Home › NDC Lookup › Ingredients › Pramoxine Hydrochloride › 11509-5035-01
VAGISIL Anti-Itch Medicated Wipes Maximum Strength pramoxine hydrochloride 10 mg/g Cloth, 12 packets — NDC 11509-5035-01 package photo

VAGISIL Anti-Itch Medicated Wipes Maximum Strength pramoxine hydrochloride 10 mg/g Cloth, 12 packets

by Combe Incorporated · 12 PACKET in 1 CARTON (11509-5035-1) / 4.5 g in 1 PACKET
NDC 11509-5035-01
🏷️ FDA NDC (as labeled) 11509-5035-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 11509-5035-1
Product NDC 11509-5035
11-digit billing NDC 11509503501
NCPDP billing unit EA — each (per item)
RxCUI 1039541, 1039550
UNII 88AYB867L5
Application # M017
SPL Set ID b848f53d-8aea-4efe-aa2c-009d5121fc33
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-06-28
Route TOPICAL
Dosage form CLOTH
Substance PRAMOXINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 11509-5035-1 — 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 → 11509-5035-01. 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 Local anesthetics class.

Drug family (ATC) Local anesthetics, Anesthetics for topical use
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.

🏭 Manufacturer & labeler

LabelerCombe Incorporated
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code11509
First marketedJun 2005
Product typeHuman Otc Drug
Portfolio8 products on file
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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Pramoxine is a local anesthetic, which means it temporarily numbs the area where you apply it. It works right at the skin's surface to block the sensation of pain and itching. It d...
  • What exactly does pramoxine do — how does it stop the itching?
  • It depends on which product you have. Most creams, sprays, and solutions are used up to 3 to 4 times daily. Some products, like Proctofoam for the rectal area, can be used up to 5...
  • No. All pramoxine products are for external use only — that means the outside of the skin. Even products intended for the genital or rectal area, like the Terramed Intimate Wash or...
📖 Read our full Pramoxine guide →

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.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII WR1WPI7EW8
    A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 18L9G3U51M
    A gentle cleansing agent derived from coconut oil. It acts as a surfactant and emulsifier, helping mix oil and water-based ingredients together and improve how the product spreads or cleanses on skin.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 14255EXE39
    Ethylparaben is a preservative, a chemical that stops bacteria and mold from growing in the medicine. It keeps the product safe and effective throughout its shelf life.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII VNX7251543
    A plant-derived emulsifier made from coconut oil and polyethylene glycol. It helps mix oil and water-based ingredients together and improves how the medicine spreads or absorbs.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII LA19WH54UL
    TEA-COCOYL GLUTAMATE is a plant-derived cleanser and emulsifier made from coconut oil and amino acids. It helps mix oil and water in formulations and may aid in product texture and spreadability.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

13 inactive ingredients listed in the exact product block matched to this NDC.

The official label also stateswater, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, ethylparaben, disodium EDTA, methylparaben, fragrance, PEG-7 glyceryl cocoate, aloe barbadensis leaf extract, tocopheryl acetate, maltodextrin

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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 eachPer 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
VAGISIL Anti-Itch Medicated Wipes Maximum Strength 10 mg/gthis 11509-5035-01 Combe 12 packets — — FDA listed —
VAGISIL Anti-Itch Medicated Wipes Maximum Strength 10 mg/g 11509-5058-01 Combe 20 packets — — FDA listed —
Anti-Itch Soothing Wipes 1 Pramoxine Hydrochloride 10 mg/mL 82637-9363-01 The 30 patches — — FDA listed —
Terramed Just Think Comfort GynoCare BV Guard Intimate Wipes 1 g/100mL 83004-0038-01 Rida 192 patches — — FDA listed —
First Degree Maximum Strength Burn 10 mg/g 24330-0130-02 Welmedix 1 tube — — FDA listed —
CeraVe Developed with Dermatologists Itch Relief Moisturizing 10 mg/g 49967-0512-01 L'Oreal 340 g — — FDA listed —
CeraVe Developed with Dermatologists Itch Relief Moisturizing 10 mg/g 82046-0620-01 L'Oreal 340 g — — 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

🏛️
2005
On the market since
Jun 2005
📍
2026
Currently FDA-listed
21 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
11509-5035-01 You're viewing this 12 PACKET in 1 CARTON (11509-5035-1) / 4.5 g in 1 PACKET 2005-06-28 Active

🧭 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) ✓ 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 FDA registers it as 11509-5035-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 11509-5035-01, written without dashes as 11509503501. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 11509-5035-01, the first segment (11509) is the labeler code FDA assigned to Combe Incorporated; the middle segment (5035) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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.

📄 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
🎯 Indications and Usage 8 words ▾

Use temporarily relieves itching

Use Temporarily relieves itching

⏱️ Dosage and Administration 106 words ▾

Directions adults and children 12 years and older Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily. Do not flush. children under 12 years consult a doctor

Directions adults and children 12 years and older Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily. Do not flush. children under 12 years consult a doctor

⚠️ Warnings 18 words ▾

Warnings For external use only Avoid contact with eyes

Warnings For external use only Avoid contact with eyes

🧪 Active Ingredient 12 words ▾

Active ingredient Pramoxine hydrochloride 1% (w/w)

Active ingredient Pramoxine hydrochloride 1% (w/w)

🧪 Inactive Ingredients 52 words ▾

Inactive ingredients water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, ethylparaben, disodium EDTA, methylparaben, fragrance, PEG-7 glyceryl cocoate, aloe barbadensis leaf extract, tocopheryl acetate, maltodextrin

Inactive ingredients water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, ethylparaben, disodium EDTA, methylparaben, fragrance, PEG-7 glyceryl cocoate, aloe barbadensis leaf extract, tocopheryl acetate, maltodextrin

🎯 Purpose 6 words ▾

Purpose External analgesic

Purpose External analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 11509-4402-01 · Combe 11509-5058-01 · Combe →
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.