NDC 61010-8203-02 — Numstat Antiseptic and Pain-Relieving Prep

🆔 Identity & classification

FDA NDC (as labeled) 61010-8203-2

Product NDC 61010-8203

11-digit billing NDC 61010820302

RxCUI 2667820, 2667826

UNII L7T10EIP3A, ND2M416302, U3RSY48JW5

Application # M003

SPL Set ID 4c9c20f2-bc17-857b-e063-6394a90a5d5c

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 2026-04-15

Route TOPICAL

Dosage form SWAB

Substance MENTHOL, UNSPECIFIED FORM; ISOPROPYL ALCOHOL; BENZOCAINE

Why two NDCs? The FDA registers this code as 61010-8203-2 — 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 → 61010-8203-02. 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.

🏭 Manufacturer & labeler

LabelerSafetec of America Inc.

FDA applicationM003 (OTC MONOGRAPH DRUG)

Labeler code61010

First marketedApr 2026

Product typeHuman Otc Drug

🔎 All NDCs from Safetec of America Inc.

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

🧪 What is this product?

Numstat Antiseptic and Pain-Relieving Prep Pad is a topical swab containing benzocaine, isopropyl alcohol, and menthol. Isopropyl alcohol is commonly used as an antiseptic to help clean skin before medical procedures. Benzocaine is a local anesthetic typically used to numb the skin surface, while menthol is often included for its cooling sensation. This is an over-the-counter monograph product, meaning it is marketed under established FDA guidelines for this category of antiseptic and pain-relief swabs.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

1 g / 100 g UNII QI80HXD6S5
Neopentyl glycol is a synthetic alcohol compound used as a humectant and solvent in medicines. It helps retain moisture and improve the stability and texture of liquid or semi-solid formulations.
2 g / 100 g UNII 5LKW3C543X
A synthetic oily liquid derived from neopentyl glycol and heptanoic acid. It serves as an emollient and solvent in formulations, helping to dissolve or suspend active ingredients and improve the texture and spreadability of topical products.
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.

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

The official label also statesInactive Ingredients Neopentyl Glycol Diheptanoate Neopentyl Glycol Diheptanoate Isododecane Purified Water

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 system	Per each	Per 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Numstat Antiseptic and Pain-Relieving Prep Pad 1 g/100g; 71 g/100g; 15 g/100gthis 61010-8203-02	Safetec	50 packets	—	—	FDA listed	—
NUMSTAT Antiseptic and Pain Relieving Prep Pad 15 g/100g; 71 g/100g; 1 g/100g 65282-1815-01	Spectra	30 packets	—	—	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

🏛️

2026

On the market since

Apr 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔒

·

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 NDC	Description	Marketing start	Status
61010-8203-02 You're viewing this	50 PACKET in 1 CARTON (61010-8203-2) / 1 g in 1 PACKET (61010-8203-1)	2026-04-15	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 61010-8203-2, 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: 61010-8203-02, written without dashes as 61010820302. 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 61010-8203-02, the first segment (61010) is the labeler code FDA assigned to Safetec of America Inc.; the middle segment (8203) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Safetec of America Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Safetec of America Inc. 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 69 words ▾

Directions for Use Directions for Use. Adults and children 2 years of age and older. Apply to the affected area.Do not appy more than 4 times daily. Apply pad to the skin, thoroughly rub in for 60 seconds and let dry. Test for effect by touching the area beform performing procedure. May need to reapply on certain skin types. For children under 2 years of age, consult a doctor.

⏱️ Dosage and Administration 28 words ▾

Uses For the temporary relief of pain associated with needle sticks, minor burns, sunburn, minor cuts, scrapes, skin irritation and insect bites. Reduces risk of infection. Kills germs.

⚠️ Warnings 37 words ▾

Warnings For External Use Only. Flammable. Keep away from heat or open flame Do not use - in eyes, mouth or mucous membranes. In caseof contact with eyes, mouth or mucous membranes, flush with water, calla doctor.

🧪 Active Ingredient 21 words ▾

Active Ingredients Active Ingredients( per application in each pad) Percent and Purpose Isopropyl Alcohol.......................................71% Antiseptic Benzocaine................................................15% Topical Analgesic Menthol......................................................1% Topical Analgesic

🧪 Inactive Ingredients 13 words ▾

Inactive Ingredients Inactive Ingredients Neopentyl Glycol Diheptanoate Neopentyl Glycol Diheptanoate Isododecane Purified Water

🎯 Purpose 7 words ▾

Purpose: Antiseptic and Pain Relieving Prep Pad

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

🔗 Related NDC lookups

🧪 All Antiseptic And Pain-Relieving Prep Pad NDCsSame ingredient 🏭 All Safetec labeler NDCsLabeler code 61010 📚 All Standardized Chemical Allergen NDCsDrug class

Numstat Antiseptic and Pain-Relieving Prep Pad 1 g/100g; 71 g/100g; 15 g/100g Swab, 50 packets

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Questions about this listing

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups