FDA.reportPublic FDA data

NDC 64539-005-01 - Cicatrix Skin Protectant

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
64539-005
Requested NDC
64539-005-01
Package NDCs from labels
64539-005-01, 64539-005-02
Manufacturer
Catalysis, SL
Effective date
2017-06-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cicatrix Skin Protectant - Catalysis, SLCatalysis, SL2017-06-28HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64539-005-022020-01-31C16284748780-19d75b9d0-b7d9-f424-e053-dadaa90a57ceCicatrix

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64539-005-01Cicatrix Skin Protectant50 mL in 1 BOTTLE, PUMPCREAM502
64539-005-02Cicatrix Skin Protectant1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64539-005CICATRIX SKIN PROTECTANT (GLYCERIN) CREAM [CATALYSIS, SL]2Legacy NDC, 2 package rows20170629_4e8c0573-9db9-02f2-e054-00144ff88e88.zip

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 22 of 29 · 566 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PREPARATION H Maximum StrengthGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLHaleon US Holdings LLC7cc03d2e-e708-589a-d9bb-58ebbda989c02024-04-05WarningsExact identifier
unii: PDC6A3C0OX
VascuflowMELATONIN, L-ARGININE, L-CITRULLINE, UBIDECARENONUM, SQUALENE, CALCAREA CARBONICA, CHOLESTERINUM, COUMARINUM, FORMALINUM, GELSEMIUM SEMPERVIRENS, ALPHA-LIPOICUM ACIDUM, MERCURIUS CORROSIVUS, PLUMBUM METALLICUM, PANTOTHENIC ACID, GLONOINUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, BERBERIS VULGARIS, RED YEAST RICE, NITRIC OXIDE, PROTEUS (MORGANI), RHUS TOXDeseret Biologicals, Inc.1ca5d57d-7cf0-4b9a-afa0-767dca99864d2024-04-02WarningsExact identifier
unii: 97C5T2UQ7J
unii: A4VZ22K1WT
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
BreatheARGENTUM NITRICUM, NATRUM MURIATICUM, SULPHUR, ACONITUM NAPELLUS, ARSENICUM ALBUM, RHUS TOX, ADENOSINUM CYCLOPHOSPHORICUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, LUNG (SUIS), MUCOSA NASALIS SUIS, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, ACETYLCHOLINE CHLORIDE, COUMARINUM, MALVIN, DYSENTERY BACILLUS, PROTEUS (MORGANI)Deseret Biologicals, Inc8dbdd623-a486-4cf8-acdb-ad051dc743482024-03-15WarningsExact identifier
unii: A4VZ22K1WT
Hormone CombinationACETALDEHYDE, DOPAMINE HYDROCHLORIDE, DHEA (DEHYDROEPIANDROSTERONE), 7-OXO- DEHYDROEPIANDROSTERONE 3-ACETATE, FOLLICULINUM, OOPHORINUM (SUIS), CHOLESTERINUM, PROGESTERONE, TESTOSTERONE, CORTISONE ACETICUM, ALDOSTERONE, ANDROSTERONE, FOLLICLE STIMULATING HORMONEDeseret Biologicals, Inc.22908e3d-492c-4b18-a070-076f99a813142024-03-11WarningsExact identifier
unii: 97C5T2UQ7J
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC699310e8-1a93-40b4-a8f4-a765be4a0cb12024-02-29WarningsExact identifier
unii: PDC6A3C0OX
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Detox ICARDUUS MARIANUS, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, TARAXACUM OFFICINALE, AVENA SATIVA, CYNARA SCOLYMUS, METHYLCOBALAMIN, MENADIONE, ALPHA-LIPOICUM ACIDUM, CINCHONA OFFICINALIS, HEPAR SUIS, VERATRUM ALBUM, COLON (SUIS), DUODENUM (SUIS), GALLBLADDER (SUIS), INTESTINE (SUIS), LYMPH NODE (SUIS), PANCREAS SUIS, THYMUS (SUIS), ACETALDEHYDE, ALPHA-KETOGLUTARICUM ACIDUM, CHOLESTERINUM, FORMICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, MALIC ACID, NATRUM OXALACETICUM, SULPHUR, CALCAREA CARBONICA,Deseret Biologicals, Inc.759c7688-0104-41fe-be1e-4809c9be86862024-02-13WarningsExact identifier
unii: 97C5T2UQ7J
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
No More ProductsGLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc102e7dbb-06dc-f4d1-e063-6394a90aa3eb2024-01-26WarningsExact identifier
unii: PDC6A3C0OX
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc.0fe10710-ac59-4fc5-e063-6294a90a48fc2024-01-26WarningsExact identifier
unii: PDC6A3C0OX
Hormone HarmonyACETALDEHYDE, DOPAMINE HYDROCHLORIDE, DHEA (DEHYDROEPIANDROSTERONE), 7-OXO- DEHYDROEPIANDROSTERONE 3-ACETATE, FOLLICULINUM, OOPHORINUM (SUIS), CHOLESTERINUM, PROGESTERONE, TESTOSTERONE, CORTISONE ACETICUM, ALDOSTERONE, ANDROSTERONE, FOLLICLE STIMULATING HORMONEPro Weight Loss Inc.123f5269-45eb-4dcd-be66-76c6665b8d132024-01-22WarningsExact identifier
unii: 97C5T2UQ7J
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
unii: PDC6A3C0OX
Hydro GelGLYCERIN 20%Trifecta Pharmaceuticals USA LLC02e8e5d0-7844-39fe-e063-6394a90a57e12024-01-19WarningsExact identifier
unii: PDC6A3C0OX
D1 Organ SupportCARDUUS MARIANUS, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, TARAXACUM OFFICINALE, AVENA SATIVA, CYNARA SCOLYMUS, METHYLCOBALAMIN, MENADIONE, ALPHA-LIPOICUM ACIDUM, CINCHONA OFFICINALIS, HEPAR SUIS, VERATRUM ALBUM, COLON (SUIS), DUODENUM (SUIS), GALLBLADDER (SUIS), INTESTINE (SUIS), LYMPH NODE (SUIS), PANCREAS SUIS, THYMUS (SUIS), THYMUS (SUIS), ALPHA-KETOGLUTARICUM ACIDUM, CHOLESTERINUM, FORMICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, MALICUM ACIDUM, NATRUM OXALACETICUM, SULPHUR, CALCAREA CARBONICA,Dr. Donna Restivo DCe295c5a0-82ca-4fe9-a2e2-9407d81b780e2024-01-18WarningsExact identifier
unii: 97C5T2UQ7J
A13 DTX-LIVERBOS TAURUS GALLBLADDER, BRYONIA, CHELIDONIUM MAJUS, CHOLESTERINUM, HEPAR SULPHURIS CALCAREUM , JUNIPERUS COMMUNIS STEM, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, PHOSPHORUS, RHAMNUS PURSHIANA, ROSMARINUS OFFICINALIS, SECALE CEREALE WHOLEApex Energetics Inc.bed751f5-a8da-cac7-e053-2a95a90a22182024-01-08WarningsExact identifier
unii: 97C5T2UQ7J

Reported adverse events (FAERS/openFDA)#

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