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Adapalene 3 mg/g Gel — NDC 51672-1377-09 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Adapalene 3 mg/g Gel — NDC 51672-1377-9 (Billing 51672-1377-09)

by Sun Pharmaceutical Industries, Inc. · 1 BOTTLE, PUMP in 1 CARTON / 45 g in 1 BOTTLE, PUMP

This is a package of Adapalene 3 mg/g Gel from Sun Pharmaceutical Industries, Inc., no longer marketed (first marketed Jun 2016), no longer in the FDA NDC Directory; retail pharmacies pay about $0.7822 per g (NADAC).

NDC 51672-1377-09
🏷️ FDA NDC (as labeled) 51672-1377-9 billing pads the package segment with a zero
This package
Contains45 g in 1 bottle, pump Cost per g$0.7822 NADAC Per package$35.20 / 45 g Pack sizes2 compare ↓
Product page 51672-1377-06 Also comes in: 45 g 51672-1377-6
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51672-1377-9
Product NDC 51672-1377
11-digit billing NDC 51672137709
NCPDP billing unit GM — per gram (weight)
RxCUI 722111
UNII 1L4806J2QF
Application # ANDA208322
SPL Set ID ca37576a-09aa-4ee8-9dc4-8ad76b999fcf
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2016-06-23
Route TOPICAL
Dosage form GEL
Substance ADAPALENE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90050003004030
GPI class Adapalene
GCN Seq No 068878
GCN 31773
HICL code 011233
Ingredient (HICL) Adapalene
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L9
Therapeutic class — intermediate (HIC2) Dermatologic Preparations,Miscellaneous
HIC3 code L9B
Therapeutic class — specific (HIC3) Vitamin A Derivatives
AHFS code 84:28.00.00
AHFS class Keratolytic Agents
FDB label name ADAPALENE 0.3% GEL PUMP
FDB brand name Adapalene
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 068878
  • GCN: 31773
  • GPI-14 (Medi-Span): 90050003004030
  • HICL (First Databank): 011233
  • AHFS class code: 84:28.00.00
  • RxCUI (RxNorm): 722111
Why two NDCs? The FDA registers this code as 51672-1377-9 — 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 → 51672-1377-09. 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

Label name ADAPALENE 0.3% GEL PUMP Ingredient Adapalene
📖 What it is MedlinePlus · NLM

Adapalene is used to treat acne in adults and children 12 years of and older. Adapalene is in a class of medications called retinoid-like compounds. It works by stopping pimples from forming under the surface of the skin.

Read the full MedlinePlus article ↗
📗 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 $0.782 $35.20 / 45 g
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.
NADAC price history (per g) — tap or hover for the price & month
Nov 2021 Nov 2022 Mar 2026 Aug 2026 $4.071 $0.745
▼ Down 81% over the last 15 months.
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 Per unit Per pack Marketing startMarketing endStatus
51672-1377-06 51672-1377-6 Main listing 1 TUBE in 1 CARTON / 45 g in 1 TUBE $0.5038 / g $22.67 2016-06-23 — Active
51672-1377-09 You're viewing this 1 BOTTLE, PUMP in 1 CARTON / 45 g in 1 BOTTLE, PUMP $0.7822 / g $35.20 2016-06-23 — Discontinued by firm

Per g, this pack runs about 55% above the cheapest pack (NDC 51672-1377-06, $0.5038 vs $0.7822 NADAC).

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, pump in 1 carton / 45 g in 1 bottle, pump.
What NDC number is used to bill for this package of Adapalene 3 mg/g Gel?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
adapalene 3 mg/g 00472-0126-45 Actavis 1 tube $0.504 AB Availability likely save 36%
Adapalene Gel USP, 0.3% 3 mg/g 21922-0051-06 Encube 1 tube $0.504 AB Availability likely save 36%
Adapalene 3 mg/g 68308-0666-25 Mayne 1 tube $0.504 AB Availability likely save 36%
Adapalene 3 mg/gthis 51672-1377-09 Sun 1 bottle $0.782 AB Discontinued —
Differin 3 mg/g 00299-5918-02 Galderma 2 g — AB Discontinued —
Adapalene 3 mg/g 46708-0549-15 Alembic 1 tube — AB FDA listed —
Adapalene 3 mg/g 62332-0549-15 Alembic 1 tube — AB FDA listed —
Adapalene Gel USP, 0.3% 3 mg/g 72162-2295-02 Bryant 1 tube — AB 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

🏛️
2016
On the market since
Jun 2016
📍
2026
Currently FDA-listed
10 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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 JX0HIX6OAG
    Poloxamer 182 is a synthetic polymer made from ethylene oxide and propylene oxide. It acts as a solubilizer and emulsifier, helping mix water and oil-based ingredients together in liquid medications.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 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.

7 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.

Manufacturer & labeler

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA208322 (ANDA)
Labeler code51672
First marketedJun 2016
Product typeHuman Prescription Drug
Portfolio890 products on file
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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 49 words ▾

1 INDICATIONS AND USAGE Adapalene Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene Gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1 )

⏱️ Dosage and Administration 164 words ▾

2 DOSAGE AND ADMINISTRATION Wash affected areas gently with a non-medicated soap. Apply a thin film of Adapalene Gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening. Avoid application to the areas of skin around eyes, lips, and mucous membranes.

A mild transitory sensation of warmth or slight stinging may occur shortly after the application of Adapalene Gel, 0.3%. Instruct patients to minimize sun exposure and to use moisturizers for relief of dry skin or irritation. If therapeutic results are not noticed after 12 weeks of treatment, therapy should be re-evaluated.

For topical use only. Not for ophthalmic, oral or intravaginal use. Wash affected areas gently with a non-medicated soap.

( 2 ) Apply a thin film of Adapalene Gel, 0.3% to the entire face and other affected areas of the skin once daily in the evening. ( 2 ) For topical use only. Not for ophthalmic, oral or intravaginal use.

( 2 )

💊 Dosage Forms and Strengths 25 words ▾

3 DOSAGE FORMS AND STRENGTHS Each gram of Adapalene Gel, 0.3% contains 3 mg adapalene in an off-white aqueous gel. Gel, 0.3% ( 3 )

⛔ Contraindications 48 words ▾

4 CONTRAINDICATIONS Adapalene Gel, 0.3% is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of Adapalene Gel, 0.3% [see WARNINGS AND PRECAUTIONS (5.1) ] . Contraindicated in patients who have known hypersensitivity to adapalene or any excipient of Adapalene Gel, 0.3%. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Allergic/Hypersensitivity Reactions: Allergy/ hypersensitivity reactions include anaphylaxis, angioedema, face edema, eyelid edema, lip swelling, and pruritis. Discontinue Adapalene Gel, 0.3% in the event of an allergic/hypersensitivity reaction. ( 5.1 ) Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps.

Wear sunscreen when sun exposure cannot be avoided ( 5.2 ). Local Cutaneous Reactions: Erythema, scaling, dryness, and stinging/burning were reported with use of Adapalene Gel, 0.3%. 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) should be approached with caution.

( 5.3 ).

5.1Allergic/ Hypersensitivity Reactions Adverse reactions including anaphylaxis angioedema, face edema, eyelid edema, lip swelling, and pruritus that sometimes required medical treatment have been reported during postmarketing use of adapalene. Advise a patient to stop using Adapalene Gel, 0.3% and seek medical attention if experiencing allergic or anaphylactoid/anaphylactic reactions during treatment.

5.2Ultraviolet Light and Environmental Exposure Exposure to sunlight, including sunlamps, should be minimized during use of Adapalene Gel, 0.3%. 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 Gel, 0.3%.

5.3Local Cutaneous Reactions Cutaneous signs and symptoms such as erythema, scaling, dryness, and stinging/burning were reported with use of Adapalene Gel, 0.3%. These were most likely to occur during the first four weeks of treatment, were mostly mild to moderate in intensity, and usually lessened with continued use of the medication. Depending upon the severity of these side effects, patients should be instructed to either use a moisturizer, reduce the frequency of application of Adapalene Gel, 0.3% or discontinue use.

Avoid application 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. As adapalene gel has the potential to induce 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) should be approached with caution.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most frequently reported (≥ 1%) adverse reactions were erythema, scaling, dryness, and/or burning/stinging. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne subjects who used Adapalene Gel, 0.3% once daily for 12 weeks. Of the subjects who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter.

The incidence of local cutaneous irritation with Adapalene Gel, 0.3% from the controlled clinical trial is provided in the following table: Table 1: Physician assessed local cutaneous irritation with Adapalene Gel, 0.3% Incidence of Local Cutaneous Irritation with Adapalene Gel, 0.3% (N = 253 Total number of subjects with local cutaneous data for at least one post-Baseline evaluation. ) Maximum Severity Scores Higher Than Baseline Mild Moderate Severe Erythema 66 (26.1%) 33 (13%) 1 (0.4%) Scaling 110 (43.5%) 47 (18.6%) 3 (1.2%) Dryness 113 (44.7%) 43 (17%) 2 (0.8%) Burning/Stinging 72 (28.5%) 36 (14.2%) 9 (3.6%) Table 2: Patient reported local cutaneous adverse reactions with Adapalene Gel, 0.3% Adapalene Gel, 0.3% Vehicle Gel N=258 N=134 Related Selected adverse reactions defined by investigator as Possibly, Probably or Definitely Related Adverse Reactions 57 (22.1%) 6 (4.5%) Dry Skin 36 (14%) 2 (1.5%) Skin Discomfort 15 (5.8%) 0 (0%) Desquamation 4 (1.6%) 0 (0%) The following adverse reactions occurred in less than 1% of subjects: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.

In a one-year, open-label safety trial of 551 subjects with acne who received Adapalene Gel, 0.3%, the pattern of adverse reactions was similar to the 12-week controlled study.

6.2Post-Marketing Experience The following adverse reactions have been identified during post approval use of adapalene: Immune system disorders: angioedema, face edema, lip swelling Skin disorders: application site pain Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from clinical trials with Adapalene Gel, 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 40 and 81 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations (see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively.

Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0.15 to 5 mg/kg/day, up to 8 times the MRHD based on a mg/m 2 comparison. However, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (40 and 81 times the MRHD, respectively, based on a mg/m 2 comparison). Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits.

Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6 mg/kg/day (9.7 and 19.5 times the MRHD, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits).

8.2Lactation Risk Summary There are no data on the presence of topical adapalene gel or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. In animal studies, adapalene is present in rat milk with oral administration of the drug. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

It is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk (see Clinical Considerations ) . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Adapalene Gel, 0.3% and any potential adverse effects on the breastfed child from Adapalene Gel, 0.3%, or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breastmilk, use Adapalene Gel, 0.3% on the smallest area of skin and for the shortest duration possible while breastfeeding.

Avoid application of Adapalene Gel, 0.3% to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child.

8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients below the age of 12.

8.5Geriatric Use Clinical studies of Adapalene Gel, 0.3% did not include subjects 65 years of age and older to determine whether they respond differently than younger subjects. Safety and effectiveness in geriatric patients age 65 and above have not been established.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Available data from clinical trials with Adapalene Gel, 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 40 and 81 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations (see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively.

Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0.15 to 5 mg/kg/day, up to 8 times the MRHD based on a mg/m 2 comparison. However, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (40 and 81 times the MRHD, respectively, based on a mg/m 2 comparison). Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits.

Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6 mg/kg/day (9.7 and 19.5 times the MRHD, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits).

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients below the age of 12.

🧓 Geriatric Use 42 words ▾

8.5Geriatric Use Clinical studies of Adapalene Gel, 0.3% did not include subjects 65 years of age and older to determine whether they respond differently than younger subjects. Safety and effectiveness in geriatric patients age 65 and above have not been established.

🆘 Overdosage 24 words ▾

10 OVERDOSAGE Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.

12.2Pharmacodynamics Clinical pharmacodynamic studies have not been conducted for Adapalene Gel, 0.3%.

12.3Pharmacokinetics Systemic exposure of adapalene following topical application of Adapalene Gel, 0.3% was evaluated in a clinical trial. Sixteen acne subjects were treated once daily for 10 days with 2 grams of Adapalene Gel, 0.3% applied to the face, chest and back, corresponding to approximately 2 mg/cm 2 . Fifteen subjects had quantifiable (LOQ = 0.1 ng/mL) adapalene levels resulting in a mean C max of 0.553 ± 0.466 ng/mL on Day 10 of treatment.

The mean AUC 0-24hr was 8.37 ± 8.46 ng∙h/mL as determined in 15 of the 16 subjects on Day 10. The terminal apparent half-life, determined in 15 of 16 subjects, ranged from 7 to 51 hours, with a mean of 17.2 ± 10.2 hours. Adapalene was rapidly cleared from plasma and was not detected 72 hours after the last application for all but one subject.

Exposure of potential circulating metabolites of adapalene was not measured. Excretion of adapalene appears to be primarily by the biliary route. In another clinical trial in subjects with moderate to moderately severe acne, Adapalene Gel, 0.3% or Adapalene Gel, 0.1% was applied to the face and optionally to the trunk, once daily for 12 weeks.

Seventy-eight (78) subjects had plasma adapalene levels evaluated at Weeks 2, 8, and 12. Of the 209 plasma samples analyzed, adapalene concentrations were below the limit of detection (LOD = 0.15 ng/mL) of the method in all samples but three. For the three samples, traces of adapalene below the limit of quantification (LOQ = 0.25 ng/mL) of the method were found.

One of these samples was taken at Week 12 from a male subject treated with Adapalene Gel, 0.3% who treated the face and the trunk for eight weeks (thereafter, only the face was treated). The second and third samples were from the Week 2 and 12 visits of a female subject treated with Adapalene Gel, 0.1% who treated only the face for 12 weeks. In this study, the average daily usage of product was 1 g/day.

🧬 Mechanism of Action 61 words ▾

12.1Mechanism of Action Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.

📦 How Supplied / Storage and Handling 50 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Adapalene Gel, 0.3% is supplied in the following sizes. 45 g tube – NDC 51672-1377-6 45 g pump – NDC 51672-1377-9 S torage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep out of reach of children.

📦 Storage and Handling 24 words ▾

S torage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep out of reach of children.

📋 Description 96 words ▾

11 DESCRIPTION Adapalene Gel, 0.3% contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer homopolymer type C, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. 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, very slightly 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. Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Information for Patients Patients using Adapalene Gel, 0.3% should receive the following information and instructions: Apply a thin film of Adapalene Gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided.

This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin. Wax depilation should not be performed on treated skin due to the potential for skin erosions. Minimize exposure to sunlight including sunlamps.

Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided. Contact the doctor if skin rash, pruritus, hives, chest pain, edema, and shortness of breath occurs, as these may be signs of allergy or hypersensitivity. This product is for external use only.

Lactation: Use Adapalene Gel, 0.3% on the smallest area of skin and for the shortest duration possible while breastfeeding. Avoid application of Adapalene Gel, 0.3% to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child [see Use in Specific Populations, Lactation (8.2) ] .

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Systemic exposure of adapalene following topical application of Adapalene Gel, 0.3% was evaluated in a clinical trial. Sixteen acne subjects were treated once daily for 10 days with 2 grams of Adapalene Gel, 0.3% applied to the face, chest and back, corresponding to approximately 2 mg/cm 2 . Fifteen subjects had quantifiable (LOQ = 0.1 ng/mL) adapalene levels resulting in a mean C max of 0.553 ± 0.466 ng/mL on Day 10 of treatment.

The mean AUC 0-24hr was 8.37 ± 8.46 ng∙h/mL as determined in 15 of the 16 subjects on Day 10. The terminal apparent half-life, determined in 15 of 16 subjects, ranged from 7 to 51 hours, with a mean of 17.2 ± 10.2 hours. Adapalene was rapidly cleared from plasma and was not detected 72 hours after the last application for all but one subject.

Exposure of potential circulating metabolites of adapalene was not measured. Excretion of adapalene appears to be primarily by the biliary route. In another clinical trial in subjects with moderate to moderately severe acne, Adapalene Gel, 0.3% or Adapalene Gel, 0.1% was applied to the face and optionally to the trunk, once daily for 12 weeks.

Seventy-eight (78) subjects had plasma adapalene levels evaluated at Weeks 2, 8, and 12. Of the 209 plasma samples analyzed, adapalene concentrations were below the limit of detection (LOD = 0.15 ng/mL) of the method in all samples but three. For the three samples, traces of adapalene below the limit of quantification (LOQ = 0.25 ng/mL) of the method were found.

One of these samples was taken at Week 12 from a male subject treated with Adapalene Gel, 0.3% who treated the face and the trunk for eight weeks (thereafter, only the face was treated). The second and third samples were from the Week 2 and 12 visits of a female subject treated with Adapalene Gel, 0.1% who treated only the face for 12 weeks. In this study, the average daily usage of product was 1 g/day.

🧬 Pharmacodynamics 13 words ▾

12.2Pharmacodynamics Clinical pharmacodynamic studies have not been conducted for Adapalene Gel, 0.3%.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES The safety and efficacy of once daily use of Adapalene Gel, 0.3% for treatment of acne vulgaris were assessed in one 12 week, multi-center, controlled, clinical trial, conducted in a total of 653 subjects 12 to 52 years of age with acne vulgaris of mild to moderate severity. All female subjects of child-bearing potential enrolled in the trial were required to have a negative urine pregnancy test at the beginning of the trial and were required to practice a highly effective method of contraception during the trial.

Female subjects who were pregnant, nursing or planning to become pregnant were excluded from the trial. Subjects enrolled in the trial were Caucasian (72%), Hispanic (12%), African-American (10%), Asian (3%), and other (2%). An equal number of males (49.5%) and females (50.5%) enrolled.

Success was defined as "Clear" or "Almost Clear" in the Investigator's Global Assessment (IGA). The success rate, mean reduction, and percent reduction in acne lesion counts from Baseline after 12 weeks of treatment are presented in the following table: Table 3: Clinical study primary efficacy results at Week 12 Adapalene Gel, 0.3% Adapalene Gel, 0.1% Vehicle Gel N=258 N=261 N=134 IGA Success Rate 53 (21%) 41 (16%) 12 (9%) Inflammatory Lesions Mean Baseline Count 27.7 28.1

27.2Mean Absolute (%) Reduction 14.4 (51.6%) 13.9 (49.7%) 11.2 (40.7%) Non-inflammatory Lesions Mean Baseline Count 39.4 41 40 Mean Absolute (%) Reduction 16.3 (39.7%) 15.2 (35.2%) 10.3 (27.2%) Total Lesions Mean Baseline Count 67.1 69.1

67.2Mean Absolute (%) Reduction 30.6 (45.3%) 29 (41.8%) 21.4 (33.7%)

🧪 Nonclinical Toxicology 175 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, genotoxicity, or impairment of fertility studies were conducted with Adapalene Gel, 0.3%. Carcinogenicity studies with adapalene were conducted in mice at topical doses of 0.4, 1.3, and 4 mg/kg/day (1.2, 3.9, and 12 mg/m 2 /day) and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3, and 9.0 mg/m 2 /day). The highest dose levels are 3.2 (mice) and 2.4 (rats) times the MRHD based on a mg/m 2 comparison.

In the rat study, an increased incidence of benign and malignant pheochromocytomas reported in the adrenal medulla of male rats was observed. Adapalene was not mutagenic or genotoxic in vitro (Ames test, Chinese hamster ovary cell assay, or mouse lymphoma TK assay) or in vivo (mouse micronucleus test). In rat oral studies, 20 mg/kg/day adapalene (32 times the MRHD based on a mg/m 2 comparison) did not affect the reproductive performance and fertility of F 0 males and females or the growth, development, or reproductive function of F 1 offspring.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 172 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, genotoxicity, or impairment of fertility studies were conducted with Adapalene Gel, 0.3%. Carcinogenicity studies with adapalene were conducted in mice at topical doses of 0.4, 1.3, and 4 mg/kg/day (1.2, 3.9, and 12 mg/m 2 /day) and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3, and 9.0 mg/m 2 /day). The highest dose levels are 3.2 (mice) and 2.4 (rats) times the MRHD based on a mg/m 2 comparison.

In the rat study, an increased incidence of benign and malignant pheochromocytomas reported in the adrenal medulla of male rats was observed. Adapalene was not mutagenic or genotoxic in vitro (Ames test, Chinese hamster ovary cell assay, or mouse lymphoma TK assay) or in vivo (mouse micronucleus test). In rat oral studies, 20 mg/kg/day adapalene (32 times the MRHD based on a mg/m 2 comparison) did not affect the reproductive performance and fertility of F 0 males and females or the growth, development, or reproductive function of F 1 offspring.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Adapalene (a dap` a leen) Gel, 0.3% This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: June 2024 Important: Adapalene Gel, 0.3% is for use on the skin only (topical).

Do not use Adapalene Gel, 0.3% in or on your mouth, eyes, or vagina. What is Adapalene Gel, 0.3%? Adapalene Gel, 0.3% is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older.

It is not known if Adapalene Gel, 0.3% is safe and effective in children under 12 years of age or in people 65 years of age and older. Do not use Adapalene Gel, 0.3% if you are allergic to adapalene or any of the ingredients in Adapalene Gel, 0.3%. See the end of this Patient Information leaflet for a complete list of ingredients in Adapalene Gel, 0.3%.

Before using Adapalene Gel, 0.3% tell your healthcare provider about all your medical conditions, including if you: have other skin problems, including cuts, abrasions, sunburn, or skin that is dry, itchy, or red. are pregnant or plan to become pregnant. It is not known if Adapalene Gel, 0.3%, can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if adapalene passes into your breast milk and if it can harm your baby.

Talk to your healthcare provider about the best way to feed your baby if you use Adapalene Gel, 0.3%. If you use Adapalene Gel, 0.3% while breastfeeding, use Adapalene Gel, 0.3% on the smallest area of the skin and for the shortest time needed. Do not apply Adapalene Gel, 0.3% to areas that may increase the risk of getting Adapalene Gel, 0.3% in your child's mouth or eyes.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use Adapalene Gel, 0.3%? Use Adapalene Gel, 0.3% exactly as your healthcare provider tells you to use it.

Apply Adapalene Gel, 0.3% 1 time a day in the evening. Tell your healthcare provider if you do not notice a difference in your acne after using Adapalene Gel, 0.3% for 12 weeks. Applying Adapalene Gel, 0.3%: Wash the area where Adapalene Gel, 0.3% will be applied with a mild soap that does not contain a medicine and pat dry.

Adapalene Gel, 0.3% comes in a tube and a pump. If you have been prescribed the: Tube: Squeeze a small amount onto your fingertips and spread a thin layer over the entire face and any other affected areas. Pump: Depress the pump to dispense a small amount of Adapalene Gel, 0.3% and spread a thin layer over the entire face and any other affected area.

Do not apply Adapalene Gel, 0.3% on areas of the skin around your eyes, lips, nose, and mouth. Wash your hands after applying Adapalene Gel, 0.3%. What should I avoid while using Adapalene Gel, 0.3%?

Avoid spending time in sunlight, including sunlamps. Adapalene Gel, 0.3% can make your skin sensitive to the sun and the light from sunlamps. Use sunscreen and wear hat and clothes that cover the areas treated with Adapalene Gel, 0.3% if you have to be in sunlight.

Cold weather and wind may irritate your skin treated with Adapalene Gel, 0.3%. Do not apply Adapalene Gel, 0.3% to cuts, abrasions, sunburned skin, or skin that is dry, itchy, or red. Avoid skin products that may dry or irritate your skin such as harsh soaps or cleansers, soaps and cosmetics that make your skin dry, and products that contain high levels of alcohol, astringents, spices, or limes.

Avoid the use of "waxing" as a hair removal method on skin treated with Adapalene Gel, 0.3%. What are the possible side effects of Adapalene Gel, 0.3%? Adapalene Gel, 0.3% may cause serious side effects including: Allergic reactions.

Adapalene Gel, 0.3% may cause serious allergic reactions that sometimes may require medical treatment. Stop using Adapalene Gel, 0.3% and tell your healthcare provider or get medical help right away if you have any of these symptoms of an allergic reaction: skin rash, itching or hives trouble breathing… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 49 words ▾

PRINCIPAL DISPLAY PANEL - 45 g Bottle Carton 45 g NDC 51672-1377-9 Adapalene Gel 0.3% PUMP FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. Keep this and all medications out of the reach of children. Rx only TARO PRINCIPAL DISPLAY PANEL - 45 g Bottle Carton

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tube51672-1377-06 8,844 Rx · $314,333
1 bottle this page51672-1377-09 No Medicaid data
Drug total (last 4 qtrs): 8,844 Rx · 400,725 units · $314,333 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 No longer marketed (per FDA listing data)
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) ✓ Available
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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (51672-1377-06). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sun Pharmaceutical Industries, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 51672-1376-03 · Sun 51672-1381-04 · Sun →
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.