FDA.reportPublic FDA data

NDC 64539-019-01 - Blue Cap Cream

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
64539-019
Requested NDC
64539-019-01
Package NDCs from labels
64539-019-01, 64539-019-02
Manufacturer
Catalysis, SL
Effective date
2018-07-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Blue Cap Cream - Catalysis, SLCatalysis, SL2018-07-29HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64539-019-022020-01-31C16284748780-19d75b9d0-ba97-f424-e053-dadaa90a57ceBlue Cap Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64539-019-01Blue Cap Cream56 mL in 1 TUBECREAM561
64539-019-02Blue Cap Cream1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64539-019BLUE CAP CREAM (ZINC PYRITHIONE) CREAM [CATALYSIS, SL]1Legacy NDC, 2 package rows20180730_722baecb-08d5-0763-e053-2991aa0a8a9b.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 33 of 60 · 1,191 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nikzon HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDEGenomma Lab USA8f9a9939-2c99-489f-b597-9a51ec2684f92025-07-14WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DANDRX ANTI-DANDRUFFZINC PYRITHIONEdandRX LLC399fb507-2263-962f-e063-6394a90ae9a82025-07-10WarningsExact identifier
unii: R953O2RHZ5
Maximum Strength Hemorrhoidal Cream with AloeGLYCERIN, PHENYLEPHINE HCI, PRAMOXINE HCI, PETROLATUMChain Drug Marketing Association396ea654-8be1-591a-e063-6294a90a11e22025-07-08WarningsExact identifier
unii: PDC6A3C0OX
CeraVe 2 in 1 Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc7f5ff142-15cb-44be-aa0e-ccd06de233002025-07-08WarningsExact identifier
unii: R953O2RHZ5
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc38cf4e43-280b-eb96-e063-6294a90a59492025-07-02WarningsExact identifier
unii: PDC6A3C0OX
STRESS / FATIGUEADRENALINUM, PITUITARUM GLAND, THYROIDINUM, ARSENICUM ALB, CALC CARB, CONIUM, CORTISONE ACETICUM, CROTALUS HOR, FERRUM MET, NUX VOMICA, PHOSPHORICUM AC, PHOSPHORUS, SELENIUM, SEPIA, XANTHOXYLUMNatural Creations, Inc.2ab1ac84-e233-4c54-a128-a3400e13e7ca2025-07-02WarningsExact identifier
unii: E4GA8884NN
Red Scalpfixer Anti DandruffPYRINTHIONE ZINCOrange Lab, Inc386c83c3-8d23-b3b0-e063-6394a90a27ee2025-07-01WarningsExact identifier
unii: R953O2RHZ5
SEFUDUN FUNGAL NAIL PATCHESGLYCERINShenzhen Shandian Jingling Technology Co., Ltd.38db97d6-27c8-da99-e063-6294a90aac662025-07-01WarningsExact identifier
unii: PDC6A3C0OX
Stress IIEPINEPHRINE, THYROID, UNSPECIFIED, BOS TAURUS PITUITARY GLAND, POSTERIOR, ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CONIUM MACULATUM FLOWERING TOP, CORTISONE ACETATE, CROTALUS HORRIDUS HORRIDUS VENOM, IRON, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, SELENIUM, SEPIA OFFICINALIS JUICE, AND ZANTHOXYLUM AMERICANUM BARKZorex52dd7249-3ba5-4ed7-bce9-052fe3e28d102025-06-24WarningsExact identifier
unii: E4GA8884NN
Glycerin LaxativeGLYCERIN LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cc266a-196f-16ce-e063-6394a90a24af2025-06-20WarningsExact identifier
unii: PDC6A3C0OX
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 0THT5PCI0R
EyeOne CleanerHYALURONIC ACID, TOCOPHERYL ACETATEIDO PHARM37311080-b269-5ba2-e063-6394a90a2c6c2025-06-10WarningsExact identifier
unii: 9E8X80D2L0
Emetrol CherryPHOSPHORATED CARBOHYDRATEWellSpring Pharmaceutical Corporationa8469128-592a-4682-82c7-4d2a6f97a9982025-06-10WarningsExact identifier
unii: E4GA8884NN
Hair Thinning Therapy Energizing Scalp SerumHAIR THINNING THERAPY ENERGIZING SCALP SERUMGuangdong Xinjie Cosmetics Co.,Ltd.36ddf29c-8a21-af27-e063-6294a90a80152025-06-05WarningsExact identifier
unii: 5965N8W85T
Code Red Eye Drops MicroGLYCERIN AND NAPHAZOLINE HYDROCHLORIDE4 Trees LLC2a15ea9a-ff67-446b-8b83-6517d25ff38a2025-05-29WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DermaZincPYRITHIONE ZINCWynnPharm Ince71e87ba-2a62-44f3-e053-2995a90a8b112025-05-25WarningsExact identifier
unii: R953O2RHZ5
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: Z8IX2SC1OH
unii: E4GA8884NN
unii: A2I8C7HI9T

Reported adverse events (FAERS/openFDA)#

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