Q

Reported adverse events (FAERS/openFDA)#

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