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 1 of 33 · 657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kidney Tonic IECHINACEA (ANGUSTIFOLIA), PETROSELINUM SATIVUM, SOLIDAGO VIRGAUREA, UVA-URSI, GLUTATHIONE, PAREIRA BRAVA, KIDNEY (SUIS), CANTHARIS, LYCOPODIUM CLAVATUMBioActive Nutritional, Inc.e906713f-16d4-40bf-b665-e59f77c350642026-09-09WarningsExact identifier
unii: 3Q034RO3BT
NerveFix SciaticaBELLADONNA, CIMICIFUGA RACEMOSA, GELSEMIUM SEMPERVIRENS, SPIGELIA ANTHELMIA, GNAPHALIUM POLYCEPHALUM, MAGNESIA PHOSPHORICANaturalCare1e95fafb-0da8-4b39-984f-c8cd56b0d4f52026-09-03WarningsExact identifier
unii: WQZ3G9PF0H
Genexa Allergy CareALLIUM CEPA, AMBROSIA ARTEMISIIFOLIA, ARUNDO MAURITANICA, DULCAMARA, EUPHRASIA OFFICINALIS, NUX VOMICA, PULSATILLA, RANUNCULUS BULBOSUS, SABADILLA, SINAPIS NIGRA, STICTA PULMONARIA, WYETHIA HELENOIDESGenexa Inc.b5fddd8f-a380-6e88-e053-2a95a90a6b892026-08-22WarningsExact identifier
unii: AEQ8NXJ0MB
BM BM125 DROPSARSENIC ALBUM, DOLICHOS, HEPAR SULPH, MEZEREUM, RANUNCULUS BULB, RHUS TOXBM Private Limited5903117f-5278-a1bc-e063-6294a90a8f642026-08-14WarningsExact identifier
unii: AEQ8NXJ0MB
Vespa Crabro DKSVESPA CRABRO DKSUriel Pharmacy Inc.06e9e1ff-911f-c048-e063-6394a90ad4312026-08-14WarningsExact identifier
unii: 710FLW4U46
GLP SupportABIES NIGRA, ABROTANUM (ARTEMISIA ABROTANUM), ANTIMONIUM CRUDUM, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANTHARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, FEL TAURI, IRIS VERSICOLOR, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NUX VOMICA, PANCREAS SUIS, PHOSPHORUS, SECALE CORNUTUMDeseret Biologicals, Inc.e9d189fa-dbb5-424f-9c5a-8aafc805c5b22026-08-11WarningsExact identifier
unii: 3Q034RO3BT
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: WQZ3G9PF0H
Inflamma-ToneACONITUM NAPELLUS, BELLADONNA, BRYONIA (ALBA), CHAMOMILLAEnergetix Corporation2dfc3e14-5b3e-4a9a-bdbb-97bae3e461502026-08-11WarningsExact identifier
unii: WQZ3G9PF0H
Kidney-ToneAGRIMONIA EUPATORIA, BERBERIS VULGARIS, CALCAREA OXALICA, CALCAREA PHOSPHORICA, CANTHARIS, ECHINACEA, EQUISETUM ARVENSE, FERRUM PHOSPHORICUM, LYCOPODIUM CLAVATUM, PAREIRA BRAVA, PETROSELINUM SATIVUM, RUBIA TINCTORUM, SARSAPARILLA, SOLIDAGO VIRGAUREA, UVA-URSI.Energetix Corporation9ca2cbee-5251-4e96-b48b-823bc5605c2c2026-08-11WarningsExact identifier
unii: 3Q034RO3BT
Medi-ChordHOMEOPATHIC LIQUIDEnergetix Corporation57bc618b-15bd-4d04-8037-fb192e743e302026-08-11WarningsExact identifier
unii: WQZ3G9PF0H
Vac-ChordALUMINA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BOLDO, CALCAREA CARBONICA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA, HYDRASTIS CANADENSIS, LECITHIN, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MORBILLINUM, PERTUSSINUM, PHYTOLACCA DECANDRA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS, THYROIDINUM.Energetix Corporation880ea1e6-8d4d-486e-9a8f-9d3158a996672026-08-11WarningsExact identifier
unii: WQZ3G9PF0H
Relief-ToneARNICA MONTANA, BELLADONNA, CORTISONE ACETICUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALEEnergetix Corporation12279a0d-af0c-4983-b58d-921f2ea484782026-08-11WarningsExact identifier
unii: WQZ3G9PF0H
OWELL NATURALS DRAW MAXAPIS MELLIFICA, CALENDULA OFFICINALIS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, LEDUM PALUSTRE, URTICA DIOICAOWELL NATURALS LLC57b30ce7-31c3-ed55-e063-6294a90a68f32026-07-28WarningsExact identifier
unii: 710FLW4U46
PNV-OmegaASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENTAcella Pharmaceuticals, LLC735c5531-137f-4cee-8c68-ae121045a8ff2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H4N855PNZ1
Thyreoidea FerrumTHYREOIDEA FERRUMUriel Pharmacy Inc.213a9c60-51c7-9f2c-e063-6294a90a43d72026-07-21WarningsExact identifier
unii: 710FLW4U46
BM BM18 DROPSBELLADONNA, BELLIS PER, EUPHRASIA, FERR PHOS, PASSIFLORA, PHYSOSTIGMA, RUTA GRAVEBM Private Limited55b745c6-42b6-da4e-e063-6394a90ad6272026-07-03WarningsExact identifier
unii: WQZ3G9PF0H
BM BM13BELLADONNA, CUPRUM ACETICUM, DROSERA, GRINDELIA, IPECAC, LOBELIA INFLATA, NAPHTHALINUM, YERBA SANTATotal Operations Management LLC DBA:Bestmade Natural Products Micro5447d1ed-f06b-9b6b-e063-6394a90ac9812026-06-15WarningsExact identifier
unii: WQZ3G9PF0H
BM BM203 DROPSCIMICIFUGA, FORMIC ACID, GNAPHALIUM, COLOCYNTHIS, RANUNCULUS BULB, LEDUM PALTotal Operations Management LLC DBA:Bestmade Natural Products Micro5438dd99-05be-4d63-e063-6294a90a76682026-06-14WarningsExact identifier
unii: AEQ8NXJ0MB
HEALMUSZ HEALTHY FEETUREA 40% SALICYLIC ACID 2% GREEN TEA LEAFL 1% COCONUT OIL 1% HEALTHY FEETJiangxi Yudexi Pharmaceutical Co., LTD4a34b6de-03ec-3be4-e063-6294a90afb522026-06-14WarningsExact identifier
unii: Q9L0O73W7L
BM BM128 DROPSBAPTISIA, BELLADONNA, BRYONIA, ECHINACEA, TRITICUM REPTotal Operations Management LLC DBA:Bestmade Natural Products Micro542363c9-f83b-b8e8-e063-6394a90a4e5a2026-06-13WarningsExact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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