DARKSPOTREMOVERILLUMINATINGFACECREAM .3 g/30mL; .03 g/30mL; .015 g/30mL Emulsion, 30 mL — NDC 84423-0046-01 package photo

DARKSPOTREMOVERILLUMINATINGFACECREAM .3 g/30mL; .03 g/30mL; .015 g/30mL Emulsion, 30 mL

by Guangzhou Kadiya Biotechnology Co., Ltd. · 30 mL in 1 BOTTLE, GLASS (84423-046-01)
NDC 84423-0046-01
🏷️ FDA NDC (as labeled) 84423-046-01 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ 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 →
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 84423-046-01
Product NDC 84423-046
11-digit billing NDC 84423004601
UNII 72VUP07IT5, R0ZB2556P8, PQ6CK8PD0R
Application # M016
SPL Set ID 29726662-5b37-d884-e063-6294a90a1f26
Established class (EPC) Vitamin C
Chemical class Ascorbic Acid
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2024-12-17
Route CUTANEOUS
Dosage form EMULSION
Substance ALPHA-ARBUTIN; TOCOPHEROL; ASCORBIC ACID
Why two NDCs? The FDA registers this code as 84423-046-01 — 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 → 84423-0046-01. 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 Kadiya Biotechnology Co., Ltd.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code84423
First marketedDec 2024
Product typeHuman Otc Drug
Portfolio27 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 over-the-counter moisturizing face cream formulated as an emulsion applied to the skin. It contains three active ingredients commonly used in skin-lightening and antioxidant products: alpha-arbutin and vitamin C (ascorbic acid) are typically used to help reduce the appearance of dark spots and even skin tone, while vitamin E (tocopherol) functions as an antioxidant. This product is marketed under FDA's monograph rules for over-the-counter skin-care agents rather than as an individually reviewed drug application.

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 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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • 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 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 MCU2324216
    A silicone-based oil that reduces foaming and helps ingredients mix evenly. It's used as an antifoaming agent and lubricant in tablets, capsules, and liquid formulations.
  • 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 7EV65EAW6H
    Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
  • 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 T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 0I3V7S25AW
    Myristic acid is a natural fatty acid commonly derived from palm or coconut oil. In medicines, it acts as a lubricant and binding agent, helping tablets hold together and slide smoothly through manufacturing equipment.
  • UNII 2V16EO95H1
    Palmitic acid is a saturated fatty acid derived from plant and animal sources. It serves as an emulsifier and lubricant in medicines, helping ingredients mix smoothly and preventing sticking during manufacturing.
  • UNII 2U8P432R6Z
    PEG-50 lanolin is a waxy substance derived from sheep's wool that has been chemically modified to mix easily with water. It acts as an emulsifier and moisturizer in medications, helping blend oil and water-based ingredients together in creams, ointments, and lotions.
  • UNII 09179OX7TB
    PEG-75 Lanolin is a waxy substance derived from sheep's wool that has been chemically modified to mix easily with water and oil. It acts as an emulsifier and moisturizer in topical formulations, helping blend different ingredients and soften the skin.
  • 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 CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • 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 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 6T84R30KC1
    Tranexamic acid is a synthetic compound that helps reduce bleeding by slowing the breakdown of blood clots. In medicines, it acts as an active pharmaceutical ingredient rather than an inactive filler, and is included to provide therapeutic effects related to bleeding control.
  • 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.

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

The official label also statesAQUA,PROPYLENE GLYCOL,GLYCERIN,MINERAL OIL,PALMITIC ACID,DIMETHICONE,POLYSORBATE 60,GLYCERYL STEARATE,STEARYL ALCOHOL,TRANEXAMIC ACID,TITANIUM DIOXIDE,CETYL ALCOHOL,PEG-50 LANOLIN,TRIETHANOLAMINE,PEG-75 LANOLIN,PHENOXYETHANOL,HYDROGENATED LECITHIN,ALLANTOIN,STEARIC ACID,LANOLIN,METHYLPARABEN,MYRISTIC ACID,PROPYLPARABEN,ALUMINA,YEAST FERMENT 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 DailyMedingredient 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 mLPer 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
Darkspotremoverilluminatingfacecream .3 g/30mL; .03 g/30mL; .015 g/30mLthis 84423-0046-01 Guangzhou 30 ml Discontinued
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
Dec 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
84423-0046-01 You're viewing this 30 mL in 1 BOTTLE, GLASS (84423-046-01) 2024-12-17 Inactivated by FDA

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 84423-046-01, 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: 84423-0046-01, written without dashes as 84423004601. 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 84423-0046-01, the first segment (84423) is the labeler code FDA assigned to Guangzhou Kadiya Biotechnology Co., Ltd.; the middle segment (0046) 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.
Who lists this product with the FDA?
Guangzhou Kadiya 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.

📄 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 53 words

Thie s mdieturizina croam onrichod fem avouieito and powertul ingredients that also removes dark spots (from acne. hvper pigmentation, etc). It contains vitamins C & E and provides a SPF of 15. This product will nourish and refine skin. linhten dark snots and smooth nores This product has been formulated for sensitive skin.

⏱️ Dosage and Administration 26 words

Apply to Hyperpigmented area 2-3 times daily to even out face and neck tone. Avoid contact with eyes. Results will continue to improve with daily use.

⚠️ Warnings 16 words

1、For external use only, avoid contact with eyes when used 2、Keep out of reach of children

🧪 Active Ingredient 7 words

ALPHA-ARBUTIN1% HYDROLYZED COLLAGEN EXTRACT0.5% TOCOPHEROL0.5% ASCORBIC ACID0.1%

🧪 Inactive Ingredients 17 words

AQUA,PROPYLENE GLYCOL,GLYCERIN,MINERAL OIL,PALMITIC ACID,DIMETHICONE,POLYSORBATE 60,GLYCERYL STEARATE,STEARYL ALCOHOL,TRANEXAMIC ACID,TITANIUM DIOXIDE,CETYL ALCOHOL,PEG-50 LANOLIN,TRIETHANOLAMINE,PEG-75 LANOLIN,PHENOXYETHANOL,HYDROGENATED LECITHIN,ALLANTOIN,STEARIC ACID,LANOLIN,METHYLPARABEN,MYRISTIC ACID,PROPYLPARABEN,ALUMINA,YEAST FERMENT EXTRACT

🎯 Purpose 7 words

For skin whitening, moisturising and dark spots

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