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 7 of 201 · 4,017 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PNV PrenatolMULTIVITAMINPureTek Corporation583f0194-0306-f31b-e063-6394a90a2a102026-08-06Warnings, Adverse reactionsExact identifier
unii: 1C6V77QF41
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECardinal Health, 110 dba Leader3ed7b8a1-012f-459d-878c-813b93d4673c2026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLThe Kroger Co.6fb0acc8-8dab-452c-b09e-de97306e1c322026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Lidocaine Tattoo WipeLIDOCAINE HYDROCHLORIDEMD Tattoo Company369c1d16-597c-e1dc-e063-6394a90a31042026-08-06WarningsExact identifier
application number: M017
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.5868c5a1-273f-f023-e063-6394a90ac9d82026-08-06WarningsExact identifier
unii: U3RSY48JW5
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58690bb5-9604-26a4-e063-6394a90afdbe2026-08-06WarningsExact identifier
unii: U3RSY48JW5
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586918cf-7b13-5999-e063-6294a90a88a92026-08-06WarningsExact identifier
unii: U3RSY48JW5
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586924a0-322d-5dc3-e063-6294a90a15562026-08-06WarningsExact identifier
unii: U3RSY48JW5
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58692e90-de74-52d3-e063-6394a90a97022026-08-06WarningsExact identifier
unii: U3RSY48JW5
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586937ae-46af-7066-e063-6294a90ae53e2026-08-06WarningsExact identifier
unii: U3RSY48JW5
ROROBELL WAWA Kids Tooth Natural Green Grape FlavorHYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEROROBELL586b499d-23bf-0116-e063-6394a90aa7d42026-08-06WarningsExact identifier
unii: 9E8X80D2L0
Non-proprietary nameHEADACHE PATCHNanjing 3H Medical Products Co.,Ltd.586d73f1-0b0b-f596-e063-6394a90a4d572026-08-06WarningsExact identifier
application number: M017
Point Relief Coldspot Pain RelievingMENTHOLFabrication Enterprises Inc479fb728-4aeb-42e3-b238-f04255514baa2026-08-05WarningsExact identifier
application number: M017
Dealmed BurnLIDOCAINEDealmed Medical Supplies, LLC.3b5f7ded-c275-4d7f-9fd4-539797d5507e2026-08-05WarningsExact identifier
application number: M017
Mineral OilMINERAL OILOld East Main Co.4bae831d-caba-40c9-bdb5-2611eac35dd52026-08-05Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Lidocaine HClLIDOCAINE HCLTopco Associates LLC584e1f35-4d99-9c85-e063-6294a90ab3d02026-08-05Warnings, Adverse reactionsExact identifier
application number: M017
Hempe HOT Muscle and Joint GelHEMPEHealthcare International Research Limited5854a80e-c92b-3ff5-e063-6294a90a2d052026-08-05WarningsExact identifier
application number: M017
Lidocaine Plantar Relief Roll-OnLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.585ccb4b-3bff-39b9-e063-6294a90a0e182026-08-05WarningsExact identifier
application number: M017
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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