FDA.reportPublic FDA data

NDC 64616-047-01 - Bye Bye Diaper Rash

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
64616-047
Requested NDC
64616-047-01
Package NDCs from labels
64616-047-01, 64616-047-02
Manufacturer
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
Bye Bye Diaper RashVitality Works, Inc.2017-12-04HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64616-047-022021-01-29C16284748780-1ba0f9c33-18a1-a910-e053-dadaa90a0b85Bye Bye Diaper Rash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-047-01Bye Bye Diaper Rash59 mL in 1 BOTTLE, SPRAYLIQUID593
64616-047-02Bye Bye Diaper Rash1 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-047BYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]3Legacy NDC, 2 package rows20171207_7d699efc-9aac-43f3-8b06-74520e7f0984.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51QBYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BTBYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
SULFURACTIVE INGREDIENT70FD1KFU70BYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7ABYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
CALCIUM SULFIDEACTIVE MOIETY1MBW07J51QBYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BTBYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
SULFURACTIVE MOIETY70FD1KFU70BYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7ABYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1BYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LBYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EBYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]2
SHARK LIVER OILINACTIVE INGREDIENT4B24275HEUBYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [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 33 of 71 · 1,411 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Swimmers FriendANTIMONIUM TART., ARNICA MONTANA, BELLIS PERENNIS, BRYONIA, CALCAREA CARBONICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, CUPRUM METALLICUM, DIGITALIS PURPUREA, DROSERA, LACHESIS MUTUS, LACTICUM ACIDUM, LEDUM PALUSTRE, MAGNESIA CARBONICA, MANGANUM ACETICUM, NUX VOMICA, PHYTOLACCA DECANDRA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SULPHURICUM ACIDUM, VERBASCUM THAPSUS, VIPERA BERUSNewton Laboratories, Inc.9d260197-0c81-0df2-e053-2a95a90a44102025-02-10WarningsExact identifier
unii: 6IO182RP7A
Teeth-GumsCHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9d27b1e4-a966-5495-e053-2a95a90a965b2025-02-10WarningsExact identifier
unii: 6IO182RP7A
unii: 1MBW07J51Q
Tobacco WithdrawalARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANANewton Laboratories, Inc.9d38fd5a-1657-11e5-e053-2a95a90a47ee2025-02-10WarningsExact identifier
unii: 3Q034RO3BT
unii: 6IO182RP7A
Teeth-GumsCHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9d363a40-a17b-2b6f-e053-2a95a90a33842025-02-10WarningsExact identifier
unii: 6IO182RP7A
unii: 1MBW07J51Q
Tobacco WithdrawalARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANANewton Laboratories, Inc.9d399697-69dc-217d-e053-2a95a90a65e42025-02-10WarningsExact identifier
unii: 3Q034RO3BT
unii: 6IO182RP7A
VitalityECHINACEA, LAPPA MAJOR, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ADRENALINUM, ALOE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, BRYONIA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, FERRUM METALLICUM, GLONOINUM, HYDROCOTYLE ASIATICA, IODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, THUJA OCCIDENTALIS, THYROIDINUM, GLYCYRRHIZA GLABRANewton Laboratories, Inc.9d3a6b0e-a23f-9f2d-e053-2995a90a75cf2025-02-10WarningsExact identifier
unii: 6IO182RP7A
Rheumatic-Joint CareURICUM ACIDUM, ACONITUM NAP.,APIS MEL., ARNICA, ARSENICUM ALB, BELLADONNA,BENZOICUM ACIDUM, BRYONIA, CALC. CARB., CHAMOMILLA, CINCHONA, COLCHICUM, EUPATORIUM PERF., GAULTHERIAPROCUMBENS, GUAIACUM, IODIUM, KALI BIC, KALMIA,LEDUM, PULSATILLA, RHUS TOXICODENDRON, RUTA,SABINA, STRYCHNINUM, LAPPA, PHYTOLACCA, SYMPHYTUM,Newton Laboratories, Inc.9cae7d07-19f5-f661-e053-2995a90a944d2025-02-10WarningsExact identifier
unii: 6IO182RP7A
PrimeGINKGO BILOBA, RUTA GRAVEOLENS, AGNUS CASTUS, ALLIUM SATIVUM, AMBRA GRISEA, ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARNICA MONTANA, ARSENICUM ALBUM, AVENA SATIVA, BAPTISIA TINCTORIA, BARYTA CARBONICA, BRYONIA, CANTHARIS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PULSATILLA, RUTA GRAVEOLENS, SABAL SERRULATA, SELENIUM METALLICUM, ZINCUM METALLICUM.Newton Laboratories, Inc.9b40f630-0b91-9816-e053-2a95a90a16ec2025-02-10WarningsExact identifier
unii: 3Q034RO3BT
Restless LegMYGALE, AGARICUS MUSC., CAUSTICUM, CINCHONA, CONIUM, CUPRUM MET., GELSEMIUM, HYOSCYAMUS, HYPERICUM, KALI CARB., MAG. CARB., MERC. VIV., NUX VOM., PLUMB. MET., RHUS TOXICODENDRON, SECALE, STRYCHNINUM, TARENTULA HISPANA, VALERIANA, VERBASCUM, ZINC. MET., CHAMOMILLA,PASSIFLORANewton Laboratories, Inc.9b2e2194-fda3-6837-e053-2995a90ac61a2025-02-10WarningsExact identifier
unii: 6IO182RP7A
Restless LegMYGALE, AGARICUS MUSC., CAUSTICUM, CINCHONA, CONIUM, CUPRUM MET., GELSEMIUM, HYOSCYAMUS, HYPERICUM, KALI CARB., MAG. CARB., MERC. VIV., NUX VOM., PLUMB. MET., RHUS TOXICODENDRON, SECALE, STRYCHNINUM, TARENTULA HISPANA, VALERIANA, VERBASCUM, ZINC. MET., CHAMOMILLA,PASSIFLORANewton Laboratories, Inc.9b3f076e-7edd-ea51-e053-2a95a90abd9b2025-02-10WarningsExact identifier
unii: 6IO182RP7A
Dust-Mold-DanderIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.Newton Laboratories, Inc.99fdc906-3a55-e4c4-e053-2a95a90a76ba2025-02-10WarningsExact identifier
unii: 6IO182RP7A
Gas-IndigestionCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, DAPHNE INDICA, IPECACUANHA, IRIS VERSICOLOR, KALI CARBONICUM, KREOSOTUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, MERCURIUS VIVUS, NUX VOMICA, PHOSPHORUS, PULSATILLA, SPIGELIA ANTHELMIA, SULPHUR, PYROGENIUMNewton Laboratories, Inc.9a125a53-39c2-d849-e053-2a95a90a98452025-02-10WarningsExact identifier
unii: 70FD1KFU70
Rhus toxicodendronRHUS TOXICODENDRONNewton Laboratories, Inc.9e67cfa5-b944-f4a7-e053-2a95a90a38a82025-02-10WarningsExact identifier
unii: 6IO182RP7A
Leg Cramps-SwellingECHINACEA, ARGENTUM NITRICUM, BRYONIA, CALCAREA CARBONICA, COLOCYNTHIS, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, CUPRUM METALLICUM, DIGITALIS , GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LATHYRUS SATIVUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ELAPSNewton Laboratories, Inc.9c315126-e61e-f649-e053-2a95a90a7f082025-02-07WarningsExact identifier
unii: 6IO182RP7A
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.9c0cd92b-905d-f90f-e053-2995a90a47052025-02-07WarningsExact identifier
unii: 3Q034RO3BT
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.9c0d8c82-6c4f-a511-e053-2995a90a793f2025-02-07WarningsExact identifier
unii: 3Q034RO3BT
Lymphatic CareECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..Newton Laboratories, Inc.9c3507de-1def-4019-e053-2a95a90a14752025-02-07WarningsExact identifier
unii: 3Q034RO3BT
Lymphatic CareECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..Newton Laboratories, Inc.9c36201a-2153-0600-e053-2995a90a6bbf2025-02-07WarningsExact identifier
unii: 3Q034RO3BT
MenopauseELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANANewton Laboratories, Inc.9c4872fd-bfe5-2472-e053-2995a90a361f2025-02-07WarningsExact identifier
unii: 3Q034RO3BT
MenopauseELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANANewton Laboratories, Inc.9c4718ef-86ac-7bb7-e053-2a95a90a56272025-02-07WarningsExact identifier
unii: 3Q034RO3BT

Reported adverse events (FAERS/openFDA)#

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