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 33 of 47 · 936 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
BABY FRESH SCENT PETROLEUMWHITE PETROLEUMJell Pharmaceuticals Pvt Ltd.d80d21cf-9463-7184-e053-2995a90a23f32024-12-18WarningsExact identifier
unii: 4T6H12BN9U
Health Smart Baby PetroleumWHITE PETROLEUMHome Smart Productsedd9d018-c2c9-4a9a-b727-0a92cd463c022024-12-18WarningsExact identifier
unii: 4T6H12BN9U
Health Smart Cocoa Butter PetroleumWHITE PETROLEUMHome Smart Productsa65c8267-d34f-4542-a7ca-5180e860a03d2024-12-18WarningsExact identifier
unii: 4T6H12BN9U
Princess PetroleumWHITE PETROLATUMUltra Distributors Inc.6d9c92bf-9263-40a4-acac-5c3f0b08c69d2024-12-18WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc50cc6ad-e8a0-47c1-e053-2a95a90a4de62024-12-18WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCfe18fa61-83f9-8bf9-e053-6294a90a75852024-12-18WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc59dcb2a-392b-670b-e053-2995a90a96822024-12-18WarningsExact identifier
unii: 4T6H12BN9U
TheraCare HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLVeridian Healthcarefab95657-d257-e671-e053-6294a90a59e02024-12-18WarningsExact identifier
unii: 4T6H12BN9U
Meijer Petroleum JellyWHITE PETROLATUMMeijer Distribution, Incb299cf2a-2c6a-68f4-e053-2995a90a5bd72024-12-18WarningsExact identifier
unii: 4T6H12BN9U
Caring Mills Petroleum JellyWHITE PETROLATUMVeridian Healthcarefbbfa780-0e2b-1874-e053-6394a90a5eeb2024-12-18WarningsExact identifier
unii: 4T6H12BN9U
TheraCare Petroleum JellyWHITE PETROLATUMVeridian Healthcared6fad49b-8a49-7f7c-e053-2a95a90ae6382024-12-18WarningsExact identifier
unii: 4T6H12BN9U
Shea Butter Petroleum JellyPETROLATUM JELLYWalgreense35d913e-2195-4e3d-ae38-f010317140fd2024-12-17WarningsExact identifier
unii: 4T6H12BN9U
Jell Pharmaceuticals Vitamin A DPETROLATUMJell Pharmaceuticals Pvt. Ltd.6ab8ba54-3679-4fd0-a876-cb89aace96ca2024-12-17WarningsExact identifier
unii: 4T6H12BN9U
Shea Butter Petroleum JellyPETROLATUM JELLYJell Pharmaceuticals Pvt. Ltd.cd848f33-e863-d3af-e053-2a95a90a45b12024-12-17WarningsExact identifier
unii: 4T6H12BN9U
Recticare AdvancedLIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUMFerndale Laboratories, Inc.209212a7-7b6e-4b26-9f31-0eeb76f026bf2024-12-17WarningsExact identifier
unii: 4T6H12BN9U
RECTICARELIDOCAINE AND GLYCERINFerndale Laboratories, Inc.2b94136a-4975-2925-e054-00144ff88e882024-12-17WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIRugbya5b5e0a9-eee9-2a1e-e053-2a95a90a464e2024-12-17WarningsExact identifier
unii: 4T6H12BN9U
White PetrolatumPETROLATUMGeri-Care Pharmaceuticals, Corpf40a29c2-65ea-91f9-e053-2a95a90ac4392024-12-17WarningsExact identifier
unii: 4T6H12BN9U
Vitamin A and DPETROLATUMGeri-care Pharmaceutials Corpfd76c101-a287-f92c-e053-6294a90a44682024-12-17WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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