FDA.reportPublic FDA data

NDC 64616-046-01 - Bye Bye Burns

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
64616-046
Requested NDC
64616-046-01
Package NDCs from labels
64616-046-01, 64616-046-02
Manufacturer
Vitality Works, Inc | 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
Topical Skin Spray - Vitality Works, Inc | Vitality Works, Inc.Vitality Works, Inc | Vitality Works, Inc.2017-12-04HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64616-046-022021-01-29C16284748780-1ba0f9c33-2cd9-a910-e053-dadaa90a0b85Bye Bye Burns

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-046-01Bye Bye Burns59 mL in 1 BOTTLE, SPRAYSPRAY593
64616-046-02Bye Bye Burns1 in 1 CARTONSPRAY13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-046BYE BYE BURNS (TOPICAL SKIN SPRAY) SPRAY [VITALITY WORKS, INC]3Legacy NDC, 2 package rows20171208_7c6c3a42-6dc9-400f-9bfd-59cdaf33ca41.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HBYE BYE BURNS (TOPICAL SKIN SPRAY) SPRAY [VITALITY WORKS, INC]2
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BTBYE BYE BURNS (TOPICAL SKIN SPRAY) SPRAY [VITALITY WORKS, INC]2
RANUNCULUS BULBOSUSACTIVE INGREDIENTAEQ8NXJ0MBBYE BYE BURNS (TOPICAL SKIN SPRAY) SPRAY [VITALITY WORKS, INC]2
URTICA DIOICAACTIVE INGREDIENT710FLW4U46BYE BYE BURNS (TOPICAL SKIN SPRAY) SPRAY [VITALITY WORKS, INC]2
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HBYE BYE BURNS (TOPICAL SKIN SPRAY) SPRAY [VITALITY WORKS, INC]2
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BTBYE BYE BURNS (TOPICAL SKIN SPRAY) SPRAY [VITALITY WORKS, INC]2
RANUNCULUS BULBOSUSACTIVE MOIETYAEQ8NXJ0MBBYE BYE BURNS (TOPICAL SKIN SPRAY) SPRAY [VITALITY WORKS, INC]2
URTICA DIOICAACTIVE MOIETY710FLW4U46BYE BYE BURNS (TOPICAL SKIN SPRAY) SPRAY [VITALITY WORKS, INC]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1BYE BYE BURNS (TOPICAL SKIN SPRAY) SPRAY [VITALITY WORKS, INC]2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LBYE BYE BURNS (TOPICAL SKIN SPRAY) SPRAY [VITALITY WORKS, INC]2
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EBYE BYE BURNS (TOPICAL SKIN SPRAY) SPRAY [VITALITY WORKS, INC]2
SHARK LIVER OILINACTIVE INGREDIENT4B24275HEUBYE BYE BURNS (TOPICAL SKIN SPRAY) SPRAY [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 9 of 33 · 653 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triflora GelURTICA DIOICA, TOXICODENDRON PUBESCENS LEAF, LEDUM PALUSTRE TWIGSchwabe Mexico S.A. de C.V.a1c113ad-8c6c-4f19-b611-426e30f1db0e2025-11-18WarningsExact identifier
unii: 710FLW4U46
Lavender Quartz Ear OilLAVENDER QUARTZ EAR OILUriel Pharmacy Inc.b1a8d75c-77a9-40a7-8dd8-9c32cac31d2c2025-11-17WarningsExact identifier
unii: WQZ3G9PF0H
BLISTER HPJUGLANS CINEREA BRANCH BARK/ROOT BARK, POTASSIUM IODIDE, LYCOPODIUM CLAVATUM SPORE, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, RANUNCULUS BULBOSUS, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG.Natural Creations, Inc.e76f05e7-6d7b-4d2e-ba26-bf776bf0e6572025-11-13WarningsExact identifier
unii: AEQ8NXJ0MB
BURN RELIEFARSENIC TRIOXIDE, ATROPA BELLADONNA, LYTTA VESICATORIA, CAUSTICUM, PICRIC ACID, URTICA URENS, HYPERICUM PERFORATUMNatrural Creations, Inc.79c80c6c-1fd9-4b32-81e0-ff6a1f6102272025-11-13WarningsExact identifier
unii: 3Q034RO3BT
unii: WQZ3G9PF0H
BELLA HPATROPA BELLADONNA, CONIUM MACULATUM FLOWERING TOP, SOLANUM DULCAMARA TOP, CALCIUM SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, ANEMONE PULSATILLA, SILICON DIOXIDE, MATRICARIA RECUTITA.Natural Creations, Inc.8e46906b-9c22-4a8e-ae4e-f1fbfb3d35b12025-11-13WarningsExact identifier
unii: WQZ3G9PF0H
ANXIETY II HPACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ACTIVATED CHARCOAL, HUMAN BREAST TUMOR CELL, CAUSTICUM, GELSEMIUM SEMPERVIRENS ROOT, LACHESIS MUTA VENOM, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAFNatural Creations, Inc.02fa45a5-08e1-41ad-acd4-0f85db07e89e2025-11-13WarningsExact identifier
unii: WQZ3G9PF0H
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db30229-3031-ff10-e053-2995a90aff752025-11-06WarningsExact identifier
unii: WQZ3G9PF0H
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db4790e-28c2-2dce-e053-2a95a90ae7922025-11-06WarningsExact identifier
unii: WQZ3G9PF0H
Apis Belladonna MercuriusAPIS BELLADONNA MERCURIUSUriel Pharmacy Inc.85c71f6f-3792-4679-aeae-18eaee7db31c2025-11-06WarningsExact identifier
unii: WQZ3G9PF0H
Belladonna 6XBELLADONNA 6XTrue Botanica, LLC3c1ca101-4859-b62e-e063-6294a90a2fd32025-10-23WarningsExact identifier
unii: WQZ3G9PF0H
Silicea BelladonnaSILICEA BELLADONNAUriel Pharmacy Inc.a142eb87-c5fb-4138-bc98-e7f1391fe2212025-10-10WarningsExact identifier
unii: WQZ3G9PF0H
Fibromyalgia SupportACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, CONIINUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI BICHROMICUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, URICUM ACIDUMThe Magni Company36892361-994e-4a6d-972a-9ea9b72f89fe2025-10-09WarningsExact identifier
unii: WQZ3G9PF0H
Kidney LiquescenceJUNIPERUS COMMUNIS, UVA-URSI, EQUISETUM HYEMALE, TARAXACUM OFFICINALE, EUPATORIUM PURPUREUM, KIDNEY (BOVINE), NITRICUM ACIDUM, CANTHARIS, HEPAR SULPHURIS CALCAREUMNutritional Specialties, Inc.34cc5ee6-ef07-49fc-9ba3-fae27d4a75202025-10-08WarningsExact identifier
unii: 3Q034RO3BT
BelladonnaBELLADONNAHistorical Remediesc6784560-5d61-78b3-e053-2995a90adc252025-10-07WarningsExact identifier
unii: WQZ3G9PF0H
RenatoneBERBERIS VULGARIS, SOLIDAGO VIRGAUREA, CANTHARIS, ARSENICUM ALBUM, COCCUS CACTI, LYCOPODIUM CLAVATUM, PHOSPHORUS, SENECIO AUREUSEnergique, Inc.a1b88ba5-18e1-480b-8bd8-03bda85a7ef12025-10-06WarningsExact identifier
unii: 3Q034RO3BT
PyostatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ARSENICUM ALBUM, BELLADONNA, CROTALUS HORRIDUS, HYOSCYAMUS NIGER, LACHESIS MUTUS, PYROGENIUM, TARENTULA CUBENSIS, ANTHRACINUMEnergique, Inc.427417ce-72a8-4d46-be24-b8b0fdc854582025-10-06WarningsExact identifier
unii: WQZ3G9PF0H
TopricinAESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CROTALUS HORRIDUS, ECHINACEA, GRAPHITES, HELODERMA HORRIDUM, LACHESIS MUTUS, NAJA TRIPUDIANS, PHOSPHORUS, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SULFURTopical BioMedics, Inc.321e83de-71e8-20b4-e054-00144ff8d46c2025-10-03WarningsExact identifier
unii: WQZ3G9PF0H
TopricinAESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLADONNA, CROTALUS HORRIDUS, ECHINACEA, GRAPHITES, HELODERMA, LACHESIS MUTUS, NAJA TRIPUDIANS, RHUS TOXICODENDRON, RUTA GRAVEOLENSTopical BioMedics, Inc.53f5778f-ab62-4dda-9bd9-8cc7fdd69d1e2025-10-01WarningsExact identifier
unii: WQZ3G9PF0H
Rashes-HivesANTIMON. CRUD., APIS MEL., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.Newton Laboratories, Inc.9988637d-d023-399e-e053-2a95a90abca62025-09-29WarningsExact identifier
unii: 3Q034RO3BT
Rashes-HivesANTIMON. CRUD., APIS MEL., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.Newton Laboratories, Inc.9988c585-381d-1ec5-e053-2995a90a12022025-09-29WarningsExact identifier
unii: 3Q034RO3BT

Reported adverse events (FAERS/openFDA)#

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