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Anna Guanche MD Miracle Cream The Pimple Cream Sulfur 100 mg/mL Cream, 29.5 mL — NDC 80841-0100-01 package photo

Anna Guanche MD Miracle Cream The Pimple Cream Sulfur 100 mg/mL Cream, 29.5 mL

by Bella Cosmeceuticals, Inc. · 29.5 mL in 1 JAR (80841-100-01)
NDC 80841-0100-01
🏷️ FDA NDC (as labeled) 80841-100-01 billing pads the product segment with a zero
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

🆔 Identity & classification

FDA NDC (as labeled) 80841-100-01
Product NDC 80841-100
11-digit billing NDC 80841010001
RxCUI 315220
UNII 70FD1KFU70
Application # M006
SPL Set ID b4562cf4-aae3-e9db-e053-2995a90a7210
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-11-17
Route TOPICAL
Dosage form CREAM
Substance SULFUR
Why two NDCs? The FDA registers this code as 80841-100-01 — 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 → 80841-0100-01. 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.

🏷️ RxNorm drug class

This medicine belongs to the Preparations containing sulfur class.

Drug family (ATC) Preparations containing sulfur
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerBella Cosmeceuticals, Inc.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code80841
First marketedNov 2020
Product typeHuman Otc Drug
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 cream containing sulfur, marketed as an over-the-counter monograph product under FDA's established rules for this drug category. Sulfur is commonly used in skin care products for its antimicrobial and keratolytic properties, meaning it is typically applied to help address acne and other skin conditions. The cream form is applied directly to the skin surface.

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 105S6I733Z
    A natural oil extracted from chamomile and other plants. It acts as a fragrance and flavoring agent to improve the taste and smell of the medicine.
  • UNII A7E6112E4N
    A form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down, helping maintain stability and shelf life.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • 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 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 609A3V1SUA
    A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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.
  • UNII KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • UNII 86FQE96TZ4
    A synthetic polymer, this ingredient acts as a thickener and suspending agent in liquid formulations. It helps maintain uniform consistency and keeps particles evenly distributed throughout the medicine.
  • UNII R33S7TK2EP
    Hydroxyethyl cellulose is a thickening agent made from processed plant cellulose. It's used in medicines to increase viscosity, improve texture, and help distribute active ingredients evenly throughout liquid or semi-solid formulations.
  • UNII 25KRT26H77
    A synthetic organic compound used as a preservative and antioxidant in medicines. It helps prevent breakdown and spoilage of the active ingredients during storage.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 5N1WD9784U
    A plant-derived ingredient from honeysuckle flowers, used as a natural flavoring or fragrance component to improve taste or aroma in the medicine.
  • UNII 4465L2WS4Y
    A plant extract from Japanese honeysuckle flowers used as a natural flavoring and fragrance ingredient in medicines. It may also help preserve the product and add pleasant taste or aroma.
  • UNII 5M609NV974
    A plant extract from magnolia bark used as a natural flavoring agent and preservative in medicines. It may help mask bitter tastes and protect the product from spoilage.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII 6941286E4I
    A waxy substance made from polyethylene glycol and stearic acid (a fatty component). It helps mix oil and water together in the formula and may soften the texture of tablets or creams.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • 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 GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • 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 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.

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

The official label also statesInactive ingredients Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Dicaprylyl Carbonate, Acacia Senegal Gum, Squalane, Glycerin, Calamine, Shea Butter, Glycerides, Dimethicone, Cetearyl Alcohol, Glyceryl Stearate, PEG-100, Stearane, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Bisabolol, Tocopheryl Acetate, Magnolia Officinalis Bark Extract, Hydroxyphenyl Propamidobenzoic Acid, Stearic Acid, Ethylhexylglycerin, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ceteareth-20, Pentylene Glycol, Disodium EDTA, Butylene Glycol, Caprylyl Glycol, Penoxyethanol, Fragrance (Parfum)

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
Derma E Acne Clarifying Mask 100 mg/g 54108-3710-05 derma 1 tube — — FDA listed —
Anna Guanche MD Miracle Cream The Pimple Cream 100 mg/mLthis 80841-0100-01 Bella 29.5 ml — — FDA listed —
Sulfur Spot Treatment 10 g/100mL 85439-0102-01 Banuskin, 15 ml — — FDA listed —
Vichy Laboratoires Normaderm SOS Acne Rescue Spot Corrector 100 mg/mL 49967-0648-01 L'Oreal 1 tube — — FDA listed —
Kiehls Since 1851 Dermatologist Solutions Breakout Control Targeted Acne Spot Treatment 100 mg/mL 49967-0895-01 L'Oreal 1 tube — — FDA listed —
Thayers Natural Remedies Since 1847 Rapid Acne Treatment 100 mg/mL 49967-0415-01 L'Oreal 1 tube — — FDA listed —
Neutrogena Stubborn Acne Spot Drying 100 mg/mL 69968-0761-01 Kenvue 1 bottle — — 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

🏛️
2020
On the market since
Nov 2020
📍
2026
Currently FDA-listed
6 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.

🔬 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 Anna Guanche MD Miracle Cream The Pimple Cream (this brand).

Top reported reactions

Drug Hypersensitivity162
Pain22
Dizziness20
Headache19
Malaise19
Fatigue18
Abdominal Distension16

Reporter sex

0 reports
Male · 22%
Female · 78%
Unknown · 0%

Serious outcomes

Hospitalization57
Disabling12
Death6
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 25 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80841-0100-01 You're viewing this 29.5 mL in 1 JAR (80841-100-01) 2020-11-17 Active

🧭 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 80841-100-01, 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: 80841-0100-01, written without dashes as 80841010001. 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 80841-0100-01, the first segment (80841) is the labeler code FDA assigned to Bella Cosmeceuticals, Inc.; the middle segment (0100) 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 Bella Cosmeceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bella Cosmeceuticals, 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 5 words ▾

Uses For Treatment of acne

⏱️ Dosage and Administration 95 words ▾

Directions clean the skin thoroughly before applying this product cover the entire affected area with a thin layer one to two times daily because excessive drying of the skin may occur, start with one application daily then gradually increase to two times daily if needed or as directed by a doctor. if bothersome dryness or peeling occurs, reduce application to once a day or every other day Sensitivity Test for New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomforts occurs, follow directions stated above.

⚠️ Warnings 4 words ▾

For external use only.

📦 Storage and Handling 8 words ▾

Other information Store at 68°F- 77°F (20°C- 25°C).

🧪 Active Ingredient 4 words ▾

Active Ingredient Sulfur 10%

🧪 Inactive Ingredients 66 words ▾

Inactive ingredients Water ( Aqua), Helianthus Annuus (Sunflower) Seed Oil, Dicaprylyl Carbonate, Acacia Senegal Gum, Squalane, Glycerin, Calamine, Shea Butter, Glycerides, Dimethicone, Cetearyl Alcohol, Glyceryl Stearate, PEG-100, Stearane, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Bisabolol, Tocopheryl Acetate, Magnolia Officinalis Bark Extract, Hydroxyphenyl Propamidobenzoic Acid, Stearic Acid, Ethylhexylglycerin, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ceteareth-20, Pentylene Glycol, Disodium EDTA, Butylene Glycol, Caprylyl Glycol, Penoxyethanol, Fragrance (Parfum)

🎯 Purpose 3 words ▾

Purpose Acne Treatment

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 80830-2613-02 · Amneal 80855-0201-05 · Virtue →
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.