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 47 of 47 · 936 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VUSIONMICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUMMylan Pharmaceuticals Inc.b44b452d-3630-4cb5-8ed1-1f8edac4690c2018-08-15Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
VUSIONMICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUMMylan Pharmaceuticals Inc.b026bc7d-3a18-41e8-88c4-1e063cd2f42c2018-08-14Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Natures Choice Vitamins A and DA AND D OINTMENTUnipack, Inc.17861122-2231-4a54-b3d8-894153c708d72018-01-15WarningsExact identifier
unii: 4T6H12BN9U
Ivy-Dry SuperBENZYL ALCOHOL, CAMPHOR, MENTHOLIvy-Dry, Inc.4792a667-2378-4b3d-968d-9efb1866792f2017-12-27WarningsExact identifier
unii: LKG8494WBH
Vitamin A and DLANOLIN AND PETROLATUMFamily Dollar Services Inc4826b36d-3326-4f5c-8b22-c5ff79e550622017-11-08WarningsExact identifier
unii: 4T6H12BN9U
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
unii: LKG8494WBH
unii: 2KR89I4H1Y
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FIND BICHON CLEANSING MASKGLYCERINPioom Cosmetic Co.,ltd50b7db48-7b55-6df4-e054-00144ff88e882017-05-30WarningsExact identifier
unii: PDC6A3C0OX
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
CVS Health Original SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMCVS6d58a18c-62ba-4cee-b3cc-51db746ba50e2016-09-14WarningsExact identifier
unii: 4T6H12BN9U
CVS Health Cherry SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMCVS84a621fe-890e-4c88-9f26-f013c32b52b72016-09-14WarningsExact identifier
unii: 4T6H12BN9U
CVS Health Cherry SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMCVSbfbf0241-51a6-4d9d-bee1-741d1645037d2016-09-14WarningsExact identifier
unii: 4T6H12BN9U
CVS Health Original SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMCVSe49680bd-bd61-40cf-abc8-51a1c88087262016-09-14WarningsExact identifier
unii: 4T6H12BN9U
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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