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14% Azelaic Acid Acne 14 g/100g Cream, 30 g — NDC 84753-0056-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

14% Azelaic Acid Acne 14 g/100g Cream, 30 g — NDC 84753-056-01 (Billing 84753-0056-01)

by Guangdong Bisutang Biotechnology Co., Ltd. · 30 g in 1 BOTTLE

This is a package of 30 g of 14% Azelaic Acid Acne 14 g/100g Cream from Guangdong Bisutang Biotechnology Co., Ltd., marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 84753-0056-01
🏷️ FDA NDC (as labeled) 84753-056-01 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

⚠️
Other active recalls for Azelaic Acid (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 23, 2026 — CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0731-2026
Class II · Sep 17, 2025 — CGMP Deviations: Market complaints received for gritty texture (grainy) (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0662-2025
Class II · Jul 22, 2024 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0621-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84753-056-01
Product NDC 84753-056
11-digit billing NDC 84753005601
RxCUI 2738813
UNII F2VW3D43YT
Application # M006
SPL Set ID 4ccaa734-83be-611b-e063-6294a90ab3bf
Physiologic effect Decreased Protein Synthesis; Decreased Sebaceous Gland Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-12
Route TOPICAL
Dosage form CREAM
Substance AZELAIC ACID
Quick answers
  • RxCUI (RxNorm): 2738813
Why two NDCs? The FDA registers this code as 84753-056-01 — 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 → 84753-0056-01. 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 Other anti-acne preparations for topical use class.

Drug family (ATC) Other anti-acne preparations for topical use
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 it is MedlinePlus · NLM

Azelaic acid gel and foam is used to clear the bumps, lesions, and swelling caused by rosacea (a skin disease that causes redness, flushing, and pimples on the face). Azelaic acid cream is used to treat the pimples and swelling caused by acne. Azelaic acid is in a class of medications called dicarboxylic acids. It works to treat rosacea by decreasing the swelling and redness of the skin. It works to treat acne by killing the bacteria that infect pores and by decreasing production of keratin, a natural substance that can lead to the development of acne.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Azelaic acid gel, 15% treats the red bumps and pimples of mild to moderate rosacea. It has not been studied for redness alone, without bumps and pimples.
  • It goes on your skin only. For FINACEA Foam, shake it, wash your face with a very mild cleanser, pat dry, and apply a thin layer to your whole face morning and evening. Wash your h...
  • Yes, burning, stinging, itching and dryness are the most common effects, usually in the first few weeks. If irritation becomes severe or doesn't go away, stop and call your doctor.
  • Get help for swelling of your face or eyes, hives or trouble breathing, since these can be signs of an allergic reaction. Also call your doctor if your asthma gets worse.
📖 Read our full Azelaic Acid Topical guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Azelaic Acid — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Azelaic Acid (3 interactions) — ranked by severity →
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
84753-0056-01 You're viewing this Main listing 30 g in 1 BOTTLE 2026-03-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
14% Azelaic Acid Acne 14 g/100gthis 84753-0056-01 Guangdong 30 g — — FDA listed —
Bloomellee 14%Gel Azelaic Acid Cream .14 g/g 87386-0002-01 Shenzhen 1 bottle — — Discontinued —
14% Azelaic Acid 14 g/100g 87815-0003-01 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

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 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 E4F12ROE70
    A refined mineral oil derived from crude petroleum containing 13 to 14 carbon chains. It acts as a solvent, emollient, and carrier in topical formulations to help dissolve active ingredients and improve product texture and spreadability.
  • UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII CI71S98N1Z
    A mineral salt containing potassium and phosphate, used as a buffer to help maintain the medicine's pH level and stability during storage.
  • 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 6V475AX06U
    A chelating agent derived from ethylenediaminetetraacetic acid (EDTA) combined with copper. It binds metals in formulations to prevent discoloration and degradation, helping preserve the medicine's stability and appearance.
  • 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 TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII 4YI0729529
    A synthetic oil made from plant-derived hydrocarbons that has been chemically saturated. It acts as a lubricant and glidant to help the medicine flow smoothly during manufacturing and improve tablet handling.
  • 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 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • UNII Z95S6G8201
    A synthetic surfactant derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oily and watery ingredients in liquid formulations, and may improve how the medicine spreads or is absorbed.
  • 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 RHA9LWJ494
    A synthetic polymer formed by linking acrylamide molecules together. It functions as a binder and thickener in medicines, helping hold ingredients together and adjust the product's texture and consistency.
  • 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 03KCY6P7UT
    A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
  • 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 1DXE3F3OZX
    A synthetic polymer that forms a gel-like network. It absorbs and holds water, thickens the medicine, and helps keep ingredients evenly mixed throughout the formulation.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • 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.

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

The official label also statesWATER GLYCERIN PROPYLENE GLYCOL CAPRYLIC/CAPRIC TRIGLYCERIDE DIMETHICONE HYDROGENATED POLYDECENE POTASSIUM CETYL PHOSPHATE POLYACRYLATE CROSSPOLYMER-6 METHYLPROPANEDIOL HYDROXYACETOPHENONE POLYACRYLAMIDE ALLANTOIN SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER C13-14 ISOPARAFFIN ISOHEXADECANE XANTHAN GUM DISODIUM EDTA SODIUM HYALURONATE CAPRYLHYDROXAMIC ACID POLYSORBATE 80 LAURETH-7 DIPOTASSIUM PHOSPHATE SORBITAN OLEATE GLYCERYL CAPRYLATE

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

LabelerGuangdong Bisutang Biotechnology Co., Ltd.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code84753
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio3 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

Uses: Helps treat acne and reduce the appearance of blemishes.Helps improve uneven-looking skin tone caused by acne.

⏱️ Dosage and Administration 28 words ▾

30g, Cleanse the skin thoroughly before applying.Apply a thin layer to affected area and gently massage until fully absorbed.Use once or twice daily,or as directed by a doctor

⚠️ Warnings 59 words ▾

Warnings:For external use only Avoid contact with eyes and mucous membranes.Mild irritation,redness.or dryness may occur.Stop use and ask a doctor if severe irritation occurs or if symptoms worsen.Do not use on broken or irritated skin or if allergic to any ingredient.lf pregnant or breast-feeding,ask a health professional before use.Keep out of reach of children.If swallowed,get medical help right away.

🧪 Active Ingredient 2 words ▾

Azelaic Acid

🧪 Inactive Ingredients 43 words ▾

WATER GLYCERIN PROPYLENE GLYCOL CAPRYLIC/CAPRIC TRIGLYCERIDE DIMETHICONE HYDROGENATED POLYDECENE POTASSIUM CETYL PHOSPHATE POLYACRYLATE CROSSPOLYMER-6 METHYLPROPANEDIOL HYDROXYACETOPHENONE POLYACRYLAMIDE ALLANTOIN SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER C13-14 ISOPARAFFIN ISOHEXADECANE XANTHAN GUM DISODIUM EDTA SODIUM HYALURONATE CAPRYLHYDROXAMIC ACID POLYSORBATE 80 LAURETH-7 DIPOTASSIUM PHOSPHATE SORBITAN OLEATE GLYCERYL CAPRYLATE

🎯 Purpose 2 words ▾

Acne treatment

📄 Keep Out of Reach of Children 10 words ▾

Keep out of reach of children,If swallowed,get medical help rightaway

📄 Package Label / Principal Display Panel 2 words ▾

Label image

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 Azelaic Acid (matched by generic name) — the program that covers self-administered drugs. 5 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 Azelaic Acid. CMS lists 3 products for this generic; we show the highest-spend one. 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
$1.6M
Claims incl. refills
26.4K
Beneficiaries
21.7K
Spend / beneficiary
$73.90
Spend / claim
$60.70
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.

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 Guangdong Bisutang Biotechnology Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guangdong Bisutang Biotechnology 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.
← 84753-0044-01 · Guangdong 84753-0057-01 · Guangdong →
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.