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VAGISIL Anti-Itch Creme Regular Strength Benzocaine and Resorcinol 50 mg/g; 20 mg/g Cream — NDC 11509-5103-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

VAGISIL Anti-Itch Creme Regular Strength Benzocaine and Resorcinol 50 mg/g; 20 mg/g Cream — NDC 11509-5103-1 (Billing 11509-5103-01)

by Combe Incorporated · 1 TUBE in 1 CARTON / 28 g in 1 TUBE

This is a package of VAGISIL Anti-Itch Creme Regular Strength Benzocaine and Resorcinol 50 mg/g; 20 mg/g Cream from Combe Incorporated, marketed since Jan 2016 and currently FDA-listed. It is this product's only package size.

NDC 11509-5103-01
🏷️ FDA NDC (as labeled) 11509-5103-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 11509-5103-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
11509 labeler · 5103 product · 1 package
Package marketed since
Jan 1, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1150951031 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11509-5103-1
Product NDC 11509-5103
11-digit billing NDC 11509510301
NCPDP billing unit GM — per gram (weight)
RxCUI 243587, 849742
UNII U3RSY48JW5, YUL4LO94HK
Application # M017
SPL Set ID dd303ff8-0deb-4292-bfd8-5bda91f86d51
Established class (EPC) Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-01-01
Route TOPICAL
Dosage form CREAM
Substance BENZOCAINE; RESORCINOL
Quick answers
  • RxCUI (RxNorm): 243587
Why two NDCs? The FDA registers this code as 11509-5103-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 11509-5103-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Standardized Chemical Allergen class.

Pharmacologic class Standardized Chemical Allergen
Drug family (ATC) Local anesthetics, Anesthetics for topical use, Esters of aminobenzoic acid
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

🧪 What is this product?

Vagisil Anti-Itch Creme is a topical cream marketed as an over-the-counter monograph drug. It contains benzocaine, a local anesthetic, and resorcinol, an antimicrobial and keratolytic agent. These ingredients are typically used together to help relieve itching and irritation in the vaginal area. This product is not individually reviewed by the FDA but is marketed under the agency's established rules for nonprescription vaginal itch-relief products.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
11509-5103-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 28 g in 1 TUBE 2016-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
VAGISIL Anti-Itch Creme Regular Strength 50 mg/g; 20 mg/gthis 11509-5103-01 Combe 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2016
On the market since
Jan 2016
📍
2026
Currently FDA-listed
10 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCombe Incorporated
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code11509
First marketedJan 2016
Product typeHuman Otc Drug
Portfolio8 products on file

More NDCs from Combe Incorporated labeler code 11509

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 4 words ▾

Use temporarily relieves itching

⏱️ Dosage and Administration 49 words ▾

Directions adults and children 12 years and older apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. Clean nozzle of tube by wiping thoroughly before replacing cap. Keep cap tightly closed between uses. children under 12 years consult a doctor

⚠️ Warnings 64 words ▾

Warnings For external use only Avoid contact with eyes Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days Do not apply over large areas of the body Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 8 words ▾

Active ingredient Benzocaine 5%

Active ingredient Resorcinol 2%

🧪 Inactive Ingredients 42 words ▾

Inactive ingredients Water, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Mineral Oil, Isopropyl Palmitate, Lactitol, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Retinyl Palmitate, Zea Mays (Corn) Oil, Cholecalciferol, Lanolin Alcohol, Fragrance, Methylparaben, Carbomer, Isopropyl Myristate, Isopropyl Stearate, Sodium Sulfite, Triethanolamine, Trisodium HEDTA, Maltodextrin

🎯 Purpose 6 words ▾

Purpose External analgesic

Purpose External analgesic

📄 Stop Use and Ask a Doctor If 36 words ▾

Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days Do not apply over large areas of the body

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL Vagisil Regular strength Anti Itch Crème Net Wt. 1 Oz (28 g) MEXICO Benzal Crema Vagisil Fórmula: Cada 100g contiene: Benzocaina 5g, Resorcinol 2g, Excipiente cbp 100 Auxiliar en el alivio al contacto de la comezón femenina, ayuando a prevenir una mayor irritación. Benzal Crema Vagisil auxiliar en aliviar al contacto la comezón, ardor, irritaciones y molestias menores del área externa que rodea la vagina.

Contiene un anestésico que actúa para calmar la comezón, el ardor y la irritación leve. Indicaciones: Auxiliar en el tratamiento de comezón, ardor e irritación leve. Modo de E mpleo: Únicamente para USO EXTERNO Evite el contacto con los ojos.

No se aplique en grandes áreas del cuerpo. Si las molestias persisten por más de 3 días o desaparecen y vuelven a aparecer en pocos días, o la condición empeora, suspenda su uso y consulte a su médico. En caso de ingestión accidental, busque ayuda médica inmediamente.

Vía de A dministra ción : Tópica. Unicamente para USO EXTERNO VAGINAL. No se deje al alcance de los niños.

Consérvese del tubo bien tapado. Consérvese a no más de 30°C. Dosis: Adultos y niñas mayores de 2 años.

Aplique una capa en el área afectada no más de 3 ó 4 veces al día. Uso en Embarazo y Lactancia: No se use durante el embarazo o lactancia. Uso Pediátrico: No se use en niñas menores de 2 años, Contraindicaciones: Infecciones vaginales graves.

Infecciones vaginales repetidas. Hipersensibilidad a los componentes de la fórmula. Si persisten las molestias por más 3 días, los síntomas no mejoran o empeoran, consulte a su médico.

Reporte las sospechas de reacción adversa a correo: [email protected] PRINCIPAL DISPLAY PANEL Benzal Crema Vagisil Benzocaína / Resorcinol Crema 5%, 2% Con anestésico Calma la comezón Caja con tubo con 30g PRINCIPAL DISPLAY PANEL Vagisil Regular strength Anti Itch Crème Net Wt. 1 Oz (28 g) PRINCIPAL DISPLAY PANEL Benzal Crema Vagisil Benzocaína / Resorcinol Crema 5%, 2% Con anestésico Calma la comezón Caja con tubo con 30g

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for VAGISIL Anti-Itch Creme Regular Strength (this brand).

Top reported reactions

Chest Pain1
Cyanosis1
Eructation1
Generalised Erythema1
Generalised Oedema1
Nausea1
Pruritus Generalised1

Reporter sex

1 reports
Female · 100%

Serious outcomes

Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Combe Incorporated. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Combe Incorporated is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 11509-5101-01 · Combe 11517-0012-01 · Kindeva →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.