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Atralin Tretinoin .05 g/100g Gel — NDC 13548-0070-45 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Atralin Tretinoin .05 g/100g Gel — NDC 13548-070-45 (Billing 13548-0070-45)

by Bausch Health US, LLC · 1 TUBE in 1 PACKAGE / 45 g in 1 TUBE

This is a package of Atralin Tretinoin .05 g/100g Gel from Bausch Health US, LLC, marketed since Jul 2007 and currently FDA-listed. It is this product's only package size.

NDC 13548-0070-45
🏷️ FDA NDC (as labeled) 13548-070-45 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 13548-070-45 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
13548 labeler · 070 product · 45 package
Package marketed since
Jul 26, 2007
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1354807045 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 13548-070-45
Product NDC 13548-070
11-digit billing NDC 13548007045
NCPDP billing unit GM — per gram (weight)
RxCUI 245723, 749329
UNII 5688UTC01R
Application # NDA022070
SPL Set ID b6b45969-a64a-4ce3-b3b6-157d2568a301
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-07-26
Route TOPICAL
Dosage form GEL
Substance TRETINOIN
TE code (Orange Book) AB · RLD · RS

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

GPI-14 90050030004015
GPI class Atralin
GCN Seq No 021108
GCN 22872
HICL code 002468
Ingredient (HICL) Tretinoin
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 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name ATRALIN 0.05% GEL
FDB brand name Atralin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 021108
  • GCN: 22872
  • GPI-14 (Medi-Span): 90050030004015
  • HICL (First Databank): 002468
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 245723
Why two NDCs? The FDA registers this code as 13548-070-45 — 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 → 13548-0070-45. 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, Retinoids for cancer treatment
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 ATRALIN 0.05% GEL Ingredient Tretinoin
📖 What it is MedlinePlus · NLM

Tretinoin is used to treat acne. Tretinoin is also used to reduce fine wrinkles. Tretinoin is in a class of medications called retinoids. It works by increasing production of new skin cells and unclogging pores.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the form. Creams, gels and lotions treat acne, and Renova eases fine facial wrinkles. The capsules treat a blood cancer called acute promyelocytic leukemia.
  • Wash the area, pat dry, and apply a thin layer once daily, usually in the evening. Keep it away from your eyes, mouth, nose creases and mucous membranes. More does not work faster...
  • Mild warmth or stinging, redness and peeling are common. If it becomes severe, call your prescriber, who may have you use less or pause. Acne can seem to flare early on, which is n...
  • What side effects should I expect on the skin?
📖 Read our full Tretinoin guide →
1
Nutrient depletion considerations

Tretinoin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Tretinoin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.
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
13548-0070-45 You're viewing this Main listing 1 TUBE in 1 PACKAGE / 45 g in 1 TUBE 2007-07-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tretinoin .05 g/100g 68682-0800-45 Oceanside 1 tube $3.892 AB FDA listed —
Tretinoin .5 mg/g 00378-8090-45 Mylan 1 tube $3.933 AB Availability likely —
Atralin .05 g/100gthis 13548-0070-45 Bausch 1 tube — AB FDA listed —
Tretinoin .05 g/100g 62032-0413-20 Obagi 20 g — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2007
On the market since
Jul 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

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?
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 Tretinoin 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 3QPI1U3FV8
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • 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 14255EXE39
    Ethylparaben is a preservative, a chemical that stops bacteria and mold from growing in the medicine. It keeps the product safe and effective throughout its shelf life.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 0QQJ25X58G
    Isobutylparaben is a preservative derived from para-hydroxybenzoic acid. It prevents bacterial and fungal growth in medicines, extending shelf life and maintaining product safety during storage.
  • UNII 8JC99XGU4W
    Soluble fish skin collagen is a protein derived from fish skin that acts as a binder and thickening agent in medicines. It helps hold ingredients together and gives the product the right texture or 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 7JPC6Y25QS
    A synthetic nonionic surfactant, a type of cleaning agent used in pharmaceutical formulations. It functions as an emulsifier and solubilizer, helping mix water and oil-based ingredients and improving how the medicine dissolves and spreads in the body.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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.

15 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

LabelerBausch Health US, LLC
Application holderDOW PHARMACEUTICAL SCIENCES
FDA applicationNDA022070 (NDA)
Labeler code13548
First marketedJul 2007
Product typeHuman Prescription Drug
Portfolio51 products on file

More NDCs from Bausch Health US, LLC labeler code 13548

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 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

1 INDICATIONS AND USAGE Atralin Gel is indicated for topical treatment of acne vulgaris. Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris. ( 1 )

⏱️ Dosage and Administration 208 words ▾

2 DOSAGE AND ADMINISTRATION For topical use only. Not for oral, ophthalmic, or intravaginal use. Atralin Gel should be applied once daily, before bedtime, to the skin where acne lesions appear, using a thin layer to cover the entire affected area.

Atralin Gel should be kept away from the eyes, the mouth, paranasal creases, and mucous membranes. Application of excessive amounts of gel will not provide incremental efficacy. Patients treated with Atralin Gel may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied.

When treating with Atralin Gel, caution should be exercised with the use of concomitant topical over-the-counter preparations, topical medications, medicated or abrasive soaps and cleansers, products that have strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Allow the effects of such preparations to subside before use of Atralin Gel has begun. • Apply a thin layer of Atralin Gel once daily, before bedtime, to skin where lesions occur.

Keep away from eyes, mouth, nasal creases, and mucous membranes. ( 2 ) • Atralin Gel is not for oral, ophthalmic, or intravaginal use. ( 2 )

💊 Dosage Forms and Strengths 31 words ▾

3 DOSAGE FORMS AND STRENGTHS Gel, 0.05% Each gram of Atralin Gel contains 0.5 mg (0.05%) tretinoin in a translucent to opaque, pale yellow topical gel. Gel, 0.05% ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Atralin Gel should not be used on eczematous or sunburned skin due to potential for severe irritation. ( 5.1 ) • Topical over-the-counter acne preparations, concomitant topical medications, medicated cleansers, topical products with alcohol or astringents: Use with caution, irritation may occur. ( 5.1 ) • Avoid unprotected exposure to sunlight including sunlamps (UV light) when using Atralin Gel due to potential for increased photosensitization.

Use sunscreen of at least SPF 15 and protective clothing during exposure. ( 5.2 ) • Avoid use of Atralin Gel with weather extremes, such as wind or cold due to potential for increased irritation. ( 5.2 ) • Use Atralin Gel with caution if allergic to fish due to potential for allergenicity to fish protein.

Patients who develop pruritus or urticaria should contact their healthcare provider. ( 5.3 )

5.1Skin Irritation The skin of certain individuals may become dry, red, or exfoliated while using Atralin Gel. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use all together. Efficacy at reduced frequencies of application has not been established.

If a reaction suggesting sensitivity occurs, use of the medication should be discontinued. Mild to moderate skin dryness may also be experienced; if so, use of an appropriate moisturizer during the day may be helpful. Tretinoin has been reported to cause severe irritation on eczematous or sunburned skin and should be used with caution in patients with these conditions.

To help limit skin irritation, patients must: • wash the treated skin gently, using a mild, non-medicated soap, and pat it dry, • avoid washing the treated skin too often and scrubbing the affected skin area, and • avoid contact with the peels of limes.

5.2Ultraviolet Light and Environmental Exposure Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Atralin Gel. 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 of at least SPF 15 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 tretinoin-treated skin.

5.3Fish Allergies Atralin Gel contains soluble fish proteins and should be used with caution in patients with known sensitivity or allergy to fish. Patients who develop pruritus or urticaria should contact their healthcare provider.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥5%) with Atralin Gel are dry skin, peeling/scaling/flaking skin, skin burning sensation, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under prescribing conditions, adverse reaction 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 two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Atralin Gel [see Clinical Studies (14) ]. In these studies, 50% of the subjects who were treated with Atralin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions.

In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction; 5% of the subjects reported events that were treatment-related. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups. Selected adverse reactions that occurred in at least 1% of subjects in the two trials combined are shown in Table 1 (below).

Most skin-related adverse reactions first appear during the first two weeks of treatment with Atralin Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment. In some subjects, the skin-related adverse reactions persist throughout the treatment period. Table 1: Number of Subjects with Selected Adverse Reactions (Occurring in at Least 1% of Subjects) Event Atralin Gel (N = 674) Vehicle (N = 487) Dry Skin 109 (16%) 8 (2%) Peeling/Scaling/Flaking Skin 78 (12%) 7 (1%) Skin Burning Sensation 53 (8%) 8 (2%) Erythema 47 (7%) 1 (<1%) Pruritus 11 (2%) 3 (1%) Pain of Skin 7 (1%) 0 (0%) Sunburn 7 (1%) 3 (1%)

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of Atralin Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy There are no well-controlled trials in pregnant women treated with Atralin Gel. Atralin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Atralin Gel at doses of 0.1, 0.3 and 1 g/kg/day was tested for maternal and developmental toxicity in pregnant Sprague-Dawley rats by dermal application.

The dose of 1 g/kg/day was approximately four times the clinical dose assuming 100% absorption and based on body surface area comparison. Possible tretinoin-associated teratogenic effects (craniofacial abnormalities [hydrocephaly], asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) were noted in the fetuses of Atralin Gel-treated animals. These findings were not observed in control animals.

Other maternal and reproductive parameters in the Atralin Gel-treated animals were not different from control. For purposes of comparison of the animal exposure to human exposure, the clinical dose is defined as 2 g of Atralin Gel applied daily to a 50 kg person. Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters and nonhuman primates.

Tretinoin was teratogenic in Wistar rats when given orally in doses greater than 1 mg/kg/day (approximately eight times the clinical dose based on body surface area comparison). In the cynomolgus monkey, fetal malformations were reported for doses of 10 mg/kg/day, but none were observed at 5 mg/kg/day (approximately 80 times the clinical dose based on body surface area comparison), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported.

Similar results have also been reported in pigtail macaques. Topical tretinoin in a different formulation has generated equivocal results in animal teratogenicity tests. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (approximately eight times the clinical dose assuming 100% absorption and based on body surface area comparison).

Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 160 times the clinical dose assuming 100% absorption and based on body surface area comparison) was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids. With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone.

Cases of temporally associated congenital malformations have been reported with use of other topical tretinoin products. The significance of these spontaneous reports in terms of risk to the fetus is not known. Nonteratogenic Effects on Fetuses: Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 20 times the clinical dose based on body surface area comparison.

Topical tretinoin has been shown to be fetotoxic in rabbits when administered in doses eight times the clinical dose based on body surface area comparison.

8.3Nursing 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 Atralin Gel is administered to a nursing woman.

8.4Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. A total of 381 pediatric subjects (aged 10 to 16 years) treated with Atralin Gel were enrolled into the two clinical studies. Across these two studies, comparable safety and efficacy were observed between pediatric and adult subjects.

8.5Geriatric Use Safety and effectiveness in a geriatric population have not been established. Clinical studies of Atralin Gel did not include any subjects over age 65 to determine whether they respond differently from younger subj… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy There are no well-controlled trials in pregnant women treated with Atralin Gel. Atralin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Atralin Gel at doses of 0.1, 0.3 and 1 g/kg/day was tested for maternal and developmental toxicity in pregnant Sprague-Dawley rats by dermal application.

The dose of 1 g/kg/day was approximately four times the clinical dose assuming 100% absorption and based on body surface area comparison. Possible tretinoin-associated teratogenic effects (craniofacial abnormalities [hydrocephaly], asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) were noted in the fetuses of Atralin Gel-treated animals. These findings were not observed in control animals.

Other maternal and reproductive parameters in the Atralin Gel-treated animals were not different from control. For purposes of comparison of the animal exposure to human exposure, the clinical dose is defined as 2 g of Atralin Gel applied daily to a 50 kg person. Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters and nonhuman primates.

Tretinoin was teratogenic in Wistar rats when given orally in doses greater than 1 mg/kg/day (approximately eight times the clinical dose based on body surface area comparison). In the cynomolgus monkey, fetal malformations were reported for doses of 10 mg/kg/day, but none were observed at 5 mg/kg/day (approximately 80 times the clinical dose based on body surface area comparison), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported.

Similar results have also been reported in pigtail macaques. Topical tretinoin in a different formulation has generated equivocal results in animal teratogenicity tests. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (approximately eight times the clinical dose assuming 100% absorption and based on body surface area comparison).

Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 160 times the clinical dose assuming 100% absorption and based on body surface area comparison) was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids. With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone.

Cases of temporally associated congenital malformations have been reported with use of other topical tretinoin products. The significance of these spontaneous reports in terms of risk to the fetus is not known. Nonteratogenic Effects on Fetuses: Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 20 times the clinical dose based on body surface area comparison.

Topical tretinoin has been shown to be fetotoxic in rabbits when administered in doses eight times the clinical dose based on body surface area comparison.

🧒 Pediatric Use 54 words ▾

8.4Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. A total of 381 pediatric subjects (aged 10 to 16 years) treated with Atralin Gel were enrolled into the two clinical studies. Across these two studies, comparable safety and efficacy were observed between pediatric and adult subjects.

🧓 Geriatric Use 36 words ▾

8.5Geriatric Use Safety and effectiveness in a geriatric population have not been established. Clinical studies of Atralin Gel did not include any subjects over age 65 to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tretinoin is a metabolite of Vitamin A that binds with high affinity to specific retinoic acid receptors located in both the cytosol and nucleus, but cutaneous levels of tretinoin in excess of physiologic concentrations occur following application of a tretinoin-containing topical drug product. Although tretinoin activates three members of the retinoid acid (RAR) nuclear receptors (RARα, RARβ, and RARγ) which act to modify gene expression, subsequent protein synthesis, and epithelial cell growth and differentiation, it has not been established whether the clinical effects of tretinoin are mediated through activation of retinoic acid receptors, other mechanisms, or both.

Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

12.3Pharmacokinetics In two studies, the plasma levels of tretinoin and its major metabolites (13-cis-retinoic acid and 4-oxo-13-cis-retinoic acid) were investigated in a total of 14 patients (age: 13 – 25 years) with severe acne, who applied 4 g ± 0.5 g (range 3.5 g – 4.5 g) of Atralin Gel once daily to face, back and chest, as compared to a mean of 0.71 g (range of 0.07 – 3.71 g) applied in the controlled clinical trials. Blood samples were taken at baseline and immediately prior to treatment on Days 1, 5, 10 and 14.

On Day 14, the final study day, samples also were taken 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post-treatment. The plasma concentrations of tretinoin and its metabolites could be measured (LOQ = 0.5 ng/mL for all three analytes) in all patients at all time points. The range of plasma concentrations of tretinoin and its metabolites, 13-cis-retinoic acid and all-trans-4-oxo-retinoic acid at baseline and after multiple once-daily applications of Atralin Gel, 0.05% for 14 days are given in Table 2 (below).

Although some patients had increased concentrations of tretinoin or its metabolites over baseline values, no consistent increase in these concentrations were observed across patients. Table 2: Concentrations of Active and Metabolites at Baseline and at Day 14 After Exposure to Atralin Gel, 0.05% Compound Baseline Concentration Range (ng/mL) Day 14 Concentration Range (ng/mL) Tretinoin 0.68-1.62 0.69-2.88 13-cis-retinoic acid 0.67-1.79 0.51-2.26 4-oxo-13-cis-retinoic acid 0.82-5.92 0.59-6.96

🧬 Mechanism of Action 144 words ▾

12.1Mechanism of Action Tretinoin is a metabolite of Vitamin A that binds with high affinity to specific retinoic acid receptors located in both the cytosol and nucleus, but cutaneous levels of tretinoin in excess of physiologic concentrations occur following application of a tretinoin-containing topical drug product. Although tretinoin activates three members of the retinoid acid (RAR) nuclear receptors (RARα, RARβ, and RARγ) which act to modify gene expression, subsequent protein synthesis, and epithelial cell growth and differentiation, it has not been established whether the clinical effects of tretinoin are mediated through activation of retinoic acid receptors, other mechanisms, or both.

Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

📦 How Supplied / Storage and Handling 60 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Atralin (tretinoin) Gel, 0.05% is a translucent to opaque, pale yellow topical gel and available as: • 45 g tube NDC 13548-070-45 Storage and Handling: Store at controlled room temperature 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Protect from freezing. Keep out of reach of children.

📦 Storage and Handling 33 words ▾

Storage and Handling: Store at controlled room temperature 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Protect from freezing. Keep out of reach of children.

📋 Description 131 words ▾

11 DESCRIPTION Atralin (tretinoin) Gel, 0.05% is a translucent to opaque, pale yellow gel containing 0.05% tretinoin, by weight for topical administration. Chemically, tretinoin is all- trans -retinoic acid, also known as (all- E )-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid class of compounds, and a metabolite of Vitamin A.

Tretinoin has a molecular weight of 300.44, a molecular formula of C 20 H 28 O 2 and the following structure: Each gram of Atralin Gel, 0.05% contains 0.5 mg of tretinoin. Other components of this formulation are benzyl alcohol, butylparaben, butylated hydroxytoluene, carbomer homopolymer Type C, ethylparaben, fish collagen hydrolyzates, glycerin, isobutylparaben, methylparaben, octoxynol 9, phenoxyethanol, propylparaben, purified water, sodium hyaluronate, and trolamine. The contribution to efficacy of individual components of the vehicle has not been evaluated. chem.jpg

💬 Information for Patients 199 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Instruct patients to clean the affected areas with an appropriate cleanser before applying Atralin Gel. Patients may use moisturizers that are noncomedogenic and should avoid products that could be drying or irritating.

Patients may also wear cosmetics while being treated with Atralin Gel; however, they should be instructed to remove the cosmetics and clean the area thoroughly before applying Atralin Gel. Warn patients of the drying and irritation effects often seen during treatment. Continue use of the medication if these effects are tolerable.

Caution patients against application of Atralin Gel around the eyes, mouth, paranasal creases, and mucous membranes as the skin is especially prone to irritation. Minimize exposure to sunlight, including sunlamps. Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided.

Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada Atralin is a trademark of Bausch Health Companies Inc. or its affiliates. All other product/brand names and/or logos are trademarks of the respective owners. © 2024 Bausch Health Companies Inc. or its affiliates 9549701

🍼 Nursing Mothers 36 words ▾

8.3Nursing 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 Atralin Gel is administered to a nursing woman.

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics In two studies, the plasma levels of tretinoin and its major metabolites (13-cis-retinoic acid and 4-oxo-13-cis-retinoic acid) were investigated in a total of 14 patients (age: 13 – 25 years) with severe acne, who applied 4 g ± 0.5 g (range 3.5 g – 4.5 g) of Atralin Gel once daily to face, back and chest, as compared to a mean of 0.71 g (range of 0.07 – 3.71 g) applied in the controlled clinical trials. Blood samples were taken at baseline and immediately prior to treatment on Days 1, 5, 10 and 14.

On Day 14, the final study day, samples also were taken 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post-treatment. The plasma concentrations of tretinoin and its metabolites could be measured (LOQ = 0.5 ng/mL for all three analytes) in all patients at all time points. The range of plasma concentrations of tretinoin and its metabolites, 13-cis-retinoic acid and all-trans-4-oxo-retinoic acid at baseline and after multiple once-daily applications of Atralin Gel, 0.05% for 14 days are given in Table 2 (below).

Although some patients had increased concentrations of tretinoin or its metabolites over baseline values, no consistent increase in these concentrations were observed across patients. Table 2: Concentrations of Active and Metabolites at Baseline and at Day 14 After Exposure to Atralin Gel, 0.05% Compound Baseline Concentration Range (ng/mL) Day 14 Concentration Range (ng/mL) Tretinoin 0.68-1.62 0.69-2.88 13-cis-retinoic acid 0.67-1.79 0.51-2.26 4-oxo-13-cis-retinoic acid 0.82-5.92 0.59-6.96

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The safety and efficacy of Atralin Gel used once daily before bedtime for the treatment of mild to moderate acne vulgaris were assessed in two 12-week prospective, multicenter, randomized, controlled trials. Subjects in these two trials ranged from 10 to 65 years of age, were approximately 52% female, 48% male, and were 74% Caucasian, 15% Black or African American, 3% Asian, and 8% Other. Efficacy results at Week 12 are presented in Table 3.

Success on the 6-point Global Severity Score is defined as a score of 0 (clear) or 1 (very mild). In Trial 2, subjects were also required to have at least two grades reduction from baseline for success. ‘Very mild’ acne is defined as: skin almost clear; rare non-inflammatory lesions present, with rare non-inflamed papules (papules may be hyperpigmented, though not pink-red, less than 4 lesions). The database was not large enough to assess whether there were differences in effects in age, gender, or race subgroups.

Table 3: Efficacy Results at Week 12 in Trials 1 and 2 Trial 1 Atralin Gel (N=375) Vehicle (N=185) Global Severity Score Success Success was defined as 0 (clear) or 1 (very mild) 78 (21%) 23 (12%) Non-Inflammatory Facial Lesions Mean Baseline Count 50.7

52.4Mean Absolute Reduction 21.8

10.3Mean Percent Reduction 43% 21% Inflammatory Facial Lesions Mean Baseline Count 23.4

23.9Mean Absolute Reduction 9.7

5.8Mean Percent Reduction 41% 26% Total Facial Lesions Mean Baseline Count 74.1

76.3Mean Absolute Reduction 31.4

16.1Mean Percent Reduction 43% 22% Trial 2 Atralin Gel (N=299) Vehicle (N=302) Global Severity Score Success Success was defined as 0 (clear) or 1 (very mild) with at least two grades reduction from baseline 69 (23%) 42 (14%) Non-Inflammatory Facial Lesions Mean Baseline Count 51.9

52.7Mean Absolute Reduction 18.7

10.8Mean Percent Reduction 37% 20% Inflammatory Facial Lesions Mean Baseline Count 22.9

23.4Mean Absolute Reduction 7.0

4.0Mean Percent Reduction 30% 17% Total Facial Lesions Mean Baseline Count 74.8

76.1Mean Absolute Reduction 25.7

14.7 Mean Percent Reduction 35% 19%

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A 2-year dermal mouse carcinogenicity study was initiated with topical administration of 0.005%, 0.025% and 0.05% Atralin Gel. Although no drug-related tumors were observed in surviving animals, the irritating nature of the drug product precluded daily dosing, confounding data interpretation and reducing the biological significance of these results. Studies in hairless albino mice with a different formulation suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator.

This effect was confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources. The genotoxic potential of tretinoin was evaluated in an in vitro bacterial reversion test, an in vitro chromosomal aberration assay in human lymphocytes and an in vivo rat micronucleus assay.

All tests were negative. In dermal fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0.5 mg/kg/day (3 mg/m 2 , approximately four times the clinical dose based on body surface area comparison), and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with 0.25 mg/kg/day and above (1.5 mg/m 2 , approximately two times the clinical dose based on body surface area comparison) were observed.

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

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A 2-year dermal mouse carcinogenicity study was initiated with topical administration of 0.005%, 0.025% and 0.05% Atralin Gel. Although no drug-related tumors were observed in surviving animals, the irritating nature of the drug product precluded daily dosing, confounding data interpretation and reducing the biological significance of these results. Studies in hairless albino mice with a different formulation suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator.

This effect was confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources. The genotoxic potential of tretinoin was evaluated in an in vitro bacterial reversion test, an in vitro chromosomal aberration assay in human lymphocytes and an in vivo rat micronucleus assay.

All tests were negative. In dermal fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0.5 mg/kg/day (3 mg/m 2 , approximately four times the clinical dose based on body surface area comparison), and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with 0.25 mg/kg/day and above (1.5 mg/m 2 , approximately two times the clinical dose based on body surface area comparison) were observed.

📄 Patient Package Insert ~3 min read ▾

Patient Information Atralin ® (A-truh-lin) (tretinoin) Gel, 0.05% for topical use Important information: Atralin is for use on skin only. Do not get Atralin in your mouth, eyes, vagina, or the corners of your nose. What is Atralin?

Atralin is a prescription medicine used on the skin (topical) to treat acne. Acne is a condition in which the skin has blackheads, whiteheads, and other pimples. It is not known if Atralin is safe and effective in children under 10 years of age.

What should I tell my healthcare provider before using Atralin? Before using Atralin, tell your healthcare provider about all of your medical conditions, including if you: • are allergic to fish. Atralin contains fish proteins.

Tell your healthcare provider if you get hives or itching during treatment with Atralin. • have a skin condition called eczema. • have a sunburn. • are pregnant or plan to become pregnant. It is not known if Atralin will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if Atralin passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and any skin products that you use. Especially tell your healthcare provider if you use any other medicines to treat your acne, including medicated cleansers or soaps. Using other topical acne products may increase the irritation of your skin when used with Atralin.

How should I use Atralin? • Use Atralin exactly as your healthcare provider tells you to use it. • Before you apply Atralin, gently wash the affected skin area with a mild, non-medicated soap. Rinse and pat your skin dry. • Apply Atralin 1 time a day before bedtime. • Apply a thin layer of Atralin to cover the affected skin areas. Gently rub Atralin into your skin. • Do not use more Atralin than you need to cover the affected area and do not apply Atralin more than 1 time a day.

Using too much Atralin may irritate or increase the irritation of your skin, and will not give faster or better results. • You may use moisturizers and cosmetics. What should I avoid while using Atralin? • Avoid washing your skin too often and scrubbing the affected skin area. • You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with Atralin. • Minimize exposure to sunlight. • If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with a (SPF) sun protection factor of 15 or more and wear protective clothing, and a wide brimmed hat to cover the treated areas. • If you do get sunburned, stop using Atralin until your skin has healed and is back to normal. • Cold weather and wind may irritate skin treated with Atralin.

Skin treated with Atralin may dry out or get wind burned more easily. Talk to your healthcare provider about ways to manage skin irritation. • Avoid contact with the peels of limes. What are the possible side effects of Atralin?

Atralin may cause skin irritation, including: skin dryness, burning, redness, excessive flaking or peeling. If you develop these symptoms, your healthcare provider may tell you to stop using Atralin for a while, decrease the number of times you apply Atralin, or completely stop treatment with Atralin. It is not known if Atralin is effective when used less than 1 time a day.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the side effects possible with Atralin. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. How should I store Atralin? • Store Atralin at room temperature, 68°F to 77°F (20°C to 25°C). • Protect from freezing. Keep Atralin and all medicines out of the reach of children.

General information about the safe and effective use of Atralin Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Atralin for a condition for whic… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 22 words ▾

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton NDC 13548-070-45 Atralin ® (tretinoin) gel 0.05% Rx only Net Wt. 45 g carton

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 Tretinoin (matched by generic name) — the program that covers self-administered drugs. 12 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 Tretinoin. CMS lists 3 products for this generic; we show the highest-spend one. 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
$5.59M
Claims incl. refills
77.6K
Beneficiaries
59.9K
Spend / beneficiary
$93.38
Spend / claim
$72.01
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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Atralin (this brand).

Top reported reactions

Pain470
Vomiting438
Paraesthesia362
Abdominal Pain Upper354
Rash349
Nausea343
Diarrhoea339

Age at onset

Neonate8
Infant3
Child35
Adolescent98
Adult870
Elderly165

Reporter sex

6,386 reports
Male · 26%
Female · 74%
Unknown · 1%

Serious outcomes

Death825
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 376 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
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 ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bausch Health US, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bausch Health US, LLC 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.
← 13538-0009-01 · Curia 13548-0132-50 · Bausch →
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.