Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Drs. ACNE CLEAR SALICYLIC ACID 5 mg/g Gel — NDC 80489-300-01 (Billing 80489-0300-01)
by OL PHARMA TECH, LLC Drs. PHARMACY · 1 TUBE, WITH APPLICATOR in 1 CARTON / 20 g in 1 TUBE, WITH APPLICATOR
This is a package of Drs. ACNE CLEAR SALICYLIC ACID 5 mg/g Gel from OL PHARMA TECH, LLC Drs. PHARMACY, marketed since Feb 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC 80489-0300-01
🏷️ FDA NDC (as labeled)
80489-300-01
billing pads the product segment with a zero
This package
Contains20 g in 1 tube, with applicator
Pack sizes2 compare ↓
Main listing for product 80489-300 · Also comes in:
30 g 80489-300-02
🗂️ 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
80489-300-01
Product NDC
80489-300
11-digit billing NDC
80489030001
RxCUI
252296
UNII
O414PZ4LPZ
Application #
M006
SPL Set ID
d6faa57c-d081-b57c-e053-2a95a90a7926
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2022-02-01
Route
TOPICAL
Dosage form
GEL
Substance
SALICYLIC ACID
Quick answers
- RxCUI (RxNorm): 252296
Why two NDCs?
The FDA registers this code as 80489-300-01 — 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 → 80489-0300-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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 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.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about SALICYLIC ACID?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per 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.
Try another pack size:
30 g
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 80489-0300-01 You're viewing this Main listing | 1 TUBE, WITH APPLICATOR in 1 CARTON / 20 g in 1 TUBE, WITH APPLICATOR | 2022-02-01 | — | Active |
| 80489-0300-02 80489-300-02 | 1 TUBE, WITH APPLICATOR in 1 CARTON / 30 g in 1 TUBE, WITH APPLICATOR | 2022-02-01 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 1 tube, with applicator in 1 carton / 20 g in 1 tube, with applicator.
What NDC number is used to bill for this package of Drs. ACNE CLEAR SALICYLIC ACID 5 mg/g Gel?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Proactiv Blackhead Dissolving .5 g/100mL 11410-0024-05 | Alchemee, | 1 tube | — | — | FDA listed | — |
| Shiseido Waso Koshirice Acne Calming Treatment .1 g/20mL 58411-0615-60 | SHISEIDO | 1 tube | — | — | FDA listed | — |
| All Acne Treatment .5 g/100g 63347-0130-01 | Blaine | 1 bottle | — | — | FDA listed | — |
| Acne Treatment 5 mg/g 67234-0007-01 | Natureplex, | 1 tube | — | — | FDA listed | — |
| Clear Smart Clear Pore Hydrator .5 g/100mL 68828-0701-01 | Distribuidora | 50 ml | — | — | FDA listed | — |
| Neutrogena Evenly Clear Acne Gel Moisturizer 5 mg/g 69968-0946-01 | Kenvue | 12 tubes | — | — | FDA listed | — |
| Scrub So Clean Acne-Fighting Super Scrub .5 g/100mL 70626-0107-11 | ASPIRE | 100 ml | — | — | FDA listed | — |
| CAUDALIE Vinopure Acne Serum .15 g/30mL 76296-0070-10 | Caudalie | 1 bottle | — | — | FDA listed | — |
| Drs. ACNE CLEAR 5 mg/gthis 80489-0300-01 | OL | 1 tube | — | — | FDA listed | — |
| Gentle Acne Serum .5 g/100mL 83286-0016-01 | Drmtlgy, | 59 ml | — | — | FDA listed | — |
| Azelaq 5 mg/mL 87110-0003-01 | METHODIQ | 1 bottle | — | — | FDA listed | — |
| Derm Acne Solution Gel .5 g/100g 87512-0003-01 | Yantai | 10 g | — | — | FDA listed | — |
| SOS Rituals Glow Away Blemish Spot Treatment 5 mg/g 85179-0007-00 | I | 14.5 g | — | — | FDA listed | — |
| Neutrogena deep clean purifying cooling gel scrub 5 mg/g 69968-0740-04 | Kenvue | 119 g | — | — | FDA listed | — |
| Neutrogena Skin Clearing Blemish Concealer - Light 10 5 mg/g 69968-0805-01 | Kenvue | 1 applicator | — | — | FDA listed | — |
| Neutrogena Skin Clearing Blemish Concealer - Medium 15 5 mg/g 69968-0812-01 | Kenvue | 1 applicator | — | — | FDA listed | — |
| b pure Blemish Concealer for Acne Prone Skin Nude 5 mg/g 80684-0108-00 | Fourstar | 1.4 g | — | — | FDA listed | — |
| b pure Blemish Concealer for Acne Prone Skin Fair 5 mg/g 80684-0109-00 | Fourstar | 1.4 g | — | — | FDA listed | — |
| Neutrogena Skin Clearing Blemish Concealer - Fair 05 5 mg/g 69968-0810-01 | Kenvue | 1 applicator | — | — | FDA listed | — |
| Neutrogena Skin Clearing Blemish Concealer - Buff 09 5 mg/g 69968-0811-01 | Kenvue | 1 applicator | — | — | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2022
On the market since
Feb 2022
📍
2026
Currently FDA-listed
4 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.
- FDA Orange Book · refreshed Sep 3, 2026
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 H4N855PNZ1
Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
-
UNII 59TL3WG5CO
A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
UNII 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 A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII 9O3K93S3TK
Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
-
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.
8 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescarbomer interpolymer type A, trolamine, vitamin E, propylene glycol, water, isopropyl alcohol, methyl paraben, EDTA, propyl paraben, DMDM hydantoin
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerOL PHARMA TECH, LLC Drs. PHARMACY
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code80489
First marketedFeb 2022
Product typeHuman Otc Drug
Portfolio2 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Do Not Use
📄 When Using This Product
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Recent Major Changes
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
USES For the treatment of acne. Dries and clears acne pimples
⏱️ Dosage and Administration ▾
DIRECTIONS Morning and evening, after a thorough cleansing of the skin, apply acne clear gel locally on cutanous imperfections. Then apply the usual day or night cream. Renew application 1 to 3 times daily.
⚠️ Warnings ▾
WARNINGS For external use only . Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Avoid direct contact with the eyes. If product gets into the eyes, rinse liberally with water. Discontinue use if skin irritation develops or increases. If irritation persists, consult a doctor.
📦 Storage and Handling ▾
OTHER INFORMATION store at 15-30 C ( 59-86 F) close cap tightly after use keep away from heat
🧪 Active Ingredient ▾
ACTIVE INGREDIENT Salicylic Acid 0.5% w/w.
🧪 Inactive Ingredients ▾
carbomer interpolymer type A, trolamine, vitamin E, propylene glycol, water, isopropyl alcohol, methyl paraben, EDTA, propyl paraben, DMDM hydantoin
🎯 Purpose ▾
PURPOSE Acne treatment For treatment of acne.Dries and clears acne pimples
📄 Do Not Use ▾
DO NOT USE if you have sensitive skin or are sensitive to salicylic acid
📄 When Using This Product ▾
WHEN USING THIS PRODUCT Avoid contact with eyes, lips, and mouth.
📄 Keep Out of Reach of Children ▾
KEEP OUT OF REACH OF CHILDREN if swallowed, get medical help or contact poison control center right away
📄 Questions or Comments ▾
QUESTIONS www.drspharmacyusa.com
📄 Recent Major Changes ▾
For treatment of acne.Dries and clears acne pimples
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL acne clear
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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 Drs. ACNE CLEAR (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 37%
Female · 63%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 | ✓ 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 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 OL PHARMA TECH, LLC Drs. PHARMACY. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (80489-0300-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
OL PHARMA TECH, LLC Drs. PHARMACY 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.
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.