For brands selling benzocaine or lidocaine male desensitizer sprays and wipes

“Maximum strength” at 10%. The monograph stops at 7.5.

Gauge checks each desensitizer’s active ingredient and strength against the monograph, keeps its FDA listing, and tracks every OTC monograph facility fee installment — and will not clear a product for sale while it is outside the monograph, unlisted, or made where an installment is due and unpaid.

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Opens in this browser with an invented brand already in it. No account, no email address, nothing installed.

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The problem

The monograph is the product’s permit.

An over-the-counter male genital desensitizer is sold under the FDA monograph, not an approval: benzocaine from 3 to 7.5 percent in a water-soluble base, or lidocaine in a metered spray of about 10 milligrams a spray. Each must be listed, and every facility that makes an OTC monograph drug pays a yearly facility fee.

3–7.5%

benzocaine, in a water-soluble base; or lidocaine in a metered spray of about 10 mg.

21 CFR 348.10 →

$47,891

the FY 2027 fee for a monograph drug facility; $31,927 for a contract manufacturer.

FDA, OMUFA →

Two parts

FY 2027 fees fall due in halves: October 1, 2026 and February 1, 2027.

FDA, OMUFA →

Will not clear a product outside the rules.

Not a reminder. Clear for sale refuses, naming each problem, while a product’s strength or form is outside the monograph, it has no listing recorded, no facility is linked, or the facility has not paid every installment for the fiscal year due by today. A clearance is frozen for its year. There is no override.

How it works

Formula, listing, fee

Record each product

The active ingredient, the strength, metered or not, the base, and where it is made.

Record the listing

The drug listing for each product, from FDA’s own system.

Track the fees

Each facility’s installments as they are paid — then clear each product for the fiscal year.

What it will never do

It checks your records. It files nothing.

Gauge uses the strengths, listings and payments you give it.

No FDA connection.Nothing is filed or looked up.

It formulates nothing.Your formula is your manufacturer’s. Gauge checks it against the monograph.

It is not regulatory advice.It is the calendar and the check.

It never touches a payment.The subscription is for software.

Pricing

Priced per brand

A sliver of one installment.

Most brands

Brand

$19/month

One brand and its facilities.

Every product against the monograph
Clear-for-sale gate, no override
Fee installment calendar

Manufacturer

$49/month

A contract maker with several brands.

Everything in Brand
Many brands
Export per customer

Monthly subscription. Your bank statement says Gauge Software. Your licence key is emailed to you within two working days of payment.

Checkout is our own bitcoin server, not a card processor — nobody we had to apply to and nobody who can close the account. The button takes you straight to it. Give your email address there — that is where your key is sent.

Questions

The ones we actually get asked

How close to 10 mg must a lidocaine spray be?

The monograph says about 10 mg a spray. Gauge uses a tolerance you set from your manufacturer’s specification, ten percent by default.

Who pays the facility fee?

The facility. If a contract maker makes your product, record its payments; Gauge holds the product until they are in.

Is this regulatory advice?

No. It is the calendar you keep and a check you cannot skip.

What do I actually get when I pay?

The demo on this page is the whole program, running on invented records. Paying gets you a licence key — one line of text, emailed to the address you give at checkout within two working days. Paste it into the program and from then on it keeps your own records. Until then, nothing you type into it is kept.

The key is checked inside the page, on your own machine. It never calls us, so there is still no account and nothing about your business goes anywhere. If you ever stop paying, your records stay exactly where they are, read-only, and Export still hands you every one of them.

Open the demo before the next shipment

The metered lidocaine spray is cleared. The wipes are made where the October installment is unpaid. The ten-percent gel is above the monograph, and the unmetered lidocaine pump has no listing.

Open the demo See pricing