Dr. Numb Lidocaine and Benzethonium Chloride Cream 4 mg/50g; .25 mg/50g Cream — NDC 69903-0002-50 package photo

Dr. Numb Lidocaine and Benzethonium Chloride Cream 4 mg/50g; .25 mg/50g Cream

by Shinpharma Inc · 1 TUBE in 1 CARTRIDGE (69903-002-50) / 50 g in 1 TUBE
NDC 69903-0002-50
🏷️ FDA NDC (as labeled) 69903-002-50 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 69903-002-50
Product NDC 69903-002
11-digit billing NDC 69903000250
UNII 98PI200987, PH41D05744
Application # M017
SPL Set ID d8cdccdb-775b-4970-a6ea-50b62df221d6
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-09-12
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE; BENZETHONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 69903-002-50 — 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 → 69903-0002-50. 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.

🏭 Manufacturer & labeler

LabelerShinpharma Inc
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code69903
First marketedSep 2017
Product typeHuman Otc Drug
Portfolio6 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

🧪 What is this product?

Dr. Numb Lidocaine and Benzethonium Chloride Cream is a topical anesthetic product sold without a prescription as an over-the-counter monograph drug. It contains lidocaine, a local anesthetic commonly used to numb or reduce sensation in the skin, and benzethonium chloride, an antimicrobial agent. These ingredients are typically combined in topical creams intended for temporary relief of minor pain or discomfort on the skin surface.

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.

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dr. Numb 4 mg/50g; .25 mg/50gthis 69903-0002-50 Shinpharma 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

🏛️
2017
On the market since
Sep 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.

🔬 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 Dr. Numb (this brand).

Top reported reactions

Pain3,169
Fatigue3,039
Nausea3,029
Headache2,802
Dyspnoea2,167
Pneumonia2,002
Diarrhoea1,965

Age at onset

Neonate144
Infant62
Child363
Adolescent258
Adult4,906
Elderly3,132

Reporter sex

48,649 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization17,527
Death4,963
Life-threatening4,199
Disabling1,187
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,398 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69903-0002-50 You're viewing this 1 TUBE in 1 CARTRIDGE (69903-002-50) / 50 g in 1 TUBE 2017-09-12 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) — 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 FDA registers it as 69903-002-50, 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: 69903-0002-50, written without dashes as 69903000250. 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 69903-0002-50, the first segment (69903) is the labeler code FDA assigned to Shinpharma Inc; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 Shinpharma Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Shinpharma 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 48 words

Uses Can be used instead of soap and water to help clean minor cuts, scrapes, and burns For the temporary relief of discomfort and pain associated with dermal procedures such as tattoo removal, dermarolling, electrolysis, microblading, and piercing Temporarily relieves pain and itch while helping to prevent infection.

⏱️ Dosage and Administration 110 words

Directions Use Dr.Numb® Topical Anesthetic Foam Soap to cleanse the targeted area. Shake well before each use. Apply 2 to 3 pumps of foam soap andgently rub into the skin.

Leave it onfor 5 to 10 minutes. Rinse off gentlywith running water or wipe with cleanpaper towel. Use before, during andafter the procedure.

Make sure tocover the bottle tightly when not inuse, otherwise, the anesthetic effect will be lessened. Adults and children two years old and older: Use to clean minor cuts, scrapes, and burns by thoroughly washing with water. Rinse and air dry.

Use no more than three times daily. Children under two years of age, ask a doctor.

⚠️ Warnings 118 words

Warnings For external use only avoid contact with eyes ​​ Do not use do not use in large quantities particularly over raw surfaces or blistered area do not exceed the recommended dosage unless directed by a doctor in the eyes or apply over large areas of body longer than one week unless directed by a doctor Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns Stop the use and consult doctor if: condition worsenss or symptoms persist for more than 7 days or clear up and occur again within few days.

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

📦 Storage and Handling 31 words

Other information Store at controlled room temperature 59 0 ​-86 0 ​F (15 0 -30 0 C) Do not expose to temperature above 120 0 F(49 0 C) Protect from freezing

🧪 Active Ingredient 7 words

Active Ingredient Lidocaine 4% benzethonium Chloride 0.25%

🧪 Inactive Ingredients 29 words

Inactive Ingredients Allantoin, Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Benzyl Alcohol, Glycerin , Lauramidopropyl Betaine, Leuconostoc/Radish Root Ferment Filtrate, Menthoxypropanediol, Phenoxyethanol, Selaginella Lepidophylla Extract, Sodium Hydroxide, Water.

🎯 Purpose 7 words

Purpose External Analgesic and First Aid Antiseptic

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