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Restoral Menthol .2 g/100g Ointment, 13.5 g — NDC 70983-0022-02 package photo

Restoral Menthol .2 g/100g Ointment, 13.5 g

by Saje Natural Business Inc. · 13.5 g in 1 CONTAINER (70983-022-02)
NDC 70983-0022-02
🏷️ FDA NDC (as labeled) 70983-022-02 billing pads the product segment with a zero
This package
Contains13.5 g Pack sizes2 compare ↓
Also comes in: 54.1 g 70983-0022-01
OTC On market Non-controlled
🗂️ 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 Menthol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 20, 2026 — This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. (Xiamen Kang Zhongyuan Biotechnology Co., Ltd.) · FDA recall D-0458-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70983-022-02
Product NDC 70983-022
11-digit billing NDC 70983002202
RxCUI 418609
UNII L7T10EIP3A
Application # M017
SPL Set ID 5b6176c1-9ed9-1950-e053-2a91aa0a434e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-02-01
Route TOPICAL
Dosage form OINTMENT
Substance MENTHOL
Why two NDCs? The FDA registers this code as 70983-022-02 — 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 → 70983-0022-02. 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

LabelerSaje Natural Business Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code70983
First marketedFeb 2018
Product typeHuman Otc Drug
Portfolio20 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

📗 Our plain-language guide HelloPharmacist
  • Menthol is found in a lot of over-the-counter topical products — creams, gels, patches, sprays, and powders. Depending on the product, it's used to temporarily ease minor muscle an...
  • Start with clean, dry skin — free of lotions or creams — before applying the patch. Peel the backing off and press the sticky side firmly to the sore area. Most menthol patches sho...
  • Yes, a mild burning or tingling feeling right after applying a menthol product is common and usually settles down within a few days of regular use. What's not normal is severe burn...
  • Is that burning sensation after I apply it normal?
📖 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.

🧪 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 8Z160YZ4AP
    Agrimonia eupatoria leaf is a plant-derived ingredient used in herbal formulations. It may serve as a flavoring agent, colorant, or contribute to the product's botanical composition in traditional remedy preparations.
  • UNII TRW2FUF47H
    A plant-derived powder from marshmallow root used as a binder and thickener in medicines. It helps hold ingredients together and can soothe irritated surfaces in throat lozenges and syrups.
  • UNII 746TB9VNDP
    A plant extract from Oregon grape root used as a natural preservative and flavoring agent in medicines. It helps prevent microbial growth and may add bitter taste to formulations.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • UNII M9VVZ08EKQ
    Comfrey root is a plant-derived ingredient used in some formulations as a natural thickener and binder to help hold the medicine together and improve its consistency.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • UNII PK0TXD049P
    A plant extract from creosote bush leaves, used as a natural flavoring agent and preservative in some formulations. It may help maintain shelf stability and add taste to the medicine.
  • UNII 7QFT17RLRG
    A plant-derived ingredient from the lobelia plant. It may be used in formulations for its potential flavoring or traditional herbal properties, though its specific role in this product depends on the formulation type.
  • UNII 3VNC7T6Z02
    A plant extract from chamomile flowers used as a flavoring and fragrance agent in medicines. It adds taste and aroma to improve how the medicine smells and tastes.
  • UNII 6UYK2W1W1E
    A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII 6Y8XYV2NOF
    A waxy substance made by honeybees from plant resins and pollen. In medicines, it acts as a binder and coating agent to hold ingredients together and protect the product.
  • UNII 93LP7Y8EGT
    A natural extract from white oak tree bark, used as a binder and thickening agent to help hold the medicine together and improve its consistency.
  • UNII IJ67X351P9
    A natural plant extract from rosemary leaves used as a preservative to help prevent oils and fats in the medicine from spoiling or becoming rancid during storage.
  • UNII UFH8805FKA
    St. John's Wort is a plant extract used as an inactive ingredient in some dietary supplements and herbal formulations. It's included primarily for its traditional herbal content rather than as a structural component like binders or fillers.
  • UNII 2H03479QVR
    Stellaria media is a plant extract used in some medicines as a natural ingredient. It may function as a skin-soothing agent or help preserve the product's stability.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII 4JS0838828
    A plant extract from red clover flowers used in herbal or natural formulations. It may serve as an active botanical ingredient or flavor/color component, though its specific role depends on the product's intended use.
  • UNII 101I4J0U34
    Witch hazel is a plant extract obtained from the leaves and bark of the North American shrub Hamamelis virginiana. It functions as an astringent and skin-conditioning agent in topical products, helping to tone and prepare the skin.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

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

The official label also statesAgrimonia eupatoria leaf extract, althaea officinalis root extract, beeswax (yellow), berberis aquifolium extract, calendula officinalis flower, chamomilla recutita (matricaria) flower extract, eucalyptus oil, larrea tridentata extract, lobelia inflata extract (lobelia), melaleuca alternifolia (tea tree) leaf oil, olive oil, peppermint oil, propolis extract, quercus alba bark extract, rosmarinus officinalis (rosemary) leaf extract, St. John’s wort, stellaria media (chickweed) extract, symphytum officinalis leaf extract, trifolium pratense (clover) flower extract and witch hazel

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.
Try another pack size: 54.1 g
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
Restoral .2 g/100gthis 70983-0022-02 Saje 13.5 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

🏛️
2018
On the market since
Feb 2018
📍
2026
Currently FDA-listed
8 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70983-0022-01 1 CONTAINER in 1 BOX (70983-022-01) / 54.1 g in 1 CONTAINER 2018-09-12 Active
70983-0022-02 You're viewing this 13.5 g in 1 CONTAINER (70983-022-02) 2018-09-12 Active

Pack size FAQ

What quantity is in NDC 70983-0022-02?
NDC 70983-0022-02 contains 13.5 g — 13.5 g in 1 container.
What is the difference between NDC 70983-0022-02 and NDC 70983-0022-01?
Both are Restoral Menthol .2 g/100g Ointment — the drug itself is identical. NDC 70983-0022-02 is the 13.5 g package, while NDC 70983-0022-01 is the 54.1 g package.
What NDC number is used to bill for this package of Restoral Menthol .2 g/100g Ointment?
Bill NDC 70983-0022-02 — the 11-digit billing format is 70983002202. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 70983-022-02, 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: 70983-0022-02, written without dashes as 70983002202. 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 70983-0022-02, the first segment (70983) is the labeler code FDA assigned to Saje Natural Business Inc.; the middle segment (0022) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Saje Natural Business Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 54.1 g (70983-0022-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Saje Natural Business 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📋 Description
🎯 Indications and Usage 23 words ▾

Uses For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations

⏱️ Dosage and Administration 31 words ▾

Directions Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Not recommended for children under 12 years of age.

⚠️ Warnings 124 words ▾

Warnings For external use only Flammable - keep away from fire or flame Use may result in increased topical anti-inflammatory effects of steroids, due to presence of marshmallow herb Drug facts box When using this product Avoid contact with eyes and mucous membranes; if this happens, rinse with vegetable oil Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days Do not use On wounds or damaged skin If allergic to marshmallow root or chickweed if pregnant or breast-feeding ask a health professional before use keep out of reach of children if product is swallowed, get medical help or contact a Poison Control Centre right away

🧪 Active Ingredient 4 words ▾

Active Ingredient Menthol 0.2%

🧪 Inactive Ingredients 72 words ▾

Inactive ingredients Agrimonia eupatoria leaf extract, althaea officinalis root extract, beeswax (yellow), berberis aquifolium extract, calendula officinalis flower, chamomilla recutita (matricaria) flower extract, eucalyptus oil, larrea tridentata extract, lobelia inflata extract (lobelia), melaleuca alternifolia (tea tree) leaf oil, olive oil, peppermint oil, propolis extract, quercus alba bark extract, rosmarinus officinalis (rosemary) leaf extract, St. John’s wort, stellaria media (chickweed) extract, symphytum officinalis leaf extract, trifolium pratense (clover) flower extract and witch hazel

🎯 Purpose 3 words ▾

Purpose Topical analgesic

📋 Description 17 words ▾

Principle Display Panel information Restoral topical analgesic ointment net wt. 54.1g (1.91oz) and net wt. 13.5g (0.47oz)

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70983-0021-01 · Saje 70983-0023-02 · Saje →
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.