NDC 11509-4402-01 - VAGISIL Anti-Itch Medicated Creme Maximum Strength

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
11509-4402
Requested NDC
11509-4402-01
Package NDCs from labels
11509-4402-1, 11509-4402-01
Manufacturer
Combe Incorporated
Effective date
2024-12-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VAGISIL Anti-Itch Medicated Creme Maximum Strength - Combe IncorporatedCombe Incorporated2024-12-12HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11509-4402-12020-04-20C16284748780-19d75b9d0-ed22-f424-e053-dadaa90a57ceVagisil Maximum Strength Anti-Itch Creme
11509-4402-12020-01-31C16284748780-19d75b9d0-ed22-f424-e053-dadaa90a57ceVagisil Maximum Strength Anti-Itch Creme

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11509-4402-1VAGISIL Anti-Itch Medicated Creme Maximum Strength1 in 1 CARTONCREAM19
11509-4402-1VAGISIL Anti-Itch Medicated Creme Maximum Strength28 g in 1 TUBECREAM289

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11509-4402VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]9Current NDC, Legacy NDC, 2 package rows20241211_bb73ebd7-ceb0-4b54-9e8f-77486d9037fb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11509-4402-1GM - Gram11509-4402220844e9-5407-48f4-922a-790ee69a58f412022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
RESORCINOLACTIVE INGREDIENTYUL4LO94HKVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
BENZOCAINEACTIVE MOIETYU3RSY48JW5VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
RESORCINOLACTIVE MOIETYYUL4LO94HKVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK31VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
CORN OILINACTIVE INGREDIENT8470G57WFMVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
ISOPROPYL STEARATEINACTIVE INGREDIENT43253ZW1MZVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
TRISODIUM HEDTAINACTIVE INGREDIENTK3E0U7O8KIVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4
WATERINACTIVE INGREDIENT059QF0KO0RVAGISIL ANTI-ITCH MEDICATED CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4

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 5 of 201 · 4,017 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedPrideHYDROCORTISONEShield Line LLC2f15d3b3-d1e6-4742-9eac-f956c0ffbba42026-08-18WarningsExact identifier
application number: M017
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Pain Relieving Cream AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEGarcoa, Inc.2f736307-5cd4-4a76-9044-4aeecba096cc2026-08-18WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll onPAIN RELIEF ROLL ONNeilMed Pharmaceuticals Inc58ff9d2d-99e6-8f98-e063-6394a90a8de72026-08-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1/2%Sun Pharmaceutical Industries, Inc.59337940-c9be-58af-e063-6394a90abe132026-08-16WarningsExact identifier
application number: M017
SIERQ NumbingMENTHOLPutian Licheng District Zhijiancheng Trading Co., Ltd.5936c070-d8e4-56e8-e063-6294a90a56002026-08-16WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5911d9b0-1acb-3546-e063-6294a90adb3a2026-08-15WarningsExact identifier
application number: M017
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5905b300-6f1f-a61f-e063-6394a90a11232026-08-14WarningsExact identifier
unii: T5L8T28FGP
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology59072f05-eefa-d823-e063-6394a90a0e1a2026-08-14WarningsExact identifier
application number: M017
JJ Care First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCINantong Health & Beyond Hygienic Products Inc.c41621fb-c549-4394-a4cb-cb81ef8c98df2026-08-13WarningsExact identifier
application number: M017
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
application number: M017
CVS Pain Relief Roll-On Lidocaine with LavenderLIDOCAINE HYDROCHLORIDECVS Pharmacy4aa53176-2103-b47b-e063-6394a90ac7352026-08-12WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC5384e80f-c242-76a1-e063-6294a90aba0b2026-08-12WarningsExact identifier
application number: M017
RELIBONEOintmentTOPICAL ANALGESICOINTMENTGuangdong Jiaoyu Biotechnology Co., Ltd58ddaaf6-18ec-8c5b-e063-6294a90a28282026-08-12WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58de3a29-2bec-6e44-e063-6394a90a9c1a2026-08-12WarningsExact identifier
application number: M017
Mineral oilMINERAL OILEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)92f2147d-b52d-4282-b217-28f6095dca0e2026-08-12WarningsExact identifier
unii: T5L8T28FGP
HYDROCORTISONEHYDROCORTISONEAmazon.com Services LLCf40b4223-e81f-4cd0-bc9b-d3d33ce8cce52026-08-12WarningsExact identifier
application number: M017

Reported adverse events (FAERS/openFDA)#

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