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XtraCare Dandruff Hair Wash Salicylic Acid 10 g/325g Shampoo, 325 g — NDC 57337-0053-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

XtraCare Dandruff Hair Wash Salicylic Acid 10 g/325g Shampoo, 325 g — NDC 57337-053-01 (Billing 57337-0053-01)

by Rejoice International · 325 g in 1 BOTTLE

This is a package of 325 g of XtraCare Dandruff Hair Wash Salicylic Acid 10 g/325g Shampoo from Rejoice International, marketed since Feb 2014 and currently FDA-listed. It is this product's only package size.

NDC 57337-0053-01
🏷️ FDA NDC (as labeled) 57337-053-01 billing pads the product segment with a zero
OTC 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 57337-053-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
57337 labeler · 053 product · 01 package
Package marketed since
Feb 5, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0849607059482
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57337-053-01
Product NDC 57337-053
11-digit billing NDC 57337005301
RxCUI 205023
UNII O414PZ4LPZ
UPC 0849607059482
Application # M032
SPL Set ID 1902e6bb-e829-4b1a-b85a-1394913c77ca
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-02-05
Route TOPICAL
Dosage form SHAMPOO
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 205023
Why two NDCs? The FDA registers this code as 57337-053-01 — 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 → 57337-0053-01. 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.

RxNorm drug class

This medicine belongs to the Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives, Other antifungals for topical use, Antiinflammatory agents, non-steroids
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

📖 What it is MedlinePlus · NLM

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or b...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It is used in a facial routine for acne-prone and oil-prone skin. The routine includes a cleanser, serum, toner and emulsion. Salicylic acid helps loosen and shed dead skin cells.
  • Use the cleanser morning and evening, and the serum in the morning after cleansing. Use the toner in the evening on dry skin, and the emulsion at night after cleansing. Avoid your...
  • Mild stinging, burning, itching, dryness and extra peeling can happen. If dryness or peeling bothers you, try using the serum or toner every other day. If it gets excessive, stop a...
  • It is best not to. Using another topical acne medication at the same time makes irritation and dryness more likely. If you get irritated, use only one at a time.
📖 Read our full Salicylic Acid Topical 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.
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
57337-0053-01 You're viewing this Main listing 325 g in 1 BOTTLE 2014-02-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Therapeutic Dandruff Anti-Dandruff, anti-seborrheic dematitis and anti-psoriasis 30 mg/mL 70000-0550-01 Cardinal 133 ml $0.022 — Availability likely —
DHS SAL 4 oz. .035 g/g 00096-0738-04 Person 123.84 g — — FDA listed —
Dhs Sal 30 mg/mL 00096-0812-04 Person 120 ml — — FDA listed —
Walgreens Tplus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 30 mg/mL 00363-2735-01 Walgreen 133 ml — — FDA listed —
Walgreens Dandruff Itchy Dry Scalp Defense Plus Vitamins and Botanicals Anti-dandruff 30 mg/mL 00363-4137-01 Walgreen 325 ml — — FDA listed —
Walgreens 30 mg/mL 00363-9536-07 Walgreens 207 ml — — FDA listed —
Walgreens 30 mg/mL 00363-9537-11 Walgreens 325 ml — — FDA listed —
TriDerma Itchy Scalp 3 g/100g 10738-0045-23 Genuine 370 g — — FDA listed —
TRIDERMA Psoriasis Control 3 g/100mL 10738-0980-50 Genuine 1 tube — — FDA listed —
Selsun Blue Naturals Itchy, Dry Scalp .03 g/mL 41167-6180-03 Chattem, 325 ml — — FDA listed —
Dr. Groot Anti-dandruff Scalp Care 30 mg/mL 43136-0701-01 TAI 300 ml — — FDA listed —
Dr. Groot Anti-dandruff Scalp Care 2 in 1 30 mg/mL 43136-0702-01 TAI 300 ml — — FDA listed —
CVS Health MAXIMUM STRENGTH Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 30 mg/mL 51316-0443-01 CVS 1 bottle — — FDA listed —
Dr. Groot Anti-dandruff Scalp Care 30 mg/mL 53208-0901-36 LG 300 ml — — FDA listed —
Dr. Groot Anti-dandruff Scalp Care 2 in 1 30 mg/mL 53208-0902-36 LG 300 ml — — FDA listed —
Nizoral Psoriasis 3 g/100mL 55505-0202-64 Kramer 1 bottle — — FDA listed —
XtraCare Dandruff Hair Wash 10 g/325gthis 57337-0053-01 Rejoice 325 g — — FDA listed —
Cantu Guava Ginger Anti Dandruff .03 g/mL 61012-0740-13 PDC 400 ml — — FDA listed —
Denorex Extra Strength .03 g/mL 62673-0059-10 Neoteric 296 ml — — FDA listed —
Denorex Multi-Symptom Anti-Dandruff .03 g/mL 62673-0060-10 Neoteric 296 ml — — FDA listed —
Dermarest Psoriasis Medicated 3 g/100mL 63736-0302-24 Insight 1 bottle — — FDA listed —
bhs beautiful hair and scalp 3 g/100mL 64942-1973-01 Conopco, 400 ml — — FDA listed —
bhs beautiful hair and scalp 3 g/100mL 64942-2063-01 Conopco, 400 ml — — FDA listed —
Therapeutic TPlus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 30 mg/mL 67385-0512-01 Garcoa, 133 ml — — FDA listed —
MG217 Psoriasis Therapeutic Conditioner .03 g/g 68093-7242-01 Wisconsin 1 bottle — — FDA listed —
Neutrogena T/Sal Therapeutic 30 mg/mL 69968-0434-01 Kenvue 12 bottles — — FDA listed —
Neutrogena Scalp Therapy Anti-Dandruff Extra Strength 30 mg/mL 69968-0723-01 Kenvue 354 ml — — FDA listed —
NTG T/Sal 3% Salicylic Acid Anti-Dandruff for Scalp Build Up Control 30 mg/mL 69968-0938-08 Kenvue 1 bottle — — FDA listed —
Neutrogena T/Sal Plus 3% Salicylic Acid Anti-Dandruff for Dry, Itchy Scalp Control 30 mg/mL 69968-0939-08 Kenvue 1 bottle — — FDA listed —
Dermaharmony Unscented Bar 3 g/100g 71819-0020-04 D3 113 g — — FDA listed —
Kenkoderm Psoriasis 3 g/100mL 73632-0003-01 Olympus 118 ml — — FDA listed —
Pert 2 in 1 Extra Strength 3 g/100mL 81277-0803-12 Sodalis 355 ml — — FDA listed —
upandup Anti-dandruff with Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 30 mg/mL 82442-0743-01 TARGET 355 ml — — FDA listed —
HAIRCARE Physicians Recommended 30 mg/mL 82499-0267-00 LAWRENCE 237 ml — — FDA listed —
Scalp Revival 3 g/100mL 82594-0001-50 Beccair, 248 ml — — FDA listed —
Neoketramin Antifungal Dandruff Seborrheic Dermatitis Psoriasis Treatment 3 g/100mL 83004-0019-01 Rida 1 tube — — Discontinued —
Quality Choice Therapeutic 3 g/100mL 83324-0295-45 Chain 1 bottle — — FDA listed —
Quality Choice Psoriasis 3 g/100mL 83324-0342-11 Chain 1 bottle — — FDA listed —
Dermoia Psoriasis Treatment Salicylic Acid 30 mg/mL 83524-0945-00 Treasurewise 355 ml — — FDA listed —
DermaSolve Medicated 3 g/100g 84285-0101-08 Fortitude 226 g — — FDA listed —
anti-dandruff 3 g/100mL 84558-0010-01 GUANGZHOU 300 ml — — FDA listed —
VERB PRODUCTS Balance Relief Salicylic Acid Dandruff Clinical Strength 30 mg/mL 84607-0545-00 Verb 235 ml — — FDA listed —
Shailee Psoriasis Treatment 3 g/100mL 84938-0008-01 Foshan 1 bottle — — FDA listed —
Pharmlitalia Psoriasis Treatment 3 g/100mL 84938-0019-01 Foshan 1 bottle — — FDA listed —
Listarfe Anti-Dandruff Shampoo. 3 g/100mL 85150-0005-01 Guangzhou 300 ml — — FDA listed —
Quality Choice Therapeutic 3 g/100mL 85161-0295-45 Longway 1 bottle — — FDA listed —
Quality Choice Psoriasis 3 g/100mL 85161-0342-11 Longway 1 bottle — — FDA listed —
Kenkoderm Psoriasis 3 g/100mL 85286-0003-01 Nexgel,Inc. 118 ml — — FDA listed —
RoyceDerm Seborrheic Dermatitis and Psoriasis shampoo. 7.5 g/250g 85424-0015-01 RoyceDerm 250 g — — FDA listed —
RoyceDerm Seborrheic Dermatitis and Psoriasis Shampoo. 7.5 g/250g 85424-0020-01 RoyceDerm 250 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

🏛️
2014
On the market since
Feb 2014
📍
2026
Currently FDA-listed
12 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 Salicylic Acid Topical 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 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 C80684146D
    A foaming agent and thickener derived from coconut oil. It helps create a smooth texture and stable foam in liquid or semi-solid medicines, improving how the product feels and applies.
  • 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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII GMR4PEN8PK
    A synthetic polymer used as a thickener and film-former in liquid formulations. It increases viscosity to improve texture and help the medicine spread or adhere evenly on the skin or mucous membranes.
  • UNII BPV390UAP0
    Sodium laureth sulfate is a mild detergent and surfactant derived from coconut oil or petroleum. It helps mix oil and water in formulations and is often used as a cleaning or foaming agent in topical products like shampoos and cleansers.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 4NM5039Y5X
    Triclosan is an antimicrobial agent added to medicines to prevent bacterial and fungal growth, helping preserve the product's shelf life and maintain sterility during storage and use.
  • 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.

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

The official label also statesInactive Ingredients : water, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, cocamide MEA, fragrance, polyquaternium-10, disodium EDTA, citric acid, benzyl alcohol, panthenol (pro-vitamin B5), triclosan, fd&c blue no.1

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 applicationM032 (OTC MONOGRAPH DRUG)
Labeler code57337
First marketedFeb 2014
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 31 words ▾

*compare to active ingredients in Selsun Blue® naturals dandruff shampoo XtraCare® Dandruff Shampoo Salicylic Acid 3% Controls Flakes & Itch Intensive Moisturizers Enriched with Vitamin B5 11 Fl Oz (325 mL)

⏱️ Dosage and Administration 20 words ▾

Directions shampoo, then rinse thoroughly for best results, use at least twice a week or as directed by a doctor

⚠️ Warnings 58 words ▾

Warnings For external use only Ask a doctor before use if you have sebhorreic dermatitis in areas other than the scalp When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

🧪 Active Ingredient 8 words ▾

Active Ingredient Purpose Salicylic Acid 3% ........................... Anti-dandruff

🧪 Inactive Ingredients 29 words ▾

Inactive Ingredients : water, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, cocamide MEA, fragrance, polyquaternium-10, disodium EDTA, citric acid, benzyl alcohol, panthenol (pro-vitamin B5), triclosan, fd&c blue no.1

🎯 Purpose 19 words ▾

Uses for relief of flaking and itching due to dandruff and sebhorreic dermatitis, and to help prevent their recurrence

📄 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 40 words ▾

Other Information store at room temperature Questions/Comments? 1-855-345-5575 *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Selsun Blue® Naturals Dandruff Shampoo. 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 ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Salicylic Acid (matched by generic name) — the program that covers self-administered drugs. 2 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 Salicylic Acid. 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
$11.2K
Claims incl. refills
43
Beneficiaries
35
Spend / beneficiary
$319.01
Spend / claim
$259.66
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ 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.
← 57337-0052-01 · Rejoice 57337-0054-01 · 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.