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ACNE SPOT TREATMENT 2% BHA SALICYLIC ACID 2 g/100mL Cream, 15 mL — NDC 61328-0404-05 package photo

ACNE SPOT TREATMENT 2% BHA SALICYLIC ACID 2 g/100mL Cream, 15 mL

by Skinfix, Inc. · 15 mL in 1 TUBE (61328-404-05)
NDC 61328-0404-05
🏷️ FDA NDC (as labeled) 61328-404-05 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) 61328-404-05
Product NDC 61328-404
11-digit billing NDC 61328040405
RxCUI 317152
UNII O414PZ4LPZ
Application # M006
SPL Set ID ceccea68-07d8-0903-e053-2995a90ab2b7
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-03-16
Route TOPICAL
Dosage form CREAM
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 61328-404-05 — 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 → 61328-0404-05. 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.

🏷️ RxNorm drug class

This medicine belongs to the Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives, Other antifungals for topical use, Antiinflammatory agents, non-steroids
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

LabelerSkinfix, Inc.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code61328
First marketedMar 2021
Product typeHuman Otc Drug
Portfolio9 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 it is MedlinePlus · NLM

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or b...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's designed to treat acne. Salicylic acid helps by loosening and removing dead skin cells that clog pores — the buildup that leads to breakouts. The multi-step system on this lab...
  • What is this salicylic acid product actually supposed to do for my skin?
  • Some mild tingling, stinging, and peeling is actually expected — that's the salicylic acid doing its job by clearing away dead skin cells. But if the burning or peeling feels exces...
  • My skin feels like it's burning and peeling. Is that normal?
📖 Read our full Salicylic Acid Topical 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 4XO4QFV777
    A branched starch polymer derived from plant sources. It acts as a binder to hold tablet ingredients together and as a filler to add bulk and structure to solid dosage forms.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 5SL0G7R0OK
    A simple sugar made from corn or other plants, used in medicines as a filler and sweetener. It helps create the right texture and taste in tablets, powders, and liquid formulations.
  • UNII F2VW3D43YT
    Azelaic acid is a naturally occurring compound that acts as a preservative and antimicrobial agent in medications. It helps prevent bacterial and fungal growth, extending the product's shelf life and stability.
  • UNII A3N5ZCN45C
    Bentonite is a naturally occurring clay mineral used in medicines as a binder and absorbent. It helps hold tablet ingredients together and can absorb moisture or unwanted substances in the formulation.
  • UNII K67N5Z1RUA
    A plant-derived surfactant made from natural sugars and fatty alcohols. It helps dissolve and mix ingredients evenly throughout the medicine, acting as an emulsifier and solubilizer in liquid formulations.
  • UNII B1K89384RJ
    A mixture of fatty alcohols derived from natural oils or fats, typically containing 14 to 22 carbon atoms. Used as an emollient, thickener, and emulsifier to improve texture and help blend oil and water components in formulations.
  • UNII ICS790225B
    A plant-derived cleaning agent made from coconut oil and glucose. It works as a surfactant and emulsifier to help mix oil and water-based ingredients together in the formulation.
  • UNII 13F4MW8Y9K
    Coconut alcohol is a natural alcohol derived from coconut oil. It's used in medicines as a solvent to dissolve other ingredients and help distribute them evenly throughout the product.
  • 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 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII 2NX48Z0A9G
    Icodextrin is a glucose polymer derived from starch. It acts as a thickening agent and osmotic agent in medicines, helping to control texture and absorption in formulations like eye drops or injectable solutions.
  • UNII 24H4NWX5CO
    Kaolin is a naturally occurring clay mineral. It's used in tablets and capsules as a filler and absorbent to add bulk, improve texture, and help bind ingredients together.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • 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 VH2XOU12IE
    Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
  • UNII 03KCY6P7UT
    A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
  • 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 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII 3YYE6VJS0P
    A compound derived from licorice root extract combined with stearyl alcohol. It acts as an emollient and skin-conditioning agent that helps soften and smooth the product's texture while providing a protective barrier on the skin or mucous membranes.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII C32PQ86DH4
    Zinc PCA is a zinc salt of pyroglutamic acid, a naturally occurring amino acid derivative. It's used in medications as a skin-conditioning agent and to help maintain product stability and texture in topical formulations.

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

The official label also statesWATER (EAU), KAOLIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, AZELAIC ACID, PROPANEDIOL, STEARYL ALCOHOL, POLYGLYCERYL-2 STEARATE, NIACINAMIDE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, GLYCERIN, BENTONITE, TOCOPHEROL, POLYDEXTROSE, DEXTRIN, AMYLOPECTIN, GLYCERYL STEARATE, ZINC PCA, STEARYL GLYCYRRHETINATE, ETHYLHEXYLGLYCERIN, XANTHAN GUM, CITRIC ACID, POTASSIUM CETYL PHOSPHATE, PHENOXYETHANOL, SODIUM HYDROXIDE, POTASSIUM SORBATE, SODIUM BENZOATE

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
Anew Bare Acne Clearing Treatment 2% Salicylic Acid 20 mg/mL 10096-2932-01 THE 1 tube — — FDA listed —
Proactiv Plus Retexturizing Toner 20 mg/mL 11410-0051-00 Alchemee, 1 bottle — — FDA listed —
Nas Max Strength Spot Treatment 2 g/100g 26052-0022-01 BURT'S 1 tube — — FDA listed —
CeraVe Developed with Dermatologists Psoriasis Moisturizing 20 mg/g 49967-0701-01 L'Oreal 227 g — — FDA listed —
Asepxia Acne Treatment 20 mg/g 50066-0064-01 Genomma 1 tube — — FDA listed —
Clear Exfoliating Solution Paulas Choice 2 g/100mL 56152-5002-01 Cosmetic 118 ml — — FDA listed —
Spot Acne Treatment Oil Free 0.75oz 2 g/100g 57337-0168-01 Rejoice 21 g — — FDA listed —
Spot Acne Treatment Oil Free 0.75oz 2 g/100g 58503-0204-01 China 21 g — — FDA listed —
Atrix Acne Treatment 20 mg/mL 59088-0446-05 PureTek 59 ml — — FDA listed —
Acne Spot Treatment 2% Bha 2 g/100mLthis 61328-0404-05 Skinfix, 15 ml — — FDA listed —
DermaClear Serum 20 mg/mL 62742-4069-02 Allure 1 tube — — FDA listed —
Dermaclear Mask 20 mg/g 62742-4074-02 Allure 1 tube — — FDA listed —
Advanced DermaClear Serum 2 g/100g 62742-4280-02 Allure 1 bottle — — FDA listed —
Natureplex Psoriasis 20 mg/g 67234-0073-01 Natureplex, 1 tube — — FDA listed —
Alumier MD Acne Balancing Serum 20 mg/mL 69473-0002-01 Alumier 1 bottle — — FDA listed —
DermaD ATOPIC DERMATITIS Therapeutic 20 mg/g 70794-0101-28 Chen 81 g — — FDA listed —
DermaD JOCK ITCH Therapeutic 20 mg/g 70794-0201-82 Chen 81 g — — FDA listed —
DermaD Psoriasis Therapeutic 20 mg/g 70794-0261-25 Chen 81 g — — FDA listed —
DermaD ANTI-ITCH Therapeutic 20 mg/g 70794-0313-94 Chen 81 g — — FDA listed —
DermaD ANTIFUNGAL Therapeutic 20 mg/g 70794-0708-85 Chen 81 g — — FDA listed —
MILANI ERASE BASE BLEMISH CONTROL PRIMER Salicylic Acid 20 mg/mL 71435-0005-00 New 30 ml — — FDA listed —
Tiege Hanley 20 mg/mL 71714-0003-24 Tiege 24 ml — — FDA listed —
MDacne Customized Acne Treatment Salicylic Acid 20 mg/mL 71804-0533-00 MDAlgorithms 1 tube — — FDA listed —
Soraresal 2 g/100g 73526-0002-02 Summer 1 bottle — — FDA listed —
Kenkoderm Psoriasis Moisturizing 2 g/100g 73632-0004-01 Olympus 295 g — — FDA listed —
ELF Blemish Control Face Primer Clear 2 g/100mL 76354-0210-10 e.l.f. 30 ml — — FDA listed —
ELF Clear Blemish Control Face Primer 2 g/100mL 76354-0624-01 e.l.f. 14 ml — — FDA listed —
Therapeutic Hydrogel 1 g/50g 78863-1090-01 Noon 1 bottle — — FDA listed —
Equate 20 mg/mL 79903-0317-68 Walmart 200 ml — — FDA listed —
VANIBISS BUTT and THIGHS Acne Treatment Cream 20 mg/mL 81890-0192-00 Vanibiss 1 jar — — FDA listed —
SIMPLY VITAL Acne Face Cream 20 mg/mL 82460-0272-00 ALPHA 60 ml — — FDA listed —
Acne Toner Serum 2 g/100mL 82870-0003-01 Dime 60 ml — — FDA listed —
Acne Spot Treatment 2 g/100mL 82870-0006-01 Dime 15 ml — — FDA listed —
Pureskin Seborrheic Dermatitis Psoriasis Cream 2 g/100mL 83887-0007-01 Changsha 100 ml — — Discontinued —
Tula Skincare Breakout Star Lightweight Acne Moisturizer 2 g/100mL 84126-0229-15 The 15 ml — — FDA listed —
Acne Treatment Cream 2 g/100mL 84356-0006-01 Guangzhou 50 ml — — FDA listed —
Perricone MD Acne Relief Maximum Strength Clearing Treatment 2 g/100mL 84448-0301-59 THG 1 bottle — — FDA listed —
Kenkoderm Psoriasis Moisturizing 2 g/100g 85286-0004-01 Nexgel,Inc. 295 g — — FDA listed —
Cleansing Wipes 2 g/100mL 71613-0001-01 Nextcell 25 applicators — — FDA listed —
Oxygenetix Oxygenating Foundation Acne Control 2 g/100mL 10258-0101-11 COLONIAL 15 ml — — Discontinued —
Spot Stopper Acne Spot Treatment 2 g/100mL 69366-0412-32 The 1 tube — — FDA listed —
Pert 2 in 1 Advanced plus 2 g/100mL 81277-0802-13 Sodalis 400 ml — — FDA listed —
Eradikate Acne Mark Fading 2 g/100mL 43479-0112-51 KATE 1 bottle — — FDA listed —
Acne Control Face Wash 2 g/100mL 54111-0185-01 Bentley 180 ml — — FDA listed —
Salicylic Wash 2 g/100mL 70764-0102-56 CONTROL 1 bottle — — FDA listed —
Acne Spot Treatment 2 g/100mL 70764-0105-51 CONTROL 1 bottle — — FDA listed —
Acne Correction Pads 2 g/100mL 72957-0012-01 Private 1 jar — — FDA listed —
Multi-Action Clear - Acne Clearing Treatment 2% Salicylic Acid 2 g/100mL 76147-0301-07 StriVectin 1 tube — — FDA listed —
PanOxyl Acne Gel Wash 2 g/100mL 00316-0299-01 Crown 192 ml — — FDA listed —
PCA Gel 2 g/100mL 68726-0445-02 CP 1 bottle — — FDA listed —
First Aid Beauty FAB Acne Spot Treatment 2 g/100mL 69423-0724-22 The 1 tube — — FDA listed —
SEYTU Spot 2 g/100mL 84271-0002-00 Omnilife 1 tube — — FDA listed —
Pharma Clear Cleanser 2 g/100mL 67879-0101-11 PHARMAGEL 175 ml — — FDA listed —
Start So Fresh 2 g/100mL 70626-0105-13 ASPIRE 100 ml — — FDA listed —
Treat So Deep Acne-Fighting Treatment 2 g/100mL 70626-0106-15 ASPIRE 1 tube — — FDA listed —
Good Molecules Acne Foaming Cleanser 2 g/100mL 82730-0100-05 Good 148 ml — — FDA listed —
Acne Control Superclean Body Wash AHA BHA Formula 2 g/100mL 54111-0170-50 Bentley 250 ml — — FDA listed —
Tula Skincare Clear It Up Acne Clearing and Tone Correcting Gel 2 g/100mL 84126-0121-15 The 1 tube — — FDA listed —
Perricone MD Acne Relief Gentle and Soothing Cleanser 2 g/100mL 84448-0539-17 THG 1 tube — — FDA listed —
Clearasil Stubborn Acne Control 5in1 Exfoliating Wash 2 g/100mL 63824-0436-01 Reckitt 200 ml — — FDA listed —
Curology Acne-Clearing Gel Serum 2 g/100mL 82575-0500-00 Curology, 1 tube — — FDA listed —
First Aid Beauty Acne Clearing Pads 2 g/100mL 84126-0119-60 The 60 patches — — FDA listed —
Perricone MD Acne Relief Calming and Soothing Clay Mask 2 g/100mL 84448-0955-10 THG 10 ml — — FDA listed —
Proactiv Deep Cleansing Wash 2 g/100mL 11410-0048-05 THE 1 bottle — — FDA listed —
Good Molecules Acne Foaming Cleanser 2 g/100mL 64412-1005-02 Twincraft 1 bottle — — FDA listed —
Ultra Clear Treatment 2 g/100mL 10028-0051-01 ULTRACEUTICALS 50 ml — — FDA listed —
Clear System Clarifying Gel Cleanser 2 g/100mL 54111-0189-20 Bentley 20 ml — — FDA listed —
anna lotan PURIFYING PADS with 2% Salicylic Acid 2 g/100mL 76446-0039-50 Anna 1 jar — — FDA listed —
Clarifying Peel 2 g/100mL 46007-0102-11 Skin 20 ml — — Discontinued —
Acne Control Body Wash 2 g/100mL 54111-0184-01 Bentley 250 ml — — FDA listed —
Bha Cleanser 2% 2 g/100mL 61328-0403-01 Skinfix, 30 ml — — FDA listed —
Eradikate Acne Mark Fading 2 g/100mL 72204-0903-02 Rare 1 bottle — — FDA listed —
Triderma Psoriasis Control Body Wash 2 g/100mL 10738-0217-63 Genuine 473 ml — — FDA listed —
Proactivplus Pore Clearing Treatment 2 g/100mL 11410-0047-30 Alchemee, 1 tube — — FDA listed —
First Aid Beauty FAB Pharma White Clay Acne Treatment 2 g/100mL 69423-0555-60 The 60 patches — — FDA listed —
ESSENCE BY CATHERINE HINDS PURIFYING PADS with 2% Salicylic Acid 2 g/100mL 76446-0022-50 Anna 1 jar — — FDA listed —
Good Molecules Maximum Strength Acne Gel Cream 2 g/100mL 82730-0102-01 Good 1 tube — — FDA listed —
Dry It Out Acne Spot Treatment 2 g/100mL 61197-0122-00 Pacifica 29 ml — — FDA listed —
Clearasil Rapid Rescue Deep Treatment Wash 2 g/100mL 63824-0432-01 Reckitt 200 ml — — FDA listed —
Good Molecule Maximum Strenght Acne 2 g/100mL 68577-0287-00 COSMAX 1 tube — — FDA listed —
ORLASKIN ACNE Treatment 2 g/100mL 87582-0005-01 Guangzhou 50 ml — — FDA listed —
SUZANOBAGIMD Acne Cleansing Wipes 2 g/100mL 62032-0617-25 Obagi 25 patches — — 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

🏛️
2021
On the market since
Mar 2021
📍
2026
Currently FDA-listed
5 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Salicylic Acid (matched by generic name) — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Salicylic Acid. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.2K
Claims incl. refills
43
Beneficiaries
35
Spend / beneficiary
$319.01
Spend / claim
$259.66
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 ACNE SPOT TREATMENT 2% BHA (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Age at onset

Neonate7
Infant1
Child8
Adolescent5
Adult170
Elderly94

Reporter sex

1,853 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization623
Death611
Life-threatening174
Disabling124
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 243 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
61328-0404-05 You're viewing this 15 mL in 1 TUBE (61328-404-05) 2021-03-16 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 61328-404-05, 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: 61328-0404-05, written without dashes as 61328040405. 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 61328-0404-05, the first segment (61328) is the labeler code FDA assigned to Skinfix, Inc.; the middle segment (0404) 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 Skinfix, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Skinfix, 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 25 words ▾

USES HELPS CLEAR ACNE BLEMISHES AND ALLOWS SKIN TO HEAL. HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES. HELPS PREVENT NEW ACNE BLEMISHES FROM FORMING.

⏱️ Dosage and Administration 28 words ▾

Directions APPLY DIRECTLY ONYO BLEMISH OR AFFECTED AREA AFTER CLEANSING 1-2X DAILY. ALLERGY ALERT DO NOT USE THIS PRODUCT IF YOU HAVE A KNOWN ALLERGY TO SALICYLIC ACID.

⚠️ Warnings 41 words ▾

WARNINGS FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME. IF IRRITATION OCCURS, ONLY USE ONE TOPICAL ACNE MEDICATION AT A TIME.

🧪 Active Ingredient 5 words ▾

Active Ingredient SALICYLIC ACID 2%

🧪 Inactive Ingredients 51 words ▾

Inactive Ingredients WATER (EAU), KAOLIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, AZELAIC ACID, PROPANEDIOL, STEARYL ALCOHOL, POLYGLYCERYL-2 STEARATE, NIACINAMIDE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, GLYCERIN, BENTONITE, TOCOPHEROL, POLYDEXTROSE, DEXTRIN, AMYLOPECTIN, GLYCERYL STEARATE, ZINC PCA, STEARYL GLYCYRRHETINATE, ETHYLHEXYLGLYCERIN, XANTHAN GUM, CITRIC ACID, POTASSIUM CETYL PHOSPHATE, PHENOXYETHANOL, SODIUM HYDROXIDE, POTASSIUM SORBATE, SODIUM BENZOATE

🎯 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 ↗
← 61328-0403-01 · Skinfix, 61330-0123-01 · Brevard →
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.