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Natrience Broad Spectrum SPF 30 Skin Shield 20 g/100g Cream — NDC 84352-0402-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Natrience Broad Spectrum SPF 30 Skin Shield 20 g/100g Cream — NDC 84352-402-01 (Billing 84352-0402-01)

by Sisel International, LLC · 1 TUBE in 1 BOX / 20 g in 1 TUBE

This is a package of Natrience Broad Spectrum SPF 30 Skin Shield 20 g/100g Cream from Sisel International, LLC, marketed since Jun 2024 and currently FDA-listed. It is this product's only package size.

NDC 84352-0402-01
🏷️ FDA NDC (as labeled) 84352-402-01 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 84352-402-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84352 labeler · 402 product · 01 package
Package marketed since
Jun 15, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8435240201 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84352-402-01
Product NDC 84352-402
11-digit billing NDC 84352040201
UNII SOI2LOH54Z
Application # M020
SPL Set ID 1989370f-68a6-6f22-e063-6394a90aacaf
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-06-15
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 84352-402-01 — 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 → 84352-0402-01. 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?

Natrience Broad Spectrum SPF 30 Skin Shield is a topical cream containing zinc oxide, an inorganic mineral commonly used in sunscreen products to reflect and scatter ultraviolet light from the skin. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and labeling rules for sunscreen ingredients rather than undergoing individual product review. Zinc oxide functions as a broad-spectrum UV filter intended to help protect skin from sun exposure when applied topically.

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
84352-0402-01 You're viewing this Main listing 1 TUBE in 1 BOX / 20 g in 1 TUBE 2024-06-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Natrience Broad Spectrum SPF 30 20 g/100gthis 84352-0402-01 Sisel 1 tube — — 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

🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 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 A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII 6VNO72PFC1
    A natural oil extracted from avocado fruit. It's used in medicines as an emollient and carrier to help dissolve or deliver active ingredients and improve how the product feels on skin or mucous membranes.
  • UNII N2UDM48ZD6
    A carbohydrate extracted from sugar beet roots that contains short chains of fructose molecules. In medicines, it acts as a sweetener and may help bind ingredients together or improve texture.
  • UNII 3SCV180C9W
    Betaine is a naturally occurring organic compound found in plants and animals. In medicines, it acts as an osmoprotectant and stabilizer, helping maintain the product's moisture balance and preserve its chemical stability during storage.
  • UNII BOJ6T9AR90
    A heat-resistant glass made from silicon and boron compounds. It's used as the material for vials, bottles, and containers that hold medicines, protecting the drug from contamination and degradation.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • UNII 7J5R5W72QM
    C9-12 alkane is a clear, colorless liquid hydrocarbon mixture derived from petroleum. In medicines, it serves as a solvent, lubricant, or component in liquid formulations to help dissolve or suspend active ingredients.
  • UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII ISE9I7DNUG
    Cocoglycerides are fatty substances derived from coconut oil. They act as emulsifiers and solubilizers in medicines, helping blend water and oil-based ingredients together and improve how the body absorbs certain drugs.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • UNII HTC7G3S2PV
    Ethylhexyl olivate is an emollient and skin-conditioning agent derived from olive oil. It helps soften the product's texture and improves how the medicine spreads or absorbs on skin or mucous membranes.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII Q47ST02F58
    A waxy, solid oil derived from jojoba plant seeds. It acts as a binder and emollient to help hold ingredients together and improve texture in topical or oral formulations.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII Y5W63E7HLV
    A type of brown algae used as a natural colorant and nutritional ingredient in medicines and supplements. It may serve as a filler or source of beneficial compounds in formulations.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII 59Z907ZB69
    A synthetic silicone polymer used as a glidant and anti-caking agent. It reduces friction between particles, helping powders and tablets flow smoothly during manufacturing and use.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 8W46YN971G
    Sodium dehydroacetate is a salt derived from dehydroacetic acid, a compound used as a preservative. It helps prevent mold, bacteria, and yeast growth in medicines, extending shelf life and maintaining product safety.
  • UNII 9K7IG15M0Q
    Arthrospira maxima is a blue-green algae (spirulina) used as a natural colorant and nutritional ingredient in medicines. It adds blue-green color to tablets and capsules while providing vitamins and minerals.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII 5EHL50I4MY
    A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
  • UNII 06YD7896S3
    A waxy, fatty substance derived from stearic acid. It acts as a thickener and texture modifier in medicines, helping control how quickly the drug dissolves and improving the product's firmness and consistency.
  • 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.

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

The official label also statesWater (Aqua), Ethylhexyl Olivate, C9-12 Alkane, Hydroxyethyl Dimethicone Laurate, Propanediol, Calcium Sodium Borosilicate, Pentylene Glycol, Polymethylsilsesquioxane, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cocoglycerides, Jojoba Esters, Dimethicone, Betaine, Sucrose, Spirulina Maxima Extract, Fructooligosaccharides, Beta Vulgaris (Beet) Root Extract, Hydrolyzed Rhodophyceae Extract, Helianthus Annuus (Sunflower) Seed Oil, Phaeodactylum Tricornutum Extract, Dipotassium Glycyrrhizate, Persea Gratissima (Avocado) Oil, Squalane, Caprylic/Capric Triglyceride, Tocopherol, Lecithin, Hydroxyacetophenone, Disteardimonium Hectorite, Polyhydroxystearic Acid, Trihydroxystearin, Triethyl Citrate, Caprylyl Glycol, Tetrasodium Glutamate Diacetate, Sodium Dehydroacetate, Hydrogenated Vegetable Oil, Caprylhydroxamic Acid, Sodium Chloride, Sodium Citrate, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Fragrance (Natural).

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

LabelerSisel International, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84352
First marketedJun 2024
Product typeHuman Otc Drug
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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 61 words ▾

Boxed Warnings For external use only. • Do not use on damaged or broken skin. • When using this product keep out of eyes. Rinse with water to remove. • Stop use and ask a doctor if rash occurs. • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

🎯 Indications and Usage 140 words ▾

Indications and Usage • Apply liberally 15 minutes before sun exposure • reapply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses • For children under 6 months of age: Ask a doctor

Indications and Usage Apply a generous amount in an even layer to face and neck. Use daily as the last step in your skin care routine, before makeup, and at least 15 minutes before sun exposure. Tube Directions

⏱️ Dosage and Administration 4 words ▾

Dosage and Administration Cream

⚠️ Warnings 25 words ▾

Warnings For external use only. Avoid contact with eyes. Do not apply to damaged or irritated skin. If irritation or redness occurs, discontinue use. Tube

🧪 Active Ingredient 6 words ▾

Active Ingredients Zinc Oxide 20%........................ Sunscreen

🧪 Inactive Ingredients 96 words ▾

Inactive Ingredients Water (Aqua), Ethylhexyl Olivate, C9-12 Alkane, Hydroxyethyl Dimethicone Laurate, Propanediol, Calcium Sodium Borosilicate, Pentylene Glycol, Polymethylsilsesquioxane, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cocoglycerides, Jojoba Esters, Dimethicone, Betaine, Sucrose, Spirulina Maxima Extract, Fructooligosaccharides, Beta Vulgaris (Beet) Root Extract, Hydrolyzed Rhodophyceae Extract, Helianthus Annuus (Sunflower) Seed Oil, Phaeodactylum Tricornutum Extract, Dipotassium Glycyrrhizate, Persea Gratissima (Avocado) Oil, Squalane, Caprylic/Capric Triglyceride, Tocopherol, Lecithin, Hydroxyacetophenone, Disteardimonium Hectorite, Polyhydroxystearic Acid, Trihydroxystearin, Triethyl Citrate, Caprylyl Glycol, Tetrasodium Glutamate Diacetate, Sodium Dehydroacetate, Hydrogenated Vegetable Oil, Caprylhydroxamic Acid, Sodium Chloride, Sodium Citrate, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Fragrance (Natural).

🎯 Purpose 4 words ▾

OTC - Purpose Sunscreen

📄 Keep Out of Reach of Children 14 words ▾

OTC - Keep out of reach of Children Keep out of reach of children

📄 Package Label / Principal Display Panel ~1 min read ▾

Principal Display DRUG FACTS Active Ingredients Purpose Zinc Oxide 20%........................ Sunscreen Uses • Helps prevent sunburn. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. Warnings For external use only. • Do not use on damaged or broken skin. • When using this product keep out of eyes.

Rinse with water to remove. • Stop use and ask a doctor if rash occurs. • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Directions • Apply liberally 15 minutes before sun exposure • reapply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses • For children under 6 months of age: Ask a doctor Inactive Ingredients: Water (Aqua), Ethylhexyl Olivate, C9-12 Alkane, Hydroxyethyl Dimethicone Laurate, Propanediol, Calcium Sodium Borosilicate, Pentylene Glycol, Polymethylsilsesquioxane, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cocoglycerides, Jojoba Esters, Dimethicone, Betaine, Sucrose, Spirulina Maxima Extract, Fructooligosaccharides, Beta Vulgaris (Beet) Root Extract, Hydrolyzed Rhodophyceae Extract, Helianthus Annuus (Sunflower) Seed Oil, Phaeodactylum Tricornutum Extract, Dipotassium Glycyrrhizate, Persea Gratissima (Avocado) Oil, Squalane, Caprylic/Capric Triglyceride, Tocopherol, Lecithin, Hydroxyacetophenone, Disteardimonium Hectorite, Polyhydroxystearic Acid, Trihydroxystearin, Triethyl Citrate, Caprylyl Glycol, Tetrasodium Glutamate Diacetate, Sodium Dehydroacetate, Hydrogenated Vegetable Oil, Caprylhydroxamic Acid, Sodium Chloride, Sodium Citrate, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Fragrance (Natural).

Other Information Protect the product in this container from excessive heat and direct sun. Principal Display

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 Sisel International, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sisel International, 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 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.
← 84347-0215-01 · Shenzhen 84355-0003-01 · Guangzhou →
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.