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AOSORW Folliculitis and Acne Treatment Cream 1 g/100g Cream, 100 g

by SpineStatus LLC · 100 g in 1 JAR (85498-012-01)
NDC 85498-0012-01
🏷️ FDA NDC (as labeled) 85498-012-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 85498-012-01
Product NDC 85498-012
11-digit billing NDC 85498001201
RxCUI 417424
UNII O414PZ4LPZ
Application # M006
SPL Set ID 3a07f7dd-8159-46b1-e063-6294a90a774b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-30
Route TOPICAL
Dosage form CREAM
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 85498-012-01 — 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 → 85498-0012-01. 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.

🏭 Manufacturer & labeler

LabelerSpineStatus LLC
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code85498
First marketedJul 2025
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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It's designed to treat acne. Salicylic acid helps by loosening and removing dead skin cells that clog pores — the buildup that leads to breakouts. The multi-step system on this lab...
  • What is this salicylic acid product actually supposed to do for my skin?
  • Some mild tingling, stinging, and peeling is actually expected — that's the salicylic acid doing its job by clearing away dead skin cells. But if the burning or peeling feels exces...
  • My skin feels like it's burning and peeling. Is that normal?
📖 Read our full Salicylic Acid Topical guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • UNII 3UVP41R77R
    Avena sativa kernel oil is a natural oil extracted from oat seeds. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • UNII F2VW3D43YT
    Azelaic acid is a naturally occurring compound that acts as a preservative and antimicrobial agent in medications. It helps prevent bacterial and fungal growth, extending the product's shelf life and stability.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • 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 09FUA47KNA
    Cetearyl glucoside is a plant-derived surfactant made from vegetable oils and glucose. It helps oils and water mix together in creams and lotions, and can also soften and smooth the skin feel of the product.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII VAD2K35XAJ
    A carbohydrate polymer made from corn starch through partial breakdown. It acts as a binder to hold tablet ingredients together and as a filler to give the tablet proper size and texture.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII CA2Y0FE3FX
    A salt derived from licorice root extract, used as a flavoring agent and sweetener. It may also help soothe and protect mucous membranes in throat lozenges and cough products.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII Z396QHB97F
    A plant extract from Oldenlandia capensis used as a natural colorant or coloring agent in medicines. It provides pigmentation to tablets or liquids to make them visually distinct.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII Q7UI015FF9
    A synthetic polymer material used as a thickener and stabilizer in liquid formulations. It helps create the right texture and prevents separation of ingredients in medicines and topical products.
  • 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 7C98FKB43H
    Sodium acrylate is a synthetic polymer (plastic-like material) used as a superabsorbent and thickening agent in medicines. It helps control the consistency and release of active ingredients, particularly in gel or semi-solid formulations.
  • UNII IYR6K8KQ5K
    A plant extract from sophora flavescens root used as a natural colorant and flavoring agent in medicines. It may also help preserve the product and provide texture.
  • 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.

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

The official label also statesWater, Glycerin, Cetearyl Alcohol, Propylene Glycol,Dimethicone,Sophora Flavescens Extract, Butyrospermum, Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Oldenlandia Diffusa Extract, PEG-100 Stearate, Dextrin, 1,2-HexanediolAloe Barbadensis Leaf Juice, Hydroxyacetophenone, CetearylGlucoside, Glyceryl Stearate, Panthenol, Triethanolamine Polyacrylate Crosspolymer-6, Carbomer, Allantoin, Niacinamide.Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,Tocopheryl Acetate, Dipotassium Glycyrrhizate, Avena Sativa(Oat)Kernel Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Azelaic Acid, Ceramide NP

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acne Advanced Clarifying Hydrator 10 mg/mL 15751-3030-02 Eminence 1 bottle — — FDA listed —
blackhead solutions self-heating blackhead extractor acne medication 10 mg/mL 49527-0061-01 CLINIQUE 1 tube — — Discontinued —
clear days ahead oil-free salicylic acid acne treatment and moisturizer .6 g/60mL 50184-1010-01 Philosophy 60 ml — — FDA listed —
Organic Fruits Acne Spot Treatment - Yuja (1% Salicylic Acid) .3 g/30g 73391-0103-02 ENS 1 tube — — FDA listed —
Acne Calming Water Cream 10 mg/mL 76354-0416-01 e.l.f. 1 bottle — — FDA listed —
The Inkey List Succinic Acid Acne Treatment 10 mg/mL 81136-0017-01 Brand 15 ml — — FDA listed —
Blemish Spot Treatment .01 g/g 83657-0472-01 Skin 15 g — — FDA listed —
AOSORW Folliculitis and Acne Treatment Cream 1 g/100gthis 85498-0012-01 SpineStatus 100 g — — FDA listed —
Milia remover .01 g/mL 87278-0005-01 Guangxi 15 ml — — 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
Jul 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85498-0012-01 You're viewing this 100 g in 1 JAR (85498-012-01) 2025-07-30 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — 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 FDA registers it as 85498-012-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 85498-0012-01, written without dashes as 85498001201. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 85498-0012-01, the first segment (85498) is the labeler code FDA assigned to SpineStatus LLC; the middle segment (0012) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by SpineStatus LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SpineStatus LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 9 words ▾

For the treatment of acne Helps prevent newacne blemishes

⏱️ Dosage and Administration 97 words ▾

Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to threetimes daily. Because excessive drying of the skin may occur,start with one application daily, then gradually increase to two or three daily if needed or as directed by a doctor. lf bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. lf no discomfort occurs, follow the directions stated elsewhere on this label.

⚠️ Warnings 64 words ▾

For external use only lf you are under 2 years of age. Skin irritation and dryness are morelikely to occur when using another topical acne product at thesame time. lf irritation occurs, use only one product at a time Avoid eye area. In case of eye contact, flush gently and thoroughlywith water lf swallowed, get medical helpor contact the Poison Control Center right away

🧪 Active Ingredient 3 words ▾

Salicylic Acid 1%

🧪 Inactive Ingredients 57 words ▾

Water, Glycerin, Cetearyl Alcohol, Propylene Glycol,Dimethicone,Sophora Flavescens Extract, Butyrospermum, Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Oldenlandia Diffusa Extract, PEG-100 Stearate, Dextrin, 1,2-HexanediolAloe Barbadensis Leaf Juice, Hydroxyacetophenone, CetearylGlucoside, Glyceryl Stearate, Panthenol, Triethanolamine Polyacrylate Crosspolymer-6, Carbomer, Allantoin, Niacinamide.Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,Tocopheryl Acetate, Dipotassium Glycyrrhizate, Avena Sativa(Oat)Kernel Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Azelaic Acid, Ceramide NP

🎯 Purpose 2 words ▾

Acne Treatment

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85498-0011-01 · SpineStatus 85499-0203-50 · ATLANTA →
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.