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Pain Release Menthol Kit — NDC 70983-0010-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pain Release Menthol Kit — NDC 70983-010-12 (Billing 70983-0010-12)

by Saje Natural Business Inc. · 1 KIT in 1 KIT * 1 POUCH in 1 PACKAGE / 120 g in 1 POUCH * 10 mL in 1 BOTTLE, DROPPER * 40 mL in 1 BOTTLE, DROPPER * 30 mL in 1 BOTTLE, SPRAY

This is a package of Pain Release Menthol Kit from Saje Natural Business Inc., marketed since Oct 2016 and currently FDA-listed. It is this product's only package size.

NDC 70983-0010-12
🏷️ FDA NDC (as labeled) 70983-010-12 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

NDC database record

One package, one record: these facts belong to NDC 70983-010-12 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70983 labeler · 010 product · 12 package
Package marketed since
Oct 16, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7098301012 0
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70983-010-12
Product NDC 70983-010
11-digit billing NDC 70983001012
Application # M017
SPL Set ID 481a493b-0620-46ac-8228-e9964b7eb24b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-10-16
Dosage form KIT
Why two NDCs? The FDA registers this code as 70983-010-12 — 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 → 70983-0010-12. 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 eachPer 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
70983-0010-12 You're viewing this Main listing 1 KIT in 1 KIT * 1 POUCH in 1 PACKAGE / 120 g in 1 POUCH * 10 mL in 1 BOTTLE, DROPPER * 40 mL in 1 BOTTLE, DROPPER * 30 mL in 1 BOTTLE, SPRAY 2016-10-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
DG Health Cough Drops Assorted Flavors 75712-0001-01 Dollar 26 lozenges — — FDA listed —
Menthol 1 kg/kg 59593-0005-01 Sharp 25 kg — — FDA listed —
Menthol 1 kg/kg 59593-0004-01 Sharp 25 kg — — FDA listed —
Menthol 1 kg/kg 70440-0001-01 Mentha 25 kg — — FDA listed —
Home Farmacy 70983-0012-14 Saje 1 kit — — FDA listed —
Pocket Farmacy 70983-0014-16 Saje 1 kit — — FDA listed —
Pain Releasethis 70983-0010-12 Saje 1 kit — — 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

🏛️
2016
On the market since
Oct 2016
📍
2026
Currently FDA-listed
10 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.

What it looks like

Color white
ShapeFreeform
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

🧪 Avoiding an ingredient? See Menthol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

From the label’s inactive-ingredient sectionAnthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, and vitis vinifera (grape) seed oil.  Anthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, prunus armeniaca (apricot) kernel oil, rosmarinus officinalis (rosemary) leaf oil, tocopherol, and vitis vinifera (grape) seed oil. Anthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, and water. Anthemis nobilis flower oil, cinnamomum camphora (camphor) bark oil, corn starch, epsom salt, eucalyptus oil, lavender oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, sea salt, and sodium bicarbonate.

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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.

Manufacturer & labeler

LabelerSaje Natural Business Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code70983
First marketedOct 2016
Product typeHuman Otc Drug
Portfolio20 products on file

More NDCs from Saje Natural Business Inc. labeler code 70983

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 56 words ▾

Directions Adults and children 12 years of age and older: Apply to affected area

Directions Adults and children 12 years of age and older: Apply to affected area

Directions Adults and children 12 years of age and older: Apply to affected area

Directions Adults and children 12 years of age and older: Apply to affected area

⏱️ Dosage and Administration 81 words ▾

not more than 3 to 4 times daily. Not recommended for children under 12 years of age.

not more than 3 to 4 times daily Children under 12 years of age: Consult a doctor.

not more than 3 to 4 times daily Children under 12 years of age: Consult a doctor.

by dissolving 2 teaspoons of salt soak in warm water and soaking area not more than 3 to 4 times daily. Children under 12 years of age: Consult a doctor.

⚠️ Warnings 36 words ▾

Warnings For external use only. Flammable . Keep away from fire or flame.

Warnings For external use only. Flammable . Keep away from fire or flame.

Warnings For external use only.

Warnings For external use only.

🧪 Active Ingredient 48 words ▾

PAIN RELEASE topical analgesic oil blend Drug Facts Active ingredient Menthol 1.98%

PAIN RELEASE topical analgesic massage oil Drug Facts Active ingredient Menthol 1.37%

PAIN RELEASE topical analgesic mist Drug Facts Active ingredient Menthol 0.25%

PAIN RELEASE pain relieving bath salt soak Drug Facts Active ingredient Menthol 0.16%

🧪 Inactive Ingredients 130 words ▾

Inactive ingredients Anthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, and vitis vinifera (grape) seed oil.

Inactive ingredients Anthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, prunus armeniaca (apricot) kernel oil, rosmarinus officinalis (rosemary) leaf oil, tocopherol, and vitis vinifera (grape) seed oil.

Inactive ingredients Anthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, and water.

Inactive ingredients Anthemis nobilis flower oil, cinnamomum camphora (camphor) bark oil, corn starch, epsom salt, eucalyptus oil, lavender oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, sea salt, and sodium bicarbonate.

🎯 Purpose 93 words ▾

Purpose Topical Analgesic Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Purpose Topical Analgesic Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Purpose Topical Analgesic Uses For the temporary relief of pain and itching associated with minor cuts, scrapes, or insect bites

Purpose External Analgesic Uses For the temporary relief of pain and itching associated with scrapes, insect bites, and minor skin irritations.

📄 Do Not Use 46 words ▾

Do not use on wounds or damaged skin if epileptic with high blood pressure

Do not use on wounds or damaged skin if epileptic with high blood pressure

Do not use if epileptic with high blood pressure

Do not use if epileptic with high blood pressure

📄 When Using This Product 44 words ▾

When using this product avoid contact with the eyes do not bandage tightly

When using this product, avoid contact with the eyes do not bandage tightly

When using this product, avoid contact with the eyes.

When using this product, avoid contact with the eyes.

📄 Stop Use and Ask a Doctor If 112 words ▾

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.

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.

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.

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.

🤰 If Pregnant or Breast-Feeding 36 words ▾

If pregnant or breastfeeding, do not use this product.

If pregnant or breast-feeding, do not use this product

If pregnant or breastfeeding, do not use this product

If pregnant or breast-feeding, do not use this product.

📄 Keep Out of Reach of Children 85 words ▾

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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right awa y.

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

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

📄 Package Label / Principal Display Panel 56 words ▾

Saje Natural Wellness PAIN RELEASE KIT topical analgesic convenience kit 1 TOPICAL ANALGESIC OIL BLEND

0.34FL.OZ. | 10 mL 1 TOPICAL ANALGESIC MASSAGE OIL

1.4FL.OZ. | 40 mL 1 TOPICAL ANALGESIC MIST 1 FL.OZ. | 30 mL 1 TOPICAL ANALGESIC BATH SALT SOAK NET WT.

4.2OZ. | 120 g PAIN RELEASE KIT BOX

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

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 Menthol — the ingredient across all brands.

Top reported reactions

Pain3,545
Fatigue3,324
Nausea3,269
Headache3,025
Dyspnoea2,471
Diarrhoea2,208
Pneumonia2,151

Age at onset

Neonate144
Infant64
Child375
Adolescent265
Adult5,396
Elderly3,493

Reporter sex

54,495 reports

Serious outcomes

Death5,294
Disabling1,340
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 5,728 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.

About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 Saje Natural Business Inc.. Listing status can change — the directory data on this page refreshes weekly.
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.
← 70983-0009-01 · Saje 70983-0012-14 · 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.