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Effaclar Adapalene 1 mg/g Gel — NDC 49967-592-02 (Billing 49967-0592-02)

by LOreal USA Products Inc · 1 TUBE in 1 CARTON / 3 g in 1 TUBE

This is a package of Effaclar Adapalene 1 mg/g Gel from LOreal USA Products Inc, marketed since Sep 2024 and currently FDA-listed.

NDC 49967-0592-02
🏷️ FDA NDC (as labeled) 49967-592-02 billing pads the product segment with a zero
This package
Contains3 g in 1 tube Pack sizes2 compare ↓
Product page 49967-0592-01 Also comes in: 45 g 49967-592-01
OTC 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 49967-592-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
49967 labeler · 592 product · 02 package
Package marketed since
Sep 16, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4996759202 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49967-592-02
Product NDC 49967-592
11-digit billing NDC 49967059202
RxCUI 307731
UNII 1L4806J2QF
Application # ANDA091314
SPL Set ID e94854c5-6bb8-43db-b898-4d47a419d075
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 2024-09-16
Route TOPICAL
Dosage form GEL
Substance ADAPALENE
Quick answers
  • RxCUI (RxNorm): 307731
Why two NDCs? The FDA registers this code as 49967-592-02 — a 5-3-2 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 product segment → 49967-0592-02. 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 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
49967-0592-01 49967-592-01 Main listing 1 TUBE in 1 CARTON / 45 g in 1 TUBE 2024-09-16 — Active
49967-0592-02 You're viewing this 1 TUBE in 1 CARTON / 3 g in 1 TUBE 2024-09-16 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 3 g in 1 tube.
What NDC number is used to bill for this package of Effaclar Adapalene 1 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Adapalene 1 mg/g 00536-1412-20 RUGBY 1 tube $0.466 — Availability likely —
Adapalene 1 mg/g 46122-0768-36 AMERISOURCE 1 tube $0.466 — Availability likely —
Adapalene 1 mg/g 51672-2150-01 Sun 1 tube $0.466 — Availability likely —
Adapalene 1 mg/g 70000-0666-01 Cardinal 1 tube $0.466 — Availability likely —
Adapalene 1 mg/g 00168-0424-46 E. 1 tube $2.855 AB Availability likely —
Differin 1 mg/g 00299-4910-00 Galderma 1 tube — — FDA listed —
PanOxyl 1 mg/g 00316-0143-15 CROWN 1 tube — — FDA listed —
PanOxyl 1 mg/g 00316-0284-15 CROWN 1 tube — — FDA listed —
Adapalene 1 mg/g 00363-0888-05 Walgreens 1 tube — — FDA listed —
Adapalene 1 mg/g 00363-1401-05 Walgreens 1 tube — — FDA listed —
Adapalene 1 mg/g 00363-4110-05 Walgreens 1 tube — — FDA listed —
Proactiv MD Adapalene Acne Treatment .1 g/100g 11410-0958-15 Alchemee, 1 tube — — FDA listed —
Adapalene 1 mg/g 11822-0062-01 RITE 1 tube — — FDA listed —
Adapalene 1 mg/g 21130-0754-05 Safeway, 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 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 —
Effaclar 1 mg/gthis 49967-0592-02 LOreal 1 tube — — FDA listed —
Adapalene 1 mg/g 51316-0114-05 CVS 1 tube — — FDA listed —
Adapalene 1 mg/g 55910-0880-05 Dolgencorp, 1 tube — — FDA listed —
Adapalene 1 mg/g 59726-0114-05 P 1 tube — — FDA listed —
Adapalene 1 mg/g 59726-0888-05 P 1 tube — — Discontinued —
Adapalene 1 mg/g 69842-0088-05 CVS 1 tube — — FDA listed —
Neutrogena Adapalene 0.1% Acne Treatment 1 mg/g 69968-0826-01 Kenvue 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 Evenly Clear Retinoid Adapalene Gel 0.1% Acne Treatment 1 mg/g 69968-1004-02 Kenvue 1 tube — — FDA listed —
Curist Acne Relief .1 g/100g 72559-0015-13 Little 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 73581-0214-06 YYBA 1 tube — — FDA listed —
Adapalene 1 mg/g 73581-0215-45 YYBA 1 tube — — FDA listed —
Adapalene 1 mg/g 73581-0216-45 YYBA 1 tube — — FDA listed —
Adapalene Gel 0.1% .1 g/100g 73715-0003-01 MOHNARK 30 g — — Discontinued —
Adapalene 1 mg/g 76162-0114-05 Topco 1 tube — — FDA listed —
Adapalene 1 mg/g 79481-1140-05 Meijer 1 tube — — FDA listed —
Adapalene 1 mg/g 79903-0338-05 Wal-Mart 1 tube — — FDA listed —
Adapalene 1 mg/g 82442-0105-01 Target 1 tube — — FDA listed —
Adapalene 1 mg/g 72162-1048-02 Bryant 1 tube — AB FDA listed —
Adapalene 1 mg/g 63629-8791-01 Bryant 1 tube — AB 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

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 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.

🧪 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.

💡 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 HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • 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.

The official label also statescarbomer homopolymer, edetate disodium, penoxyethanol, poloxamer 182, propylene glycol, purified water, and sodium hydroxide

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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

LabelerLOreal USA Products Inc
Application holderGLENMARK PHARMACEUTICALS INC USA
FDA applicationANDA091314 (ANDA)
Labeler code49967
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio44 products on file

More NDCs from LOreal USA Products Inc labeler code 49967

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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 7 words ▾

Use • for the treatment of acne

⏱️ Dosage and Administration 88 words ▾

Directions Adults and children 12 years of age and older: • use once daily • clean the skin gently and pat dry before applying the product • cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face. • do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation. Children under 12 years of age : ask a doctor

⚠️ Warnings ~1 min read ▾

Warnings For external use only Do not use • on damaged skin (cuts, abrasions, eczema, sunburn) • if you are allergic to adapalene or any of the ingredients in this product. If pregnant or breastfeeding , ask a doctor before use. When using this product • limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors • do not wax to remove hair in areas where the product has been applied • during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe • irritation (redness, itching, dryness, burning) is more likely to occur: o in the first few weeks of use o if using more than one topical acne medication at a time o but irritation usually lessens with continued use of this product • it may take up to 3 months of once daily use to see results • avoid product contact with eyes, lips, and mouth.

If contact occurs, immediately flush the area with water. • wash hands after use Stop use and ask doctor if • you become pregnant, or are planning to become pregnant, while using the product • you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath) • irritation becomes severe • you see no improvement after 3 months of once daily use

🧪 Active Ingredient 10 words ▾

Active ingredient Adapalene USP, 0.1% (retinoid)* *read consumer information leaflet

🧪 Inactive Ingredients 16 words ▾

Inactive Ingredients carbomer homopolymer, edetate disodium, penoxyethanol, poloxamer 182, propylene glycol, purified water, and sodium hydroxide

🎯 Purpose 3 words ▾

Purpose Acne treatment

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 4 words ▾

Principal Display Panel carton45g

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 (matched by generic name) — 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

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

Questions about this listing

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 LOreal USA Products Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (49967-0592-01). 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?
LOreal USA Products 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
← 49967-0591-01 · LOreal 49967-0595-01 · L'Oreal →
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.