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 8 of 33 · 653 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GERM HPAPIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDENatural Creations, Inc.15dc5391-0e6e-45d9-8ac7-142333a907162025-12-12WarningsExact identifier
unii: WQZ3G9PF0H
GermasodeARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, ARSENICUM ALBUM, BELLADONNA, BERBERIS VULGARIS, BORRELIA, CHLAMYDIA, HYDRASTIS CANADENSIS, LACHESIS MUTUS, LYMPHOGRANULOMA, MERCURIUS SOLUBILIS, OOPHORINUM, PHOSPHORUS, PNEUMOCOCCINUM, PYROGENIUM, SILICEA TERRANatural Creations, Inccad24325-e658-4427-a2e7-f821f01111702025-12-12WarningsExact identifier
unii: WQZ3G9PF0H
GBLV HPATROPA BELLADONNA, BERBERIS VULGARIS ROOT BARK, MILK THISTLE, CHELIDONIUM MAJUS, CITRULLUS COLOCYNTHIS FRUIT PULP, DIOSCOREA VILLOSA TUBER, GOLDENSEAL, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, ANEMONE PULSATILLA, VERATRUM ALBUM ROOTNatural Creations, Inc.cff4d830-6696-4cde-9cd7-4ce55e28b54b2025-12-12WarningsExact identifier
unii: WQZ3G9PF0H
HEADACHE HPSILVER NITRATE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MELILOTUS OFFICINALIS TOP, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SPIGELIA ANTHELMIANatural Creations, Inc.c38b83f0-3918-4ef6-8dfd-48fe438e584a2025-12-12WarningsExact identifier
unii: WQZ3G9PF0H
Throat RemedyBELLADONNA 30C, HEAR SULPHURIS CALCAREUM 30C, LACHESIS MUTUS 30C, MERCURIUS SOLUBILIS 30C, PHYTOLACCA DECANDRA 30C, FERRUM PHOSPHORICUM 6X, KALI MURIATICUM 5X, CALCAREA SULPHURICA 6X, STREPTOCOCCINUM 200CJoyWell Co LLC51c00f80-3642-4552-a0f8-02a0f7495cf82025-12-11WarningsExact identifier
unii: WQZ3G9PF0H
FLU HPACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS ROOTNatural Creations, Inc.3d6c203a-6f30-4417-84d3-3cdab22098e32025-12-10WarningsExact identifier
unii: WQZ3G9PF0H
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.cba32ae8-45af-494c-ac1a-fea4b10f18602025-12-04WarningsExact identifier
unii: WQZ3G9PF0H
HeadacheELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC..Newton Laboratories, Inc.44ffb50a-7bfe-428b-e063-6394a90a9dcf2025-12-02WarningsExact identifier
unii: WQZ3G9PF0H
Headache-MigraineELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC..Newton Laboratories, Inc.45002cee-75e1-1d1a-e063-6294a90a6e0d2025-12-02WarningsExact identifier
unii: WQZ3G9PF0H
HeadacheELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC..Newton Laboratories, Inc.44ffafd7-8b43-5a24-e063-6294a90a80a32025-12-01WarningsExact identifier
unii: WQZ3G9PF0H
CONTACT ALLERGY ANTIGENTOXICODENDRON DIVERSILOBUM LEAF, TOXICODENDRON PUBESCENS LEAF, TOXICODENDRON VERNIX LEAFY TWIG, URTICA DIOICA, SEMECARPUS ANACARDIUM JUICE, GRAPHITE, DAPHNE MEZEREUM BARK, URTICA URENS, XEROPHYLLUM ASPHODELOIDESNatural Creations, Inc.f443e132-7bd6-40e3-b664-2a95c19a44012025-12-01WarningsExact identifier
unii: 710FLW4U46
JBA Verestor Mega Fiber PowderVITAMIN C,VITAMIN E,INULIN,BANANA STEM EXTRACT,NATTOKINASE,HOUTTUYNIA CORDATA EXTRACT,RUTIN,BETA-CAROTENEAdvanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticalse7b861da-3851-4a75-b707-4a427c938ee12025-11-28WarningsExact identifier
unii: H4N855PNZ1
DrainerCYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, NUX VOMICA, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, URICUM.Newton Laboratories, Inc.99ff92f5-91bc-120b-e053-2995a90a8d8a2025-11-26WarningsExact identifier
unii: 3Q034RO3BT
Lymphastat BBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, FERRUM PHOSPHORICUM, LACHESIS MUTUS, MERCURIUS CORROSIVUS, PHOSPHORUS, COLIBACILLINUM CUM NATRUM MURIATICUM, PYROGENIUMEnergique, Inc.0a1afc3a-be21-49bb-824c-c0f3d3c06ea72025-11-24WarningsExact identifier
unii: WQZ3G9PF0H
Stopain Migraine Pain RelievingMENTHOLUM, BELLADONNA, IRIS VERSICOLOR, SANGUINARIA CANADENSISTROY MANUFACTURING, INC5641c17f-bf3f-48a5-a3a8-c80d381c17a42025-11-24WarningsExact identifier
unii: WQZ3G9PF0H
CYSTOGES HPBERBERIS VULGARIS ROOT BARK, LYTTA VESICATORIA, CLEMATIS RECTA FLOWERING TOP, CANIS LUPUS FAMILIARIS MILK, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, SARSAPARILLA, SEPIA OFFICINALIS JUICE, DELPHINIUM STAPHYSAGRIA SEEDNatural Creations, Inc.2efe5944-7b4d-4dac-b749-971f6dd776792025-11-21WarningsExact identifier
unii: 3Q034RO3BT
Mercurialis Calendula DKSMERCURIALIS CALENDULA DKSUriel Pharmacy Inc.6e7708f6-0c04-6143-e053-2a91aa0ad9492025-11-19WarningsExact identifier
unii: 710FLW4U46
Ssssting StopECHINACEA ANGUSTIFOLIA, LEDUM PALUSTRE TWIG, URTICA DIOICASchwabe North America, Inc.b01fe801-7316-11df-93f2-0800200c9a662025-11-18WarningsExact identifier
unii: 710FLW4U46
Ssssting Stop GelECHINACEA ANGUSTIFOLIA, LEDUM PALUSTRE TWIG, URTICA DIOICA,Schwabe Mexico, S.A. de C.V.dfb2d5c4-b4d4-4252-af36-810a8354afb22025-11-18WarningsExact identifier
unii: 710FLW4U46
TrifloraURTICA DOICIA, RHUS TOXICODENDRON, LEDUM PALUSTRESchwabe North America, Inc0f7796ae-a20e-431f-bdec-bca7415b468f2025-11-18WarningsExact identifier
unii: 710FLW4U46

Reported adverse events (FAERS/openFDA)#

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