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Blemfree Salicylic Acide 1500 mg/29000mg Lotion, 29000 mg — NDC 53228-003-01 (Billing 53228-0003-01)

by Equibal, Inc. · 29000 mg in 1 TUBE

This is a package of 29,000 mg of Blemfree Salicylic Acide 1500 mg/29000mg Lotion from Equibal, Inc., marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.

NDC 53228-0003-01
🏷️ FDA NDC (as labeled) 53228-003-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 53228-003-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
53228 labeler · 003 product · 01 package
Package marketed since
Dec 17, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5322800301 9
FDA record last changed
Jul 24, 2026
Past resolved recalls for this product (1)
Class II · Jun 26, 2024 · Terminated — CGMP Deviations: Manufactured without following Current Good Manufacturing Practises. (Equibal Inc) · FDA recall D-0591-2024

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53228-003-01
Product NDC 53228-003
11-digit billing NDC 53228000301
UNII O414PZ4LPZ
Application # M006
SPL Set ID 424dba97-0d40-4801-9fec-4b80ab60f900
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-17
Route TOPICAL
Dosage form LOTION
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 53228-003-01 — 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 → 53228-0003-01. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It is used in a facial routine for acne-prone and oil-prone skin. The routine includes a cleanser, serum, toner and emulsion. Salicylic acid helps loosen and shed dead skin cells.
  • Use the cleanser morning and evening, and the serum in the morning after cleansing. Use the toner in the evening on dry skin, and the emulsion at night after cleansing. Avoid your...
  • Mild stinging, burning, itching, dryness and extra peeling can happen. If dryness or peeling bothers you, try using the serum or toner every other day. If it gets excessive, stop a...
  • It is best not to. Using another topical acne medication at the same time makes irritation and dryness more likely. If you get irritated, use only one at a time.
📖 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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
53228-0003-01 You're viewing this Main listing 29000 mg in 1 TUBE 2014-08-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Blemfree 1500 mg/29000mgthis 53228-0003-01 Equibal, 29000 mg — — 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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII C3M81465G5
    Spearmint oil is a natural flavoring extract from spearmint plants. It's added to medicines to improve taste and mask bitter flavors, making medications easier to take.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesBehentrimonium Methosulfate, Benzethonium Chloride, Bisabolol, Butylene Glycol, Cetyl Alcohol, Chamomilla (matricaria Recutita) Extract, Chlorhexidine Gluconate, Dimethicone, Mentha Spicata (Spearmint) Oil, Menthyl Lactate, Octydodecanol, Phenoxyethhanol, Polyguatemium-37, Rosemary (Rosmarinus Officinalis) Leaf Oil, Stearic Acid, Water (Aqua), Witch Hazel (Hamamelis Virginiana) Extract.

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.

Manufacturer & labeler

LabelerEquibal, Inc.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code53228
First marketedDec 2025
Product typeHuman Otc Drug
Portfolio7 products on file

More NDCs from Equibal, Inc. labeler code 53228

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 6 words ▾

Indications and Usage Management of Acne

⏱️ Dosage and Administration 32 words ▾

Dosage & Administration After area is wet with Blemfree™ Cleansing Wash Concentrate has foamed, tap Blemfree™ Cleansing Spheres with fingertips and massage in small circles for 60 seconds. Proceed to rinse step.

⚠️ Warnings 16 words ▾

Warnings For external use only. Do not use more than one acne product at a time.

🧪 Active Ingredient 6 words ▾

Active Ingredient Salicylic Acid 5% w/w

🧪 Inactive Ingredients 41 words ▾

Inactive Ingredients Behentrimonium Methosulfate, Benzethonium Chloride, Bisabolol, Butylene Glycol, Cetyl Alcohol, Chamomilla (matricaria Recutita) Extract, Chlorhexidine Gluconate, Dimethicone, Mentha Spicata (Spearmint) Oil, Menthyl Lactate, Octydodecanol, Phenoxyethhanol, Polyguatemium-37, Rosemary (Rosmarinus Officinalis) Leaf Oil, Stearic Acid, Water (Aqua), Witch Hazel (Hamamelis Virginiana) Extract.

🎯 Purpose 4 words ▾

Purpose Management of Acne

📄 Ask a Doctor Before Use If 8 words ▾

Ask doctor Ask doctor if pregnant or breastfeeding.

📄 When Using This Product 18 words ▾

When using When using product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

📄 Stop Use and Ask a Doctor If 14 words ▾

Stop Use Stop use and ask a doctor if irritation and redness become severe.

📄 Keep Out of Reach of Children 25 words ▾

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

📄 Other Information 24 words ▾

Other Safety Information Do not use in conjunction with other products containing acids or Benzoyl Peroxide. Do not use harsh cleaning pads or brushes.

📄 Package Label / Principal Display Panel ~3 min read ▾

Package Label MADE IN USA ● NOT TESTED ON ANIMALS PATENT# 8,603,550 EQUIBAL LABS, INC. 1(800)247-2405 63-65 JERSEY AVE, BLEMFREE.COM UNIONVILLE, NY 10988 Blemfree ™ A NATURAL APPROACH TO FIGHT ACNE ALL-DAY LOTION This patented antibacterial lotion protects your skin all day while fighting bacteria. The astringent formula breaks down excess oils without causing redness or excessive dryness.

1 OZ. 29 ML RETAIN INSERT FOR FULL PRODUCT USES, DIRECTIONS, WARNINGS, AND DRUG FACTS. Directions: After using Blemfree™ Cleansing Wash Concentrate and Toner & Balancer in the morning, smooth a thin layer of Blemfree™ All-Day Lotion on your face, neck, or back.

Start with one application daily, then increase to two times daily if needed or as directed by a doctor. Blemfree All Day Lotion

Blemfree All Day Lotion Package Insert CLEANSING WASH CONCENTRATE Ingredients: Sodium Laureth Sulfate, Sodium Methocoyl Taurate, RO Water (Aqua), Cocamidopropyl Betaine, 2- (dodecanoyl methyl) amino) Acetic Acid, Hexylene Glycol, Phenocyethanol, Capryl Diol, Methylcellulose, Witch Hazel (Hamamelis Virginiana) Extract, Chamomilla (Matricaria Recutita) Extract, Rosmarius Officnalis (Rosemary) Leaf Oil, Mentha Spicata (Spearmint) Oil. Directions : Dampen face by cupping lukewarm water in both hands. Add some Blemfree™ Cleansing Wash to one palm and coat fingers.

Massage in a circular motion till foam appears. Tap the Blemfree™ Cleansing spheres with wet fingertips and massage 60 seconds in small circles working toward the center of the face. Add water and continue massaging until the foam starts to subside.

Rinse 4 times with lukewarm water and then 4 times with cool water. Pat dry. Apply Blemfree™ Toner & Balancer to area with a cotton pad.

Then apply Blemfree™ All-Day Lotion in a thin film all over. TONER & BALANCER Ingredients: RO Water(Aqua), Witch Hazel (Hamamelis Virginiana) Water, Peg 8, chlorhexidine Digluconate, Chamomilla (Matricaria Recutita) Extract, Witch Hazel (Hamamelis Virginiana) Extract, Mentha Spicata (Spearmint) Leaf Oil, Rosmarinus Officinalis (Rosemary Leaf Oil, Polysorbate 20. Directions: Wash face with Blemfree™ Cleansing Wash Concentrate, Pat dry.

Use a cotton ball or pad to apply Tone & Balancer on your face, neck and/or back. MADE IN USA ● NOT TESTED ON ANIMALS CLEANSING SPHERES Ingredients: Jojoba Spheres Directions: After area is wet with Blemfree™ Cleansing Wash Concentrate has foamed, tap Blemfree™ Cleansing Spheres with fingertips and massage in small circles for 60 seconds. Proceed to rinse step.

ALL-DAY LOTION DRUG FACTS Use(s): Management of acne Active Ingredient Purpose Salicylic Acid 0.5% w/w Management of acne Warnings: For external use only. Do not use more than one acne product at a time. Ask doctor if pregnant or breastfeeding.

When using product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation and redness become severe.

Do not use in conjunction with other products containing acids or Benzoyl Peroxide. Do not use harsh cleaning pads or brushes. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Inactive Ingredients: Behentrimonium Methosulfate, Benzethonium Chloride, Bisabolol, Butylene Glycol, Cetyl Alcohol, Chamomilla (matricaria Recutita) Extract, Chlorhexidine Gluconate, Dimethicone, Mentha Spicata (Spearmint) Oil, Menthyl Lactate, Octydodecanol, Phenoxyethhanol, Polyguatemium-37, Rosemary (Rosmarinus Officinalis) Leaf Oil, Stearic Acid, Water (Aqua), Witch Hazel (Hamamelis Virginiana) Extract. Directions: After using Blemfree™ Cleansing Wash Concentrate and Toner & Balancer in the morning, smooth a thin layer of Blemfree™ All-Day Lotion on your face, neck or back.

Start with one application daily, then increase to two times daily if needed or as directed by a doctor. image description

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for BlemFree (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

0 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization622
Death611
Life-threatening174
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 252 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
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) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Equibal, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Equibal, 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.
← 53228-0002-01 · Equibal, 53228-0050-01 · Equibal, →
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.