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Topicals Clearly Mist Salicylic Acid 20 mg/mL Liquid — NDC 51326-307-01 (Billing 51326-0307-01)

by Topiderm, Inc. · 1 BOTTLE in 1 BOX / 100 mL in 1 BOTTLE

This is a package of Topicals Clearly Mist Salicylic Acid 20 mg/mL Liquid from Topiderm, Inc., marketed since Sep 2024 and currently FDA-listed. It is this product's only package size.

NDC 51326-0307-01
🏷️ FDA NDC (as labeled) 51326-307-01 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51326-307-01
Product NDC 51326-307
11-digit billing NDC 51326030701
RxCUI 1048903
UNII O414PZ4LPZ
Application # M006
SPL Set ID 1f1d6751-9566-4738-a28b-f501425b6b21
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-20
Route TOPICAL
Dosage form LIQUID
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 1048903
Why two NDCs? The FDA registers this code as 51326-307-01 — 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 → 51326-0307-01. 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 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.

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 mLPer 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
51326-0307-01 You're viewing this Main listing 1 BOTTLE in 1 BOX / 100 mL in 1 BOTTLE 2024-09-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Differin Acne Clearing Body 2 g/100g 00299-4132-00 Galderma 170 g — — FDA listed —
PanOxyl Acne Banishing Body (Spray) 2 g/100g 00316-0297-01 Crown 170 g — — FDA listed —
Ology Acne Clearing Body Mist 20 mg/mL 00363-9659-10 Walgreens 1 tube — — FDA listed —
Sulfur 8 Scalp Therapy Medicated Dandruff Control 20 mg/mL 12022-0032-00 J. 355 ml — — FDA listed —
Doo Gro Braids Twists Locs Dandruff Control Moisturizing 20 mg/mL 12022-0041-00 J. 335 ml — — FDA listed —
Topicals Clearly Mist 20 mg/mLthis 51326-0307-01 Topiderm, 1 bottle — — FDA listed —
Gly-Sal 10-2 20 mg/mL 51326-0938-01 Topiderm, 89 ml — — FDA listed —
Pacifica Bacne Warrior 2 g/100mg 61197-0103-00 Pacifica 177 mg — — FDA listed —
Neutrogena Stubborn Body Acne Treatment 20 mg/mL 69968-0758-06 Kenvue 162 ml — — FDA listed —
Tiege Hanley Acne All Over Body 2 g/100g 71714-0005-01 Tiege 1 canister — — FDA listed —
Acne Banishing Body 2 g/100g 72667-0218-06 Inspec 170 g — — Discontinued —
Body Acne Treatment 20 mg/g 73318-7007-03 Skin 1 bottle — — FDA listed —
Naturium Salicylic Acid Body 2% 20 mg/mL 76354-0124-01 e.l.f. 120 ml — — FDA listed —
e.l.f Skin Acne-Treating Body Mist 20 mg/mL 76354-0418-01 e.l.f. 1 bottle — — FDA listed —
Bha Toner 2 g/100mL 83286-0018-01 Drmtlgy, 189 ml — — FDA listed —
PAPATUI Acne Fighting Body 2 g/100g 83850-0200-00 PAPATUI, 170 g — — FDA listed —
First Aid Beauty Body Acne Clearing Mist 2 g/100mL 84126-0120-88 The 1 bottle — — FDA listed —
Saltair Acne Bodyspray 2 g/100g 87290-0003-04 Saltair 1 bottle — — FDA listed —
Kugig Acne Treatment Sprayer 2 g/100mL 87722-0001-01 Guangdong 100 ml — — FDA listed —
Skin Pharmacy Advanced Acne Therapy Clarifying Daily Cleanser 20 mg/mL 69842-0064-01 CVS 148 ml — — FDA listed —
Skinpharmacy Advanced Acne Therapy Overnight Salicylic Acid 20 mg/mL 69842-0066-01 CVS 1 tube — — FDA listed —
SKIN MEDICA Purifying Foaming Wash 20 mg/mL 00023-4948-05 Allergan, 1 bottle — — FDA listed —
Differin Acne Clearing Body Scrub 20 mg/mL 00299-4609-00 Galderma 237 ml — — FDA listed —
Sulfur 8 Anti-Dandruff Braid 20 mg/mL 12022-0021-00 J. 356 ml — — FDA listed —
Sulfur 8 Fresh Anti-Dandruff 20 mg/mL 12022-0028-00 J. 355 ml — — FDA listed —
Sulfur 8 Medicated Dandruff with Salicylic Acid 20 mg/mL 12022-0039-00 J. 222 ml — — FDA listed —
Glovers Therapeutic Care 20 mg/mL 12022-0040-00 J. 118 ml — — FDA listed —
Signature Care Acne Treatment 20 mg/mL 21130-0722-77 SAFEWAY, 177 ml — — FDA listed —
Kiehls Since 1851 Dermatologist Solutions Truly Targeted Acne Clearing Solution 20 mg/mL 49967-0055-01 L'Oreal 1 bottle — — FDA listed —
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Pads 20 mg/mL 49967-0705-01 L'Oreal 60 applicators — — FDA listed —
Dr. Gross AB Acne Daily Breakout 20 mg/mL 51326-0179-01 Topiderm, 1 bottle — — FDA listed —
Replenix Acne Gly-Sal 2-2 Foaming Cleanser 20 mg/mL 51326-0929-06 Topiderm, 200 ml — — FDA listed —
Medicated Wash 20 mg/mL 67226-1021-01 Vivier 150 ml — — FDA listed —
L BRI Pure n Natural Deep Clean Toner 20 mg/mL 71238-0218-00 L'BRI 188 ml — — FDA listed —
Peach and Lily Peaches Slices Acne Exfoliating toner 20 mg/mL 81515-0501-01 Peach 120 ml — — FDA listed —
Doing The Work Salicylic Acid Acne Treatment 20 mg/mL 84234-0001-00 Personal 1 bottle — — FDA listed —
Byoma Acne Clearing Cleanser 20 mg/mL 84821-0007-01 Byoma 175 ml — — FDA listed —
PHOFAY Salicylic Acid Acne Treatment Essence 20 mg/mL 87080-0001-00 Hangzhou 1 bottle — — FDA listed —
Hero Pore Release Blackhead Clearing 20 mg/mL 10237-0001-00 Church 100 ml — — FDA listed —
Up and Up Acne Wash 20 mg/mL 11673-0024-54 TARGET 269.1 ml — — FDA listed —
Gly-Sal 5-2 20 mg/mL 51326-0927-01 Topiderm, 200 ml — — FDA listed —
Clean and Clear Essentials Acne Toner 20 mg/mL 69968-0820-08 Kenvue 240 ml — — FDA listed —
Viaderma Clear Acne Treatment 20 mg/mL 71262-0017-15 VIADERMA 1 bottle — — FDA listed —
Naturium Salicylic Acid Serum 2% 20 mg/mL 76354-0122-01 e.l.f. 1 bottle — — FDA listed —
OXY Volcanic Ash Acne Face Wash 20 mg/mL 10742-8334-01 The 207 ml — — FDA listed —
Clean and Clear Essentials Deep Cleaning Astringent 20 mg/mL 69968-0209-08 Kenvue 240 ml — — FDA listed —
Neutrogena Oil Free Acne Wash 20 mg/mL 69968-0675-01 Kenvue 12 tubes — — Discontinued —
Neutrogena Oil Free Acne Wash 20 mg/mL 69968-0770-01 Kenvue 12 tubes — — Discontinued —
CeraVe Developed with Dermatologists BHA Exfoliating Toner Acne Treatment 20 mg/mL 82046-0291-01 L'Oreal 237 ml — — FDA listed —
Byoma Acne Clearing Body Wash 20 mg/mL 84821-0005-01 Byoma 400 ml — — FDA listed —
Nativae Milia Acne Serum 20 mg/mL 85065-0557-00 CDE 30 ml — — FDA listed —
pHisoderm Clear Confidence Daily Gel Face Wash 20 mg/mL 10742-1412-01 The 177 ml — — FDA listed —
Thayers Since 1847 Natural Remedies Double Action Acne Serum 20 mg/mL 49967-0062-01 L'Oreal 1 bottle — — FDA listed —
Exuviance Daily Acne Peel 20 mg/mL 58414-0017-02 NeoStrata 1 bottle — — FDA listed —
Atrix Clarifying Toner 20 mg/mL 59088-0444-08 PureTek 118 ml — — FDA listed —
Neutrogena Clear Pore Oil-Eliminating Astringent 20 mg/mL 69968-0028-08 Kenvue 236 ml — — FDA listed —
Sunday Riley Peacekeeper Acne Treatment Serum 20 mg/mL 73001-0505-01 Sunday 1 pouch — — FDA listed —
Replenix Gly-Sal 10-2 cleanser 20 mg/mL 51326-0928-01 Topiderm, 200 ml — — FDA listed —
Clenziderm Daily Care Foaming Cleanser Acne Treatment 20 mg/mL 62032-0610-11 Obagi 118 ml — — FDA listed —
Neutrogena Body Clear Body Wash Pink Grapefruit 20 mg/mL 69968-0910-09 Kenvue 250 ml — — FDA listed —
Amazon Basics Acne Wash Acne treatment 20 mg/mL 72288-0955-01 AMAZON.COM 177 ml — — FDA listed —
e.l.f. PLZ Clarify Facial Oil 20 mg/mL 76354-0419-01 e.l.f. 1 bottle — — FDA listed —
Lancome Paris Clarifique BX-Interceptor Topical Acne Clearing Treatment 20 mg/mL 82046-0955-01 LOreal 1 bottle — — FDA listed —
Personal Day Doing the Work Daily Exfoliating Treatment 20 mg/mL 84234-0002-00 Personal 1 bottle — — FDA listed —
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Toner 20 mg/mL 49967-0523-01 L'Oreal 355 ml — — FDA listed —
Lancome Paris Clarifique BX-Interceptor Topical Acne Clearing Treatment 20 mg/mL 51150-0995-01 SICOS 1 bottle — — FDA listed —
Clenziderm Pore Therapy Acne Treatment 20 mg/mL 62032-0612-04 Obagi 148 ml — — FDA listed —
Neutrogena Oil Free Acne Stress Control Triple Action Toner 20 mg/mL 69968-0521-08 Kenvue 237 ml — — FDA listed —
Acne Control Cleanser 20 mg/mL 79903-0339-12 Walmart 355 ml — — FDA listed —
Target Up and Up Salicylic Acid Acne Wash 20 mg/mL 82442-0014-87 TARGET 236.5 ml — — FDA listed —
Replenix Gly-Sal 2-2 20 mg/mL 51326-0925-01 Topiderm, 200 ml — — FDA listed —
Neutrogena Oil-Free Acne Wash Sensitive Skin Facial Cleanser Fragrance Free 20 mg/mL 69968-0889-01 Kenvue 14 ml — — FDA listed —
Neutrogena Oil-Free Acne Wash Daily Scrub 20 mg/mL 69968-0908-04 Kenvue 124 ml — — FDA listed —
Neutrogena Oil-Free Acne Stress Control Power Clear Scrub 20 mg/mL 69968-0909-04 Kenvue 125 ml — — FDA listed —
The Inkey List 360 Acne Clearing Serum 20 mg/mL 81136-0028-01 Brand 1 bottle — — FDA listed —
Acne Wash 20 mg/mL 63940-0053-54 Harmon 269 ml — — FDA listed —
AGE Bright Clearing Serum 20 mg/mL 68479-0184-00 Dermalogica, 3 ml — — FDA listed —
Clean and Clear Acne Exfoliating Cleanser 20 mg/mL 69968-0822-05 Kenvue 148 ml — — FDA listed —
Neutrogena Oil Free Acne Wash Pink Grapefruit Facial Cleanser 20 mg/mL 69968-0926-06 Kenvue 177 ml — — FDA listed —
Neutrogena Evenly Clear Acne Cleanser 20 mg/mL 69968-0942-01 Kenvue 12 tubes — — FDA listed —
pHisoderm Clear Confidence Body Wash 20 mg/mL 10742-1442-01 The 295 ml — — FDA listed —
Phisoderm Anti Blemish Body Wash 20 mg/mL 10742-8451-01 The 295 ml — — FDA listed —
Neutrogena Oil Free Acne Wash Pink Grapefruit Facial Cleanser 20 mg/mL 69968-0686-06 Kenvue 177 ml — — FDA listed —
Salicylic acid 20 mg/mL 76162-0414-32 Topco 355 ml — — FDA listed —
Bubble Super Clear Blemish Prevention Serum 20 mg/mL 83509-0001-01 BUBBLE 1 bottle — — FDA listed —
Satinique Anti Dandruff Scalp and Hair 20 mg/mL 10056-0536-00 Access 280 ml — — FDA listed —
Kroger Clarify Care Acne Wash 20 mg/mL 30142-0945-77 THE 177 ml — — FDA listed —
Neutrogena All in 1 Acne Control Daily Scrub 20 mg/mL 69968-0092-04 Kenvue 124 ml — — FDA listed —
Neutrogena Body Clear Body Wash 20 mg/mL 69968-0655-09 Kenvue 250 ml — — FDA listed —
Neutrogena Oil-Free Acne Wash Pink Grapefruit Foaming Scrub 20 mg/mL 69968-0912-02 Kenvue 59 ml — — FDA listed —
Mara Clear Skin Mineral Milk Acne Treatment 20 mg/mL 81461-0002-00 Mara 30 ml — — FDA listed —
Atrix Antibacterial Wash 20 mg/mL 59088-0445-08 PURETEK 118 ml — — FDA listed —
Neutrogena Oil Free Acne Stress Control Triple Action Toner 20 mg/mL 69968-0925-08 Kenvue 236 ml — — FDA listed —
L BRI Deep Clean Toner 20 mg/mL 71238-0921-00 L'BRI 177 ml — — FDA listed —
Acne Control Cleanser 20 mg/mL 51316-0893-01 CVS 237 ml — — FDA listed —
RFA Purifying Cleanser Clear and Clarify 20 mg/mL 51326-0502-01 Topiderm, 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

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 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.

Inactive Ingredients / Excipients

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

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerTopiderm, Inc.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code51326
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio47 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 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 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 6 words ▾

Use For the treatment of acne

⏱️ Dosage and Administration 40 words ▾

Directions Spray a thin layer onto clean skin 1-3 times daily. Allow product to sink in for 30-60 seconds and do not rub in. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

⚠️ Warnings 60 words ▾

Warnings For external use only. When using this product, keep away from face. If contact occurs, flush thoroughly with water. If irritation occurs when using two acne topical medications, only use one topical acne medication at a time. Do not inhale. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 9 words ▾

Other information Do not store at temperatures above 120°F.

🧪 Active Ingredient 5 words ▾

Active ingredient Salicylic acid 2%

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients Water/Aqua/Eau, Alcohol Denat., Hypochlorous Acid, Glycolic Acid, Allantoin, Zinc PCA, Potassium Hydroxide, Sodium Benzoate

🎯 Purpose 3 words ▾

Purpose Acne treatment

📄 When Using This Product 36 words ▾

When using this product, keep away from face. If contact occurs, flush thoroughly with water. If irritation occurs when using two acne topical medications, only use one topical acne medication at a time. Do not inhale.

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Questions or Comments 2 words ▾

Questions? +1-323-776-1963

📄 Package Label / Principal Display Panel 31 words ▾

PRINCIPAL DISPLAY PANEL - 100 ml Bottle Carton CLEARLY TOPICALS Clarifying & Calming Mist For acne-prone skin 100 ml / 3.4 fl oz PRINCIPAL DISPLAY PANEL - 100 ml Bottle Carton

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 Salicylic Acid — the ingredient across all brands.

Top reported reactions

Dry Skin12,766
Erythema12,318
Acne11,763
Skin Burning Sensation11,557
Skin Irritation7,730
Skin Exfoliation5,759
Rash4,766

Age at onset

Neonate7
Infant1
Child16
Adolescent30
Adult334
Elderly131

Reporter sex

52,594 reports
Male · 27%
Female · 73%
Unknown · 0%

Serious outcomes

Hospitalization799
Death632
Life-threatening214
Disabling147
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 18,985 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "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 Topiderm, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topiderm, 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.
← 51326-0245-01 · Topiderm, 51326-0370-01 · Topiderm, →
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.