Home › NDC Lookup › Ingredients › 10% Azelaic Acid Acne Cream › 84148-0009-01
10% azelaic acid acne cream 10 g/100g; .055 g/100g; .03 g/100g; .03 g/100g; .015 g/100g; .09 g/100g; .15 g/100g; .5 g/100g Cream, 30 g — NDC 84148-0009-01 package photo

10% azelaic acid acne cream 10 g/100g; .055 g/100g; .03 g/100g; .03 g/100g; .015 g/100g; .09 g/100g; .15 g/100g; .5 g/100g Cream, 30 g

by Guangzhou Ariel Biotech Co., Ltd. · 30 g in 1 BOTTLE (84148-009-01)
NDC 84148-0009-01
🏷️ FDA NDC (as labeled) 84148-009-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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) 84148-009-01
Product NDC 84148-009
11-digit billing NDC 84148000901
UNII F2VW3D43YT, CQ2F5O6YIY, 4YS74Q4G4J, 9RES347CKG, PKO39VY215, H41B6Q1I9L +3 more
SPL Set ID 233ed88c-7e76-f8ad-e063-6394a90aa53e
Physiologic effect Decreased Protein Synthesis; Decreased Sebaceous Gland Activity
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-29
Route CUTANEOUS
Dosage form CREAM
Substance AZELAIC ACID; MADECASSOSIDE; CENTELLA ASIATICA TRITERPENOIDS; LAVANDIN OIL; ASIATICOSIDE; O-CYMEN-5-OL; CAPRYLOYL GLYCINE; HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID; TARAXACUM OFFICINALE LEAF
Why two NDCs? The FDA registers this code as 84148-009-01 — 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 → 84148-0009-01. 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.

🏭 Manufacturer & labeler

LabelerGuangzhou Ariel Biotech Co., Ltd.
Labeler code84148
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio23 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

🧪 What is this product?

This is an unapproved topical cream applied to the skin that contains azelaic acid as its primary active ingredient, typically used to address acne and related skin concerns. The formulation also includes plant extracts and compounds derived from centella asiatica (sometimes called cica) and lavender oil, which are commonly included in skincare products for their soothing and skin-conditioning properties. Additional components such as capryloyl glycine and o-cymen-5-ol are antimicrobial or skin-conditioning agents found in various personal care formulations. Because this product is marketed without FDA approval, it has not been reviewed for safety or effectiveness through the standard drug application process.

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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • 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 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 7E6SK9QDT8
    Cyclodextrins are ring-shaped sugar molecules derived from starch. They're used in medicines as solubilizers to help poorly dissolving drugs dissolve better, and sometimes as binders or stabilizers.
  • 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 E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 N8F53B3R4R
    A synthetic humectant and solvent derived from propane. It draws and holds moisture in the formulation, helping keep the medicine stable and improving texture or flow in liquid and semi-solid products.
  • UNII MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesWATER, AZEL AIC ACID, BUTYLENE GLYCOL, METHYLPROPANEDIOL, DIMETHICONE, CETEARYL GLUCOSIDE, DIPROPYLENE GLYCOL, SORBITAN OLIVATE, POLYACRYLATE-6, SQUAL ANE, CETYL ALCOHOL, HYDROXYPROPYL CYCLODEXTRIN, 1,2-HEXANEDIOL, 4-HYDROXYACETOPHENONE, HYDROXYETHYLPIPERAZINEETHANE SULFONIC ACID, STEARYL ALCOHOL, ALLANTOIN, CYCLODEXTRIN, CAPRYLOYL GLYCINE, XANTHAN GUM, O-CYMEN-5-OL, MADECASSOSIDE, CENTELLA ASIATICA EXTRACT, LAVANDULA ANGUSTIFOLIA OL, CENTELLA ASIATICA, SAURURUS CHINENSIS LEAF/ROOT EXTRACT, TARAXACUM OFFICINALE LEAF EXTRACT, STEPHANIA TETRANDRAE EXTRACT

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

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

Inactive ingredient FAQ

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

💲 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
10% azelaic acid acne cream 10 g/100g; .055 g/100g; .03 g/100g; .03 g/100g; .015 g/100g; .09 g/100g; .15 g/100g; .5 g/100gthis 84148-0009-01 Guangzhou 30 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

🏛️
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84148-0009-01 You're viewing this 30 g in 1 BOTTLE (84148-009-01) 2024-09-29 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 "Unapproved Drug Other". 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 84148-009-01, 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: 84148-0009-01, written without dashes as 84148000901. 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 84148-0009-01, the first segment (84148) is the labeler code FDA assigned to Guangzhou Ariel Biotech Co., Ltd.; the middle segment (0009) 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 Guangzhou Ariel Biotech Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guangzhou Ariel Biotech 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.

📄 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
🎯 Indications and Usage 23 words ▾

Use Apply a thin layer to cleansed face or affected areas morning and evening. Avoid the eye area. Use sunscreen during the day.

⏱️ Dosage and Administration 23 words ▾

Directions Apply a thin layer to cleansed face or affected areas morning and evening. Avoid the eye area. Use sunscreen during the day.

⚠️ Warnings 26 words ▾

Warnings WARNINGS:For external use only. avoid the eye area. Avoid direct sunlight during use. Discontinue use immediately if rritation occurs. Store in a cool, dry place.

📦 Storage and Handling 4 words ▾

Other information No Data

🧪 Active Ingredient 42 words ▾

Active Ingredient(s) AZELAIC ACID 10.00000% HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID 0.50000% CAPRYLOYL GLYCINE 0.15000% o-CYMEN-5-OL 0.09000% MADECASSOSIDE 0.05500% CENTELLA ASIATICA EXTRACT 0.03000% LAVANDULA HYBRIDA OIL 0.03000% ASIATICOSIDE 0.01500% SAURURUS CHINENSIS LEAF/ROOT EXTRACT 0.01000% TARAXACUM OFFICINALE (DANDELION) LEAF EXTRACT 0.01000% STEPHANIA TETRANDRA EXTRACT 0.00160%

🧪 Inactive Ingredients 57 words ▾

Inactive ingredients WATER, AZEL AIC ACID, BUTYLENE GLYCOL, METHYLPROPANEDIOL, DIMETHICONE, CETEARYL GLUCOSIDE, DIPROPYLENE GLYCOL, SORBITAN OLIVATE, POLYACRYLATE-6, SQUAL ANE, CETYL ALCOHOL, HYDROXYPROPYL CYCLODEXTRIN, 1,2-HEXANEDIOL, 4-HYDROXYACETOPHENONE, HYDROXYETHYLPIPERAZINEETHANE SULFONIC ACID, STEARYL ALCOHOL, ALLANTOIN, CYCLODEXTRIN, CAPRYLOYL GLYCINE, XANTHAN GUM, O-CYMEN-5-OL, MADECASSOSIDE, CENTELLA ASIATICA EXTRACT, LAVANDULA ANGUSTIFOLIA OL, CENTELLA ASIATICA, SAURURUS CHINENSIS LEAF/ROOT EXTRACT, TARAXACUM OFFICINALE LEAF EXTRACT, STEPHANIA TETRANDRAE EXTRACT

🎯 Purpose 21 words ▾

Purpose Acne treatment ①Treatments for acne. ②Reduces acne and blemishes. ③Evens skin tone & fades spots. ④Balances oil & prevents breakouts.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84148-0008-01 · Guangzhou 84148-0010-01 · Guangzhou →
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.