Home › NDC Lookup › Ingredients › Coal Tar Topical Gel › 52389-0166-01
🧴image loading
(from DailyMed)

Psoriasin Gel Coal Tar Topical 12.5 mg/g Gel, 1 tube — NDC 52389-166-01 (Billing 52389-0166-01)

by Kobayashi Healthcare International, Inc. · 1 TUBE in 1 CARTON / 28.35 g in 1 TUBE

This is a package of 1 tube of Psoriasin Gel Coal Tar Topical 12.5 mg/g Gel from Kobayashi Healthcare International, Inc., no longer marketed (first marketed Feb 1996), no longer in the FDA NDC Directory, this package's marketing ended Jul 2026. It is the main listing for this product, which comes in 4 package sizes.

NDC 52389-0166-01
🏷️ FDA NDC (as labeled) 52389-166-01 billing pads the product segment with a zero
This package
Contains1 tube Pack sizes4 compare ↓
Main listing for product 52389-166 · Also comes in: 56.7 g 52389-166-57 2 tubes 52389-166-43 2 tubes 52389-166-56
OTC 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

NDC database record

One package, one record: these facts belong to NDC 52389-166-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
52389 labeler · 166 product · 01 package
Package marketed since
Mar 15, 2013
Package marketing ended
Jul 31, 2026
Sample package
No — commercial package
Barcode (UPC)
0072959665425
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2026. 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) 52389-166-01
Product NDC 52389-166
11-digit billing NDC 52389016601
RxCUI 415978, 1043397
UNII R533ESO2EC
UPC 0072959665425
Application # M032
SPL Set ID a046878f-ffc7-417e-9145-5ccc176b4683
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2026)
Marketing start 1996-02-18
Marketing end 2026-07-31
Route TOPICAL
Dosage form GEL
Substance COAL TAR
Quick answers
  • RxCUI (RxNorm): 415978
Why two NDCs? The FDA registers this code as 52389-166-01 — 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 → 52389-0166-01. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It relieves the itching, scaling, flaking and redness of psoriasis, seborrheic dermatitis and dandruff. Which of these a product treats depends on the brand, so check your package....
  • It depends on the product. Most coal tar shampoos say to use them at least twice a week, leaving the lather on for several minutes. Some ointments, gels and lotions can be used one...
  • Be careful. Coal tar can make you more likely to sunburn for up to 24 hours after you apply it. Cover up and limit sun exposure during that time.
  • Don't combine it with light therapy or prescription psoriasis medicines unless your doctor says it's okay. Check with me or your doctor first if you're not sure.
📖 Read our full Coal Tar 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: 56.7 g 2 tubes 2 tubes
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
52389-0166-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 28.35 g in 1 TUBE 2013-03-15 Jul 31, 2026 Discontinued by firm
52389-0166-43 52389-166-43 2 TUBE in 1 BOX / 21.25 g in 1 TUBE 2020-06-01 Jul 31, 2026 Discontinued by firm
52389-0166-56 52389-166-56 2 TUBE in 1 CARTON / 28.35 g in 1 TUBE 2013-10-01 Jul 31, 2026 Discontinued by firm
52389-0166-57 52389-166-57 1 TUBE, WITH APPLICATOR in 1 CARTON / 56.7 g in 1 TUBE, WITH APPLICATOR 2024-08-05 Jul 31, 2026 Discontinued by firm

Pack size FAQ

What quantity is in this package?
This package contains 1 tube — 1 tube in 1 carton / 28.35 g in 1 tube.
How does this package differ from NDC 52389-0166-57?
Both are Psoriasin Gel Coal Tar Topical 12.5 mg/g Gel — the drug itself is identical. This page's package is the 1 tube one, while NDC 52389-0166-57 is the 1 tube package.
What NDC number is used to bill for this package of Psoriasin Gel Coal Tar Topical 12.5 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
Psoriasin Gel 12.5 mg/gthis 52389-0166-01 Kobayashi 1 tube — — Discontinued —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where 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

🏛️
1996
On the market since
Feb 1996
📍
2026
Currently FDA-listed
30 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 Coal Tar 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerKobayashi Healthcare International, Inc.
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code52389
First marketedFeb 1996
Product typeHuman Otc Drug
Portfolio26 products on file

More NDCs from Kobayashi Healthcare International, Inc. labeler code 52389

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. 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 ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 💬 Information for Patients 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 25 words ▾

Uses For the relief of symptoms associated with psoriasis and/or seborrheic dermatitis including itching, scaling, flaking, redness and irritation of the skin. Helps prevent recurrence.

⏱️ Dosage and Administration 121 words ▾

Directions Read all package directions and warnings before use. Use only as directed. Apply (gently massage in) a small amount of Psoriasin Gel to affected areas.

Apply one to four times daily or as directed by a doctor. Apply to thoroughly dry skin. The active ingredient, coal tar, in Psoriasin Gel may affect very light hair color; test first on a few strands of hair before broader application to areas where light colored hair is present.

Wash affected area at least daily with mild soap and warm water and dry thoroughly. Intended for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.

⚠️ Warnings 5 words ▾

Warnings For external use only.

🧪 Active Ingredient 11 words ▾

Active ingredient Coal Tar 1.25% (from coal tar topical solution, USP)

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients Aloe vera gel, ethanol, hydroxypropyl cellulose, isopropyl alcohol, polyethylene glycol, polysorbate 80, purified water and vitamin E acetate.

🎯 Purpose 4 words ▾

Purpose Psoriasis/Seborrheic Dermatitis Treatment

💬 Information for Patients 16 words ▾

Other Information You may report serious side effects to the phone number provided under Questions? below.

📄 Ask a Doctor Before Use If 40 words ▾

Ask a doctor before use for prolonged periods if condition covers a large area of the body around the rectum or in the genital area or groin with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs.

📄 When Using This Product 17 words ▾

When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

📄 Stop Use and Ask a Doctor If 61 words ▾

Stop use and ask a doctor if condition worsens condition does not improve after regular use of this product as directed. Use caution in exposing skin to sunlight after applying this product, as it may increase your tendency to sunburn for up to 24 hours after application. Warning: This product contains chemicals known to the State of California to cause cancer.

📄 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.

📄 Questions or Comments 2 words ▾

Questions? 1-800-792-2582

📄 Patient Package Insert ~3 min read ▾

Package Insert Psoriasin DAYTIME RELIEF VANISHING GEL DERMATOLOGIST RECOMMENDED Stops Psoriasis itching, scaling, redness Can complement topical steroids Dries quickly, low odor Visible results in just days Helps prevent recurrence Psoriasin Daytime Relief Vanishing Gel gets to work quickly to help stop the itching, flaking, redness and related discomforts associated with psoriasis. Formulated in a vanishing gel base with aloe and vitamin E, it applies easily, dries quickly and absorbs thoroughly, leaving no greasy appearance or lingering odor.

Use Psoriasin Daytime Relief Vanishing Gel with confidence to relieve symptoms of psoriasis and help restore you skin to a more natural looking appearance. How Coal Tar Works The coal tar in Psoriasin Daytime Relief Vanishing Gel slows down the excessive skin cell production that is the root cause of psoriasis symptoms. No other FDA compliant non-prescription drug ingredient works this way.

Slowing excesive skin cell production means it can help reduce the itching, scaling and redness of psoriasis. With regular use as directed, Psoriasin Daytime Relief Vanishing Gel can even help prevent recurrence of psoriasis symptoms. And coal tar can be used to complement topical steroid therapies.

The Role of Topical Steroids Topical steroids - similar to the natural corticosteroid hormones produced by the adrenal glands - are a frequently used psoriasis symptom treatment. Topical steroids are used as anti-inflammatory agents to reduce the swelling and redness of lesions. Although topical steroids can produce rapid symptom relief, continuous use of them may cause potential side effects such as skin thinning.

Topical Therapy Choices for Psoriasis Symptom Control Due to the well documented side effects of topical steroids, some experts recommend using intermittent therapy (also called weekend or pulse therapy). This type of treatment involves applying a topical steroid for three consecutive days each week followed by four days of a coal tar medication like Psoriasin Daytime Relief Vanishing Gel . Ask your doctor if this approach might be right for you.

PSORIASIS SELF-CARE TIPS In addition to psoriasis treatments recommended by a doctor, you can help reduce psoriasis symptoms by using self-care approaches, including: Keep Skin Moisturized Using a moisturizer is an important part of self-care for psoriasis. Dry skin makes irritation and itching caused by psoriasis worse than it needs to be. A vicious cycle can result: dry skin can cause itching and scratching, leading to new psoriasis patches developing on the irritated skin.

Dermatologists recommend ointments and heavy creams to lock water into the skin. Bathe with Care Too many baths and showers can dry your skin. Here are a few suggestions: Don't bathe or shower with hot water, which can irritate.

Use lukewarm water instead. Don't dry off by rubbing with a towel. Pat yourself somewhat dry and then apply cream.

Plain water can dry your skin. Adding salts, oil, or finely ground oatmeal to bath water can help to soothe your skin. Take fewer showers and baths.

They can strip your skin of natural oils. Bathe every other day or every third day, especially during the winter months. Reduce Stress Stress can cause psoriasis to flare for the first time or aggravate existing psoriasis.

Relaxation and stress reduction may help prevent stress from making your psoriasis symptoms worse. Engage in relaxation techniques, such as yoga, meditation, or massage Excercise regularly Get enough sleep Be Smart About Sunlight The ultraviolet rays in sunlight slow the growth of skin cells, so getting moderate doses of sun is good. But make it brief and use sunscreen, because sunburn can trigger psoriasis flare-ups.

Some medications can make your skin more sensitive to ultraviolet rays, so talk to your doctor first. Stick to the Plan Applying creams and ointments day after day can be inconvenient. But compliance is the key for topical therapies.

Once you have a topical treatme… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 1 words ▾

PsoriasinGelPDP

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

About this NDC listing & data coverage

Over-the-counter (OTC) 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — 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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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.
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 3 other package presentations of this same product, including 1 tube (52389-0166-57), 2 tubes (52389-0166-43), 2 tubes (52389-0166-56). 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?
Kobayashi Healthcare International, 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.
← 52389-0155-80 · Kobayashi 52389-0173-21 · Kobayashi →
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.