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Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum Zinc Oxide 17 g/100mL Cream, 50 mL — NDC 84616-0002-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum Zinc Oxide 17 g/100mL Cream, 50 mL — NDC 84616-002-01 (Billing 84616-0002-01)

by SEORIN COMPANY Co., Ltd. · 50 mL in 1 TUBE

This is a package of 50 mL of Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum Zinc Oxide 17 g/100mL Cream from SEORIN COMPANY Co., Ltd., marketed since Aug 2024 and currently FDA-listed. It is this product's only package size.

NDC 84616-0002-01
🏷️ FDA NDC (as labeled) 84616-002-01 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

⚠️
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) 84616-002-01
Product NDC 84616-002
11-digit billing NDC 84616000201
UNII SOI2LOH54Z
UPC 8809962541215
Application # M020
SPL Set ID 1e7cc417-3c57-c87c-e063-6394a90a670b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-08-13
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 84616-002-01 — 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 → 84616-0002-01. 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 an over-the-counter sunscreen cream containing zinc oxide, a mineral ingredient that functions as a broad-spectrum ultraviolet light filter. Zinc oxide is commonly included in sunscreen products to help protect skin from both UVA and UVB radiation when applied topically to exposed skin. This particular formulation is labeled SPF 50 and is marketed as an OTC monograph product, meaning it is regulated under FDA's established category rules for sunscreen drugs rather than as an individually approved application.

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
84616-0002-01 You're viewing this Main listing 50 mL in 1 TUBE 2024-08-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
PAPATUI Facial Moisturizer Broad Spectrum SPF 30 17 g/100mL 83850-0300-00 PAPATUI, 74 ml — — FDA listed —
Correct and Protect Serum Broad Spectrum SPF 45 17 g/100mL 70381-0120-02 Murad, 1 bottle — — FDA listed —
DAYDREAM Broad Spectrum Sunscreen SPF 40 17 g/100mL 83286-0001-01 Drmtlgy, 1 jar — — FDA listed —
Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30 17 g/100mL 84126-0206-20 The 207 ml — — FDA listed —
Native Mineral Suncare Zinc Oxide Sunscreen Vanilla Milk and Shea Broad Spectrum SPF 30 17 g/100mL 84126-0207-20 The 207 ml — — FDA listed —
Beverly Hills Md Sheer Radiance Spf Drops Sunscreen 17 g/100mL 87280-0005-02 Beverly 1 tube — — FDA listed —
Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum 17 g/100mLthis 84616-0002-01 SEORIN 50 ml — — FDA listed —
Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30 17 g/100mL 84126-0205-20 The 207 ml — — FDA listed —
Correct and Protect Serum Broad Spectrum SPF 45 17 g/100mL 70381-0135-02 Murad, 1 bottle — — FDA listed —
Native Mineral Suncare Zinc Oxide Sunscreen Tropical Breeze Broad Spectrum SPF 30 17 g/100mL 84126-0204-20 The 207 ml — — 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
Aug 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 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 E4M09UY5BL
    A dried plant material from sweet wormwood. It's used in some formulations as a natural filler or ingredient to add bulk to the product.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII 1B33PG6N4K
    A plant resin derived from Japanese white birch bark. It acts as a binder and film-former in tablets and capsules, helping hold ingredients together and create protective coatings on medication surfaces.
  • 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 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 UB27587839
    A plant-derived oil from Roman chamomile flowers. It's used in medicines as a flavoring agent and fragrance to improve taste and smell.
  • UNII SCM4971GZQ
    A plant extract from Japanese cedar leaves used as a natural preservative and antioxidant in medicines. It helps prevent spoilage and maintains product stability during storage.
  • UNII XHK3U310BA
    Cyclohexasiloxane is a silicon-based liquid that acts as a solvent and conditioning agent in medicines. It helps dissolve or carry other ingredients and improves how the product spreads or feels on the skin.
  • 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 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 3297VXM8Z6
    A plant-derived humectant and emollient made from glycerin and glucose. It helps retain moisture in the formulation and improves texture and spreadability in topical products.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • 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 EG97988M5Q
    A synthetic plastic polymer that forms a three-dimensional network. It's used as a coating on tablets and capsules to control how fast the medicine releases into the body, or as a binder to hold pill ingredients together.
  • UNII S73ZQI0GXM
    Methyl trimethicone is a silicone-based lubricant and glidant used in tablets and capsules. It reduces friction between particles and equipment during manufacturing, helping the medicine flow smoothly and compress evenly.
  • UNII 60C608DPVT
    A plant extract from lotus leaves used as a natural ingredient in formulations. It may serve as an antioxidant, preservative, or botanical additive to support product stability and shelf life.
  • UNII 5EXL5H740Y
    A natural oil extracted from Scotch pine needles, used as a flavoring agent and fragrance component in medicines. It adds taste and aroma to improve how the medication tastes or smells.
  • UNII 9229XJ4V12
    A synthetic emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients in formulations, keeping them mixed and preventing separation.
  • UNII RLA2U05Z4Q
    A silicone-based compound that acts as an emulsifier and skin-conditioning agent in topical formulations. It helps blend oil and water components together and creates a smooth, protective texture on the skin's surface.
  • 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 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 978D8U419H
    A yeast strain commonly used in food and pharmaceutical manufacturing. In medicines, it may serve as a filler, culture medium carrier, or source of beneficial compounds in probiotic formulations.
  • 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 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.

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

The official label also statesInactive ingredients Water, Cyclohexasiloxane, Butyloctyl Salicylate, Propanediol, Propylheptyl Caprylate, Isododecane, Caprylyl Methicone, Polyglycery-3 Polydimethylsiloxyethyl Dimethicone, Methyl Methacrylate Crosspolymer, Methyl Trimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Triethoxycaprylysilane, 1,2-Hexanediol, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Lauryl Polyglyceryl-3 Polydimethyisiloxyethyl Dimethicone, Butylene Glycol, Betula Platyphylla Japonica Juice, Glyceryl Caprylate, Caprylyl Glycol, Ethylhexy glycerin, Artemisia Ánnua Extract, Anthemis Nobilis Flower Oil, Sodium Hyaluronate, Pinus Sylvestris Leaf Oil, Glycerin, Nelumbo Nucifera Leaf Extract, Cryptomeria Japonica Leaf Extract, Saccharomyces Ferment Filtrate, Tocopherol, Glyceryl Glucoside, Hyaluronic Acid, Ascorbic Acid

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

LabelerSEORIN COMPANY Co., Ltd.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84616
First marketedAug 2024
Product typeHuman Otc Drug
Portfolio10 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

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
🎯 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 94 words ▾

Directions apply liberally and evenly 15 minutes before sun exposure. Sun protection measures. ​ Spending time in the sun increases your risk of skin cancer and early 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 children under 6 months of age: Ask a doctor reapply at least every 2 hours. use a water-resistant sunscreen if swimming or sweating

⚠️ 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 Ingredients Zinc Oxide 17%

🧪 Inactive Ingredients 77 words ▾

Inactive ingredients Water, Cyclohexasiloxane, Butyloctyl Salicylate, Propanediol, Propylheptyl Caprylate, Isododecane, Caprylyl Methicone, Polyglycery-3 Polydimethylsiloxyethyl Dimethicone, Methyl Methacrylate Crosspolymer, Methyl Trimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Triethoxycaprylysilane, 1,2-Hexanediol, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Lauryl Polyglyceryl-3 Polydimethyisiloxyethyl Dimethicone, Butylene Glycol, Betula Platyphylla Japonica Juice, Glyceryl Caprylate, Caprylyl Glycol, Ethylhexy glycerin, Artemisia Ánnua Extract, Anthemis Nobilis Flower Oil, Sodium Hyaluronate, Pinus Sylvestris Leaf Oil, Glycerin, Nelumbo Nucifera Leaf Extract, Cryptomeria Japonica Leaf Extract, Saccharomyces Ferment Filtrate, Tocopherol, Glyceryl Glucoside, Hyaluronic Acid, Ascorbic Acid

🎯 Purpose 2 words ▾

Purpose Sunscreen

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 Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum (this brand).

Top reported reactions

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

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

1,941 reports

Serious outcomes

Hospitalization988
Death204
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 272 82
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 ✓ 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 SEORIN COMPANY Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SEORIN COMPANY Co., Ltd. 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.
← 84615-0007-02 · POMG 84616-0003-01 · SEORIN →
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.