Adapalene .1 g/100g Cream — NDC 45802-453-84 (Billing 45802-0453-84)
This is a package of Adapalene .1 g/100g Cream from Padagis Israel Pharmaceuticals Ltd, marketed since Oct 2010 and currently FDA-listed; retail pharmacies pay about $2.85 per g (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 45802-453-84 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 45802 labeler · 453 product · 84 package
- Package marketed since
- Oct 27, 2010
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 4580245384 6
- Medicaid fills, this package
- 30,791 prescriptions in the last four reported quarters
- 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): 031789
- GCN: 29301
- GPI-14 (Medi-Span): 90050003003710
- HICL (First Databank): 011233
- AHFS class code: 84:28.00.00
- RxCUI (RxNorm): 313852
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Retinoid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- 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....
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 6, 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 | $2.855 | $128.45 / 45 g |
| Medicaid paysCMS SDUD · 12 mo | $2.91 | $130.90 / 45 g |
| Medicare drug plans payPart D · Q2 2026 | $2.81 | $126.31 / 45 g |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 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 |
|---|---|---|---|---|
| 45802-0453-84 You're viewing this Main listing | 1 TUBE in 1 CARTON / 45 g in 1 TUBE | 2010-10-27 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Adapalene 1 mg/g 00168-0424-46 | E. | 1 tube | $2.855 | AB | Availability likely | — |
| Adapalene .1 g/100gthis 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/g 72162-1048-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| Proactiv MD Adapalene Acne Treatment .1 g/100g 11410-0958-15 | Alchemee, | 1 tube | — | — | FDA listed | — |
| Curist Acne Relief .1 g/100g 72559-0015-13 | Little | 1 tube | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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.
🧪 Avoiding an ingredient? See Adapalene inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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 Padagis Israel Pharmaceuticals Ltd labeler code 45802
- Clobetasol Propionate .5 mg/g Aerosol, Foam NDC 45802-437-32
- hydrocortisone 1 g/100g Cream NDC 45802-438-03
- Penciclovir 10 mg/g Cream NDC 45802-440-75
- fluticasone propionate .5 mg/mL Lotion NDC 45802-441-02
- TAZAROTENE 1 mg/g Gel NDC 45802-442-01
- ESTRADIOL 1 mg/g Gel NDC 45802-452-30
- Ketoconazole 20 mg/mL Shampoo, Suspension NDC 45802-465-64
- Econazole Nitrate 10 mg/g Cream NDC 45802-466-11
- Hydrocortisone Acetate Pramoxine Hcl 2.5 g/100g; 1 g/100g Cream NDC 45802-472-53
- Fluocinolone acetonide .01 mg/100mL Oil NDC 45802-485-26
- Docusate Sodium 100 mg Capsule, Liquid Filled NDC 45802-486-78
- Naproxen Sodium 220 mg Tablet, Film Coated NDC 45802-490-71
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Adapalene Cream, 0.1% is indicated for the topical treatment of acne vulgaris.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Adapalene Cream, 0.1% 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 areas lightly. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of Adapalene Cream, 0.1%.
⛔ Contraindications ▾
CONTRAINDICATIONS Adapalene Cream, 0.1% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the cream vehicle.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In controlled clinical trials, local cutaneous irritation was monitored in 285 acne patients who used Adapalene Cream, 0.1% 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, 0.1% from the controlled clinical studies is provided in the following table: Incidence of Local Cutaneous Irritation with Adapalene Cream, 0.1% 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, 0.1% 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, 0.1% included: acne flare, dermatitis and contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.
🔄 Drug Interactions ▾
Drug Interactions As Adapalene Cream, 0.1% 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, 0.1%.
If these preparations have been used, it is advisable not to start therapy with Adapalene Cream, 0.1% until the effects of such preparations in the skin have subsided.
🤰 Pregnancy ▾
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 as doses of 0.6, 2.0, and 6.0 mg/kg/day (24 times MRHD for rats or 48 times the MRHD for rabbits) exhibited on 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 ▾
Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 have not been established.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of Adapalene Cream, 0.1% 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 ▾
OVERDOSAGE Adapalene Cream, 0.1% 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, 0.1% 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 ▾
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, 0.1% 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, 0.1% 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 ▾
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 ▾
HOW SUPPLIED Adapalene Cream, 0.1% is available as follows: 45 g tube (NDC 45802- 453 -84)
📦 Storage and Handling ▾
STORAGE Store at controlled room temperatures 68˚ to 77˚F (20˚ - 25˚C) with excursions permitted between 59˚ and 86˚F (15˚ - 30˚C). Protect from freezing.
📋 Description ▾
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 412.53. Adapalene is represented by the following structural formula. structural formula image
💬 Information for Patients ▾
Information for Patients Patients using Adapalene Cream, 0.1% 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 ▾
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, 0.1%. 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, 0.1% 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, 0.1% 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, 0.1%. If these preparations have been used, it is advisable not to start therapy with Adapalene Cream, 0.1% until the effects of such preparations in the skin have subsided. Carcinogenesis, Mutagenesis, 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, 0.1%, 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 (… [Excerpted — this section continues on DailyMed.]
🍼 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 Adapalene Cream, 0.1% is administered to a nursing woman.
🧬 Pharmacokinetics ▾
Pharmacokinetics Absorption of adapalene from Adapalene Cream, 0.1% 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, 0.1% 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 ▾
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, 0.1% 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, 0.1%, were to be applied to the face during the studies. Adapalene Cream, 0.1% 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 Efficacy Variable Study No.
1 Study No. 2 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, 0.1% when compared to the cream vehicle.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, 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, 0.1%, 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 micronucleus 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 0 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 ▾
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - CARTON For topical use only. Not for ophthalmic, oral, or intravaginal use. Usual Dosage: Apply a thin film once a day at nighttime to affected areas.
See package insert for complete prescribing information. 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. Store at controlled room temperature 68-77°F (20-25°C) excursions permitted between 59 and 86°F (15-30°C).
Protect from freezing. Rx Only NDC 45802- 453 -84 Adapalene Cream, 0.1% NET WT 45 g Padagis Made in Canada Manufactured by G Production Inc Baie d'Urfé, QC, H9X 3S4 Canada Distributed By Padagis Allegan, MI 49010 • www.padagis.com P57355-0 9A184 RC C5 Rev. 12/2022