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Monistat Care Instant Itch Relief Benzocaine 11.4 g/57g Spray, 57 g — NDC 63736-0050-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Monistat Care Instant Itch Relief Benzocaine 11.4 g/57g Spray, 57 g — NDC 63736-050-01 (Billing 63736-0050-01)

by Insight Pharmaceuticals LLC · 57 g in 1 CAN

This is a package of 57 g of Monistat Care Instant Itch Relief Benzocaine 11.4 g/57g Spray from Insight Pharmaceuticals LLC, marketed since Oct 2017 and currently FDA-listed. It is this product's only package size.

NDC 63736-0050-01
🏷️ FDA NDC (as labeled) 63736-050-01 billing pads the product 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 63736-050-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63736 labeler · 050 product · 01 package
Package marketed since
Oct 1, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6373605001 6
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Benzocaine (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0602-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0605-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0601-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0603-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0604-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0606-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63736-050-01
Product NDC 63736-050
11-digit billing NDC 63736005001
RxCUI 360349, 1991422
UNII U3RSY48JW5
Application # M017
SPL Set ID 4e9dc791-419f-4c79-aed4-760f8c17a5dd
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 2017-10-01
Route TOPICAL
Dosage form SPRAY
Substance BENZOCAINE
Quick answers
  • RxCUI (RxNorm): 360349
Why two NDCs? The FDA registers this code as 63736-050-01 — a 5-3-2 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 product segment → 63736-0050-01. 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?

Monistat Care Instant Itch Relief is an over-the-counter topical spray containing benzocaine, a local anesthetic. It is typically used to numb and relieve itching and discomfort on the skin. This product is marketed under FDA's over-the-counter monograph rules for topical anesthetics rather than through individual product approval. The spray form allows direct application to affected areas.

Supplement & herbal interactions

Some supplements/herbs that may interact with Benzocaine — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Benzocaine (3 interactions) — ranked by severity →
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 mLPer 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
63736-0050-01 You're viewing this Main listing 57 g in 1 CAN 2017-10-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dermoplast Post Partum 200 mg/g 16864-0640-01 Advantice 78 g — — FDA listed —
Monistat Care Instant Itch Relief 11.4 g/57gthis 63736-0050-01 Insight 57 g — — FDA listed —
Americaine 11.4 g/57g 63736-0378-02 Insight 57 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

🏛️
2017
On the market since
Oct 2017
📍
2026
Currently FDA-listed
9 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.

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

  • UNII 5655G9Y8AQ
    A synthetic liquid polymer used as a solvent and humectant in medications. It helps dissolve active ingredients, maintain moisture in the formulation, and improve how the medicine flows and is absorbed.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesPolyethylene glycol 300  Propellant:  Isobutane, normal butane, propane

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.

Manufacturer & labeler

LabelerInsight Pharmaceuticals LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code63736
First marketedOct 2017
Product typeHuman Otc Drug
Portfolio30 products on file

More NDCs from Insight Pharmaceuticals LLC labeler code 63736

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 7 words ▾

Uses Temporary relief of pain and itching

⏱️ Dosage and Administration 41 words ▾

Directions shake can well, hold 8" to 12" from affected area; spray liberally. adults and children 1 2 years and older: apply to affected area not more than 3 to 4 times daily children under 1 2 years: consult a physician

⚠️ Warnings 130 words ▾

Warnings For external use only Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics Contents under pressure. Do not puncture or incinerate. Flammable mixture; do not use near fire or flame, or expose to heat or temperatures above 49°C (120°F).

Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. When using this product avoid contact with the eyes Stop use and ask a doctor if condition worsens, or symptoms persists for more than 7 days symptoms clear up and occur again within a few days Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 4 words ▾

Active ingredient Benzocaine 20%

🧪 Inactive Ingredients 10 words ▾

Inactive ingredients Polyethylene glycol 300 Propellant: Isobutane, normal butane, propane

🎯 Purpose 3 words ▾

Purpose Topical analgesic

📄 When Using This Product 9 words ▾

When using this product avoid contact with the eyes

📄 Stop Use and Ask a Doctor If 27 words ▾

Stop use and ask a doctor if condition worsens, or symptoms persists for more than 7 days symptoms clear up and occur again within a few days

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Other Information 10 words ▾

Other information Store at room temperature 15°– 25°C (59°– 77°F).

📄 Questions or Comments 5 words ▾

Questions? Call toll free 1-877-666-4782

📄 Package Label / Principal Display Panel 39 words ▾

PRINCIPAL DISPLAY PANEL MONISTAT Care 20% Benzocaine/ Tropical Analgesic MAXIMUM STRENGTH INSTANT Itch Relief SPRAY Net WT.2 OZ(57g) PRINCIPAL DISPLAY PANEL INTENSE ITCH RELIEF MONISTAT Care 20% Benzocaine/ Tropical Analgesic MAXIMUM STRENGTH INSTANT Itch Relief SPRAY Net WT.2 OZ(57g)

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 Monistat Care Instant Itch Relief (this brand).

Top reported reactions

Methaemoglobinaemia124
Drug Hypersensitivity61
Asthenia48
Nausea46
Dyspnoea38
Arthralgia36
Anxiety35

Reporter sex

757 reports
Male · 35%
Female · 65%
Unknown · 1%

Serious outcomes

Life-threatening112
Death68
Disabling50
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 62 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) ✓ 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 Insight Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Insight Pharmaceuticals LLC 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.
← 63736-0040-28 · Insight 63736-0200-04 · Insight →
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.