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ANUA MINERAL WEIGHTLESS FINISH SUNSCREEN Zinc Oxide 178 mg/mL Cream — NDC 84610-500-01 (Billing 84610-0500-01)

by Thefounders · 1 TUBE in 1 CARTON / 50 mL in 1 TUBE

This is a package of ANUA MINERAL WEIGHTLESS FINISH SUNSCREEN Zinc Oxide 178 mg/mL Cream from Thefounders, marketed since May 2026 and currently FDA-listed. It is this product's only package size.

NDC 84610-0500-01
🏷️ FDA NDC (as labeled) 84610-500-01 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 84610-500-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84610 labeler · 500 product · 01 package
Package marketed since
May 18, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8461050001 4
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84610-500-01
Product NDC 84610-500
11-digit billing NDC 84610050001
UNII SOI2LOH54Z
Application # M020
SPL Set ID 4e37d291-84fb-252a-e063-6294a90acd1f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-18
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 84610-500-01 — 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 → 84610-0500-01. 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?

This is a topical sunscreen cream containing zinc oxide as its active ingredient. Zinc oxide is a mineral UV filter that is commonly used in sunscreen products to reflect and scatter ultraviolet rays away from the skin. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for sunscreen ingredients and labeling rather than being individually reviewed by the agency. The formulation is described as providing a weightless finish when applied to the skin.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
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
84610-0500-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 50 mL in 1 TUBE 2026-05-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Anua Mineral Weightless Finish Sunscreen 178 mg/mLthis 84610-0500-01 Thefounders 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

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • 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 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 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 Q95M2P1KJL
    A silicone-based ingredient that acts as a lubricant and glidant. It helps the tablet or capsule move smoothly through manufacturing equipment and improves powder flow during production.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII D21K655H52
    A waxy substance derived from stearic acid (a fat), used as an emulsifier and thickener in medications. It helps blend oily and water-based ingredients together and gives the product a stable, smooth texture.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII D7M4659BPU
    A silicone-based oil used as a lubricant and anti-foaming agent in medicines. It helps prevent clumping, reduces foam during manufacturing, and allows tablets or capsules to move smoothly through equipment.
  • 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII 806K32R50Z
    A synthetic liquid alcohol used in pharmaceuticals as a humectant and solvent. It helps keep the product moist and can dissolve or mix other ingredients together in liquid formulations.
  • 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 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 991Z19V2OD
    Propylheptyl caprylate is a synthetic oily liquid made from fatty acids. It's used in medicines as an emollient and solvent to help dissolve active ingredients and improve how the product spreads or absorbs.
  • 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 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • 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 LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 7K3W1BIU6K
    A synthetic oil derived from glycerin and hexanoic acid. It acts as an emollient and lubricant in topical formulations to soften skin and improve product spreadability.
  • 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.

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

The official label also statesWater (Aqua), Butyloctyl Salicylate, Propylheptyl Caprylate, Butylene Glycol, Isododecane, C9-12 Alkane, Cetyl Diglyceryl Tris(Trimethylsiloxy) silylethyl Dimethicone, Caprylyl Methicone, Disiloxane, Triethylhexanoin, Glycerin, Methyl Methacrylate Crosspolymer, Disteardimonium Hectorite, Sodium Chloride, Triethoxycaprylylsilane, Polymethylsilsesquioxane, 1,2-Hexanediol, Dipentaerythrityl Tri-Polyhydroxystearate, Lauryl Polyglyceryl-3 Polydimethyl siloxyethyl Dimethicone, Lauryl Dimethicone/Polyglycerin-3 Crosspolymer, Magnesium Sulfate, CaprylylGlycol, Glyceryl Caprylate, Dipropylene Glycol, Tocopherol, Sodium Citrate, Centella Asiatica Extract, Allantoin, Panthenol, Pentylene Glycol, Caprylic/Capric Triglyceride, Octanediol, Hydrogenated Lecithin, Ceramide NP, Sodium Stearoyl Glutamate

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

LabelerThefounders
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84610
First marketedMay 2026
Product typeHuman Otc Drug

More NDCs from Thefounders labeler code 84610

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 📋 Description 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 words ▾

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

⏱️ Dosage and Administration 101 words ▾

Directions For sunscreen use: ■ Apply liberally 15 minutes before sun exposure ■ Reapply at least every 2 hours ■ Use a water resistant sunscreen if swimming or sweating ■ Children under 6 months of age: Ask a doctor ■ 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

⚠️ Warnings 54 words ▾

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 swallowed, get medical help or contact a Poison Control Center right away

🧪 Active Ingredient 5 words ▾

Active ingredient Zinc Oxide 17.8%

🧪 Inactive Ingredients 70 words ▾

Inactive ingredients Water (Aqua), Butyloctyl Salicylate, Propylheptyl Caprylate, Butylene Glycol, Isododecane, C9-12 Alkane, Cetyl Diglyceryl Tris(Trimethylsiloxy) silylethyl Dimethicone, Caprylyl Methicone, Disiloxane, Triethylhexanoin, Glycerin, Methyl Methacrylate Crosspolymer, Disteardimonium Hectorite, Sodium Chloride, Triethoxycaprylylsilane, Polymethylsilsesquioxane, 1,2-Hexanediol, Dipentaerythrityl Tri-Polyhydroxystearate, Lauryl Polyglyceryl-3 Polydimethyl siloxyethyl Dimethicone, Lauryl Dimethicone/Polyglycerin-3 Crosspolymer, Magnesium Sulfate, CaprylylGlycol, Glyceryl Caprylate, Dipropylene Glycol, Tocopherol, Sodium Citrate, Centella Asiatica Extract, Allantoin, Panthenol, Pentylene Glycol, Caprylic/Capric Triglyceride, Octanediol, Hydrogenated Lecithin, Ceramide NP, Sodium Stearoyl Glutamate

🎯 Purpose 2 words ▾

Purpose Sunscreen

📋 Description ~1 min read ▾

Drug Facts Drug Facts Active ingredient Zinc Oxide 17.8% Purpose Sunscreen Other in f ormation ■ protect the product in this container from excessive heat and direct sun Directions For sunscreen use: ■ Apply liberally 15 minutes before sun exposure ■ Reapply at least every 2 hours ■ Use a water resistant sunscreen if swimming or sweating ■ Children under 6 months of age: Ask a doctor ■ 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 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 swallowed, get medical help or contact a Poison Control Center right away Inactive ingredients Water (Aqua), Butyloctyl Salicylate, Propylheptyl Caprylate, Butylene Glycol, Isododecane, C9-12 Alkane, Cetyl Diglyceryl Tris(Trimethylsiloxy) silylethyl Dimethicone, Caprylyl Methicone, Disiloxane, Triethylhexanoin, Glycerin, Methyl Methacrylate Crosspolymer, Disteardimonium Hectorite, Sodium Chloride, Triethoxycaprylylsilane, Polymethylsilsesquioxane, 1,2-Hexanediol, Dipentaerythrityl Tri-Polyhydroxystearate, Lauryl Polyglyceryl-3 Polydimethyl siloxyethyl Dimethicone, Lauryl Dimethicone/Polyglycerin-3 Crosspolymer, Magnesium Sulfate, CaprylylGlycol, Glyceryl Caprylate, Dipropylene Glycol, Tocopherol, Sodium Citrate, Centella Asiatica Extract, Allantoin, Panthenol, Pentylene Glycol, Caprylic/Capric Triglyceride, Octanediol, Hydrogenated Lecithin, Ceramide NP, Sodium Stearoyl Glutamate Questions? +1-888-899-9083 Monday–Friday (9 a.m.–5 p.m.

EST) www.anua.com

📄 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 17 words ▾

Other in f ormation ■ protect the product in this container from excessive heat and direct sun

📄 Questions or Comments 8 words ▾

Questions? +1-888-899-9083 Monday–Friday (9 a.m.–5 p.m. EST) www.anua.com

📄 Package Label / Principal Display Panel 3 words ▾

Package 2 1

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ANUA MINERAL WEIGHTLESS FINISH SUNSCREEN (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Reporter sex

0 reports
Male · 37%
Female · 63%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 272 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 — Not published for this NDC No photo available yet for this listing.
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 Thefounders. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Thefounders 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.
← 84610-0400-01 · The 84612-0055-01 · Nuvaila →
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.