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 4 of 33 · 653 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Constitutional EnhancerACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR.King Bio Inc.448becd7-58aa-40ae-9b4b-39f48a8f13dd2026-03-10WarningsExact identifier
unii: 3Q034RO3BT
ConvoforceBELLADONNA, BUFO RANA, CICUTA VIROSA, CINA, CUPRUM METALLICUM, HYOSCYAMUS NIGER, MOSCHUS, STRAMONIUMBioActive Nutritional, Inc.e9729c5c-6b64-4aac-9710-66fe8dc998f92026-03-10WarningsExact identifier
unii: WQZ3G9PF0H
Gout Symptom ReliefAMMON PHOS, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA AND URTICA URENS.King Bio Inc.41dc03fc-169b-4691-bd62-9a41d7a6d2f72026-03-06WarningsExact identifier
unii: WQZ3G9PF0H
STYE EYE RELIEF SERUMVITAMIN E, LYSINEGuangzhou Mizi Biotechnology Co., LTD.4c592b9b-53ad-4fe6-e063-6294a90ae9792026-03-06WarningsExact identifier
unii: H4N855PNZ1
Advance PlusCARDUUS MARIANUS, CYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA (ALBA), CANTHARIS, CARDUUS BENEDICTUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, NUX VOMICA, PTELEA TRIFOLIATA, URICUM ACIDUMVitaminMed, LLC97824fb3-e2b4-4807-943b-88e26b211bf12026-03-06WarningsExact identifier
unii: 3Q034RO3BT
CystoforceSARSAPARILLA, SOLIDAGO VIRGAUREA, UVA URSI, APIS MELLIFICA, ARSENICUM ALBUM, CANTHARIS, HEPAR SULPHURIS CALCAREUMBioActive Nutritional, Inc.85287944-4722-48ed-b060-fb9ba6275c142026-03-06WarningsExact identifier
unii: 3Q034RO3BT
V Force HPARSENICUM ALBUM, BELLADONNA, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOXBioActive Nutritional, Inc.415ce4af-40fa-4510-8b35-3da217c859f22026-03-06WarningsExact identifier
unii: WQZ3G9PF0H
Headache and Migraine ReliefBELLADONNA, BRYONIA, CAPSICUM ANNUUM, GELSEMIUM, GLONOINUM, IGNATIA AMARA, KALI BICHROMICUM, KALI CARBONICUM, LYCOPODIUM, NATRUM MURIATICUM, NICCOLUM METALLICUM, NUX VOMICA, SANGUINARIA, SECALE CORNUTUM, SPIGELIA ANTH AND SULPHUR.King Bio Inc.efbfd58c-f3a6-4734-a37f-9f58fded990a2026-03-06WarningsExact identifier
unii: WQZ3G9PF0H
Respiforce A-HPARSENICUM ALBUM, BELLADONNA, IPECACUANHA, KALI CARBONICUM, LOBELIA INFLATA, NATRUM SULPHURICUM, SILICEABioActive Nutritional, Inc.ebf5f0c7-e7a4-45fe-acfd-52c46a8d789c2026-03-05WarningsExact identifier
unii: WQZ3G9PF0H
Bio Chem DetoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, TRITICUM AESTIVUM, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, CARBO VEGETABILIS, CINCHONA OFFICINALIS, CONIUM MACULATUM, MERCURIUS CORROSIVUS, PHOSPHORUS, SULPHUR, TABACUM, NITRICUM ACIDUM, AGARICUS MUSCARIUS,BioActive Nutritional, Inc.3f9bd6c8-6fc9-4af1-8263-ab42f99fba372026-03-05WarningsExact identifier
unii: WQZ3G9PF0H
Sciatic Nerve FormulaAESCULUS HIPPOCASTANUM, AMMONIUM MURIATICUM, ARSENICUM ALBUM, BELLADONNA, CAPSICUM ANNUUM, CAUSTICUM, COLCHICUM AUTUMNALE, COLOCYNTHIS, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, IGNATIA AMARA, KALMIA, MAGNESIA PHOSPHORICA, RHUS TOX AND RUTA GRAVEOLENS.King Bio Inc.23ca6b5a-c4ca-41df-8dec-323e6e26d5342026-03-04WarningsExact identifier
unii: WQZ3G9PF0H
Total Body DetoxALUMINA, BRYONIA, CALCAREA IODATA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MAR, CHELIDONIUM MAJ, CINCHONA OFFICINALIS, CYNARA SCOLYMUS, DIOSCOREA VILLOSA, HEPAR SULPHURIS CALCAREUM, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, KALI IODATUM, MERCURIUS CORROSIVUS, MERCURIUS VIVUS, NATRUM CARBONICUM, NUX VOMICA, PLUMBUM METALLICUM, PTELEA TRIFOLIATA, RICINUS COMMUNIS, ROBINIA PSEUDOACACIA, SERUM ANGUILLAE, SOLIDAGO VIRGAUREA, SULPHUR, SULPHURICUM ACIDUM AND TARAXACUM OFFICINALE.King Bio Inc.c803733e-b5e2-46f2-bdfe-b239f38d93122026-03-04WarningsExact identifier
unii: 3Q034RO3BT
Sleep AidACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, PHOSPHORUS, PULSATILLA, AND VALERIANA OFFICINALIS.King Bio Inc.794b7e4f-b084-4aee-8c07-96bac459d6982026-03-04WarningsExact identifier
unii: WQZ3G9PF0H
Pain ReliefARNICA MONTANA, BELLADONNA, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, MAGNESIA PHOSPHORICA, SANGUINARIA CANADENSIS, SALIX ALBANaturalCare6eba2caa-958f-47a1-823c-c73bbb1d7fa92026-03-02WarningsExact identifier
unii: WQZ3G9PF0H
First Aid mind and BodyACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CISTUS CANADENSIS, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM PERFORATUM, IGNATIA AMARA, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, PHOSPHORUS, PRUNUS CERASIFERA, FLOS, RHUS TOX, SULPHUR, SYMPHYTUM, TRIFOLIUM PRATENSE, AND VERATRUM ALBUM.King Bio Inc.20d4a0a3-7e69-4956-aaff-21703e2bb0302026-03-02WarningsExact identifier
unii: WQZ3G9PF0H
RenatoneBERBERIS VULGARIS, SOLIDAGO VIRGAUREA, CANTHARIS, ARSENICUM ALBUM, COCCUS CACTI, LYCOPODIUM CLAVATUM, PHOSPHORUS, SENECIO AUREUS, STAPHYSAGRIAEnergique, Inc.c2fbeb1b-a19f-4c09-947e-adbdabe256bf2026-02-27WarningsExact identifier
unii: 3Q034RO3BT
Rhus AconitumRHUS ACONITUMUriel Pharmacy Inc.a176c241-fc2d-4fea-82d9-81183971b4cf2026-02-27WarningsExact identifier
unii: WQZ3G9PF0H
Allergy Maximum StrengthURTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature122ca23e-43f1-4e5c-afc2-1418b17176792026-02-20WarningsExact identifier
unii: 710FLW4U46
ColdCalmONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLEBoiron4ae2f15e-45f3-e2e4-e063-6294a90a92bc2026-02-15WarningsExact identifier
unii: WQZ3G9PF0H
ThroatCalmARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, ATROPA BELLADONNA, BROMINE, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLEBoiron4ae45fc7-c0f4-3770-e063-6394a90ac80e2026-02-15WarningsExact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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