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SOUTH MOON Numbing Cream GLYCERIN .01 mg/100mg; .01 mg/100mg; .01 mg/100mg; 5 mg/100mg Cream, 100 mg

by Shantou South Moon Biotechnology Co., Ltd. · 100 mg in 1 BOTTLE, PLASTIC (84983-022-01)
NDC 84983-0022-01
🏷️ FDA NDC (as labeled) 84983-022-01 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced 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

⚠️
Other active recalls for Glycerin (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 27, 2026 — Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. (Oasis Medical, Inc.) · FDA recall D-0525-2026
Class II · Apr 20, 2026 — Lack of Assurance of Sterility (SCOPE HEALTH) · FDA recall D-0499-2026
Class II · Mar 25, 2026 — Lack of Assurance of Sterility (Preferred Pharmaceuticals, Inc.) · FDA recall D-0443-2026
Class II · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc) · FDA recall D-0411-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2027. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 84983-022-01
Product NDC 84983-022
11-digit billing NDC 84983002201
UNII 344821WD61, 463JZS0XJ3, OZ0E5Y15PZ, 98PI200987
Application # M016
SPL Set ID 49e2d991-7682-fcf3-e063-6394a90a952d
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 Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2027)
Marketing start 2026-02-03
Route TOPICAL
Dosage form CREAM
Substance EMU OIL; CREAM; ARNICA MONTANA FLOWER; LIDOCAINE
Why two NDCs? The FDA registers this code as 84983-022-01 — 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 → 84983-0022-01. 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.

🏭 Manufacturer & labeler

LabelerShantou South Moon Biotechnology Co., Ltd.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code84983
First marketedFeb 2026
Product typeHuman Otc Drug
Portfolio38 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?

South Moon Numbing Cream is a topical over-the-counter monograph product containing lidocaine, arnica montana flower extract, emu oil, and glycerin in cream form. Lidocaine is a local anesthetic typically used to numb skin and reduce discomfort on contact. Arnica montana flower is commonly included in topical products for its traditional use in minor muscle and joint care. Emu oil and glycerin function as moisturizing and conditioning agents in the formulation.

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.

  • 0.5 mg / 100 mg UNII TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 82.87 mg / 100 mg 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.
  • 0.3 mg / 100 mg UNII 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • 0.3 mg / 100 mg UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • 5 mg / 100 mg UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 1 mg / 100 mg UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • 5 mg / 100 mg UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.

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

The official label also statesAQUA、MINERAL OIL、GLYCERIN、GLYCERYL STEARATE、1,2-HEXANEDIOL、CARBOMER、ARGININE

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 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
SOUTH MOON Numbing Cream .01 mg/100mg; .01 mg/100mg; .01 mg/100mg; 5 mg/100mgthis 84983-0022-01 Shantou 100 mg — — Discontinued —
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
Feb 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.

🔬 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 GLYCERIN — the ingredient across all brands.

Top reported reactions

Oral Herpes2,427
Condition Aggravated2,018
Eye Irritation1,068
Eye Pain1,013
Incorrect Drug Administration Duration806
Pain758
Herpes Simplex709

Reporter sex

23,937 reports
Male · 27%
Female · 73%
Unknown · 0%

Serious outcomes

Death681
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,507 647
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
84983-0022-01 You're viewing this 100 mg in 1 BOTTLE, PLASTIC (84983-022-01) 2026-02-03 Inactivated by FDA

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 84983-022-01, 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: 84983-0022-01, written without dashes as 84983002201. 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 84983-0022-01, the first segment (84983) is the labeler code FDA assigned to Shantou South Moon Biotechnology Co., Ltd.; the middle segment (0022) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Shantou South Moon Biotechnology 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.

📄 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
🎯 Indications and Usage 29 words ▾

1. Thoroughly cleanse and dry your skin. 2. Apply an appropriate amount of this product evenly to the desired area of ​​skin. 3. Gently massage to promote better absorption.

⏱️ Dosage and Administration 29 words ▾

1. Thoroughly cleanse and dry your skin. 2. Apply an appropriate amount of this product evenly to the desired area of ​​skin. 3. Gently massage to promote better absorption.

⚠️ Warnings 39 words ▾

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

📦 Storage and Handling 7 words ▾

Store in a cool and dry place.

🧪 Active Ingredient 5 words ▾

LIDOCAINE、CREAM、ARNICA MONTANA FLOWER EXTRACT、EMU OIL

🧪 Inactive Ingredients 3 words ▾

AQUA、MINERAL OIL、GLYCERIN、GLYCERYL STEARATE、1,2-HEXANEDIOL、CARBOMER、ARGININE

🎯 Purpose 56 words ▾

1. Helps soothe skin, reduce acne redness and swelling, eliminate skin blemishes, and keep your facial skin soft. 2. It can provide moisturizing effect to the skin, moisturize the skin, and keep your skin hydrated. 3. It has a light texture and can be quickly absorbed by the skin, leaving it refreshing and non-greasy after use.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84983-0021-01 · Shantou 84983-0023-01 · Shantou →
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.