Home › NDC Lookup › Ingredients › Phytolacca Decandra, Gnaphalium Polyceph... › 43846-0200-01
Back, Neck and Sciatic Rescue Phytolacca Decandra, Gnaphalium Polycephalum, Hypericum Perforatum, Colocynthis, Gelsemium Sempervirens, Guaiacum, Ledum Palustre, Conium Maculatum 4 [hp_X]/g; 3 [hp_X]/g; 3 [hp_X]/g; 6 [hp_X]/g; 6 [hp_X]/g; 6 [hp_X]/g Gel, 113.4 g — NDC 43846-0200-01 package photo

Back, Neck and Sciatic Rescue Phytolacca Decandra, Gnaphalium Polycephalum, Hypericum Perforatum, Colocynthis, Gelsemium Sempervirens, Guaiacum, Ledum Palustre, Conium Maculatum 4 [hp_X]/g; 3 [hp_X]/g; 3 [hp_X]/g; 6 [hp_X]/g; 6 [hp_X]/g; 6 [hp_X]/g Gel, 113.4 g

by Peaceful Mountain, Inc. · 113.4 g in 1 BOTTLE, PUMP (43846-0200-1)
NDC 43846-0200-01
🏷️ FDA NDC (as labeled) 43846-0200-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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

FDA NDC (as labeled) 43846-0200-1
Product NDC 43846-0200
11-digit billing NDC 43846020001
UNII 11E6VI8VEG, 36XQ854NWW, XK4IUX8MNB, 23H32AOH17, 639KR60Q1Q, N0K2Z502R6 +2 more
UPC 0818692009504
SPL Set ID 1ea9e2d4-874e-4482-92b5-5ae319f7edee
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-15
Route TOPICAL
Dosage form GEL
Substance PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE; HYPERICUM PERFORATUM WHOLE; CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT; GUAIACUM OFFICINALE RESIN; RHODODENDRON TOMENTOSUM LEAFY TWIG; CONIUM MACULATUM FLOWERING TOP
Why two NDCs? The FDA registers this code as 43846-0200-1 — a 5-4-1 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 package segment → 43846-0200-01. 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

LabelerPeaceful Mountain, Inc.
Labeler code43846
First marketedMay 2026
Product typeHuman Otc Drug
Portfolio10 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 gel marketed as a homeopathic product containing eight plant-derived ingredients, including phytolacca, gnaphalium, hypericum, colocynthis, gelsemium, guaiacum, ledum, and conium. In homeopathic practice, these ingredients are traditionally used for complaints involving the back, neck, and sciatic nerve area. Homeopathic products are marketed based on traditional use and have not been evaluated by the FDA for effectiveness. The concentration and preparation of these ingredients reflect homeopathic dilution methods rather than standard pharmaceutical dosing.

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 YQR8R0SQEA
    Achillea millefolium flower is a dried plant extract used in some formulations as a natural flavoring agent and botanical additive. It may help contribute mild taste and aroma characteristics to the medicine.
  • UNII YY2HMJ9NZF
    A synthetic polymer made from acrylic compounds that forms a thick, gel-like substance. It's used as a thickener and stabilizer in topical products to create the right consistency and help ingredients stay evenly mixed.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII OZ0E5Y15PZ
    A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII DG4F8T839X
    A plant extract from comfrey leaves used as a natural ingredient in formulations. It may serve as a soothing agent or botanical additive in topical or oral preparations.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 19AH1RAF4M
    A plant extract from lavender flowers used as a flavoring and fragrance agent in medicines. It adds taste and aroma to make the product more pleasant to take.
  • UNII GIA7T764OD
    A silicone-based ingredient combined with polyethylene glycol. It acts as an emulsifier and surfactant to help blend oils and water-based ingredients, and reduces foaming in liquid formulations.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII BOW48C81XP
    A plant extract from the kava root, used as a flavoring agent to add taste to medicines. It may also help mask bitter flavors in oral formulations.
  • UNII 1212Z7S33A
    PEG-32 is a synthetic polymer derived from ethylene oxide. It acts as a humectant and solvent in medications, helping to dissolve or suspend active ingredients and maintain moisture in solid dosage forms.
  • UNII 762678AC5R
    Polyethylene glycol 700 is a synthetic liquid polymer derived from petroleum. It acts as a solvent, humectant, and lubricant in medicines to improve texture, prevent drying, and help ingredients dissolve or mix evenly.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 205MXS71H7
    A plant extract from white willow bark. It's used as a natural flavoring agent and may help preserve the medicine by providing mild antioxidant properties in the formulation.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe 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 R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • 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.

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

The official label also statesWater/Arnica (Arnica Montana) Flower/ Comfrey (Symphytum Officinale) Leaf/Kava (Piper Methysticum) Root/Poke (Phytolacca Americana) Root/St. John’s Wort (Hypericum Perforatum) Leaf, Flower, Stem/White Willow (Salix Alba) Bark/Yarrow (Achillea Millefolium) Flower/Lavender (Lavandula Angustifolia) Buds/Ascorbic Acid Extract, Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Vera Leaf Juice, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, PEG-33, PEG-8 Dimethicone, PEG-14, Sodium Hydroxide, Tocopherols (Soy), Disodium EDTA, Potassium Sorbate, Sodium Benzoate, Ethanol and Citric Acid

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
Back, Neck and Sciatic Rescue 4 [hp_X]/g; 3 [hp_X]/g; 3 [hp_X]/g; 6 [hp_X]/g; 6 [hp_X]/g; 6 [hp_X]/g 43846-0076-01 Peaceful 57 g — — FDA listed —
Back, Neck and Sciatic Rescue 4 [hp_X]/g; 3 [hp_X]/g; 3 [hp_X]/g; 6 [hp_X]/g; 6 [hp_X]/g; 6 [hp_X]/gthis 43846-0200-01 Peaceful 113.4 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
May 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
43846-0200-01 You're viewing this 113.4 g in 1 BOTTLE, PUMP (43846-0200-1) 2026-05-15 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Back, Neck and Sciatic Rescue Phytolacca Decandra, Gnaphalium Polycephalum, Hypericum Perforatum, Colocynthis, Gelsemium Sempervirens, Guaiacum, Ledum Palustre, Conium Maculatum 4 [hp_X]/g; 3 [hp_X]/g; 3 [hp_X]/g; 6 [hp_X]/g; 6 [hp_X]/g; 6 [hp_X]/g GEL is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

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 "Unapproved Homeopathic". 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 43846-0200-1, 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: 43846-0200-01, written without dashes as 43846020001. 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 43846-0200-01, the first segment (43846) is the labeler code FDA assigned to Peaceful Mountain, Inc.; the middle segment (0200) 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.
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 Peaceful Mountain, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Peaceful Mountain, 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
🎯 Indications and Usage 40 words ▾

USES: May temporarily relieve minor symptoms of back and neck discomfort and sharp pain along the sciatic nerve, lower back and down the back of the legs.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

⏱️ Dosage and Administration 20 words ▾

DIRECTIONS: Apply at least 3 times daily over the affected area. Children under 12 years of age: Consult a doctor.

⚠️ Warnings 81 words ▾

WARNINGS: For external use only. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. When using this product • Do not get into eyes. Stop use and ask a doctor if • Conditions worsens • Symptoms last more than 7 days. Do not use if safety seal is broken or missing. unscented • non-greasy • no petroleum • no animal testing

🧪 Active Ingredient 28 words ▾

ACTIVE INGREDIENTS: (in gel) 0.13% of Colocynthis 6X, Conium Maculatum 30X, Gelsemium Sempervirens 6X, Gnaphalium Polycephalum 3X, Guaiacum 6X, Hypericum Perforatum 3X, Ledum Palustre 6X, Phytolacca Decandra 4X.

🧪 Inactive Ingredients 67 words ▾

INACTIVE INGREDIENTS: Water/Arnica (Arnica Montana) Flower/ Comfrey (Symphytum Officinale) Leaf/Kava (Piper Methysticum) Root/Poke (Phytolacca Americana) Root/St. John’s Wort (Hypericum Perforatum) Leaf, Flower, Stem/White Willow (Salix Alba) Bark/Yarrow (Achillea Millefolium) Flower/Lavender (Lavandula Angustifolia) Buds/Ascorbic Acid Extract, Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Vera Leaf Juice, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, PEG-33, PEG-8 Dimethicone, PEG-14, Sodium Hydroxide, Tocopherols (Soy), Disodium EDTA, Potassium Sorbate, Sodium Benzoate, Ethanol and Citric Acid

🎯 Purpose 40 words ▾

PURPOSE: May temporarily relieve minor symptoms of back and neck discomfort and sharp pain along the sciatic nerve, lower back and down the back of the legs.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 43846-0083-01 · Peaceful 43853-0013-01 · ProBLEN →
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.