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SOUTH MOON Essential Oil For Restoration GLYCERIN .004 mg/20mg; .004 mg/20mg; .004 mg/20mg Liquid, 20 mg

by Shantou South Moon Biotechnology Co., Ltd. · 20 mg in 1 BOTTLE, GLASS (84983-020-01)
NDC 84983-0020-01
🏷️ FDA NDC (as labeled) 84983-020-01 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) 84983-020-01
Product NDC 84983-020
11-digit billing NDC 84983002001
UNII VIF565UC2G, M89NIB437X, XE54U569EC
Application # M016
SPL Set ID 49457b38-e25e-7671-e063-6294a90a208a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2027)
Marketing start 2026-01-26
Route TOPICAL
Dosage form LIQUID
Substance TEA TREE OIL; BORNEOL; CINNAMON BARK OIL
Why two NDCs? The FDA registers this code as 84983-020-01 — 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 → 84983-0020-01. 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 marketedJan 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?

This is a topical liquid product marketed as an OTC monograph drug containing borneol, cinnamon bark oil, and tea tree oil in glycerin. These botanical ingredients are commonly used in over-the-counter preparations for their aromatic and skin-conditioning properties. The product is applied to the skin and is intended for external use only. As an OTC monograph product, it is marketed under FDA's established rules for this category of drugs rather than as an individually reviewed application.

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.

  • 0.1 mg / 20 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.
  • 0.02 mg / 20 mg UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • 0.004 mg / 20 mg UNII MOR84MUD8E
    Chlorhexidine digluconate is an antimicrobial compound added to some medicines as a preservative to prevent bacterial and fungal growth, extending shelf life and maintaining product safety.
  • 0.02 mg / 20 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 / 20 mg UNII 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.
  • 18.84 mg / 20 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.
  • 0.004 mg / 20 mg UNII SOI2LOH54Z
    Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.

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

The official label also statesWATER、UREA、1,2-HEXANEDIOL、GLYCERIN、ALLANTOIN、ZINC OXIDE

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
SOUTH MOON Essential Oil For Restoration .004 mg/20mg; .004 mg/20mg; .004 mg/20mgthis 84983-0020-01 Shantou 20 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
Jan 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84983-0020-01 You're viewing this 20 mg in 1 BOTTLE, GLASS (84983-020-01) 2026-01-26 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 84983-020-01, 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: 84983-0020-01, written without dashes as 84983002001. 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 84983-0020-01, the first segment (84983) is the labeler code FDA assigned to Shantou South Moon Biotechnology Co., Ltd.; the middle segment (0020) 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 25 words ▾

Penetrates deeply into the base of nails to fight nail fungus; repairs damaged nail beds and promotes nail growth; penetrates deeply to restore nail luster.

⏱️ Dosage and Administration 25 words ▾

Penetrates deeply into the base of nails to fight nail fungus; repairs damaged nail beds and promotes nail growth; penetrates deeply to restore nail luster.

⚠️ 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 6 words ▾

CHLORHEXIDINE GLUCONATE、BORNEOL、TEA TREE OIL、CINNAMON BARK OIL

🧪 Inactive Ingredients 2 words ▾

WATER、UREA、1,2-HEXANEDIOL、GLYCERIN、ALLANTOIN、ZINC OXIDE

🎯 Purpose 186 words ▾

1. Powerful antibacterial: effectively sterilizes, inhibits fungal growth, and quickly relieves onychomycosis. 2.

Deep repair: Go deep into the root of the nail to promote healthy nail growth and repair damaged tissue. 3. Mild ingredients: It uses mild ingredients, does not contain harmful chemicals, is safe, mild and non-irritating.

4. Easy to use: easy to apply, quickly absorbed, and leaves no greasy feeling. 5.

Provide long-term protection to prevent the recurrence of onychomycosis and keep nails healthy. 6. Mild formula, suitable for long-term use without side effects.

7. Provides anti-inflammatory effects, reduces redness, swelling and pain, and relieves discomfort. 8.

Suitable for all nail types, comprehensive care for nail health. 9. Provides moisturizing effect and prevents nails from dryness and brittleness.

10. Can stimulate blood circulation and promote nail growth. 11.

Contains nourishing ingredients to enhance nail toughness and prevent breakage. 12. No irritating smell, more comfortable to use.

13. Quick results, significantly improving onychomycosis in a short period of time. 14.

Provide a protective layer to resist external pollution and bacterial invasion. 15. Suitable for use by the whole family, including the elderly and adults.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84983-0019-01 · Shantou 84983-0021-01 · 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.