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 10 of 61 · 1,207 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Suave Men Antidandruff 2 IN 1 Classic CleanANTI DANDRUFF SHAMPOO AND CONDITIONERSuave Brands Co., LLC425264b9-62a9-fd7b-e063-6294a90a37a22026-03-26WarningsExact identifier
unii: R953O2RHZ5
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: PDC6A3C0OX
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX
Pyrithione ZincPYRITHIONE ZINCNice-Pak Products, LLC4db2aaf4-5caf-d9e5-e063-6294a90aa4ea2026-03-23Warnings, Adverse reactionsExact identifier
unii: R953O2RHZ5
Dynamic BrainARGENTUM NITRICUM, CUPRUM ACETICUM, GINKGO BILOBA, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, THIAMINUM HYDROCHLORICUM, CEREBRUM SUIS, AMBRA GRISEA, PICRICUM ACIDUM, AGNUS CASTUS, ALUMINA, ANACARDIUM ORIENTALE, BARYTA CARBONICA, CICUTA VIROSA, CONIUM MACULATUM, HELLEBORUS NIGER, PLUMBUM METALLICUM, SELENIUM METALLICUM, ZINCUM METALLICUMDeseret Biologicals, Inc.60a1e44b-3f91-41de-82c2-4648fb800dcd2026-03-19WarningsExact identifier
unii: E4GA8884NN
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AdaptagenARALIA QUINQUEFOLIA, AVENA SATIVA, CAPSICUM ANNUUM, GINKGO BILOBA, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, THIAMINUM HYDROCHLORICUM, ASCORBICUM ACIDUM, RIBOFLAVINUM, GLANDULA SUPRARENALIS SUIS, SPLEEN (SUIS), THYROIDINUM (SUIS), CUPRUM GLUCONATE, IODIUM, LEDUM PALUSTRE, MOLYBDENUM METALLICUM, NATRUM CARBONICUM, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, SELENIUM METALLICUM, SEPIA, VANADIUM METALLICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUMBioActive Nutritional, Inc.9404d71c-8a2e-4e68-bf48-8536bb14fc882026-03-18WarningsExact identifier
unii: E4GA8884NN
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERBryant Ranch Prepackf9f15374-4809-4b96-8a07-3c2f1011d1102026-03-18WarningsExact identifier
unii: 9E8X80D2L0
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
DrainageECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHURBioActive Nutritional, Inc.7e573986-60c2-40df-9e28-e7f1d9fe1a992026-03-13WarningsExact identifier
unii: E4GA8884NN
Head and Shoulders Itchy ScalpPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company54df1acc-4265-494c-879e-c690184d7ae22026-03-13WarningsExact identifier
unii: R953O2RHZ5
2 in 1 DandruffPYRITHIONE ZINCH E Ba58b9119-2adb-459f-86f4-95df28a430c52026-03-13Warnings, Adverse reactionsExact identifier
unii: R953O2RHZ5
Dry Scalp CarePYRITHIONE ZINCBetter Living Brands, LLCf90d1fb2-4bd7-4d70-81b4-4541f4e3a3d62026-03-13Warnings, Adverse reactionsExact identifier
unii: R953O2RHZ5
Head and Shoulders Smooth and Silky ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4cec08cb-aba5-41ce-e063-6294a90adfdf2026-03-13WarningsExact identifier
unii: R953O2RHZ5
DandruffPYRITHIONE ZINCNice-Pak Products, LLC3c55b70f-7627-8667-e063-6394a90a5cf82026-03-12Warnings, Adverse reactionsExact identifier
unii: R953O2RHZ5
Head and Shoulders 2in1 Classic CleanPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company65a4082f-227b-49bf-b88c-b1c651ed13a02026-03-12WarningsExact identifier
unii: R953O2RHZ5
Head and Shoulders Green Apple 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyc036c9a6-6507-4037-b97b-1b015dd950c12026-03-12WarningsExact identifier
unii: R953O2RHZ5
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Glucoseforce HPCOLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM, URANIUM NITRICUMBioActive Nutritional, Inc.f1e89586-02ed-4b29-9902-12b17c01bee92026-03-09WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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