Hydroquinone 4% 40 mg/g Cream, 1 tube — NDC 72162-2422-2 (Billing 72162-2422-02)
This is a package of 1 tube of Hydroquinone 4% 40 mg/g Cream from Bryant Ranch Prepack, marketed since Aug 2022 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 72162-2422-2 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 72162 labeler · 2422 product · 2 package
- Package marketed since
- Aug 17, 2022
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 7216224222 3
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 006313
- GCN: 24883
- HICL (First Databank): 002721
- AHFS class code: 84:50.04.00
- RxCUI (RxNorm): 197795
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Melanin Synthesis Inhibitor class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
This is a topical cream containing 4% hydroquinone, a medication typically used to lighten areas of darkened skin. Hydroquinone functions as a melanin synthesis inhibitor, meaning it is commonly applied to reduce the production of the pigment that gives skin its color. This unapproved drug product is marketed without an FDA-approved application.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per 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. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 72162-2422-02 You're viewing this Main listing | 1 TUBE in 1 CARTON / 28.4 g in 1 TUBE | 2022-08-17 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/g 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/gthis 72162-2422-02 | Bryant | 1 tube | — | — | FDA listed | — |
| Hydro-Q 40 mg/g 30815-0040-01 | Dermavance | 1 tube | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
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.
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UNII WR1WPI7EW8
A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
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UNII 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
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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.
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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.
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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.
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UNII 0WT12SX38S
Glycolic acid is an alpha-hydroxy acid derived from sugar cane that helps dissolve and remove dead skin cells. In topical medicines, it works as an exfoliant and pH adjuster to improve skin penetration and product effectiveness.
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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.
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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.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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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.
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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.
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UNII 9LBV3F07AZ
A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
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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.
13 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Bryant Ranch Prepack labeler code 72162
- Nebivolol 20 mg Tablet NDC 72162-2416-3
- Nebivolol 5 mg Tablet NDC 72162-2417-3
- Raloxifene hydrochloride 60 mg Tablet, Coated NDC 72162-2418-0
- Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 37.5 mg/g Gel NDC 72162-2419-2
- Tazarotene .5 mg/g Cream NDC 72162-2420-3
- Celecoxib 200 mg Capsule NDC 72162-2421-1
- POTASSIUM IODIDE 1 g/mL Solution NDC 72162-2423-2
- Metformin 500 mg Tablet, Extended Release NDC 72162-2424-0
- Ciprofloxacin Ciprofolxacin 500 mg Tablet NDC 72162-2425-1
- Dexmethylphenidate hydrochloride 5 mg Tablet NDC 72162-2426-1
- Dexmethylphenidate hydrochloride 10 mg Tablet NDC 72162-2427-1
- Methylphenidate Hydrochloride 5 mg Tablet NDC 72162-2428-1
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS & 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 ▾
DOSAGE & 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 ▾
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 ▾
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 ▾
ADVERSE REACTIONS The following adverse reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued and the physician notified immediately.
🔄 Drug Interactions ▾
DRUG INTERACTIONS Patients are cautioned on concomitant use of medications that are known to be photosensitizing.
🤰 Pregnancy ▾
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 ▾
PEDIATRIC USE Safety and effectiveness for pediatric patients below the age of 12 years have not been established.
🆘 Overdosage ▾
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 ▾
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 ▾
HOW SUPPLIED Hydroquinone USP, 4% Skin Bleaching Cream is available as follows: NDC: 72162-2422-2: 1 oz (28.4 g) in a tube. STORAGE Hydroquinone USP, 4% Skin Bleaching Cream should be stored at controlled room temperature (20-25°C) (68-77°F). Darkening of this product is normal. This will not affect performance or safety. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504
📋 Description ▾
DESCRIPTION Each gram of Hydroquinone USP, 4% Skin Bleaching Cream contains 40 mg of hydroquinone USP, in a vanishing cream base of aqua (water), BHT, cetyl alcohol, disodium EDTA, glycerin, glycolic acid, methylparaben, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, stearyl alcohol, tetrahexyldecyl ascorbate, and tocopheryl acetate. 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:
💬 Information for Patients ▾
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 ▾
PRECAUTIONS (see WARNINGS ) GENERAL PRECAUTIONS 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 is 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. DRUG INTERACTIONS Patients are cautioned on concomitant use of medications that are known to be photosensitizing. 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 ▾
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 ▾
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.
📄 Package Label / Principal Display Panel ▾
Hydroquinone 4% Cream #28.4 Label Extended Label
About this NDC listing & data coverage
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) | ✓ 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. |