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Acunol Nickel Sulfate, Potassium Bromide, Sodium Bromide, Zinc Sulfate Anhydrous, and Sulfur 1 [hp_X]/1; 1 [hp_X]/1; 1 [hp_X]/1; 1 [hp_X]/1; 1 [hp_X]/1 Tablet, 90-count

by PLYMOUTH HEALTHCARE PRODUCTS LLC · 90 TABLET in 1 BOTTLE (61480-137-05)
NDC 61480-0137-05
🏷️ FDA NDC (as labeled) 61480-137-05 billing pads the product segment with a zero
Rx only 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

🆔 Identity & classification

FDA NDC (as labeled) 61480-137-05
Product NDC 61480-137
11-digit billing NDC 61480013705
NCPDP billing unit EA — each (per item)
UNII 4FLT4T3WUN, OSD78555ZM, LC1V549NOM, 0J6Z13X3WO, 70FD1KFU70
UPC 0361480137052
SPL Set ID f7f1c99e-1a67-4b34-b1f4-0ac38b9d8006
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-04-18
Route ORAL
Dosage form TABLET
Substance NICKEL SULFATE; POTASSIUM BROMIDE; SODIUM BROMIDE; ZINC SULFATE ANHYDROUS; SULFUR
GPI-14 99870010000300
GPI class Acunol
GCN Seq No 059830
GCN 25704
HICL code 033258
Ingredient (HICL) Zn Brom/Nick Sulf/Bromide/Sulf
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C5
Therapeutic class — intermediate (HIC2) Carbohydrates And/Or Proteins
HIC3 code C5F
Therapeutic class — specific (HIC3) Dietary Supplement, Miscellaneous
AHFS code 92:92.00.00
AHFS class Other Miscellaneous Therapeutic Agents
FDB label name ACUNOL 600 MG TABLET
FDB brand name Acunol
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 61480-137-05 — 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 → 61480-0137-05. 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

LabelerPLYMOUTH HEALTHCARE PRODUCTS LLC
Labeler code61480
First marketedApr 2006
Product typeHuman Prescription Drug
Portfolio7 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

Label name ACUNOL 600 MG TABLET Ingredient Zn Brom/Nick Sulf/Bromide/Sulf
🧪 What is this product?

Acunol is a homeopathic oral tablet containing nickel sulfate, potassium bromide, sodium bromide, sulfur, and zinc sulfate anhydrous. In homeopathic practice, these ingredients are traditionally used to address various skin conditions and systemic imbalances, though homeopathic products are marketed based on traditional use rather than scientific evidence evaluated by the FDA. This product is not approved by the FDA for any medical use. Homeopathic remedies operate under different regulatory standards than conventional drugs.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acunol 1 [hp_X]/1; 1 [hp_X]/1; 1 [hp_X]/1; 1 [hp_X]/1; 1 [hp_X]this 61480-0137-05 PLYMOUTH 90 tablets — — 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

🏛️
2006
On the market since
Apr 2006
📍
2026
Currently FDA-listed
20 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
61480-0137-05 You're viewing this 90 TABLET in 1 BOTTLE (61480-137-05) 2006-04-18 Active

🧭 About this NDC listing & data coverage

Finished prescription product Homeopathic listing

About homeopathic listings

Acunol Nickel Sulfate, Potassium Bromide, Sodium Bromide, Zinc Sulfate Anhydrous, and Sulfur 1 [hp_X]/1; 1 [hp_X]/1; 1 [hp_X]/1; 1 [hp_X]/1; 1 [hp_X]/1 TABLET 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 61480-137-05, 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: 61480-0137-05, written without dashes as 61480013705. 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 61480-0137-05, the first segment (61480) is the labeler code FDA assigned to PLYMOUTH HEALTHCARE PRODUCTS LLC; the middle segment (0137) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 PLYMOUTH HEALTHCARE PRODUCTS LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PLYMOUTH HEALTHCARE PRODUCTS LLC 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 32 words ▾

INDICATIONS Acunol™ is indicated for the treatment of mild to moderate acne vulgaris, acne rosacea, peri-oral dermatitis, and folliculitis. It has been found to work well with a variety of combination therapies.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Take tablets twice a day (b.i.d.) for best results. Absorption of nickel sulphate is variable among individuals. For maximum nickel absorption, tablets should be taken orally upon rising at the beginning of the day and at the end of the day before bed.

Take nothing but water for one hour after taking medication to aid nickel absorption. If taking Tetracycline or Levofloxacin allow at least two hours after taking Acunol. If taking a different Quinolone antibiotic, consult manufacturer's information.

Kg lbs Starting dose Max Daily dose 23-45 51-100 ½ ∙ b.i.d. 1 ∙ b.i.d. 46-68 101-150 1 ∙ b.i.d.

2 ∙ b.i.d. 69-90 151-200 1½ ∙ b.i.d. 3 ∙ b.i.d.

91+ 201+ 2 ∙ b.i.d. 4 ∙ b.i.d. Increase dose only if needed on a monthly basis up to the max daily dose.

Treatment dose and duration depends on the individual. In the setting of significant renal impairment Dosage should be adjusted and serum nickel and bromide levels should be followed. Steady state trough nickel level should be drawn prior to ingesting the day's dose after one week of dosing or at appropriate intervals.

Target trough serum nickel level is 10-40 mcg/L. (Caution: post dose peak levels are unreliable.) Serum bromide assay by spectrophotometry is the historic standard. 36 Concentrations higher than 50 mg/dl may be compatible with toxicity.

No therapeutic target levels exist for bromide.

⛔ Contraindications 30 words ▾

CONTRAINDICATIONS Although there are no known contraindications, patients who are allergic to any Acunol™ ingredient should consult a physician prior to taking the medication. (Refer to Section on Hypersensitivity )

⚠️ Warnings 53 words ▾

WARNING Do not use if imprinted seal under bottle cap is missing or broken. Do not use if pregnant or nursing. If allergic to nickel or metal objects such as jewelry, see PRECAUTIONS for hypersensitivity information. Lactose intolerant patients may have gastrointestinal difficulty. This has very rarely been reported at the doses used.

🤒 Adverse Reactions 21 words ▾

ADVERSE REACTIONS Acunol™ contains low doses of active ingredients. Therefore there are minimal known side effects. (see PRECAUTIONS for hypersensitivity information)

🔄 Drug Interactions 48 words ▾

Drug interactions There are no known drug interactions. Since copper deficiency in human nutrition has occasionally been induced by supplemental zinc therapy, copper has been added in order to minimize this rare occurrence. (see Inactive ingredients ) For Tetracycline or Quinolones co-administration with Acunol, see Dosage and Administration

🤰 Pregnancy 22 words ▾

Pregnancy Pregnancy category C Animal reproduction studies have not been conducted with Acunol™. Acunol™ should not be given to a pregnant woman.

🧒 Pediatric Use 11 words ▾

Pediatric use Carefully adjust dosage to weight when treating young children.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Bromide toxicity Indications of toxicity due to oral overdosage of bromide may include nausea, vomiting, apathy, disturbed coordination, loss of memory, drowsiness, loss of emotional control, agitation, hallucination, tremors, depressed reflexes, stupor, and coma. Acute toxic reactions in humans have been reported at doses as low as 1000 mg. 19 This level is 33 times the dose received in one tablet of Acunol™.

Zinc sulphate toxicity Symptoms of acute toxicity of zinc due to oral overdoseage can include dehydration, stomach pain, lethargy, dizziness, muscular incoordination, and in severe cases renal failure. 26 Chronic zinc toxicity can occur at levels of 100-300 mg/d. 30 Sulphur toxicity The oral rat LD 50 for sulphur is reported to be greater than 5,000 mg/kg.

23 This is more than 11,000 times the maximum dose recommended for Acunol™. Ingestion of toxic levels of sulphur can cause sore throat, nausea, headache, gastrointestinal irritation, and possibly unconsciousness in severe cases. 24,25 Sulphur poses such a remote risk that is placed in the lowest toxic category possible, EPA Toxicity Category IV.

23 Nickel sulphate toxicity The oral rat LD 50 for nickel sulphate hexahydrate is 275 mg/kg. 17 Symptoms of toxicity due to oral overdosage of nickel sulphate may include nausea, vomiting, abdominal discomfort, diarrhea, giddiness, lassitude, headaches, cough, and shortness of breath. 18 The lowest observed transitory toxic effects from human ingestion of soluble nickel salts is approximately 8 mg nickel/kg body weight.

18 This is 180 times the maximum dose recommended for Acunol™. (See below )

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY The active ingredients in Acunol™ are simple biochemical compounds. The exact mechanism of action is unknown; however, it is known that bromide enhances phagocytic and bactericidal activity of neutrophils. 31 POTASSIUM BROMIDE & SODIUM BROMIDE dissolve and dissociate in the digestive tract into their ionic constituents.

Each tablet contains approximately 30 mg of bromide (calculated). Ionic bromide is rapidly and completely absorbed from the intestine and distributed almost exclusively in the extracellular fluids. 7,8 Bromide is eliminated by the kidneys and the elimination half-life is 11-12 days.

ZINC SULPHATE dissolves and dissociates in the digestive tract into its ionic constituents. Each tablet contains approximately 5 mg of zinc (calculated). Zinc is an essential trace mineral necessary for protein synthesis, enzyme stimulation, and alkaline balance.

27,28 It is primarily absorbed from the duodenum and excreted via feces, urine, and sweat. 26 SULPHUR is a naturally occurring mineral that is an essential part of the human body. It exhibits anti-bacterial, anti-parasitic, fungicidal, and keratolytic properties.

26 Each tablet contains approximately 5 mg of sulphur (calculated). Sulphur is highly water soluble and as a result is easily excreted by the body via sweat and urine. 22 Since the sulphur found in Acunol™ is a naturally occurring mineral, it is radically different from sulfa drugs (sulfonamide antibiotics).

Therefore, patients who are allergic to sulfa drugs CAN safely take Acunol™ . NICKEL SULPHATE dissolves and dissociates in the digestive tract into its ionic constituents. Each tablet contains approximately 0.5 mg of ionic nickel (calculated).

According to studies, 15% to 50% of ionic nickel is absorbed on a fasted stomach. 2 Food markedly decreases the rate and extent of nickel absorption. 3,4 Clinical studies show that serum concentrations of nickel are variable among patients after administering the same dosage.

5 Peak serum nickel concentration is reached about two hours after oral administration. Nickel is in its highly stable divalent cation state and is therefore not expected to be metabolized to any significant degree in the body. Absorbed nickel is primarily excreted in the urine and elimination half-life is about 21 hours.

3,5 Renal clearance is rapid and efficient, and nickel does not accumulate in the body. 6

📦 How Supplied / Storage and Handling 34 words ▾

HOW SUPPLIED Scored tablets, off white in color with green speckles, with imprinted on one side and a score on the other side , in child-resistant and tamper-resistant bottles of 90. NDC 61480-137-05 Symbol

📋 Description 95 words ▾

DESCRIPTION Acunol™ is a biochemical homeopathic medication indicated for the treatment of acne. 32-34 The active ingredients in each Acunol™ tablet consist of the following: Potassium Bromide (Kali Bromatum) 1X, Sodium Bromide (Natrum Bromatum) 1X, Zinc Sulphate (Zincum Sulphuricum) 1X, Sulphur 1X, and Nickel Sulphate (Niccolum Sulphuricum) 1X. These drug ingredients are listed in the Homoeopathic Pharmacopoeia of the United States (HPUS).

1 Inactive ingredients: Lactose, Magnesium Stearate, and Copper (II) Oxide. Pharmacological class: Homeopathic drug. Dosage form: Oral 600 mg scored tablet.

May be swallowed whole, chewed or dissolved in the mouth and swallowed.

💬 Information for Patients 62 words ▾

Information for patients Patients using Acunol™ should receive the following information and instructions: This medication is to be used as directed by a physician. It is important to take orally at the beginning of the day on an empty stomach and at the end of the day before bed; take nothing but water for one hour afterwards to avoid interference with absorption.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61480-0127-05 · PLYMOUTH 61480-0145-63 · PLYMOUTH →
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.