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 34 of 60 · 1,191 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hormone BalanceACETALDEHYDE, DOPAMINE HYDROCHLORIDE, DHEA (DEHYDROEPIANDROSTERONE), 7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, FOLLICULINUM, OOPHORINUM (SUIS), CHOLESTERINUM, PROGESTERONE, TESTOSTERONE, CORTISONE ACETICUM, ALDOSTERONE, ANDROSTERONE, FOLLICLE STIMULATING HORMONEDr. Donna Restivo DC421707d6-31c1-4d57-b017-796fc872efe42025-05-23WarningsExact identifier
unii: 97C5T2UQ7J
Tagrid ANTI FUNGALZINC PYRITHIONE,SALICYLIC ACIDTAGRID LLC3376b104-1f07-fab3-e063-6394a90a0ca42025-05-22WarningsExact identifier
unii: R953O2RHZ5
Adrenal TonicARALIA QUINQUEFOLIA, GLYCYRRHIZA GLABRA, SARSAPARILLA, AVENA SATIVA, GLANDULA SUPRARENALIS BOVINE, ADRENALINUM, ARSENICUM ALBUM, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, VERATRUM ALBUMBioActive Nutritional, Inc.2bbf65e2-47b9-46d3-a8de-69bc543783f82025-05-20WarningsExact identifier
unii: E4GA8884NN
Biotrue Hydration BoostGLYCERINBausch & Lomb Incorporatede2621477-e6ee-4275-ba0a-939dca2550c42025-05-19WarningsExact identifier
unii: PDC6A3C0OX
HepastatBETA VULGARIS, CARDUUS MARIANUS, TARAXACUM OFFICINALE, CHOLESTERINUM, FEL TAURI, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.d75ab44f-49cb-4a90-9e92-42457c6033192025-05-19WarningsExact identifier
unii: 97C5T2UQ7J
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.3c4c3e7f-0ef9-4de0-b0bf-97fe7f6a527c2025-05-16WarningsExact identifier
unii: PDC6A3C0OX
ApnetemPHOSPHORICUM ACIDUM, ALUMEN, PHOSPHORUS, SENEGA OFFICINALIS, ADENOSINUM CYCLOPHOSPHORICUM, ANTIMONIUM TARTARICUM, GRINDELIA, SABADILLA, ALUMINA, CUPRUM METALLICUM, SANGUINARINUM NITRICUM, SILICEA, LACHESIS MUTUS, RHEUM (PALMATUM), ZINCUM METALLICUM, LYCOPODIUM CLAVATUM, MANGANUM PHOSPHORICUM, ANTIPYRINUM, COENZYME ANucleic Products, LLCec5bc7e7-4be6-45a6-8cd9-62fdfa7fb4692025-05-14WarningsExact identifier
unii: E4GA8884NN
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
SUKKHI Polyamino Sugar Condensate Massage CreamSUKKHI POLYAMINO SUGAR CONDENSATE MASSAGE CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd34aaf4ef-26dc-f87e-e063-6394a90a9a592025-05-08WarningsExact identifier
unii: PDC6A3C0OX
PhexxLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.14b01a15-9b47-4be3-bb2e-a2010eab429e2025-05-02Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.125ffbf4-681e-451c-a96d-0b64166194742025-04-29WarningsExact identifier
unii: PDC6A3C0OX
TricitratesTRICITRATESChartwell RX, LLC2a80ea6b-6334-4c33-a35e-a5cb2939fbcb2025-04-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and MintPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3344c97b-8767-3f87-e063-6394a90a4f5d2025-04-21WarningsExact identifier
unii: R953O2RHZ5
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa ButterPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3346e2c5-af28-74ad-e063-6394a90abbab2025-04-21WarningsExact identifier
unii: R953O2RHZ5
Structure of Skin Soothing Anti-DandruffPYRITHIONE ZINCSTRUCTURE OF SKIN LLC3311fa83-a06b-b379-e063-6394a90ae2692025-04-18WarningsExact identifier
unii: R953O2RHZ5
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell RX, LLC978a5a9d-f0ca-4308-a84b-3b132263bbb82025-04-09Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
XtraCare Anti-Dandruff Hair Cleanse for normal hairPYRITHIONE ZINCRejoice International Inc.b90e574c-933c-4f86-aadc-567ffbe6ea042025-04-09WarningsExact identifier
unii: R953O2RHZ5
XtraCare Anti-Dandruff Hair Cleanse for sensitive hairPYRITHIONE ZINCRejoice International Inc.979394c2-5681-44c8-a43c-bf3a392bd0c12025-04-09WarningsExact identifier
unii: R953O2RHZ5
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Alka-Seltzer Heartburn Relief Lemon LimeANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCcc21af24-9a5b-6831-e053-2a95a90a0af42025-04-01WarningsExact identifier
unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

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