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Hydro-Q Hydroquinone 40 mg/g Gel — NDC 30815-0040-01 package photo

Hydro-Q Hydroquinone 40 mg/g Gel

by Dermavance Pharmaceuticals · 1 TUBE in 1 BOX (30815-0040-1) / 30 g in 1 TUBE
NDC 30815-0040-01
🏷️ FDA NDC (as labeled) 30815-0040-1 billing pads the package segment with a zero
Rx only On market Non-controlled
🗂️ 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 30815-0040-1
Product NDC 30815-0040
11-digit billing NDC 30815004001
RxCUI 310926
UNII XV74C1N1AE
SPL Set ID 486781be-498a-49b4-9a80-2dfd02f5e358
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 2008-12-08
Route TOPICAL
Dosage form GEL
Substance HYDROQUINONE
Why two NDCs? The FDA registers this code as 30815-0040-1 — a 5-4-1 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 package segment → 30815-0040-01. 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.

🏭 Manufacturer & labeler

LabelerDermavance Pharmaceuticals
Labeler code30815
First marketedDec 2008
Product typeHuman Prescription Drug
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?

Hydro-Q is a topical gel containing hydroquinone, a melanin synthesis inhibitor. Hydroquinone is typically used in skin-lightening products to reduce the appearance of dark spots, melasma, and other areas of unwanted skin pigmentation. This is an unapproved drug product without an FDA-approved 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.

🧪 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 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product 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.

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

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

Inactive ingredient FAQ

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

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydroquinone 4% 40 mg/g 75834-0137-01 Nivagen 1 tube $0.454 — Availability likely —
Hydroquinone 40 mg/g 69367-0174-01 Westminster 1 tube $0.517 — Availability likely —
Hydroquinone 4% 40 mg/g 42192-0151-01 Acella 1 tube $0.517 — Availability likely —
Hydro-Q 40 mg/gthis 30815-0040-01 Dermavance 1 tube — — FDA listed —
Hydroquinone cream 40 mg/g 24689-0101-01 APNAR 1 tube — — 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 —
Hydroquinone 4% 40 mg/g 50405-0800-01 SOHM, 1 tube — — FDA listed —
Hydroquinone 4% 40 mg/g 72162-2422-02 Bryant 1 tube — — FDA listed —
NU-DERM CLEAR Skin Bleaching and Corrector 40 mg/g 62032-0101-36 Obagi 57 g — — FDA listed —
Hydroquinone 4% 40 mg/g 71399-0400-01 Akron 28.35 g — — FDA listed —
NU-DERM BLENDER Skin Lightener and Blending 40 mg/g 62032-0100-10 Obagi 28 g — — FDA listed —
hydroquinone 40 mg/g 10135-0724-99 Marlex 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

🏛️
2008
On the market since
Dec 2008
📍
2026
Currently FDA-listed
18 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Hydroquinone — the ingredient across all brands.

Top reported reactions

Erythema177
Condition Aggravated104
Skin Burning Sensation100
Pruritus87
Skin Exfoliation82
Dry Skin68
Rash66

Age at onset

Adolescent1
Adult94
Elderly26

Reporter sex

1,132 reports

Serious outcomes

Hospitalization109
Death19
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 97 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
30815-0040-01 You're viewing this 1 TUBE in 1 BOX (30815-0040-1) / 30 g in 1 TUBE 2008-12-08 Active

🧭 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 ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 30815-0040-1, 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: 30815-0040-01, written without dashes as 30815004001. 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 30815-0040-01, the first segment (30815) is the labeler code FDA assigned to Dermavance Pharmaceuticals; the middle segment (0040) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Dermavance Pharmaceuticals. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Dermavance Pharmaceuticals 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.

📄 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
🎯 Indications and Usage 27 words ▾

INDICATIONS AND USAGE HYDRO-Q ® is indicated for the gradual bleaching of hyperpigmented skin conditions such as chlosma, melasma, freckles, senile lentigines and areas of melanin hyperpigmentation.

⏱️ Dosage and Administration 99 words ▾

DOSAGE AND ADMINSTRATION HYDRO-Q ® should be applied to the affected areas twice daily, morning and before bedtime or as directed by a physician. During and after the use of HYDRO-Q ® , sun exposure should be limited and a sunscreen agent or protective clothing should be used to cover up the treated areas to prevent regimentation. If no lightening effect is noted after two months of treatment, use of HYDRO-Q ® should be discontinued.

There is no recommended dosage for children under the age of 12 years of age except under the advice and supervision of a physician.

⛔ Contraindications 45 words ▾

CONTRAINDICATIONS HYDRO-Q ® is contraindicated in any patient that has a prior history of sensitivity or allergic reaction to hydroquinone or any of the other ingredients. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.

⚠️ Warnings ~1 min read ▾

WARNINGS CAUTION: Hydroquinone is a depigmenting agent that 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. Test for skin sensitivity before using HYDRO-Q ® by applying a small amount of the gel to an unbroken patch of skin and check within 24 hours.

Minor redness is not a contraindication but where there is itching and vesicle formation or excessive inflammatory response further treatment is not advised. Close patient supervision is recommended. Contact with the eyes should be avoided.

If no lightening effect is noted after 2 months of treatment the use of HYDRO-Q ® should be discontinued. HYDRO-Q ® is formulated for the treatment of dyschromia and should not be used for the prevention of sunburn. 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 Keep this and all medications out of reach of children. In case of accidental ingestion, contact a physician or a poison control center immediately. WARNING: Contains sodium metabisulfite, a sulfite that may cause serious allergic reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons On rare occasions, a gradual blue-black darkening of the skin may occur, in which case, use of HYDRO-Q ® should be discontinued and a physician contacted immediately

🤒 Adverse Reactions 29 words ▾

ADVERSE REACTIONS No systemic reactions have been reported. Occasional cutaneous hypersensitivity (localized contact dermatitis) may occur, in which case the medication should be discontinued and the physician notified immediately

🤰 Pregnancy 37 words ▾

A. Pregnancy Category C Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman, or can affect reproductive capacity.

🧒 Pediatric Use 19 words ▾

C. Pediatric usage Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

🆘 Overdosage 46 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 skin reddening and a mild burning sensation that does not preclude treatment

🧬 Clinical Pharmacology 47 words ▾

CLINICAL PHARMACOLOGY Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic hydroquinone. oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (dopa) 1 and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause regimentation of the bleached areas.

📦 How Supplied / Storage and Handling 27 words ▾

HOW SUPPLIED HYDRO-Q ® (Hydroquinone 4%) Gel is supplied in a 30 g tube. NDC: 30815-0040-1 Store at controlled room temperature, between 15° and 30°C (59°and 86°F).

📦 Storage and Handling 11 words ▾

Store at controlled room temperature, between 15° and 30°C (59°and 86°F).

📋 Description 62 words ▾

HYDRO-Q ® contains hydroquinone USP 4%. Hydroquinone is 1, 4-Benzenediol {CAS 123-31-91}. Hydroquinone is structurally related to monobenzone. Hydroquinone occurs as fine white needles. The drug is freely soluble in water and in alcohol and has a pKa of 9.96. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2; The molecular weight is 110.1. The structural formula is: Chemical Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 30807-7000-01 · WILD 31260-0200-01 · Gulbrandsen →
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.