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Kids Mineral Face Cream SPF20 Zinc Oxide 115 mg/g Cream — NDC 72113-0117-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Kids Mineral Face Cream SPF20 Zinc Oxide 115 mg/g Cream — NDC 72113-117-03 (Billing 72113-0117-03)

by Eden Brands Inc · 1 JAR in 1 CARTON / 50 g in 1 JAR

This is a package of Kids Mineral Face Cream SPF20 Zinc Oxide 115 mg/g Cream from Eden Brands Inc, marketed since Jul 2026 and currently FDA-listed. It is this product's only package size.

NDC 72113-0117-03
🏷️ FDA NDC (as labeled) 72113-117-03 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 72113-117-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
72113 labeler · 117 product · 03 package
Package marketed since
Jul 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7211311703 7
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) 72113-117-03
Product NDC 72113-117
11-digit billing NDC 72113011703
UNII SOI2LOH54Z
Application # M020
SPL Set ID fbfccb0c-e459-3282-e053-6394a90ad95d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-01
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 72113-117-03 — 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 → 72113-0117-03. 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 cream formulated for children's facial sun protection. Zinc oxide is a mineral sunscreen active ingredient that functions as a physical UV filter, reflecting ultraviolet light away from the skin. This product is marketed as an over-the-counter monograph drug, meaning it is made and sold according to FDA's established rules for sunscreen products 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
72113-0117-03 You're viewing this Main listing 1 JAR in 1 CARTON / 50 g in 1 JAR 2026-07-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Evereden Cooling Mineral Sunstick SPF 30 115 mg/g 72113-0115-22 Eden 1 canister — — FDA listed —
Evereden Kids Cooling Mineral Sunstick SPF30 115 mg/g 72113-0116-22 Eden 1 canister — — FDA listed —
Kids Mineral Face Cream SPF20 115 mg/gthis 72113-0117-03 Eden 1 jar — — 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
Jul 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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 UV3GO1D90J
    A chemical compound derived from acetophenone, used in pharmaceuticals as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in liquid formulations.
  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • 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 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 331KBJ17RK
    Canola oil is a plant-based oil derived from rapeseed. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and may improve how the body absorbs certain medications.
  • 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII YY7C30VXJT
    A natural plant extract from cucumber that adds flavor and freshness to medicines. It may also serve as a moisturizing agent or mild preservative in topical or oral formulations.
  • 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 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 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 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 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • UNII T7ZE2WA4MB
    A plant-derived oil component that doesn't break down with soap, used as an emollient and skin-conditioning agent in topical medicines and formulations. It helps soften and smooth the product's texture.
  • UNII K168T6Y0YU
    A plant-based oil derived from rapeseed that has been chemically treated to make it solid at room temperature. It acts as a binder, lubricant, and coating agent to help hold tablet ingredients together and improve how the medicine flows during manufacturing.
  • UNII UDR641JW8W
    A plant-derived oil from jojoba seeds that has been broken down into smaller components. It acts as an emollient and skin-conditioning agent to help soften and smooth the product's texture.
  • UNII 86FQE96TZ4
    A synthetic polymer, this ingredient acts as a thickener and suspending agent in liquid formulations. It helps maintain uniform consistency and keeps particles evenly distributed throughout the medicine.
  • 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 253MC0P0YV
    A waxy compound made from glycerin and stearic acid, used as an emulsifier to help mix oil and water-based ingredients together in the formulation.
  • UNII 46P231IQV8
    A synthetic emulsifier derived from glycerin and fatty acids. It helps blend oil and water-based ingredients together in cosmetic and pharmaceutical formulations to create stable, uniform products.
  • UNII 8KQ7I65XZE
    A waxy compound derived from stearic acid, used as a thickener and emulsifier to help blend oil and water-based ingredients. It improves the texture and stability of the medicine formulation.
  • UNII C2BRV53B1V
    A plant-derived oil from pongamia seeds used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product texture while improving how it spreads on skin.
  • 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 7N2B70SFEZ
    Rice germ is the nutrient-rich inner layer of the rice grain. It's used in medicines as a filler and bulking agent to add volume and help bind ingredients together in tablets and capsules.
  • UNII 2X51AD1X3T
    A fermented grain-derived polysaccharide used as a thickening and stabilizing agent in liquid formulations to improve texture and help maintain consistent suspension of active ingredients.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII 01S2G2C1E4
    Sorbitan isostearate is an emulsifier derived from sorbitol and isostearic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the medicine's shelf life.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII YA22H34H9Q
    A chelating agent derived from sodium and organic compounds. It binds to metal ions in the formulation to improve stability and prevent unwanted chemical reactions that could degrade the medicine.
  • 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.

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

The official label also statesINACTIVE INGREDIENTS: Water (Aqua), Caprylic/Capric Triglyceride, Dimethicone, Propanediol, Glycerin, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, 1,2-Hexanediol, Polyglyceryl-2 Stearate, Tocopheryl Acetate, Glyceryl Stearate, Polyhydroxystearic Acid, Vegetable Oil, Stearyl Alcohol, Glycine Soja (Soybean) Oil, Jojoba Esters, Hydroxyacetophenone, Sclerotium Gum, Simmondsia Chinensis (Jojoba) Seed Oil, Panthenol, Cucumis Sativus (Cucumber) Fruit Extract, Xanthan Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyglyceryl-3 Diisostearate, Hydrogenated Vegetable Oil, Bisabolol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Pongamia Pinnata Seed Extract, Euphorbia Cerifera (Candelilla) Wax, Trisodium Ethylenediamine Disuccinate, Sorbitan Isostearate, Citric 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

LabelerEden Brands Inc
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code72113
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from Eden Brands Inc labeler code 72113

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 5 words ▾

USES: Helps prevent sunburn. .

⏱️ Dosage and Administration 95 words ▾

DIRECTIONS DIRECTIONS: - 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 10am-2pm -Wear long-sleeved shirts, pants, hats, and sunglasses.

⚠️ Warnings 54 words ▾

WARNINGS For external use only. 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 7 words ▾

ACTIVE INGREDIENT ACTIVE INGREDIENT: Zinc Oxide, 11.5%

🧪 Inactive Ingredients 95 words ▾

INACTIVE INGREDIENTS INACTIVE INGREDIENTS: Water (Aqua), Caprylic/Capric Triglyceride, Dimethicone, Propanediol, Glycerin, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, 1,2-Hexanediol, Polyglyceryl-2 Stearate, Tocopheryl Acetate, Glyceryl Stearate, Polyhydroxystearic Acid, Vegetable Oil, Stearyl Alcohol, Glycine Soja (Soybean) Oil, Jojoba Esters, Hydroxyacetophenone, Sclerotium Gum, Simmondsia Chinensis (Jojoba) Seed Oil, Panthenol, Cucumis Sativus (Cucumber) Fruit Extract, Xanthan Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyglyceryl-3 Diisostearate, Hydrogenated Vegetable Oil, Bisabolol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Pongamia Pinnata Seed Extract, Euphorbia Cerifera (Candelilla) Wax, Trisodium Ethylenediamine Disuccinate, Sorbitan Isostearate, Citric Acid

🎯 Purpose 3 words ▾

PURPOSE 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 19 words ▾

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

📄 Other Information 14 words ▾

OTHER INFORMATION Protect the product in this container from excessive heat and direct sun.

📄 Package Label / Principal Display Panel 1 words ▾

Secondary

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 Kids Mineral Face Cream SPF20 (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
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization988
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 196 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 Eden Brands Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Eden Brands Inc 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.
← 72113-0116-22 · Eden 72113-0118-14 · Eden →
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.