FDA.reportPublic FDA data

VAGISIL Anti-Itch Medicated Creme Maximum Strength

Product NDC
11509-4402
11-digit product format
115094402
Labeler code
11509
Product ID
11509-4402_c2295da1-a600-4d65-98b2-6c81fb08c6c0
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine and Resorcinol
Dosage form
CREAM
Route
TOPICAL
Labeler
Combe Incorporated
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-03-01
Substance
BENZOCAINE; RESORCINOL
Active strength
200; 30 mg/g; mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
VAGISIL Anti-Itch Medicated Creme Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g
RESORCINOL30 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
YUL4LO94HKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637518Internal RxNorm lookup
1247441Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb73ebd7-ceb0-4b54-9e8f-77486d9037fbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

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 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

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

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 103 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arthritis HotMENTHOL AND METHYL SALICYLATEChattem, Inc.cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd2025-01-13WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b40dda-53ad-0458-e063-6394a90aa8352025-01-11WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b47eb7-6b43-d9e2-e063-6294a90a9a382025-01-11WarningsExact identifier
application number: M017
Re-Lieved 4% Lidocaine Fabric TapeLIDOCAINE 4% FABRIC TAPETransfer Technologye9a894b0-54f2-707e-e053-2a95a90a0f0d2025-01-11WarningsExact identifier
application number: M017
Re-Lieved 3 in 1 PatchMENTHOL, CAMPHOR, METHYL SALICYLATE PATCHTransfer Technologye9ab9a03-b9e3-7317-e053-2995a90a99502025-01-11WarningsExact identifier
application number: M017
ASTRAPHARM CHILLI BRANDCAPSAICINDersan Pharmaceutical Co., Ltdb4c2d4fd-7d5d-4156-ac27-e72ebc9671ec2025-01-10WarningsExact identifier
application number: M017
LABOFLEX Lidocaine Pain Relieving PatchLIDOCAINE 4%Laboflex, Inc.31995f31-c272-afdb-e063-6294a90af3f92025-01-10WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Chain Drug Marketing Association Inc.2b48cb2f-e6bf-f9de-e063-6394a90a42d42025-01-09WarningsExact identifier
application number: M017
PAIN-XMENTHOLOL PHARMA TECH,LLCb22bb19a-14e5-3d32-e053-2a95a90ae5202025-01-09WarningsExact identifier
application number: M017
MUSCLE RUBMENTHOLOL PHARMA TECH,LLCb22c7999-52d5-25c3-e053-2a95a90a01f52025-01-09WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMA-S Medication Solutionsce392c4f-cc43-484d-9c49-18fa25e4e5e92025-01-09WarningsExact identifier
application number: M017
NEW TEROCINMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLA-S Medication Solutions43e5eb27-5541-4b7b-80de-55a79a4dce552025-01-09WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMA-S Medication Solutionscbeac814-59d8-4c13-8e73-bca66f797f8d2025-01-09WarningsExact identifier
application number: M017
Bactine MaxLIDOCAINEWellSpring Pharmaceutical Corporationacd7ae37-7c42-4ec7-a2ef-42e7f628388d2025-01-08WarningsExact identifier
application number: M017
THERABLAST MAXIMUM RELIEFLIDOCAINE, MENTHOLReleaf Technologies LLC09809985-3a88-9bb7-e063-6394a90a2f5f2025-01-08WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONESafeway0bfa1653-76b7-48ed-a896-a0b5fc3bd7942025-01-08WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
application number: M017
Sinsin MulpasCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.22ea8a51-fdee-4650-abf8-f996268c93032025-01-07WarningsExact identifier
application number: M017
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
application number: M017
Burn JelLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesff621b46-2342-41db-994d-851a09796d082025-01-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamPSNbb73ebd7-ceb0-4b54-9e8f-77486d9037fb9
1247441Vagisil Maximum Strength 20 % / 3 % Vaginal CreamPSNbb73ebd7-ceb0-4b54-9e8f-77486d9037fb9
1247441benzocaine 200 MG/ML / resorcinol 30 MG/ML Vaginal Cream [Vagisil Original Formula]SBDbb73ebd7-ceb0-4b54-9e8f-77486d9037fb9
637518benzocaine 200 MG/ML / resorcinol 30 MG/ML Vaginal CreamSCDbb73ebd7-ceb0-4b54-9e8f-77486d9037fb9
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamSYbb73ebd7-ceb0-4b54-9e8f-77486d9037fb9
1247441Vagisil Maximum Strength (benzocaine 20 % / resorcinol 3 % ) Vaginal CreamSYbb73ebd7-ceb0-4b54-9e8f-77486d9037fb9
1247441Vagisil, Maximum Strength, Anti-Itch Topical CreamSYbb73ebd7-ceb0-4b54-9e8f-77486d9037fb9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11509-4402-1115094402011 TUBE in 1 CARTON (11509-4402-1) / 28 g in 1 TUBE1 tube1995-03-010000-00-00NoNoCurrent