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Hydroquinone 4% 40 mg/g Cream, 1 tube — NDC 50405-800-01 (Billing 50405-0800-01)

by SOHM, Inc. · 1 TUBE in 1 CARTON / 28.35 g in 1 TUBE

This is a package of 1 tube of Hydroquinone 4% 40 mg/g Cream from SOHM, Inc., marketed since Jun 2023 and currently FDA-listed. It is this product's only package size.

NDC 50405-0800-01
🏷️ FDA NDC (as labeled) 50405-800-01 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 50405-800-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50405 labeler · 800 product · 01 package
Package marketed since
Jun 5, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0350405800010
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50405-800-01
Product NDC 50405-800
11-digit billing NDC 50405080001
RxCUI 197795
UNII XV74C1N1AE
UPC 0350405800010
SPL Set ID 47f0cbfb-b73b-4572-95d2-992c7382df3a
Established class (EPC) Melanin Synthesis Inhibitor
Mechanism of action Melanin Synthesis Inhibitors
Physiologic effect Depigmenting Activity
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-06-05
Route TOPICAL
Dosage form CREAM
Substance HYDROQUINONE
Quick answers
  • RxCUI (RxNorm): 197795
Why two NDCs? The FDA registers this code as 50405-800-01 — 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 → 50405-0800-01. 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 Melanin Synthesis Inhibitor class.

Pharmacologic class Melanin Synthesis Inhibitor
Drug family (ATC) Other dermatologicals
How it works Melanin Synthesis Inhibitors
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 is this product?

This is a topical cream containing 4% hydroquinone. Hydroquinone is a melanin synthesis inhibitor typically used in skincare products applied to the skin to help address hyperpigmentation and uneven skin tone. This product is marketed without an approved FDA application.

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.

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
50405-0800-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 28.35 g in 1 TUBE 2023-06-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydroquinone 4% 40 mg/g 75834-0137-01 Nivagen 1 tube $0.461 — Availability likely —
Hydroquinone 4% 40 mg/g 42192-0151-01 Acella 1 tube $0.513 — Availability likely —
Hydroquinone 40 mg/g 69367-0174-01 Westminster 1 tube $0.513 — Availability likely —
hydroquinone 40 mg/g 10135-0724-99 Marlex 1 tube — — FDA listed —
Hydroquinone cream 40 mg/g 24689-0101-01 APNAR 1 tube — — FDA listed —
Hydroquinone 4% 40 mg/gthis 50405-0800-01 SOHM, 1 tube — — FDA listed —
NU-DERM BLENDER Skin Lightener and Blending 40 mg/g 62032-0100-10 Obagi 28 g — — FDA listed —
NU-DERM CLEAR Skin Bleaching and Corrector 40 mg/g 62032-0101-36 Obagi 57 g — — FDA listed —
Obagi-C Rx system C-Therapy Night Skin Lightening with Vitamins C and E 40 mg/g 62032-0105-36 Obagi 57 g — — FDA listed —
NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE 40 mg/g; 75 mg/g; 55 mg/g 62032-0116-36 Obagi 57 g — — FDA listed —
Hydroquinone 4% 40 mg/g 71399-0400-01 Akron 28.35 g — — FDA listed —
Hydroquinone 4% 40 mg/g 72162-2422-02 Bryant 1 tube — — FDA listed —
Hydro-Q 40 mg/g 30815-0040-01 Dermavance 1 tube — — 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

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerSOHM, Inc.
Labeler code50405
First marketedJun 2023
Product typeHuman Prescription Drug
Portfolio5 products on file

More NDCs from SOHM, Inc. labeler code 50405

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 33 words ▾

INDICATIONS AND USAGE Hydroquinone USP, 4% Skin Bleaching Cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

⏱️ Dosage and Administration 72 words ▾

DOSAGE AND ADMINISTRATION Hydroquinone USP, 4% Skin Bleaching Cream should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. If no improvement is seen after 2 months of treatment, use of this product should be discontinued. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.

⛔ Contraindications 38 words ▾

CONTRAINDICATIONS Prior history of sensitivity or allergic reaction to hydroquinone or to any of the ingredients of the product. The safety of topical hydroquinone use during pregnancy or for children (12 years and under) has not been established.

⚠️ Warnings 129 words ▾

WARNINGS Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

Since this product contains no sunscreen, an effective broad spectrum sun-blocking agent should be used and unnecessary solar exposure avoided, or protective clothing should be worn to cover bleached skin in order to prevent repigmentation from occurring. Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If this condition occurs, discontinue treatment and consult your physician.

The majority of patients developing this condition are Black, but it may also occur in Caucasians and Hispanics.

🤒 Adverse Reactions 40 words ▾

ADVERSE REACTIONS The following adverse reactions have been reported: dryness and fissuring of paranasal and intraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued and the physician notified immediately.

🤰 Pregnancy 52 words ▾

Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 18 words ▾

Pediatric Use Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

🆘 Overdosage 47 words ▾

OVERDOSAGE There have been no systemic reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

🧬 Clinical Pharmacology 63 words ▾

CLINICAL PHARMACOLOGY Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (dopa) (Denton, C. et al., 1952) 1 and suppression of other melanocyte metabolic processes (Jimbow, K. et al., 1974) 2 . Exposure to sunlight or ultraviolet light will cause repigmentation of bleached areas (Parrish, J.A. et al., 1978) 3 .

📦 How Supplied / Storage and Handling 28 words ▾

HOW SUPPLIED Hydroquinone USP, 4% Skin Bleaching Cream is available as follows: 1 oz (28.35 g) lube (NDC 50405-800-01) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 9 words ▾

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

📋 Description 75 words ▾

DESCRIPTION Each gram of Hydroquinone USP, 4% Skin Bleaching Cream contains 40 mg hydroquinone USP, in a vanishing cream base of Aqua (water) , Sodium Lauryl Sulfate, Sodium acrylate/Sodium Acryloyl Dimethyl Taurate Copolymer, Propanediol, Glycerin, Phenoxyethanol (and) Ethylhexyl glycerin, Sodium metabisulfite, Tocopheryl acetate, Vitamin C. Chemically, hydroquinone is C 6 H 6 O 2 and has a molecular weight of 110.11. The chemical name is 1,4 dihydroxybenzene, and the structural formula of hydroquinone is: Structure

💬 Information for Patients 83 words ▾

Information for Patients Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight sustains melanocytic activity. To prevent repigmentation, during treatment and maintenance therapy, sun exposure on treated skin should be avoided by application of a broad spectrum sunscreen (SPF 15 or greater) or by use of protective clothing. Avoid contact with eyes and mucous membranes.

Keep this and all medications out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS (see WARNINGS) General Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin; check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response further treatment ls not advised. Close patient supervision is recommended.

Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication. Information for Patients Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight sustains melanocytic activity.

To prevent repigmentation, during treatment and maintenance therapy, sun exposure on treated skin should be avoided by application of a broad spectrum sunscreen (SPF 15 or greater) or by use of protective clothing. Avoid contact with eyes and mucous membranes. Keep this and all medications out of reach of children.

In case of accidental ingestion, call a physician or a poison control center immediately. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.

Published studies have demonstrated that hydroquinone is a mutagen and a clastogen. Treatment with hydroquinone has resulted in positive findings for genetic toxicity in the Ames assay in bacterial strains sensitive to oxidizing mutagens, in in vitro studies in mammalian cells, and in the in vivo mouse micronucleus assay. Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with topical hydroquinone.

It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman. Pediatric Use Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

🍼 Nursing Mothers 35 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 74 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown. Published studies have demonstrated that hydroquinone is a mutagen and a clastogen.

Treatment with hydroquinone has resulted in positive findings for genetic toxicity in the Ames assay in bacterial strains sensitive to oxidizing mutagens, in in vitro studies in mammalian cells, and in the in vivo mouse micronucleus assay.

📚 References 73 words ▾

REFERENCES 1. DENTON C., LERNER A.B., FlTZPATRlCK T.B. Inhibition of Melanin Formation by Chemical Agents Journal of investigative Dermatology 1952, 18:119-135.

2. JIMBOW K. OBATA H., PATHAK M., FITZPATRICK T.B.

Mechanism of Depigmentation by Hydroquinone Journal of Investigative Dermatology 1974, 62-136-449. 3. PARRISH J.A., ANDERSON R.R., URBACH F., PITTS D UVA, Biological Effects of Ultraviolet Radiation with Emphasis on Human Responses to Longwave Ultraviolet Plenum Press, New York and London, 1978, p.

151

📄 Package Label / Principal Display Panel 27 words ▾

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton Rx only SOHM, Inc. NDC 50405-800-01 Hydroquinone USP, 4% Skin Bleaching Cream Net Wt 1 oz (28.35 g) tube

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

Finished prescription 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 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 SOHM, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SOHM, Inc. 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 50405-0303-01 · SOHM, 50405-0850-01 · SOHM, →
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.