Home › NDC Lookup › Ingredients › Homosalate Octocrylene Octisalate Avoben... › 84616-0003-01
Birch Juice Moisturizing UVLOCK Sunstick SPF 50 Broad Spectrum Homosalate, Octocrylene, Octisalate, Avobenzone 5 g/100g; 4.5 g/100g; 9.5 g/100g; 3 g/100g Stick, 19 g — NDC 84616-0003-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Birch Juice Moisturizing UVLOCK Sunstick SPF 50 Broad Spectrum Homosalate, Octocrylene, Octisalate, Avobenzone 5 g/100g; 4.5 g/100g; 9.5 g/100g; 3 g/100g Stick, 19 g — NDC 84616-003-01 (Billing 84616-0003-01)

by SEORIN COMPANY Co., Ltd. · 19 g in 1 CONTAINER

This is a package of 19 g of Birch Juice Moisturizing UVLOCK Sunstick SPF 50 Broad Spectrum Homosalate, Octocrylene, Octisalate, Avobenzone 5 g/100g; 4.5 g/100g; 9.5 g/100g; 3 g/100g Stick from SEORIN COMPANY Co., Ltd., marketed since Nov 2024 and currently FDA-listed. It is this product's only package size.

NDC 84616-0003-01
🏷️ FDA NDC (as labeled) 84616-003-01 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 Aug 27, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84616-003-01
Product NDC 84616-003
11-digit billing NDC 84616000301
UNII 5A68WGF6WM, 4X49Y0596W, V06SV4M95S, G63QQF2NOX
Application # M020
SPL Set ID 26442417-f238-1fc3-e063-6394a90a6f82
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-11-06
Route TOPICAL
Dosage form STICK
Substance OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE
Why two NDCs? The FDA registers this code as 84616-003-01 — 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 → 84616-0003-01. 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 stick applied to the skin, marketed under FDA's OTC monograph rules for sun protection products. It contains four UV-filtering ingredients (homosalate, octocrylene, octisalate, and avobenzone) that are commonly used together to absorb and scatter ultraviolet light across a broad spectrum of wavelengths. The product is formulated with birch juice and moisturizing agents as additional components in the stick base.

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 eachPer 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
84616-0003-01 You're viewing this Main listing 19 g in 1 CONTAINER 2024-11-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Birch Juice Moisturizing UVLOCK Sunstick SPF 50 Broad Spectrum 5 g/100g; 4.5 g/100g; 9.5 g/100g; 3 g/100gthis 84616-0003-01 SEORIN 19 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

🏛️
2024
On the market since
Nov 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 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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • 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 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 G27BTQ95MJ
    A plant-derived waxy compound made from oils and alcohols. It acts as an emulsifier and texture agent, helping blend water and oil components together and giving the medicine a smooth, stable consistency.
  • 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 U37N0S910T
    A natural oil extracted from camellia seeds, used as an emollient and conditioning agent. It helps soften the product texture and improve skin feel in topical formulations.
  • UNII WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • UNII H6HK6E4EB1
    A silicone-based ingredient that acts as a glidant and lubricant to help powder particles flow smoothly during manufacturing and improve how the medicine feels when applied to skin.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII YCD50O0Z6L
    A synthetic oily liquid used as a solvent and conditioning agent in topical formulations. It helps dissolve other ingredients and improves how the product spreads and feels on skin.
  • UNII QBS8A3XZGQ
    A synthetic oil made from diisostearyl alcohol and malic acid. It serves as an emollient and solvent in formulations, helping to dissolve and deliver active ingredients while improving texture and spreadability.
  • 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 UF7620L1W6
    A synthetic silicone polymer that acts as a thickener and absorbent in medicines. It helps create the right texture, improves how the product feels on skin or in the mouth, and can absorb excess moisture or oil in formulations.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • UNII I43FCF3356
    A plant extract from Japanese yam root used as a natural binder and thickening agent. It helps hold tablet ingredients together and adds consistency to the formulation.
  • UNII I445L28B12
    A silicone-based compound that acts as a lubricant and glidant in tablet and capsule formulations. It reduces friction between particles and on equipment surfaces, helping medicines flow smoothly during manufacturing and tablet compression.
  • UNII CA2Y0FE3FX
    A salt derived from licorice root extract, used as a flavoring agent and sweetener. It may also help soothe and protect mucous membranes in throat lozenges and cough products.
  • UNII I6KB4GE3K4
    A synthetic oil derived from petrochemicals, used as an emollient and solvent in topical formulations. It helps dissolve active ingredients and improve the texture and spreadability of creams, lotions, and ointments.
  • 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 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 8CRQ2TH63M
    Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
  • UNII WE98HW412B
    A seaweed-derived ingredient from Japanese kelp. It acts as a thickener and binder in medications, helping create the proper texture and hold the formula together.
  • UNII YK3DC63Y5M
    A mineral compound derived from natural or synthetic sources that acts as an anti-caking agent and flow aid. It helps prevent clumping and improves the powder's ability to flow smoothly during manufacturing and tablet formation.
  • 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 0C143929GK
    Phenethyl benzoate is a synthetic fragrance and flavoring agent used in medicines to mask unpleasant tastes or add pleasant aroma to improve patient acceptance of the medication.
  • 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 UG00KM4WR7
    A plastic polymer used as a container material and film coating. It helps protect the medicine from moisture and air exposure during storage and shipping.
  • 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 EU2PSP0G0W
    Silica dimethyl silylate is a silicon-based powder that acts as a glidant and anti-caking agent. It reduces friction between particles and helps powders flow smoothly during manufacturing and tablet compression.
  • 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 Q3Z4BCH099
    A manufactured wax made from refined petroleum or plant oils. It coats tablet surfaces to control how fast the medicine dissolves and releases, and improves how the tablet feels and looks.
  • UNII URQ79U8261
    A plant extract from the root of the Ulmus davidiana tree. It functions as a binder and thickening agent to help hold the medicine together and improve its texture and consistency.
  • UNII 46MR945M6X
    A plant-derived ingredient made from Viola mandshurica flowers, used primarily as a coloring agent, flavor enhancer, or botanical extract in the formulation.
  • 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.

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

The official label also statesDiethylhexyl Carbonate, Dimethicone, Methyl Methacrylate Crosspolymer, Synthetic Wax, Diphenylsiloxy Phenyl Trimethicone, Butyloctyl Salicylate, Butyl Methoxydibenzoy/methane, Isopropyl Palmitate, Phenethyl Benzoate, Diisostearyl Malate, Ethylhexyl Isononanoate, Capryty Trimethicone, Synthetic Fluorphlogopite, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Polymethylsilsesquioxane, Polyethylene, Dimethicone/ Vinyl Dimethicone Crosspolymer, Camellia Japonica Seed Oil, Ethylene/Propylene Copolymer, Silica Dimethyl Silylate, Dimethicone Crosspolymer, Candelilla Wax Esters, Artemisia Annua Extract, Copemicia Cerifera (Camauba) Wax, Pinus Sylvestris Leaf Oil, Anthemis Nobilis Flower Oil, Water, Dipotassium Glycyrrhizate, Allantoin, Glyceryl Glucoside, Butylene Glycol, Glycerin, 1,2-Hexanediol, Betula Platyphylla Japonica Juice, Ulmus Davidiana Root Extract, Aloe Barbadensis Leaf Extract, Dioscorea Japonica Root Extract, Viola Mandshurica Flower Extract, Laminaria Japonica Extract, Glyceryl Caprylate, Sodium Hyaluronate, 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 marketedNov 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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 33 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 95 words ▾

Directions reapply at least every 2 hours. apply liberally 15 minutes before sun exposure. 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. children under 6 months of age: Ask a doctor

⚠️ Warnings 103 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. Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes.

Rinse with water to remove. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away

🧪 Active Ingredient 10 words ▾

Active ingredients Homosalate 9.5% Octocrylene 5% Octisalate 4.5% Avobenzone 3%

🧪 Inactive Ingredients 110 words ▾

Inactive ingredients Diethylhexyl Carbonate, Dimethicone, Methyl Methacrylate Crosspolymer, Synthetic Wax, Diphenylsiloxy Phenyl Trimethicone, Butyloctyl Salicylate, Butyl Methoxydibenzoy/methane, Isopropyl Palmitate, Phenethyl Benzoate, Diisostearyl Malate, Ethylhexyl Isononanoate, Capryty Trimethicone, Synthetic Fluorphlogopite, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Polymethylsilsesquioxane, Polyethylene, Dimethicone/ Vinyl Dimethicone Crosspolymer, Camellia Japonica Seed Oil, Ethylene/Propylene Copolymer, Silica Dimethyl Silylate, Dimethicone Crosspolymer, Candelilla Wax Esters, Artemisia Annua Extract, Copemicia Cerifera (Camauba) Wax, Pinus Sylvestris Leaf Oil, Anthemis Nobilis Flower Oil, Water, Dipotassium Glycyrrhizate, Allantoin, Glyceryl Glucoside, Butylene Glycol, Glycerin, 1,2-Hexanediol, Betula Platyphylla Japonica Juice, Ulmus Davidiana Root Extract, Aloe Barbadensis Leaf Extract, Dioscorea Japonica Root Extract, Viola Mandshurica Flower Extract, Laminaria Japonica Extract, Glyceryl Caprylate, Sodium Hyaluronate, Hyaluronic Acid, Ascorbic Acid

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin

📄 When Using This Product 13 words ▾

When using this product keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if rash occurs

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children

📄 Other Information 24 words ▾

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

Other information protect the product from excessive heat and direct sun

📄 Questions or Comments 4 words ▾

Questions or comments? [email protected]

📄 Package Label / Principal Display Panel 17 words ▾

BIRCH JUICE MOISTURIZING UVLOCK SUN STICK SUN STICK SPF50+ Broad Spectrum ROUND LAB 19g 0.67 oz. SP

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 Homosalate, Octocrylene, Octisalate, Avobenzone — the ingredient across all brands.

Top reported reactions

Application Site Burn1
Hypersensitivity1

Reporter sex

0 reports
Female · 100%
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.
← 84616-0002-01 · SEORIN 84616-0004-01 · 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.