FDA.reportPublic FDA data

VAGISIL Anti-Itch Creme Regular Strength

Product NDC
11509-5103
11-digit product format
115095103
Labeler code
11509
Product ID
11509-5103_c557751a-53ba-467c-8bf8-2ef3c03c07b7
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
2016-01-01
Substance
BENZOCAINE; RESORCINOL
Active strength
50; 20 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 Creme Regular Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE50 mg/g
RESORCINOL20 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
243587Internal RxNorm lookup
849742Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dd303ff8-0deb-4292-bfd8-5bda91f86d51Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ee8a2ab-68f9-45f5-8e16-b382e1af7d34Product name120200618
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11509-5103-1VAGISIL Anti-Itch Creme Regular Strength28 g in 1 TUBECREAM284
11509-5103-1VAGISIL Anti-Itch Creme Regular Strength1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11509-5103-1GM - Gram11509-510336c64803-4748-45e9-9b32-08c97b1f373212022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11509-5103VAGISIL ANTI-ITCH CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4Current NDC, Legacy NDC, 2 package rows20241211_dd303ff8-0deb-4292-bfd8-5bda91f86d51.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 49 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum OTC Strength Feminine Anti-Itch CremeBENZOCAINE, RESORCINOLQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)0e9a711c-ddf4-af63-e063-6294a90a0ebe2025-12-29WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEHarris Teeter3f5b4eee-49c4-408c-9af2-e7924c26ac632025-12-29WarningsExact identifier
application number: M017
talc-free medicated bodyMENTHOLDavion, Inc27b9b4dc-4d4f-4e9d-b388-a7c6807a0e9b2025-12-29WarningsExact identifier
application number: M017
H-E-B Medicated Corn Starch Foot PowderMENTHOLDavion, Inca6675e00-bc6b-4466-a283-4cece5f919702025-12-29WarningsExact identifier
application number: M017
Maximum Strength Medicated Foot PowderMENTHOLDavion, Inc7b442d99-ac19-4f65-828d-954c5350ef5a2025-12-29WarningsExact identifier
application number: M017
HEB Medicated Cornstarch Body PowderMENTHOLDavion, Incdf1331fb-48df-4f21-8564-0468078fd12d2025-12-29WarningsExact identifier
application number: M017
Honest Med Capsaicin PatchCAPSAICINProper Buys LLC30169d44-b1b2-5c0f-e063-6294a90ae1592025-12-28WarningsExact identifier
application number: M017
Honest Med Lidocaine Lavender Roll-onLIDOCAINE HCLProper Buys LLC2dcd40a9-3fdd-a71e-e063-6294a90a704f2025-12-28WarningsExact identifier
application number: M017
Honest Med Lidocaine Pain Relief PatchLIDOCAINEProper Buys LLC13a5243f-7116-e4da-e063-6394a90aa5432025-12-28WarningsExact identifier
application number: M017
CVS Health Pain-Relieving PatchMENTHOL, METHYL SALICYLATE, CAMPHORCVS Pharmacy, Inc.1f90899c-eeca-2362-e063-6294a90aa0da2025-12-28WarningsExact identifier
application number: M017
CVS Health Cooling PatchMENTHOLCVS Pharmacy, Inc1f90cefe-bcce-5e17-e063-6294a90a57362025-12-28WarningsExact identifier
application number: M017
Point Relief LidoSpot with MentholLIDOCAINE, MENTHOLFabrication Enterprisesf0c69693-bfea-4006-9620-63b222d25d382025-12-28WarningsExact identifier
application number: M017
DISCOUNT DRUG MART PAIN RELIEF PATCHESLIDOCAINEDiscount Drug Mart, Ince36e7d0a-d554-4601-b535-b41ee84a6b242025-12-28WarningsExact identifier
application number: M017
Medicated Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEDiscount Drug Mart, Incc01e1a14-bfbc-4c52-8a67-b77acf2d88532025-12-28WarningsExact identifier
application number: M017
TopCare Pain Relief PatchLIDOCAINE, MENTHOLTopco Associates LLCd4c89c4f-d69a-7786-e053-2995a90a71e72025-12-28WarningsExact identifier
application number: M017
Kroger Lidocaine Pain RelievingLIDOCAINE HCLKroger Company12d94ba6-56ac-3816-e063-6394a90a44c62025-12-28WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEAhold U.S.A., Inc,7e7a813e-424d-4a78-9c72-541c3c62606a2025-12-28WarningsExact identifier
application number: M017
Amazon Basics Cold and Hot Medicated PatchMENTHOLAmazon.com Services LLCe3b4db12-c846-b984-e053-2a95a90a8e9a2025-12-28WarningsExact identifier
application number: M017
Amazon Basics Pain Relief Patch with 4% LidocaineLIDOCAINEAmazon.com Services LLCe3b4f9b1-ac6b-cb2a-e053-2a95a90a9e1e2025-12-28WarningsExact identifier
application number: M017
Absorbine Jr Neck and ShoulderABSORBINE JR NECK AND SHOULDERClarion Brands LLC22f2f191-9146-3075-e063-6394a90aef5f2025-12-28WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
243587benzocaine 5 % / resorcinol 2 % Vaginal CreamPSNdd303ff8-0deb-4292-bfd8-5bda91f86d514
849742Vagisil Original Strength 5 % / 2 % Vaginal CreamPSNdd303ff8-0deb-4292-bfd8-5bda91f86d514
849742benzocaine 50 MG/ML / resorcinol 20 MG/ML Vaginal Cream [Vagisil Original Formula]SBDdd303ff8-0deb-4292-bfd8-5bda91f86d514
243587benzocaine 50 MG/ML / resorcinol 20 MG/ML Vaginal CreamSCDdd303ff8-0deb-4292-bfd8-5bda91f86d514
849742Benzal Vagisil Creme Regular Strength (benzocaine 5 % / resorcinol 2 % ) Vaginal CreamSYdd303ff8-0deb-4292-bfd8-5bda91f86d514
243587benzocaine 5 % / resorcinol 2 % Vaginal CreamSYdd303ff8-0deb-4292-bfd8-5bda91f86d514
849742Vagisil Original Strength (benzocaine 5 % / resorcinol 2 % ) Vaginal CreamSYdd303ff8-0deb-4292-bfd8-5bda91f86d514
849742Vagisil, Original Strength, Anti-Itch Topical CreamSYdd303ff8-0deb-4292-bfd8-5bda91f86d514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11509-5103-1115095103011 TUBE in 1 CARTON (11509-5103-1) / 28 g in 1 TUBE1 tube2016-01-010000-00-00NoNoCurrent