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Sum 37 Micro Active Daily Moisture Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene 45 mg/mL; 90 mg/mL; 27 mg/mL; 90 mg/mL Cream — NDC 53208-0440-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sum 37 Micro Active Daily Moisture Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene 45 mg/mL; 90 mg/mL; 27 mg/mL; 90 mg/mL Cream — NDC 53208-440-02 (Billing 53208-0440-02)

by LG HOUSEHOLD & HEALTH CARE LTD. · 1 BOTTLE in 1 CARTON / 50 mL in 1 BOTTLE

This is a package of Sum 37 Micro Active Daily Moisture Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene 45 mg/mL; 90 mg/mL; 27 mg/mL; 90 mg/mL Cream from LG HOUSEHOLD & HEALTH CARE LTD., marketed since Mar 2025 and currently FDA-listed. It is this product's only package size.

NDC 53208-0440-02
🏷️ FDA NDC (as labeled) 53208-440-02 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

NDC database record

One package, one record: these facts belong to NDC 53208-440-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
53208 labeler · 440 product · 02 package
Package marketed since
Mar 10, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0803954311495
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53208-440-02
Product NDC 53208-440
11-digit billing NDC 53208044002
UNII 4X49Y0596W, 5A68WGF6WM, G63QQF2NOX, V06SV4M95S
UPC 0803954311495
Application # M020
SPL Set ID 2eea94e1-2409-8ad6-e063-6294a90a5df8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-10
Route TOPICAL
Dosage form CREAM
Substance OCTISALATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE
Why two NDCs? The FDA registers this code as 53208-440-02 — 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 → 53208-0440-02. 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?

Sum 37 Micro Active Daily Moisture Sunscreen is a topical cream formulated as an over-the-counter sunscreen product under FDA's OTC monograph rules. It contains four active UV filter ingredients: avobenzone, homosalate, octisalate, and octocrylene. These chemical sunscreen agents are typically used together to absorb and block ultraviolet radiation from reaching the skin. This product is intended for daily application to provide broad-spectrum sun protection.

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
53208-0440-02 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 50 mL in 1 BOTTLE 2025-03-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sum 37 Micro Active Daily Moisture Sunscreen 45 mg/mL; 90 mg/mL; 27 mg/mL; 90 mg/mLthis 53208-0440-02 LG 1 bottle — — 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

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year 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 45427ZB5IJ
    A clear liquid alcohol derived from fermentation or chemical synthesis. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative to extend shelf life in liquid medications.
  • UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • 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 9PA5A687X5
    Asiatic acid is a natural compound extracted from plants that acts as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while supporting skin hydration.
  • UNII PKO39VY215
    A natural compound derived from Centella asiatica plant, used as an active botanical extract or skin-conditioning agent in topical formulations to support ingredient stability and product efficacy.
  • UNII 298PX4M11X
    A synthetic chemical compound that acts as an antioxidant, helping protect the medicine's active ingredients from degradation caused by light, heat, and oxygen during storage and shelf life.
  • UNII Y3BP59PMD3
    A synthetic polymer made from acrylic compounds. It forms a protective coating on tablets or capsules to control where and how the medicine dissolves in your digestive system.
  • 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 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar formulations.
  • UNII T7EU0O9VPP
    Citral is a natural oil compound found in lemon and citrus plants. It's used in medicines as a flavoring agent and to add pleasant lemon or citrus scent to the product.
  • UNII P01OUT964K
    A fragrant plant-derived alcohol used as a flavoring agent and fragrance component in medicines. It provides taste and aroma to make the product more pleasant to use.
  • UNII UZH29XGA8G
    Lime oil is a natural fragrant liquid extracted from lime fruit peel. It's used in medicines as a flavoring agent to mask bitter or unpleasant tastes, making the medicine more pleasant to take.
  • UNII 39W1PKE3JI
    Bergamot oil is a citrus extract from bergamot orange peel. It's used as a flavoring and fragrance agent to improve taste and aroma in medicines.
  • 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 L837108USY
    Geraniol is a natural fragrant compound found in plants like roses and lemons. It's used in medicines as a flavoring agent and to improve the taste or aroma of 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 48RFF58ESG
    A plant-derived carbamate compound used as a binder and film-former in tablets and capsules. It helps hold ingredients together and may improve how the medicine breaks down in the digestive system.
  • 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 ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII GFD7C86Q1W
    A natural oil extracted from citrus peels, (+)-limonene is used as a flavoring agent and solvent in medicines. It helps dissolve active ingredients and provides a lemon or orange taste.
  • UNII D81QY6I88E
    Linalool is a natural fragrant oil found in plants like lavender and citrus. It's used in medicines as a flavoring agent and to mask unpleasant tastes or smells.
  • UNII M7O1N24J82
    Madecassic acid is a natural compound extracted from Centella asiatica plant. In medications, it acts as an active pharmaceutical ingredient or functional excipient that may support skin health and wound healing in topical formulations.
  • UNII 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • 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 3K0J1S7QGC
    A fragrant essential oil derived from geranium flowers, used as a flavoring and fragrance agent to improve the taste and aroma of medicines.
  • UNII S5J5OE47MK
    Phloretin is a natural compound found in apple trees and related plants. In medications, it's used as an antioxidant ingredient to help protect the product from degradation and maintain stability during storage.
  • UNII 03KCY6P7UT
    A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
  • UNII NG5NG5733T
    A synthetic polymer derived from acrylic acid and taurine. It functions as a suspending agent and emulsifier, helping keep ingredients evenly distributed and preventing separation in liquid or semi-solid medicines.
  • UNII MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • UNII 420IP921MB
    A chelating agent derived from edetic acid that binds to metals in the formulation. It helps stabilize the medicine by preventing metal ions from causing breakdown or discoloration.
  • UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesWATER, GLYCERIN, DIMETHICONE, CETEARYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, 1,2-HEXANEDIOL, BENZOTRIAZOLYL DODECYL P-CRESOL, PANTHENOL, GLYCERYL CAPRYLATE, ISODODECANE, GLYCERYL STEARATE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, CETEARYL OLIVATE, INULIN LAURYL CARBAMATE, SORBITAN OLIVATE, SODIUM POLYACRYLOYLDIMETHYL TAURATE, CITRUS AURANTIFOLIA (LIME) OIL, MAGNESIUM ALUMINUM SILICATE, TROMETHAMINE, XANTHAN GUM, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, TRISODIUM EDTA, VINEGAR, ANTHEMIS NOBILIS FLOWER OIL, BUTYLENE GLYCOL, ASIATICOSIDE, MADECASSIC ACID, ASIATIC ACID, PHLORETIN, 2,3-BUTANEDIOL, SACCHAROMYCES POLYPEPTIDES, LIMONENE, LINALOOL, CITRONELLOL, GERANIOL, CITRAL.

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

LabelerLG HOUSEHOLD & HEALTH CARE LTD.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code53208
First marketedMar 2025
Product typeHuman Otc Drug
Portfolio13 products on file

More NDCs from LG HOUSEHOLD & HEALTH CARE LTD. labeler code 53208

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 📦 Storage and Handling 🧪 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 📄 Questions or Comments 📖 Instructions for Use 📄 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 13 words ▾

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

⚠️ 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.

📦 Storage and Handling 14 words ▾

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

🧪 Active Ingredient 10 words ▾

Active Ingredients Avobenzone 2.7% Homosalate 9% Octisalate 4.5% Octocrylene 9%

🧪 Inactive Ingredients 79 words ▾

Inactive Ingredients WATER, GLYCERIN, DIMETHICONE, CETEARYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, 1,2-HEXANEDIOL, BENZOTRIAZOLYL DODECYL P-CRESOL, PANTHENOL, GLYCERYL CAPRYLATE, ISODODECANE, GLYCERYL STEARATE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, CETEARYL OLIVATE, INULIN LAURYL CARBAMATE, SORBITAN OLIVATE, SODIUM POLYACRYLOYLDIMETHYL TAURATE, CITRUS AURANTIFOLIA (LIME) OIL, MAGNESIUM ALUMINUM SILICATE, TROMETHAMINE, XANTHAN GUM, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, TRISODIUM EDTA, VINEGAR, ANTHEMIS NOBILIS FLOWER OIL, BUTYLENE GLYCOL, ASIATICOSIDE, MADECASSIC ACID, ASIATIC ACID, PHLORETIN, 2,3-BUTANEDIOL, SACCHAROMYCES POLYPEPTIDES, LIMONENE, LINALOOL, CITRONELLOL, GERANIOL, CITRAL.

🎯 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.

📄 Questions or Comments 2 words ▾

Questions? 1-866-993-4709

📖 Instructions for Use 95 words ▾

Directions Apply generously and evenly 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. Children under 6 months: Ask a doctor.

📄 Package Label / Principal Display Panel 2 words ▾

Bottle Carton

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 Sum 37 Micro Active Daily Moisture Sunscreen (this brand).

Top reported reactions

Acute Myeloid Leukaemia2
Exposure To Toxic Agent2
Product Contamination Chemical2
Rash2
Anaphylactic Reaction1
Application Site Erythema1
Application Site Exfoliation1

Age at onset

Adolescent2
Adult1

Reporter sex

6 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization2
Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2 1
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 LG HOUSEHOLD & HEALTH CARE LTD.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
LG HOUSEHOLD & HEALTH CARE 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.
← 53208-0422-50 · LG 53208-0461-60 · LG →
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.