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XtraCare Foaming Facial Cleanser Triclosan 1 mg/237mg Gel, 237 mg — NDC 57337-0036-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

XtraCare Foaming Facial Cleanser Triclosan 1 mg/237mg Gel, 237 mg — NDC 57337-036-01 (Billing 57337-0036-01)

by Rejoice International · 237 mg in 1 BOTTLE

This is a package of 237 mg of XtraCare Foaming Facial Cleanser Triclosan 1 mg/237mg Gel from Rejoice International, marketed since Nov 2013 and currently FDA-listed. It is this product's only package size.

NDC 57337-0036-01
🏷️ FDA NDC (as labeled) 57337-036-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 57337-036-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
57337 labeler · 036 product · 01 package
Package marketed since
Nov 26, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0849607050007
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57337-036-01
Product NDC 57337-036
11-digit billing NDC 57337003601
UNII 4NM5039Y5X
UPC 0849607050007
Application # M016
SPL Set ID 313fcd4a-8641-417e-bf0b-02359ad815fe
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-11-26
Route TOPICAL
Dosage form GEL
Substance TRICLOSAN
Why two NDCs? The FDA registers this code as 57337-036-01 — 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 → 57337-0036-01. 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

🧪 What is this product?

XtraCare Foaming Facial Cleanser is a topical gel product containing triclosan, an antimicrobial ingredient. This is an OTC monograph drug, meaning it is marketed under FDA's established rules for over-the-counter antimicrobial cleansers rather than as an individually approved application. Triclosan is typically used in cleansing products to reduce bacteria on the skin. This product is applied topically as a foaming cleanser for facial use.

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.
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
57337-0036-01 You're viewing this Main listing 237 mg in 1 BOTTLE 2013-11-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
XtraCare Foaming Facial Cleanser 1 mg/237mgthis 57337-0036-01 Rejoice 237 mg — — 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

🏛️
2013
On the market since
Nov 2013
📍
2026
Currently FDA-listed
13 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII BYR0546TOW
    DMDM hydantoin is a preservative chemical used to prevent the growth of bacteria and fungi in medicines. It helps keep the product safe and stable throughout its shelf life.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 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 4ERD2076EF
    A synthetic liquid made by combining polyethylene glycol with castor oil. It works as a solubilizer and emulsifier to help mix water and oil-based ingredients, keeping the medicine uniform throughout the product.
  • 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 O9W3D3YF5U
    A synthetic surfactant derived from petroleum-based olefins. It helps dissolve or suspend active ingredients and other substances in liquid formulations, improving how the medicine mixes and flows.
  • 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.

11 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesInactive Ingredients water, sodium c14-16 olefin sulfonate, cocamide betaine, glycerin, PEG-40 hydrogenated castor oil, fragrance, DMDM hydantoin, disodium EDTA, citric acid, methylparaben, propylparaben, fd&c yellow no.5, d&c red no.33

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

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerRejoice International
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code57337
First marketedNov 2013
Product typeHuman Otc Drug
Portfolio40 products on file

More NDCs from Rejoice International labeler code 57337

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 8 words ▾

Use to help reduce bacteria on the skin

⏱️ Dosage and Administration 18 words ▾

Directions mix in hands with water. Work into a foamy later. Smooth over face and neck. Rinse thoroughly.

⚠️ Warnings 51 words ▾

Warnings For external use only When using this product avoid contact with eyes. if eye contact occurs, immediately flush with water. Stop use and ask a doctor if excessive skin irritation develops or condition worsens symptoms last more than 7 days or clear up and occur again within a few days

🧪 Active Ingredient 7 words ▾

Active Ingredient Purpose Triclosan 0.25% ........................... Antiseptic

🧪 Inactive Ingredients 29 words ▾

Inactive Ingredients water, sodium c14-16 olefin sulfonate, cocamide betaine, glycerin, PEG-40 hydrogenated castor oil, fragrance, DMDM hydantoin, disodium EDTA, citric acid, methylparaben, propylparaben, fd&c yellow no.5, d&c red no.33

🎯 Purpose 30 words ▾

XtraCare (oil-free) foaming facial cleanser medicated to kill problem-causing bacteria without overdrying Compare to Clean & Clear® Foaming Facial Cleanser 8 fl. oz. (237 mL) oil free foaming facial cleanser

📄 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.

📄 Other Information 37 words ▾

Other Information Do not store where water may enter bottle. *This product is not manufactured or distributed by Johnson&Johnson, the distributor of clean&clear®foaming facial cleanser. DISTRIBUTED BY: REJOICE INTERNATIONAL INC. NORTHVILLE, MI 48168 USA MADE IN CHINA

📄 Package Label / Principal Display Panel 2 words ▾

label image

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
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 "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.
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 Rejoice International. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rejoice International 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.
← 57337-0035-01 · Rejoice 57337-0037-01 · Rejoice →
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.