![Prosacea Sulphur 1 [hp_X]/g Gel — NDC 52389-0173-42 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e5907672-3ee1-44d3-9c92-6345ad3f4238&name=Prosacea+Gel+17RAP.jpg)
Prosacea Sulphur 1 [hp_X]/g Gel
by Kobayashi Healthcare International, Inc. · 2 TUBE in 1 CARTON (52389-173-42) / 21 g in 1 TUBE (52389-173-01)
NDC 52389-0173-42
🏷️ FDA NDC (as labeled)
52389-173-42
billing pads the product segment with a zero
This package
Contains21 g in 1 tube
Pack sizes2 compare ↓
Also comes in:
21 g 52389-0173-21
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
52389-173-42
Product NDC
52389-173
11-digit billing NDC
52389017342
UNII
70FD1KFU70
SPL Set ID
e5907672-3ee1-44d3-9c92-6345ad3f4238
DEA schedule
Non-controlled
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2006-02-06
Route
TOPICAL
Dosage form
GEL
Substance
SULFUR
Why two NDCs?
The FDA registers this code as 52389-173-42 — 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 → 52389-0173-42. 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.
🏭 Manufacturer & labeler
LabelerKobayashi Healthcare International, Inc.
Labeler code52389
First marketedFeb 2006
Product typeHuman Otc Drug
Portfolio26 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
🧪 What is this product?
Prosacea Sulphur 1 is a topical gel marketed as a homeopathic product. It contains sulfur as its active ingredient. In homeopathic practice, sulfur is traditionally used for various skin concerns. Homeopathic products are marketed based on homeopathic tradition and theory; they are not evaluated by the FDA for effectiveness or safety.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Sulphur?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 8Z5ZAL5H3V
A synthetic polymer made from acrylate compounds. It acts as a thickener and stabilizer in topical formulations, helping create the right texture and prevent separation of ingredients.
-
UNII ZY81Z83H0X
Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
-
UNII MP1J8420LU
A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
-
UNII J2B2A4N98G
Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
-
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 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 statesAcrylates/C10-30 alkyl acrylate cosspolymer, aloe barbadensis leaf juice, lactose, phenoxyethanol, purified water, sodium hydoxide, tetrasodium EDTA.
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.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | 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:
21 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Prosacea 1 [hp_X]/gthis 52389-0173-42 | Kobayashi | 2 tubes | — | — | FDA listed | — |
| Neraxiva Men S Intimate Care (Moisture Care Cream) 1 [hp_X]/g 87681-0017-01 | Guangdong | 80 g | — | — | FDA listed | — |
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
🏛️
2006
On the market since
Feb 2006
📍
2026
Currently FDA-listed
20 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 52389-0173-21 | 1 TUBE in 1 CARTON (52389-173-21) / 21 g in 1 TUBE (52389-173-01) | 2006-02-06 | Active |
| 52389-0173-42 You're viewing this | 2 TUBE in 1 CARTON (52389-173-42) / 21 g in 1 TUBE (52389-173-01) | 2020-02-03 | Active |
Pack size FAQ
What quantity is in NDC 52389-0173-42?
NDC 52389-0173-42 is listed by the FDA — 2 tube in 1 carton / 21 g in 1 tube.
What NDC number is used to bill for this package of Prosacea Sulphur 1 [hp_X]/g Gel?
Bill NDC 52389-0173-42 — the 11-digit billing format is 52389017342. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
Homeopathic listing
About homeopathic listings
Prosacea Sulphur 1 [hp_X]/g GEL is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.
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 | — 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 "Unapproved Homeopathic". 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.
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 FDA registers it as 52389-173-42, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 52389-0173-42, written without dashes as 52389017342. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 52389-0173-42, the first segment (52389) is the labeler code FDA assigned to Kobayashi Healthcare International, Inc.; the middle segment (0173) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (42) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Kobayashi Healthcare International, 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 (52389-0173-21). 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.
📄 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
💬 Information for Patients
🎯 Indications and Usage ▾
Uses For the treatment of rosacea, redness, acne and other eruptions of the skin.
⏱️ Dosage and Administration ▾
Directions Read all package directions and warnings before use. Use only as directed. Clean the skin thoroughly before applying this product.
Cover the entire affected area with a thin layer of Prosacea Gel one to three times daily. Massage gently until absorbed into the skin. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Intended for use by normally healthy adults only. Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.
Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
⚠️ Warnings ▾
Warnings For external use only
🧪 Active Ingredient ▾
Active ingredient Sulphur 1x (10%)
🧪 Inactive Ingredients ▾
Inactive ingredients Acrylates/C10-30 alkyl acrylate cosspolymer, aloe barbadensis leaf juice, lactose, phenoxyethanol, purified water, sodium hydoxide, tetrasodium EDTA.
🎯 Purpose ▾
Purpose Rosacea/acne treatment
💬 Information for Patients ▾
Other information You may report serious side effects to the phone number provided under Questions? below.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.