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Genital Warts Remover Cream Salicylic Acid .02 g/g; .1 g/g Cream, 20 g — NDC 87278-004-01 (Billing 87278-0004-01)

by Guangxi Keyun E-commerce Co., Ltd. · 20 g in 1 BOTTLE

This is a package of 20 g of Genital Warts Remover Cream Salicylic Acid .02 g/g; .1 g/g Cream from Guangxi Keyun E-commerce Co., Ltd., marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 87278-0004-01
🏷️ FDA NDC (as labeled) 87278-004-01 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 87278-004-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
87278 labeler · 004 product · 01 package
Package marketed since
Mar 9, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8727800401 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87278-004-01
Product NDC 87278-004
11-digit billing NDC 87278000401
RxCUI 2738742
UNII 5908ZUF22Y, O414PZ4LPZ
Application # M028
SPL Set ID 4c940bec-0a2f-c760-e063-6394a90a30c6
Physiologic effect Decreased Cell Wall Integrity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-09
Route TOPICAL
Dosage form CREAM
Substance CHLORHEXIDINE DIACETATE; SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 2738742
Why two NDCs? The FDA registers this code as 87278-004-01 — 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 → 87278-0004-01. 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 Antiinfectives and antiseptics for local oral treatment class.

Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Antiinfectives, Biguanides and amidines
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

🧪 What is this product?

This is an over-the-counter topical cream marketed under FDA's monograph rules for genital warts treatment. It contains salicylic acid, which is typically used to help soften and break down the outer layers of skin growths, and chlorhexidine diacetate, an antimicrobial agent commonly used in topical products to reduce bacteria. The cream is applied directly to the affected skin area. This product is not individually reviewed by the FDA but is permitted to be marketed under established OTC guidelines for its category.

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
87278-0004-01 You're viewing this Main listing 20 g in 1 BOTTLE 2026-03-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Genital Warts Remover Cream .02 g/g; .1 g/gthis 87278-0004-01 Guangxi 20 g — — 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

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

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

  • UNII 240G38P85Z
    Bassia scoparia is a plant material used as a natural filler and bulking agent in medicines. It helps give the product structure and may aid in even distribution of active ingredients.
  • UNII 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII 50268139XV
    A plant-derived ingredient from the fruit of Brucea javanica, a tropical tree. It is used as a flavoring or functional additive in some formulations.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII V1IA3S3CUS
    A plant extract derived from Cnidium monnieri fruit, commonly used in traditional Asian medicine preparations. In formulations, it may serve as an active botanical ingredient or flavoring agent, though its specific role depends on the product type.
  • UNII 14255EXE39
    Ethylparaben is a preservative, a chemical that stops bacteria and mold from growing in the medicine. It keeps the product safe and effective throughout its shelf life.
  • UNII K57MOP2HM0
    Gentisin is a yellow dye derived from gentiobiose and gentisic acid. It serves as a colorant in medicines to make tablets or capsules visually distinct and easier to identify.
  • 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 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 3B16R130R7
    A plant-derived substance from Patrinia scabiosifolia used in traditional formulations. It may function as a filler or binding agent to help hold the medicine together.
  • UNII 1L24V9R23S
    Potassium alum is a mineral salt used in medicines as an astringent agent and buffering ingredient. It helps control moisture, maintain pH balance, and can reduce irritation in topical or oral formulations.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII EKG8030U4N
    A plant-derived ingredient from the Stemona sessilifolia root. It may be used as a natural binder or thickening agent to help hold tablet or capsule ingredients together and improve product texture.
  • 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 3CIP16A418
    A plant extract from Sichuan pepper fruit used as a flavoring agent and natural fragrance component in medicines. It adds taste and aroma to make medications more palatable.

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

The official label also statesJava Brucea Fruit (Brucea javanica Fruit) Patrinia Scabiosaefolia Zanthoxylum Bungeanum Stemona Root (Stemona japonica Root) Kochia Scoparia Cnidium Monnieri Gentian (Gentiana scabra root) Alum (Potassium Alum) Benzoic Acid Glycerin Stearic Acid Cetearyl Alcohol Methylparaben Ethyl Hydroxybenzoate (Ethylparaben) Water

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

LabelerGuangxi Keyun E-commerce Co., Ltd.
FDA applicationM028 (OTC MONOGRAPH DRUG)
Labeler code87278
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio20 products on file

More NDCs from Guangxi Keyun E-commerce Co., Ltd. labeler code 87278

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 87 words ▾

1.After washing the fecled area with warm water,take an apropriate amount of this product with a toothpick and apply it to the surface of the aflected area. Gently knead for 5-10 minutes to make it fully absorbed. Please do not to apply it fo the surrounding healthy skin andmucous membranes.

2.2-3 times a day, Use it continǔcusly fór 7 days. If it does not fall off,it is recommended to continue to use it. Scope of Application : Suitable for alleviating pain and discomfort caused by skin warts.

⏱️ Dosage and Administration 87 words ▾

1.After washing the fecled area with warm water,take an apropriate amount of this product with a toothpick and apply it to the surface of the aflected area. Gently knead for 5-10 minutes to make it fully absorbed. Please do not to apply it fo the surrounding healthy skin andmucous membranes.

2.2-3 times a day, Use it continǔcusly fór 7 days. If it does not fall off,it is recommended to continue to use it. Scope of Application : Suitable for alleviating pain and discomfort caused by skin warts.

⚠️ Warnings 42 words ▾

1.External supplies, do not let it into the mouth and eye. 2.Use with caution for those of skin allergy and pregnant. 3.Place the product in a place where chil¤fen aré nöt easy to contact 4.This product is not a substitute for drugs.

🧪 Active Ingredient 6 words ▾

Salicylic Acid 10% Chlorhexidine Diacetate 2%

🧪 Inactive Ingredients 38 words ▾

Java Brucea Fruit (Brucea javanica Fruit) Patrinia Scabiosaefolia Zanthoxylum Bungeanum Stemona Root (Stemona japonica Root) Kochia Scoparia Cnidium Monnieri Gentian (Gentiana scabra root) Alum (Potassium Alum) Benzoic Acid Glycerin Stearic Acid Cetearyl Alcohol Methylparaben Ethyl Hydroxybenzoate (Ethylparaben) Water

🎯 Purpose 2 words ▾

Wart Remover

📄 Do Not Use 11 words ▾

Do not use ifthe skin is hurt.Contrain dicated for pregnant women.

📄 When Using This Product 34 words ▾

1. Avoid direct contact with the eyeslf product comes intocontact with eyes, rinse thoroughly. 2.if there isany discomfort or irritation, afterapplication,immediately discontinue use. 3. Not suitable for children orwomen who are pregnant orbreast feeding.

📄 Stop Use and Ask a Doctor If 7 words ▾

Discontinue use if signs ofirritation orrash occur

📄 Keep Out of Reach of Children 6 words ▾

Please keep out of reach ofchildren.

📄 Package Label / Principal Display Panel 1 words ▾

label

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

Reporter sex

0 reports

Serious outcomes

Hospitalization799
Death632
Life-threatening214
Disabling147
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 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) ✓ 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 Guangxi Keyun E-commerce Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guangxi Keyun E-commerce Co., Ltd. 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.
← 87278-0003-01 · Guangxi 87278-0005-01 · Guangxi →
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.