Acne Relief SALICYLIC ACID,NIACINAMIDE,PANTHENOL. 500 mg/50mL; 500 mg/50mL; 250 mg/50mL; 210 mg/50mL; 100 mg/50mL Cream, 50 mL — NDC 84509-0114-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Acne Relief SALICYLIC ACID,NIACINAMIDE,PANTHENOL. 500 mg/50mL; 500 mg/50mL; 250 mg/50mL; 210 mg/50mL; 100 mg/50mL Cream, 50 mL — NDC 84509-114-01 (Billing 84509-0114-01)

by Guangzhou Senmai Biotechnology Co.,Ltd. · 50 mL in 1 BOTTLE

This is a package of 50 mL of Acne Relief SALICYLIC ACID,NIACINAMIDE,PANTHENOL. 500 mg/50mL; 500 mg/50mL; 250 mg/50mL; 210 mg/50mL; 100 mg/50mL Cream from Guangzhou Senmai Biotechnology Co.,Ltd., marketed since Aug 2026 and currently FDA-listed. It is this product's only package size.

NDC 84509-0114-01
🏷️ FDA NDC (as labeled) 84509-114-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 84509-114-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84509 labeler · 114 product · 01 package
Package marketed since
Aug 25, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8450911401 8
FDA record last changed
Sep 3, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84509-114-01
Product NDC 84509-114
11-digit billing NDC 84509011401
UNII O414PZ4LPZ, 25X51I8RD4, WV9CM0O67Z, U2NP04VHSG, 344S277G0Z
Application # M016
SPL Set ID 59db0143-de57-59d2-e063-6294a90a32a8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-25
Route TOPICAL
Dosage form CREAM
Substance SALICYLIC ACID; NIACINAMIDE; PANTHENOL; AZELAMIDE MEA; ALLANTOIN
Why two NDCs? The FDA registers this code as 84509-114-01 — 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 → 84509-0114-01. 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.

Clinical

🧪 What is this product?

Acne Relief is an over-the-counter topical cream formulated under FDA monograph rules for managing acne-prone skin. Salicylic acid functions as a chemical exfoliant commonly used to help unclog pores and reduce buildup. Niacinamide and panthenol are typically included to help calm irritation and support skin hydration. The product also contains azelamide MEA and allantoin, ingredients commonly found in acne and skincare products for their soothing properties.

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
84509-0114-01 You're viewing this Main listing 50 mL in 1 BOTTLE 2026-08-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acne Relief 500 mg/50mL; 500 mg/50mL; 250 mg/50mL; 210 mg/50mL; 100 mg/50mLthis 84509-0114-01 Guangzhou 50 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

🏛️
2026
On the market since
Aug 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 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 5C5403N26O
    Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
  • UNII H7UGK1GJCU
    Aspalathus linearis leaf is a plant extract from rooibos tea. It's used in medicines as a natural flavor and color agent, and may help preserve the product's stability.
  • 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 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 J1M3NA843L
    A spicy pepper extract used as a flavoring agent in medicines. It adds taste to mask bitter drug flavors and improve palatability, especially in liquid or chewable formulations.
  • 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 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 STJ856D1Z0
    A plant extract derived from chrysanthemum flowers, used as a natural colorant and flavoring agent in medicines to enhance appearance and taste.
  • UNII ICS790225B
    A plant-derived cleaning agent made from coconut oil and glucose. It works as a surfactant and emulsifier to help mix oil and water-based ingredients together in the formulation.
  • 75 mg / 50 mL UNII CXS4LJR7EL
    Coptis chinensis root is a plant extract used as a natural flavoring and preservative agent in some medicines. It may help preserve product stability and add a bitter taste component to the formulation.
  • UNII 67444F3ESD
    Coptis chinensis is a plant root extract used in traditional Chinese medicine formulations. In medicines, it may serve as an active botanical ingredient or flavoring agent, though its specific role depends on the product formulation.
  • 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 9H4PO4Z4FT
    A sulfur-containing organic compound used as a solvent and penetration enhancer in medicines. It helps dissolve active ingredients and improve their absorption through skin or mucous membranes.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 3E4MG0DM0M
    Houttuynia cordata top is a plant-derived ingredient used as a natural flavoring or botanical extract. It may help mask taste or add aroma to the medicine.
  • 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 4L6452S749
    Inositol is a naturally occurring sugar-like compound. It acts as an osmotic agent and sweetener in medications, helping draw water into the formulation and improve taste.
  • UNII 4465L2WS4Y
    A plant extract from Japanese honeysuckle flowers used as a natural flavoring and fragrance ingredient in medicines. It may also help preserve the product and add pleasant taste or aroma.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII 3TF9Z1U73O
    A plant-derived ingredient from the prickly pear cactus stem. It acts as a binder and thickener to help hold the medicine together and improve its texture.
  • UNII BUG255FE7X
    A plant-derived ingredient from tree peony root bark. It's used in traditional formulations as a natural filler and may help stabilize the medicine's consistency and appearance.
  • 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 PBG27B754G
    Phellodendron amurense bark is a plant-derived ingredient from the cork tree. It functions as a natural preservative and antimicrobial agent to help maintain product stability and prevent microbial growth.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII BOW48C81XP
    A plant extract from the kava root, used as a flavoring agent to add taste to medicines. It may also help mask bitter flavors in oral formulations.
  • UNII 82LKS4QV2Y
    Poliglusam is a synthetic polymer made from glucose units linked together. It works as a binder and thickening agent to help hold the medicine's ingredients together and control how quickly the drug dissolves.
  • 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 9JW9D9JGHZ
    A plant extract from purslane leaves used as a natural ingredient in formulations. It may serve as an antioxidant or botanical additive to help preserve product stability and quality.
  • UNII 5X73DDS97A
    A synthetic polymer used as a conditioning and antistatic agent. In medicines, it helps improve texture, reduce static buildup, and enhance how the product feels or flows.
  • UNII 1693AM5SBN
    Salvia miltiorrhiza root is a plant extract used in traditional medicine formulations. It may serve as a flavoring agent, natural colorant, or functional ingredient to support the product's intended therapeutic profile.
  • UNII 7J95K7ID2S
    A plant extract from the roots of Chinese skullcap, used as a natural coloring agent and to add mild flavor to medicines. It may also help preserve the product's stability.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • 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 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 X8KX602M5L
    Sophora flavescens is a plant extract used in medicines as a natural thickening agent and skin-conditioning ingredient. It helps adjust the medicine's texture and may support formulation stability.
  • 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.

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

The official label also statesWATER,BUTYLENE GLYCOL,GLYCERIN,CETEARYL ALCOHOL,CAPRYLIC/CAPRIC TRIGLYCERIDE,DIMETHICONE,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,COCO-GLUCOSIDE,NIACINAMIDE,INOSITOL,DIMETHYL SULFONE,GLYCERYL STEARATE,CETYL ALCOHOL,CHITOSAN,PEG-100 STEARATE,1,2-HEXANEDIOL,PANTHENOL,ACACIA SENEGAL GUM,MALTODEXTRIN,PHENOXYETHANOL,AZELAMIDE MEA,POLYACRYLATE CROSSPOLYMER-6,ALLANTOIN,PHELLODENDRON AMURENSE BARK EXTRACT,COPTIS CHINENSIS ROOT EXTRACT,SOPHORA ANGUSTIFOLIA ROOT EXTRACT,ZANTHOXYLUM BUNGEANUM FRUIT EXTRACT,CAPSICUM FRUTESCENS FRUIT EXTRACT,SALVIA MILTIORRHIZA EXTRACT,LONICERA JAPONICA EXTRACT,ASPALATHUS LINEARIS EXTRACT,SODIUM HYALURONATE,PIPER METHYSTICUM ROOT EXTRACT,ETHYLHEXYLGLYCERIN,SOPHORA FLAVESCENS EXTRACT,HYDROXYACETOPHENONE,CHRYSANTHELLUM INDICUM EXTRACT,SCUTELLARIA BAICALENSIS ROOT EXTRACT,HOUTTUYNIA CORDATA EXTRACT,CERAMIDE NP,QUATERNIUM-73,PORTULACA OLERACEA EXTRACT,OPUNTIA STREPTACANTHA STEM EXTRACT,PAEONIA SUFFRUTICOSA ROOT BARK 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.

Manufacturer & labeler

LabelerGuangzhou Senmai Biotechnology Co.,Ltd.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code84509
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio8 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 33 words ▾

Uses For emergency breakout relief, reach for our AcneBuster 1.8% Salicylic Acid Acne Drying Lotion.Simply dab it directly onto blemishes; it visiblyshrinkspimples within 24 hours while relieving redness,stinging discomfort, and fading acne scars.

⏱️ Dosage and Administration 5 words ▾

Approximately 0.01-0.02 oz each time.

⚠️ Warnings 40 words ▾

Warnings Forexternal use only.Thisproductcontainssalicylicacid.ltisrecommended totest the product behind the ear beforeuse. Ifdiscomfortoccurs, discontinue use.lf bothersomedryness or peeling occurs, reduce application use. Ifit accidentally enters the eyes, rinse immediately with water. · Do not expose to direct sunlight and high temperatures.

🧪 Active Ingredient 33 words ▾

Active Ingredients SALICYLIC ACID.....1% ... Acne Treatment NIACINAMIDE.....1%....Fades Acne Marks PANTHENOL ..... 0.5% .... Restores Skin Barrier AZELAMIDE MEA.....0.42%.....Helps Fades Acne Marks ALLANTOIN .....0.2% .... Soothes & Repairs COPTIS CHINENSIS ROOT EXTRACT.....0.15%.....Soothe Acne

🧪 Inactive Ingredients 62 words ▾

Inactive Ingredients WATER,BUTYLENE GLYCOL,GLYCERIN,CETEARYL ALCOHOL,CAPRYLIC/CAPRIC TRIGLYCERIDE,DIMETHICONE,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,COCO-GLUCOSIDE,NIACINAMIDE,INOSITOL,DIMETHYL SULFONE,GLYCERYL STEARATE,CETYL ALCOHOL,CHITOSAN,PEG-100 STEARATE,1,2-HEXANEDIOL,PANTHENOL,ACACIA SENEGAL GUM,MALTODEXTRIN,PHENOXYETHANOL,AZELAMIDE MEA,POLYACRYLATE CROSSPOLYMER-6,ALLANTOIN,PHELLODENDRON AMURENSE BARK EXTRACT,COPTIS CHINENSIS ROOT EXTRACT,SOPHORA ANGUSTIFOLIA ROOT EXTRACT,ZANTHOXYLUM BUNGEANUM FRUIT EXTRACT,CAPSICUM FRUTESCENS FRUIT EXTRACT,SALVIA MILTIORRHIZA EXTRACT,LONICERA JAPONICA EXTRACT,ASPALATHUS LINEARIS EXTRACT,SODIUM HYALURONATE,PIPER METHYSTICUM ROOT EXTRACT,ETHYLHEXYLGLYCERIN,SOPHORA FLAVESCENS EXTRACT,HYDROXYACETOPHENONE,CHRYSANTHELLUM INDICUM EXTRACT,SCUTELLARIA BAICALENSIS ROOT EXTRACT,HOUTTUYNIA CORDATA EXTRACT,CERAMIDE NP,QUATERNIUM-73,PORTULACA OLERACEA EXTRACT,OPUNTIA STREPTACANTHA STEM EXTRACT,PAEONIA SUFFRUTICOSA ROOT BARK EXTRACT

🎯 Purpose 4 words ▾

Purpose Acne Relief Cream

📋 Description 31 words ▾

Acne Relief Cream

Manufacturer Guangzhou Senmai Biotechnology Co.,Ltd.

Address 1-4/F, Building A, GuangerIntelligencelndustrial Park, No.2 QianyiEast Road, ShilingTown, Huadu District,Guangzhou, China

Shelf Life 3 Years

Place of Origin Made in P.R.C

📄 When Using This Product 21 words ▾

When using this product Keep out of eyes. Rinse with water to remove. Stop and ask a doctor if rash occurs

📄 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

📄 Package Label / Principal Display Panel 1 words ▾

125

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Guangzhou Senmai Biotechnology Co.,Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guangzhou Senmai 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.
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.