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SYLVIRENE NUMBING Menthol 5% 5 g/100g Cream, 50 g — NDC 85248-0163-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SYLVIRENE NUMBING Menthol 5% 5 g/100g Cream, 50 g — NDC 85248-163-01 (Billing 85248-0163-01)

by Jiangxi Yudexi Pharmaceutical Co., LTD · 50 g in 1 BOTTLE

This is a package of 50 g of SYLVIRENE NUMBING Menthol 5% 5 g/100g Cream from Jiangxi Yudexi Pharmaceutical Co., LTD, marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 85248-0163-01
🏷️ FDA NDC (as labeled) 85248-163-01 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85248-163-01
Product NDC 85248-163
11-digit billing NDC 85248016301
RxCUI 1039690
UNII L7T10EIP3A
Application # M017
SPL Set ID 4d47e8c7-d293-bf63-e063-6294a90a5fd9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-18
Route TOPICAL
Dosage form CREAM
Substance MENTHOL
Quick answers
  • RxCUI (RxNorm): 1039690
Why two NDCs? The FDA registers this code as 85248-163-01 — 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 → 85248-0163-01. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Mostly for temporary relief of minor aches and pains in muscles and joints, like those from arthritis, backache, strains, sprains and bruises. Some products are for other things, s...
  • It depends on the product. Many creams, gels and patches are limited to about 3 to 4 times a day, and patches also have a time limit, often 8 hours. Follow your product label and a...
  • A brief burning feeling can happen when you first apply it and usually fades in several days. But if you get severe burning pain, swelling or blistering, stop using it and call you...
  • No. Don't use menthol products with a heating pad, and avoid local heat or direct sunlight on the area. Rare cases of serious burns have been reported.
📖 Read our full Menthol 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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
85248-0163-01 You're viewing this Main listing 50 g in 1 BOTTLE 2026-03-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Joint and Muscle Pain 50 mg/g 59899-0022-00 Shaklee 85 g — — FDA listed —
Advanced Pain Relief Cream With 5 % Natural Menthol 5 g/100g 62742-4278-02 Allure 1 tube — — FDA listed —
Cheezheng Pain Relief Cream 5 g/100g 66506-0184-01 Tibet 1 tube — — FDA listed —
KT Pain Relief Cream Magnesium with Cooling 5% Menthol 5 g/100mL 69693-0108-25 Clarion 1 ml — — FDA listed —
Rubbing Dots Natural Cool Pain Relief 50 mg/mL 73294-0005-04 Awesome 110 ml — — FDA listed —
Mg Plus Menthol With Hemp 5.6 g/112g 76348-0471-04 RENU 112 g — — Discontinued —
Dr PAINES Pain Relief 50 mg/g 78970-0161-03 DOCTOR 1 tube — — FDA listed —
SCALAR Pain Relief Cream 50 mg/mL 80883-0097-00 Miracle 1 jar — — FDA listed —
FISICO Arthrozene Pain Cream 50 mg/g 83204-0375-00 FISICO 96.4 g — — FDA listed —
TIDL CLINICAL CRYOTHERAPY MENTHOL Cream 5 g/.1L 84214-0010-01 Shenzhen 3.785 l — — FDA listed —
Dermfree Numbing 5 g/100g 85248-0158-01 Jiangxi 50 g — — FDA listed —
Healmusz Numbing 5 g/100g 85248-0160-01 Jiangxi 50 g — — FDA listed —
Sylvirene Numbing 5 g/100gthis 85248-0163-01 Jiangxi 50 g — — FDA listed —
ANIXIKE Numbing 5 g/100g 85248-0167-01 Jiangxi 30 g — — FDA listed —
Puvida Numbing 5 g/100g 85248-0172-01 Jiangxi 50 g — — FDA listed —
Bellehaven numbing cream 5 g/100g 85284-0009-01 BLOOMWELL 50 g — — Discontinued —
External Analgesic Cream with Menthol 5% 5 g/100g 85284-0010-01 BLOOMWELL 50 g — — FDA listed —
tuiwaro Numbing Cream 5 g/100g 87408-0012-01 Guangzhou 1 bottle — — FDA listed —
Aemerry Numbing Cream 2.5 g/50g 87615-0002-01 Da 50 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

🏛️
2026
On the market since
Mar 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.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII Z135WT9208
    Carbomer is a synthetic polymer that forms a thick, gel-like consistency. It's used in medicines as a thickener and stabilizer to improve texture and keep ingredients evenly mixed throughout the product.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • 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.

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

The official label also statesWater,Carbomer934,Propylene Glycol,soybean Lecithin,.Alpha.-Tocopherol Acetate,Benzyl Alcohol.

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

LabelerJiangxi Yudexi Pharmaceutical Co., LTD
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code85248
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio214 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.

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 16 words ▾

Use ·Temporarily relieves pain and itching due to: minor burns,sunburn, insect bites, scrapes, minor skin irritations

⏱️ Dosage and Administration 21 words ▾

Directions ·Cleanse targeted skin area, pat dry. ·Apply a thin layer to the affected area, not more than 3-4 times daily.

⚠️ Warnings 5 words ▾

Warnings For external use only.

📦 Storage and Handling 15 words ▾

Other information Store at 15-30°C(59-86°F)·Protect from excessive heat and direct sunlight-· Use only as directed

🧪 Active Ingredient 5 words ▾

Active Ingredient Menthol 5% （w/w）

🧪 Inactive Ingredients 7 words ▾

Inactive ingredients Water,Carbomer934,Propylene Glycol,soybean Lecithin,.Alpha.-Tocopherol Acetate,Benzyl Alcohol.

🎯 Purpose 3 words ▾

Purpose External analgesic

📄 Do Not Use 28 words ▾

Do not use ·on large areas of the body.·on broken, blistered, or abraded skin. · if allergic to local anesthetics such as lidocaine, benzocaine, or other "caine" derivatives

📄 Ask a Doctor Before Use If 26 words ▾

Ask Doctor ·Condition worsens or does not improve within 7 days.·Allergic reaction occurs to ingredients in this product.·Symptoms being treated does not subside or if redness,iritation

📄 When Using This Product 22 words ▾

When Using ·avoid contact with the eyes - ·do not bandage tightly or use with heating pad -· use only as directed

📄 Stop Use and Ask a Doctor If 26 words ▾

Stop Use ·Condition worsens or does not improve within 7 days.·Allergic reaction occurs to ingredients in this product.·Symptoms being treated does not subside or if redness,iritation

📄 Keep Out of Reach of Children 19 words ▾

Keep Oot Of Reach Of Children lf swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 4 words ▾

PRINCIPAL DISPLAY PANEL 5

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

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 Jiangxi Yudexi Pharmaceutical Co., LTD. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Jiangxi Yudexi Pharmaceutical Co., LTD 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.
← 85248-0162-01 · Jiangxi 85248-0164-01 · Jiangxi →
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.