FDA.reportPublic FDA data

NDC 0168-0432-27 - 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
0168-0432
Requested NDC
0168-0432-27
Package NDCs from labels
0168-0432-27, 0168-0432-24
Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Effective date
2015-07-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
imiquimod - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.2015-07-15HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0432-242024-01-30C16284748780-11030e365-5959-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Imiquimod Cream safely and effectively. See full prescribing information for IMIQUIMOD Cream. IMIQUIMOD Cream 5% For topical use only Initial U.S. Approval: 1997

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0432-24EA - Each0168-04321dc4a498-8b02-4860-989b-40064739ab8212012-07-24
0168-0432-27EA - Each0168-043221ec68b6-6fb9-4927-84ac-f79964e8625e12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
imiquimodACTIVE INGREDIENTP1QW714R7MIMIQUIMOD CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13
imiquimodACTIVE MOIETYP1QW714R7MIMIQUIMOD CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHIMIQUIMOD CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13
cetyl alcoholINACTIVE INGREDIENT936JST6JCNIMIQUIMOD CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13
glycerinINACTIVE INGREDIENTPDC6A3C0OXIMIQUIMOD CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13
methylparabenINACTIVE INGREDIENTA2I8C7HI9TIMIQUIMOD CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13
oleic acidINACTIVE INGREDIENT2UMI9U37CPIMIQUIMOD CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13
petrolatumINACTIVE INGREDIENT4T6H12BN9UIMIQUIMOD CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MIMIQUIMOD CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHIMIQUIMOD CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XIMIQUIMOD CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YIMIQUIMOD CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13
waterINACTIVE INGREDIENT059QF0KO0RIMIQUIMOD CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13
xanthan gumINACTIVE INGREDIENTTTV12P4NEEIMIQUIMOD CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13
IMIQUIMODACTIVE INGREDIENTP1QW714R7MIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
IMIQUIMODACTIVE MOIETYP1QW714R7MIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIMIQUIMOD CREAM [PHYSICIANS TOTAL CARE, INC.]1

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 3 of 48 · 960 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProCure HydroShieldPETROLATUM 44.28%Twin Med LLC3ab7bfb2-bbcf-0822-e063-6294a90af0842026-08-03WarningsExact identifier
unii: 4T6H12BN9U
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
unii: 4T6H12BN9U
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
unii: 4T6H12BN9U
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: LKG8494WBH
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
Baby Vitamin A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a125ea-6f9f-310c-e063-6394a90acef22026-07-22WarningsExact identifier
unii: 4T6H12BN9U
First Aid A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a319d0-d39a-5ff0-e063-6394a90a671d2026-07-22WarningsExact identifier
unii: 4T6H12BN9U
CAREALL Vitamin A and DPETROLATUMNew World Imports, Incef89a68a-74c1-4c42-8078-b7a208ace0de2026-07-22WarningsExact identifier
unii: 4T6H12BN9U
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
iShancare Hemorrhoid and Fissure CreamISHANCARE HEMORRHOID CREAMShenzhen Ishan Technology Co., Ltd570775ce-a1ed-e57d-e063-6394a90aeeff2026-07-20WarningsExact identifier
unii: 4T6H12BN9U
Ma Ying Long Musk HemorrhoidsPETROLATUM, ZINC OXIDEMayinglong Pharmaceutical Group Co., Ltd.af466f21-c4bc-3b89-e053-2995a90a49f22026-07-20WarningsExact identifier
unii: 4T6H12BN9U
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC3e61191a-e0fa-3477-e063-6294a90a7d192026-07-14WarningsExact identifier
unii: 4T6H12BN9U
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC459a90b8-7d52-ef70-e063-6394a90ac1d02026-07-14WarningsExact identifier
unii: 4T6H12BN9U
HOMWIS CreamHOMWIS CREAMShenzhen Ishan Technology Co., Ltd51aeec61-bddd-fea1-e063-6394a90a2e0b2026-07-09WarningsExact identifier
unii: 4T6H12BN9U
Drs pharmacy HEMORRHOIDALPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACY164169b9-0627-9d1a-e063-6294a90ac46d2026-07-09WarningsExact identifier
unii: 4T6H12BN9U
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Baby Healing BalmPETROLATUMWalgreens561c1e1e-e896-d6e9-e063-6394a90ac0e72026-07-08WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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