FDA.reportPublic FDA data

NDC 68462-536-01 - Imiquimod

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
68462-536
Requested NDC
68462-536-01
Package NDCs from labels
68462-536-01, 68462-536-70
Manufacturer
Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited
Effective date
2025-01-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Imiquimod - Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited2025-01-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-536-01Imiquimod0.25 g in 1 PACKETCREAM0.2512
68462-536-70Imiquimod24 in 1 CARTONCREAM2412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-536IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA]11Current NDC, Legacy NDC, 2 package rows20240104_663e39a9-a29e-473f-89ec-4c7c6bc27b8a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-536-01EA - Each68462-53643d87bb5-3fbf-48c4-bb53-9968a5ae7a1912026-03-17
68462-536-70EA - Each68462-536d66c4bc1-47cd-4df9-9bb6-4c2ceff7422912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IMIQUIMODACTIVE INGREDIENTP1QW714R7MIMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
IMIQUIMODACTIVE MOIETYP1QW714R7MIMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHIMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNIMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U0062IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TIMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UIMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MIMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHIMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XIMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YIMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
WATERINACTIVE INGREDIENT059QF0KO0RIMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA]5
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA]5

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 38 of 47 · 936 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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: 4T6H12BN9U
unii: PDC6A3C0OX
Zenibell Snail IntensiveGLYCERINMISOCOS97747267-26f1-d06f-e053-2a95a90ab0872024-07-04WarningsExact identifier
unii: PDC6A3C0OX
Lip Medex Lip BalmPETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.988f97e8-a59f-4bc0-9d71-60607364a6862024-07-01WarningsExact identifier
unii: 4T6H12BN9U
Lip Medex CherryPETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORMBlistex Inc.fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af82024-06-28WarningsExact identifier
unii: 4T6H12BN9U
Astonea Vitamin A and DWHITE PETROLATUMASTONEA LABS PRIVATE LIMITEDef7c357b-5ff6-b9d7-e053-2a95a90a1dcf2024-06-25WarningsExact identifier
unii: 4T6H12BN9U
ABREVA Rapid Pain ReliefGLYCERIN, LIDOCAINEHaleon US Holdings LLC65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d2024-06-20WarningsExact identifier
unii: PDC6A3C0OX
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
MegaBabe Butt Stuff HemorrhoidalCOCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEMEGABABE, LLC01c156ff-69f9-4d5e-a9ea-abbc52d4afff2024-06-12WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
Secura ProtectivePETROLATUMSmith & Nephew Medical Ltd20906566-fbf2-46d9-a5d8-c7f7356d10802024-06-12WarningsExact identifier
unii: 4T6H12BN9U
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CVS Health Vitamin A and D Skin ProtectantLANOLIN AND PETROLATUMCVS Healthfe3ccabb-9644-4091-9dca-ffd96a43ecaf2024-05-28WarningsExact identifier
unii: 4T6H12BN9U
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
unii: LKG8494WBH
FleetGLYCERINC.B. Fleet Company, Inc.381f4179-0c3b-41f8-927c-c88534ebe06d2024-05-06WarningsExact identifier
unii: PDC6A3C0OX
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
unii: LKG8494WBH
Petrolatum JellyPETROLATUMASTONEA LABS PRIVATE LIMITED16dac8e5-aeb8-592d-e063-6394a90ae2b62024-04-24WarningsExact identifier
unii: 4T6H12BN9U
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
ChapStick Classic SpearmintPETROLATUMHaleon US Holdings LLCd39786e8-bcd8-479d-8990-142a21788a472024-04-12WarningsExact identifier
unii: 4T6H12BN9U
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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