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Adapalene 1 mg/g Cream — NDC 72162-1048-2 (Billing 72162-1048-02)

by Bryant Ranch Prepack · 1 TUBE in 1 CARTON / 45 g in 1 TUBE

This is a package of Adapalene 1 mg/g Cream from Bryant Ranch Prepack, marketed since Jun 2010 and currently FDA-listed. It is this product's only package size.

NDC 72162-1048-02
🏷️ FDA NDC (as labeled) 72162-1048-2 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 72162-1048-2 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72162 labeler · 1048 product · 2 package
Package marketed since
Feb 23, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7216210482 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72162-1048-2
Product NDC 72162-1048
11-digit billing NDC 72162104802
RxCUI 313852
UNII 1L4806J2QF
Application # ANDA090824
SPL Set ID 79454b4c-3fd4-4e6d-b984-908f8cc8ab6d
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-06-30
Route TOPICAL
Dosage form CREAM
Substance ADAPALENE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 313852
Why two NDCs? The FDA registers this code as 72162-1048-2 — 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 → 72162-1048-02. 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 Retinoid class.

Pharmacologic class Retinoid
Drug family (ATC) Retinoids for topical use in acne
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

📗 Our plain-language guide HelloPharmacist
  • It treats acne vulgaris, the common type of acne. Some products are labeled for ages 12 and up. Ask a doctor before using it in younger children.
  • Use it once a day, usually in the evening, on clean, dry skin. Apply a thin layer to the whole affected area and keep it away from your eyes, lips and inside of your mouth or nose....
  • Give it about 8 to 12 weeks. Acne can seem to flare in the early weeks, which is not a reason to stop. If you see no improvement after 12 weeks, talk to your prescriber.
  • Redness, dryness, peeling and some burning or stinging are the most common, especially in the first month. They are usually mild to moderate and often ease. A moisturizer can help....
📖 Read our full Adapalene guide →

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 · Q2 2026 $2.81 $126.31 / 45 g
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
72162-1048-02 You're viewing this Main listing 1 TUBE in 1 CARTON / 45 g in 1 TUBE 2024-02-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Adapalene 1 mg/g 70000-0666-01 Cardinal 1 tube $0.466 — Availability likely —
Adapalene 1 mg/g 46122-0768-36 AMERISOURCE 1 tube $0.466 — Availability likely —
Adapalene 1 mg/g 00536-1412-20 RUGBY 1 tube $0.466 — Availability likely —
Adapalene 1 mg/g 51672-2150-01 Sun 1 tube $0.466 — Availability likely —
Adapalene 1 mg/g 00168-0424-46 E. 1 tube $2.855 AB Availability likely —
Adapalene .1 g/100g 45802-0453-84 Padagis 1 tube $2.855 AB Availability likely —
Adapalene 1 mg/g 63629-8791-01 Bryant 1 tube — AB FDA listed —
Adapalene 1 mg/gthis 72162-1048-02 Bryant 1 tube — AB FDA listed —
Differin 1 mg/g 00299-4910-00 Galderma 1 tube — — FDA listed —
Adapalene 1 mg/g 41250-0288-05 MEIJER, 1 tube — — FDA listed —
Adapalene 1 mg/g 49967-0354-01 LOreal 1 tube — — FDA listed —
Effaclar 1 mg/g 49967-0591-01 LOreal 1 tube — — FDA listed —
Adapalene 1 mg/g 59726-0888-05 P 1 tube — — Discontinued —
Adapalene 1 mg/g 79481-1140-05 Meijer 1 tube — — FDA listed —
PanOxyl 1 mg/g 00316-0143-15 CROWN 1 tube — — FDA listed —
Adapalene 1 mg/g 73581-0215-45 YYBA 1 tube — — FDA listed —
Adapalene 1 mg/g 55910-0880-05 Dolgencorp, 1 tube — — FDA listed —
Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne Treatment 1 mg/g 69968-0945-02 Kenvue 1 tube — — FDA listed —
Neutrogena Adapalene 0.1% Acne Treatment 1 mg/g 69968-0826-01 Kenvue 1 tube — — FDA listed —
Adapalene 1 mg/g 21130-0754-05 Safeway, 1 tube — — FDA listed —
Adapalene 1 mg/g 00363-1401-05 Walgreens 1 tube — — FDA listed —
Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne Treatment 1 mg/g 69968-1004-02 Kenvue 1 tube — — FDA listed —
Adapalene 1 mg/g 72657-0158-15 GLENMARK 1 bottle — — FDA listed —
Adapalene 1 mg/g 73581-0019-06 YYBA 1 tube — — FDA listed —
Adapalene 1 mg/g 59726-0114-05 P 1 tube — — FDA listed —
Adapalene 1 mg/g 73581-0214-06 YYBA 1 tube — — FDA listed —
Adapalene 1 mg/g 76162-0114-05 Topco 1 tube — — FDA listed —
Adapalene 1 mg/g 82442-0105-01 Target 1 tube — — FDA listed —
Adapalene 1 mg/g 11822-0062-01 RITE 1 tube — — FDA listed —
Adapalene 1 mg/g 30142-0725-05 The 1 tube — — FDA listed —
Adapalene 1 mg/g 36800-0088-05 TOP 1 tube — — Discontinued —
Adapalene 1 mg/g 69842-0088-05 CVS 1 tube — — FDA listed —
Effaclar 1 mg/g 49967-0592-01 LOreal 1 tube — — FDA listed —
PanOxyl 1 mg/g 00316-0284-15 CROWN 1 tube — — FDA listed —
Adapalene 1 mg/g 00363-4110-05 Walgreens 1 tube — — FDA listed —
Adapalene 1 mg/g 73581-0216-45 YYBA 1 tube — — FDA listed —
Adapalene 1 mg/g 51316-0114-05 CVS 1 tube — — FDA listed —
Adapalene 1 mg/g 00363-0888-05 Walgreens 1 tube — — FDA listed —
Adapalene 1 mg/g 79903-0338-05 Wal-Mart 1 tube — — FDA listed —
Adapalene Paraben Free 1 mg/g 76162-0221-05 Topco 1 tube — — FDA listed —
Adapalene Paraben Free 1 mg/g 79481-2210-05 Meijer 1 tube — — FDA listed —
Adapalene Paraben Free 1 mg/g 30142-0542-05 The 1 tube — — FDA listed —
Adapalene Paraben Free 1 mg/g 51316-0219-05 CVS 1 tube — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2010
On the market since
Jun 2010
📍
2026
Currently FDA-listed
16 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

LabelerBryant Ranch Prepack
Application holderFOUGERA PHARMACEUTICALS INC
FDA applicationANDA090824 (ANDA)
Labeler code72162
First marketedJun 2010
Product typeHuman Prescription Drug
Portfolio4,436 products on file

More NDCs from Bryant Ranch Prepack labeler code 72162

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

INDICATIONS AND USAGE: Adapalene cream is indicated for the topical treatment of acne vulgaris.

⏱️ Dosage and Administration 62 words ▾

DOSAGE AND ADMINISTRATION: Adapalene cream should be applied to affected areas of the skin, once daily at nighttime. A thin film of the cream should be applied to the skin areas where acne lesions appear, using enough to cover the entire affected area lightly. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of adapalene cream.

⛔ Contraindications 23 words ▾

CONTRAINDICATIONS: Adapalene cream should not be administered to individuals who are hypersensitive to adapalene or any of the components in the cream vehicle.

🤒 Adverse Reactions 179 words ▾

ADVERSE REACTIONS: In controlled clinical trials, local cutaneous irritation was monitored in 285 acne patients who used adapalene cream once daily for 12 weeks. The frequency and severity of erythema, scaling, dryness, pruritus and burning were assessed during these studies. The incidence of local cutaneous irritation with adapalene cream from the controlled clinical studies is provided in the following table: Incidence of Local Cutaneous Irritation with Adapalene Cream from Controlled Clinical Studies (N=285) None Mild Moderate Severe Erythema 52% (148) 38% (108) 10% (28) <1% (1) Scaling 58% (166) 35% (100) 6% (18) <1% (1) Dryness 48% (136) 42% (121) 9% (26) <1% (2) Pruritus (persistent) 74% (211) 21% (61) 4% (12) <1% (1) Burning/Stinging (persistent) 71% (202) 24% (69) 4% (12) <1% (2) Other reported local cutaneous adverse events in patients who used adapalene cream once daily included: sunburn (2%), skin discomfort-burning and stinging (1%) and skin irritation (1%).

Events occurring in less than 1% of patients treated with adapalene cream included: acne flare, dermatitis and contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.

🔄 Drug Interactions 101 words ▾

Drug Interactions: As adapalene cream has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime rind) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with adapalene cream.

If these preparations have been used, it is advisable not to start therapy with adapalene cream until the effects of such preparations in the skin have subsided.

🤰 Pregnancy 129 words ▾

Pregnancy: Teratogenic effects. Pregnancy Category C. No teratogenic effects were seen in rats at oral doses of 0.15 to 5.0 mg/kg/day adapalene (up to 20 times the MRHD based on mg/m 2 comparisons).

However, adapalene administered orally at doses of ≥ 25 mg/kg, (100 times the MRHD for rats or 200 times MRHD for rabbits) has been shown to be teratogenic. Cutaneous teratology studies in rats and rabbits at doses of 0.6, 2.0, and 6.0 mg/kg/day (24 times the MRHD for rats or 48 times the MRHD for rabbits) exhibited no fetotoxicity and only minimal increases in supernumerary ribs in rats. There are no adequate and well-controlled studies in pregnant women.

Adapalene should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 17 words ▾

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

🧓 Geriatric Use 55 words ▾

Geriatric Use: Clinical studies of adapalene cream were conducted in patients 12 to 30 years of age with acne vulgaris and therefore did not include subjects 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 71 words ▾

OVERDOSAGE: Adapalene cream is intended for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, scaling, or skin discomfort may occur. The acute oral toxicity of adapalene cream in mice and rats is greater than 10 mL/kg. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.

🧬 Clinical Pharmacology 157 words ▾

CLINICAL PHARMACOLOGY: Mechanism of Action: Adapalene acts on retinoid receptors. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris. Mechanistically, adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein.

Although the exact mode of action of adapalene is unknown, it is suggested that topical adapalene normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Pharmacokinetics: Absorption of adapalene from adapalene cream through human skin is low. In a pharmacokinetic study with six acne patients treated once daily for 5 days with 2 grams of adapalene cream applied to 1000 cm 2 of acne involved skin, there were no quantifiable amounts (limit of quantification = 0.35 ng/mL) of adapalene in the plasma samples from any patient.

Excretion appears to be primarily by the biliary route.

🧬 Mechanism of Action 85 words ▾

Mechanism of Action: Adapalene acts on retinoid receptors. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris. Mechanistically, adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein.

Although the exact mode of action of adapalene is unknown, it is suggested that topical adapalene normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.

📦 How Supplied / Storage and Handling 53 words ▾

HOW SUPPLIED: Adapalene Cream, 0.1% is supplied in a 45 g tube NDC: 72162-1048-2: 45 g in a TUBE Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C). Excursions permitted between 59° and 86° F (15° and 30° C). Protect from freezing. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description 87 words ▾

DESCRIPTION: Adapalene cream, 0.1%, contains adapalene 0.1% in an aqueous cream emulsion consisting of carbomer 934P, cyclomethicone, edetate disodium, glycerin, methyl glucose sesquistearate, methylparaben, PEG-20 methyl glucose sesquistearate, phenoxyethanol, propylparaben, purified water, squalane, and trolamine. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder which is soluble in tetrahydrofuran, sparingly soluble in ethanol, and practically insoluble in water.

The molecular formula is C 28 H 28 O 3 and molecular weight is 412.52. Adapalene is represented by the following structural formula:

💬 Information for Patients 189 words ▾

Information for Patients: Patients using adapalene cream should receive the following information and instructions: 1. This medication is to be used only as directed by the physician. 2.

It is for external use only. 3. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes.

4. Cleanse area with a mild or soapless cleanser before applying this medication. 5.

Moisturizers may be used if necessary, however, products containing alpha hydroxy or glycolic acids should be avoided. 6. Exposure of the eye to this medication may result in reactions such as swelling, conjunctivitis, and eye irritation.

7. This medication should not be applied to cuts, abrasions, eczematous or sunburned skin. 8.

Wax epilation should not be performed on treated skin due to the potential for skin erosions. 9. During the early weeks of therapy, an apparent exacerbation of acne may occur.

This is due to the action of this medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Overall clinical benefit may be noticed after two weeks of therapy, but at least eight weeks are required to obtain consistent beneficial effects.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS: General: Certain cutaneous signs and symptoms of treatment such as erythema, dryness, scaling, burning, or pruritus may be experienced with use of adapalene cream. These are most likely to occur during the first two to four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Depending upon the severity of these side effects, patients should be instructed to reduce the frequency of application or discontinue use.

If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during use of adapalene. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution.

Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with adapalene. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes.

The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of "waxing" as a depilatory method should be avoided on skin treated with adapalene. Information for Patients: Patients using adapalene cream should receive the following information and instructions: 1.

This medication is to be used only as directed by the physician. 2. It is for external use only.

3. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. 4.

Cleanse area with a mild or soapless cleanser before applying this medication. 5. Moisturizers may be used if necessary, however, products containing alpha hydroxy or glycolic acids should be avoided.

6. Exposure of the eye to this medication may result in reactions such as swelling, conjunctivitis, and eye irritation. 7.

This medication should not be applied to cuts, abrasions, eczematous or sunburned skin. 8. Wax epilation should not be performed on treated skin due to the potential for skin erosions.

9. During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of this medication on previously unseen lesions and should not be considered a reason to discontinue therapy.

Overall clinical benefit may be noticed after two weeks of therapy, but at least eight weeks are required to obtain consistent beneficial effects. Drug Interactions: As adapalene cream has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime rind) should be approached with caution.

Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with adapalene cream. If these preparations have been used, it is advisable not to start therapy with adapalene cream until the effects of such preparations in the skin have subsided. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day, and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day.

These doses are up to 8 times (mice) and 6 times (rats) in terms of mg/m 2 /day the maximum potential exposure at the recommended topical human dose (MRHD), assumed to be 2.5 grams adapalene cream, which is approximately 1.5 mg/m 2 adapalene. In the oral study, increased incidence of benign and malignant pheochromocytomas in the adrenal medullas of male rats was observed. No photocarcinogenicity studies were conducted.

Animal studies have shown an increased risk of skin neoplasms with the use of pharmacologically similar drugs (e.g., retinoids) when expos… [Excerpted — this section continues on DailyMed.]

🍼 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 adapalene cream is administered to a nursing woman.

🧬 Pharmacokinetics 70 words ▾

Pharmacokinetics: Absorption of adapalene from adapalene cream through human skin is low. In a pharmacokinetic study with six acne patients treated once daily for 5 days with 2 grams of adapalene cream applied to 1000 cm 2 of acne involved skin, there were no quantifiable amounts (limit of quantification = 0.35 ng/mL) of adapalene in the plasma samples from any patient. Excretion appears to be primarily by the biliary route.

🔬 Clinical Studies 190 words ▾

CLINICAL STUDIES: Two vehicle-controlled clinical studies were conducted in patients 12 to 30 years of age with mild to moderate acne vulgaris, in which adapalene cream was compared with its vehicle. Patients were instructed to apply their treatment medication once daily at bedtime for 12 weeks. In one study patients were provided with a soapless cleanser and were encouraged to refrain from using moisturizers.

No other topical medications, other than adapalene cream, were to be applied to the face during the studies. Adapalene cream was significantly more effective than its vehicle in the reduction of acne lesion counts. The mean percent reduction in lesion counts from baseline after treatment for 12 weeks are presented in the following table: MEAN PERCENT REDUCTION IN LESION COUNTS FROM BASELINE TO WEEK 12 Study No.

1 Study No. 2 Efficacy Variable Adapalene Cream, 0.1% N=119 Cream Vehicle N=118 Adapalene Cream, 0.1% N=175 Cream Vehicle N=175 Non-inflammatory lesions 34% 18% 35% 15% Inflammatory lesions 32% 17% 14% 6% Total lesions 34% 18% 30% 15% The trend in the Investigator's global assessment of severity supported the efficacy of adapalene cream when compared to the cream vehicle.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day, and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day. These doses are up to 8 times (mice) and 6 times (rats) in terms of mg/m 2 /day the maximum potential exposure at the recommended topical human dose (MRHD), assumed to be 2.5 grams adapalene cream, which is approximately 1.5 mg/m 2 adapalene. In the oral study, increased incidence of benign and malignant pheochromocytomas in the adrenal medullas of male rats was observed.

No photocarcinogenicity studies were conducted. Animal studies have shown an increased risk of skin neoplasms with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or to sunlight. Although the significance of these studies to human use is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial UV irradiation sources.

Adapalene did not exhibit mutagenic or genotoxic effects in vivo (mouse micronucleous test) and in vitro (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) studies. Reproductive function and fertility studies were conducted in rats administered oral doses of adapalene in amounts up to 20 mg/kg/day (up to 80 times the MRHD based on mg/m 2 comparisons). No effects of adapalene were found on the reproductive performance or fertility of the F o males or females.

There were also no detectable effects on the growth, development and subsequent reproductive function of the F 1 generation.

📄 Package Label / Principal Display Panel 5 words ▾

Adapalene Cream 0.1% #45 Label

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Adapalene — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Adapalene. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$999.6K
Claims incl. refills
2.4K
Beneficiaries
1.8K
Spend / beneficiary
$553.81
Spend / claim
$410.69
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription 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 — 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 ✓ Available
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

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 Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack 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.
← 72162-1035-09 · Bryant 72162-1050-01 · Bryant →
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.