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 5 of 33 · 653 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KREOSOTEACID NIT, BELLADONNA, BORAX, CHAMOMILLA, KREOSOTE, MERC SOL, STAPHYSAGRIABM Private Limited3b3cb32b-e7e3-3455-e063-6394a90aaafb2026-02-15WarningsExact identifier
unii: WQZ3G9PF0H
SinusCalmATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA WHOLEBoiron4ae58d81-3952-b372-e063-6394a90a84992026-02-15WarningsExact identifier
unii: WQZ3G9PF0H
NerveFixACONITUM NAPELLUS, BELLADONNA, CANTHARIS, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, HYPERICUM PERFORATUM, SPIGELIA ANTHELMIANaturalCare92326b54-cac9-4fb2-ae48-120a0dcbbe562026-02-03WarningsExact identifier
unii: 3Q034RO3BT
unii: WQZ3G9PF0H
OHM-RENAPIS MELLIFICA, ARANEA DIADEMA, BERBERIS VULGARIS, CANTHARIS, EQUISETUM HYEMALE, HYDRASTIS CANADENSIS, JUGLANS REGIA, KALI BICHROMICUM, MERCURIUS SOLUBILIS, SARSAPARILLA, SOLIDAGO VIRGAUREAOHM PHARMA INC.0ed80100-8bce-4d1e-b837-2bbbde8bf9022026-01-28WarningsExact identifier
unii: 3Q034RO3BT
NeoRelief for Menstrual Pain and CrampsHOMEOPATHIC PAIN RELIEF GELBioLyte Laboratories, LLC71c2a2f7-4823-51cb-e053-2995a90a5fb82026-01-27WarningsExact identifier
unii: WQZ3G9PF0H
Gethorey MIRACLE BALMHYALURONIC ACID 1% VITAMIN E 0.5% MIRACLE BALMJiangxi Yudexi Pharmaceutical Co., LTD496a7c75-cac5-f152-e063-6394a90a5ce42026-01-27WarningsExact identifier
unii: H4N855PNZ1
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.3cb12181-ae7e-45c7-a1b1-e1952f36f8c32026-01-21WarningsExact identifier
unii: WQZ3G9PF0H
Viscum BelladonnaVISCUM BELLADONNAUriel Pharmacy Inc.a4865726-445e-4cb7-b7c8-5b74b8dd48162026-01-16WarningsExact identifier
unii: WQZ3G9PF0H
Pulmo EchinaceaPULMO ECHINACEAUriel Pharmacy Inc.14c19a33-ffcc-4b35-a0cc-9f8d44cbaf662026-01-16WarningsExact identifier
unii: WQZ3G9PF0H
Apis BelladonnaAPIS BELLADONNAUriel Pharmacy Inc.8db74171-1580-4459-a3d2-5862ef6aa8272026-01-16WarningsExact identifier
unii: WQZ3G9PF0H
COLD and FLU RELIEFCOLD AND FLU RELIEFClineva Management Services, LLC544c918d-86cc-1f8d-e054-00144ff8d46c2026-01-12WarningsExact identifier
unii: WQZ3G9PF0H
Headache ReliefATROPA BELLADONNA, CYCLAMEN PURPURASCENS TUBER, COFFEA ARABICA SEED, ROASTED, IRIS VERSICOLOR ROOT, STRYCHNOS NUX-VOMICA SEED, SANGUINARIA CANADENSIS ROOT, SPIGELIA MARILANDICA ROOT, VIBURNUM OPULUS BARKHomeocare Laboratories47f7bcbc-f4be-4cf0-a5b0-b8d5ca8d852f2026-01-12WarningsExact identifier
unii: WQZ3G9PF0H
Menopause ReliefBARIUM CARBONATE, ATROPA BELLADONNA, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SILICON DIOXIDEHomeocare Laboratories99b182d5-4102-4b25-85d3-f4be077d753f2026-01-12WarningsExact identifier
unii: WQZ3G9PF0H
SolidagoSOLIDAGO VIRGAUREA, UVA-URSI, PAREIRA BRAVA, SABAL SERRULATA, POPULUS TREMULOIDES, STAPHYSAGRIA, CANTHARIS, TEREBINTHIA, BORAXMarco Pharma International LLC.915727a5-78d9-4865-ad35-8a10cce014ca2026-01-12WarningsExact identifier
unii: 3Q034RO3BT
AllernestFORMICUM ACIDUM, LACHESIS MUTUS, LUFFA OPERCULATA. PETROLEUM, RHUS TOXICODEBDRON, ARALAI RACEMOSA,GALPHIMIA GLAUCA, THUJA OCCIDENTALIS, URTICA DICICA AND CARDIOSPERMUMMarco Pharma International LLC.97e4b6be-f93d-43de-a881-c279702010452026-01-12WarningsExact identifier
unii: 710FLW4U46
HeilenGALIUM APARINE, AGNUS CASTUS, APIS MELLIFICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, URTICA DIOICA, XANTHOXYLUM FRAXINEUM, FUCUS VESICULOSUS, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SARSAPARILLA (SMILAX REGELII), UBIDECARENONUM, CALCAREA CARBONICA, GRAPHITES, LYCOPODIUM CLAVATUM, ANACARDIUM ORIENTALE, COLCHICUM AUTUMNALE, NUX VOMICA, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), HISTAMINUM HYDROCHLORICUMHeilenef3f66f9-47bc-4fce-8950-ed2319bc30d62026-01-12WarningsExact identifier
unii: 710FLW4U46
E.O.L.STILLINGIA SYLVATICA, ZINCUM GLUCONICUM, THIAMINUM HYDROCHLORICUM, FRAGARIA VESCA, NICOTINAMIDUM, RHEUM (PALMATUM), SEROTONIN (HYDROCHLORIDE), 5-HYDROXYTRYPTOPHAN, BETAINUM MURIATICUM, BIOTIN, CHOLINUM, CYSTEINUM, DL-METHIONINE, L-ALANINE, L-CYSTINE, L-GLUTAMIC ACID, L-GLUTAMINE, L-LYSINE, L-METHIONINE, L-SERINE, PARA-AMINOBENZOIC ACID, POTASSIUM GLUCONATE, THYMUS (SUIS), THYROIDINUM (SUIS), UBIDECARENONUM, VITAMIN D3, DOPAMINE HYDROCHLORIDE, LITHIUM BROMATUM, SQUALENE, VACCINIUM MACROCARPON, OXYTOCIN,InLight Creation, LLC.b317d812-d6ed-4a2f-93f7-08b12261cc992026-01-09WarningsExact identifier
unii: Q9L0O73W7L
Mood Disorders Formula 2111MOOD DISORDERS FORMULAProfessional Complementary Health Formulas598908b0-bf1a-48fe-8dae-8d81315ba61b2026-01-08WarningsExact identifier
unii: 3Q034RO3BT
Poison Ivy Dermatosis Drops 2049POISON IVY DERMATOSIS DROPSProfessional Complementary Health Formulasddf4a44f-a919-4bf7-b54d-241ac4c7ffd22026-01-08WarningsExact identifier
unii: 3Q034RO3BT
unii: AEQ8NXJ0MB
Arsenicum Combination 9251ARSENICUM COMBINATIONProfessional Complementary Health Formulasc52598b3-7100-4410-a4cb-b3dcacf445d72026-01-08WarningsExact identifier
unii: AEQ8NXJ0MB

Reported adverse events (FAERS/openFDA)#

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