FDA.reportPublic FDA data

NDC 64539-003-01 - Glyzigen Gel Intimate

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
64539-003
Requested NDC
64539-003-01
Package NDCs from labels
64539-003-01, 64539-003-02
Manufacturer
Catalysis, SL
Effective date
2017-05-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glyzigen Gel Intimate - Catalysis, SLCatalysis, SL2017-05-07HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64539-003-022020-01-31C16284748780-19d75b9d0-835f-f424-e053-dadaa90a57ceGlyzigen Intimate Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64539-003-01Glyzigen Gel Intimate250 mL in 1 BLISTER PACKGEL2501
64539-003-02Glyzigen Gel Intimate1 in 1 BOTTLEGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64539-003GLYZIGEN GEL INTIMATE (GLYCERIN) GEL [CATALYSIS, SL]1Legacy NDC, 2 package rows20170508_4ef54518-1fcd-4c71-e054-00144ff8d46c.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 18 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMMeijer Distribution Incfb170371-2e5d-43ca-a259-538a973ee3b82024-10-15WarningsExact identifier
unii: PDC6A3C0OX
topcare hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMTopco Associates LLC5e13da07-48cf-40bc-bb11-fd891886cbea2024-10-14WarningsExact identifier
unii: PDC6A3C0OX
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
Bliss GVSGLYCERINBliss GVS Pharma Limited1a3982a1-9ce9-4a1a-ba73-ebe2d86471092024-10-10WarningsExact identifier
unii: PDC6A3C0OX
SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEZydus Pharmaceuticals USA Inc.204e84a7-5440-4537-9e40-06eb56c415e92024-09-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Sodium Phenylacetate and sodium benzoateSODIUM PHENYLACETATE AND SODIUM BENZOATENavinta LLCfbc7bfe3-6faa-45a3-befb-9ad7963c05712024-09-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 368GB5141J
hemorrhoidal maximum strength pain reliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMKroger Company3c8f90e2-fecf-4439-9faa-81a32ffe47532024-09-26WarningsExact identifier
unii: PDC6A3C0OX
equate hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWal-Mart Stores Inc5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d2024-09-26WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Hemorrhoidal Pain ReliefGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Walgreense79ed7ae-0d06-2f88-e053-2995a90a1e352024-09-20WarningsExact identifier
unii: PDC6A3C0OX
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: PDC6A3C0OX
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Up and Up Hemorrhoid MAX STRENGTH14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUMTarget Corporation867677b5-fd1d-449e-966e-1de0b5c98afb2024-08-08WarningsExact identifier
unii: PDC6A3C0OX
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Zenibell Snail IntensiveCreamGLYCERINMISOCOS97c19dca-237c-c968-e053-2a95a90aeae72024-07-05WarningsExact identifier
unii: PDC6A3C0OX
Zenibell Snail Intensive TonerGLYCERINMISOCOS97c1b556-824d-bef7-e053-2a95a90ae1f22024-07-05WarningsExact identifier
unii: PDC6A3C0OX
aewajin Derma HydrocellGLYCERINMISOCOS980fcaea-27ba-da49-e053-2995a90ad5062024-07-05WarningsExact identifier
unii: PDC6A3C0OX
aewajin Derma Hydrocell 24k Gold SerumGLYCERINMISOCOSa17b2c6e-9db8-bae4-e053-2a95a90adcf62024-07-05WarningsExact identifier
unii: PDC6A3C0OX
Bunnies Bum Soothing HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLFloCal Distributors LLC1c81582c-7ece-182f-e063-6294a90a8fbc2024-07-05WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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