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111 SKIN SUNSCREEN SPF 50 Zinc Oxide 19.5 g/100mL Solution — NDC 54111-0190-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

111 SKIN SUNSCREEN SPF 50 Zinc Oxide 19.5 g/100mL Solution — NDC 54111-190-01 (Billing 54111-0190-01)

by Bentley Laboratories, LLC · 1 BOTTLE, PUMP in 1 CARTON / 50 mL in 1 BOTTLE, PUMP

This is a package of 111 SKIN SUNSCREEN SPF 50 Zinc Oxide 19.5 g/100mL Solution from Bentley Laboratories, LLC, marketed since May 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 54111-0190-01
🏷️ FDA NDC (as labeled) 54111-190-01 billing pads the product segment with a zero
This package
Contains50 mL in 1 bottle, pump Pack sizes2 compare ↓
Main listing for product 54111-190 · Also comes in: 15 mL 54111-190-02
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) 54111-190-01
Product NDC 54111-190
11-digit billing NDC 54111019001
UNII SOI2LOH54Z
Application # M020
SPL Set ID b1265797-71dd-4302-ab26-dbff6ccec856
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-23
Route TOPICAL
Dosage form SOLUTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 54111-190-01 — 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 → 54111-0190-01. 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 solution containing zinc oxide, an over-the-counter monograph product marketed under FDA's established rules for sunscreen ingredients. Zinc oxide is a mineral UV filter typically used to reflect and scatter ultraviolet light away from the skin. This formulation is labeled SPF 50 and is applied to the skin surface to provide broad-spectrum sun protection.

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 mLPer 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.
Try another pack size: 15 mL
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
54111-0190-01 You're viewing this Main listing 1 BOTTLE, PUMP in 1 CARTON / 50 mL in 1 BOTTLE, PUMP 2025-05-23 — Active
54111-0190-02 54111-190-02 1 BOTTLE, PUMP in 1 CARTON / 15 mL in 1 BOTTLE, PUMP 2026-05-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, pump in 1 carton / 50 ml in 1 bottle, pump.
What NDC number is used to bill for this package of 111 SKIN SUNSCREEN SPF 50 Zinc Oxide 19.5 g/100mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
111 Skin Sunscreen Spf 50 19.5 g/100mLthis 54111-0190-01 Bentley 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
May 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 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 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 WYQ7N0BPYC
    A compound derived from the amino acid cysteine. It acts as a mucolytic agent to help thin and break down mucus, making it easier to expel from airways.
  • 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 C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII Q95M2P1KJL
    A silicone-based ingredient that acts as a lubricant and glidant. It helps the tablet or capsule move smoothly through manufacturing equipment and improves powder flow during production.
  • UNII V2W71V8T0X
    A silicone-based compound that mixes oil and water together. Used in formulations as an emulsifier to help blend ingredients and improve texture and stability of creams, lotions, and other topical products.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • 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 6Y9488RL8H
    A synthetic fragrance compound used as a flavoring or scent agent in medications. It helps mask unpleasant tastes or odors in the medicine to make it easier to take.
  • 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 RUU8G67GQM
    Escin is a natural mixture of plant compounds extracted from horse chestnut seeds. It acts as a surfactant and emulsifier in medicines, helping to dissolve and mix ingredients that normally don't blend well together.
  • UNII 5B8915UELW
    A plant-derived compound used as an antioxidant in medicines. It helps prevent spoilage and degradation of active ingredients during storage by protecting them from oxidative damage.
  • UNII 3W81YG7P9R
    Geranyl acetate is a fragrant compound derived from natural plant sources. It is used in medicines as a flavoring agent to improve taste or as a fragrance component.
  • 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 WZ7DY7GBV6
    A plant-based oil extract from soybeans that contains compounds resistant to saponification. Used in formulations as an emollient and skin-conditioning agent to improve texture and spreadability of topical or oral products.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII ISA73Z2140
    A synthetic emollient and conditioning agent derived from palmitic acid. It helps soften the product's texture, improve spreadability, and enhance how the medicine feels on skin or mucous membranes.
  • UNII 1I96OHX6EK
    A cyclic carbohydrate derived from plant starch that acts as a solubilizer and stabilizer. It helps dissolve poorly water-soluble drugs and protects active ingredients from degradation in the formulation.
  • 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 19NOL5474Q
    Isopentyldiol is a synthetic alcohol derived from isoprene. It functions as a humectant and solvent in formulations, helping to retain moisture and dissolve or suspend active ingredients.
  • UNII 7666FJ0J9F
    A rosin-derived compound used as a film-coating agent and binder in tablets and capsules. It helps create a protective layer around the medication and improves tablet hardness.
  • UNII CST1G9BZGD
    A plant extract from white mulberry root used as a natural ingredient. It may serve as a filler or help stabilize the medicine's formulation.
  • UNII GM2TDN9DZI
    A juice extract from physalis pubescens fruit, a plant in the nightshade family. It's used as a flavoring agent and natural coloring ingredient in medicines.
  • UNII MGE3733FR2
    Polyglutamic acid is a synthetic polymer made from linked amino acids. In medications, it acts as a binder to hold tablet ingredients together and may help control how quickly the drug dissolves and releases in your body.
  • UNII 55C81W76DH
    A synthetic emulsifier made from glycerin and oleic acid (a plant-based oil). It helps blend water and oil-based ingredients together in formulations and improves how the product spreads or absorbs.
  • 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 687U3PEB2Y
    A complex emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients together and improves the texture and stability of creams, lotions, and other formulated products.
  • UNII Q48X4BL3TV
    A synthetic emulsifier made from plant-derived glycerin and lauric acid. It helps blend oil and water-based ingredients together in creams and lotions for smooth, uniform texture.
  • 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 8D08K3S51E
    Propylene carbonate is a clear liquid solvent derived from propylene. It helps dissolve or suspend active ingredients in liquid medicines and can improve how well the product flows and mixes.
  • 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 D4H5GGS5JF
    Rice germ oil is a natural oil extracted from rice plant germs. In medicines, it serves as a lubricant to help tablets slide smoothly during manufacturing and as a vehicle to help deliver active ingredients.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII R6Q3791S76
    Sodium gluconate is a salt derived from gluconic acid, a naturally occurring compound. In medicines, it functions as a buffering agent to help maintain stable pH and as a chelating agent that can bind minerals in formulations.
  • UNII 77K6Z421KU
    Sorbitan monopalmitate is an emulsifier made from sorbitol, a natural sugar alcohol, combined with palmitic acid. It helps mix oil and water ingredients together in medications and keeps them evenly blended throughout the product's shelf life.
  • UNII 71B37NR06D
    Soy isoflavones are natural plant compounds extracted from soybeans. They are used in dietary supplements and some medications as an active botanical ingredient to support formulation claims, though they function as an additive rather than a traditional inactive excipient.
  • UNII 24SC3U704I
    A powdery carbohydrate extracted from tapioca plant roots. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your digestive system.
  • UNII R53Q4ZWC99
    Terpineol is a fragrant alcohol derived from pine oil or other plant sources. It's used in medicines as a flavoring agent and to improve the taste or aroma of the product.
  • UNII 9LBV3F07AZ
    A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
  • UNII 2JU6ZH6GRE
    A synthetic fragrance compound made by modifying naphthalene molecules. It's used in very small amounts to add pleasant scent to medications, making them more appealing to take.
  • UNII 4JS0838828
    A plant extract from red clover flowers used in herbal or natural formulations. It may serve as an active botanical ingredient or flavor/color component, though its specific role depends on the product's intended use.
  • 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 H92E6QA4FV
    Zinc stearate is a fine white powder made from zinc and stearic acid. It works as a lubricant and glidant to help the tablet or capsule move smoothly through manufacturing equipment and prevents sticking.

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

The official label also statesInactive ingredients/Ingredients inactifs Isododecane, Water (Aqua/Eau), Coco-Caprylate/ Caprate, Caprylyl Methicone, Propanediol, Glycerin, Polyglyceryl-4 Diisostearate/ Polyhydroxystearate/Sebacate, Cetyl PEG/ PPG-10/1 Dimethicone, Methyl Dihydroabietate, Tapioca Starch, Argania Spinosa Kernel Oil, Sodium Chloride, Tocopheryl Acetate, Dimethicone, Ethyl Ferulate, Disteardimonium Hectorite, Glycine Soja (Soybean) Oil, Hydroxyacetophenone, Isopentyldiol, Zinc Stearate, Propylene Carbonate, Physales Pubescens Fruit Juice, 1,2-Hexanediol, Caprylyl Glycol, Caprylic/Capric Triglyceride, Sodium Gluconate, Polyglyceryl-3 Diisostearate, Bisabolol, Escin, Fragrance (Parfum), Hydroxypropyl Cyclodextrin, Morus Alba Root Extract, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Tetrahexyldecyl Ascorbate, Polyglutamic Acid, Polyglyceryl-6 Laurate, Polycglyceryl-10 Oleate, Trifolium Pratense (Clover) Flower Extract Sorbitan Palmitate, Acetyl Cysteine, Soy Isoflavones, Glycosphingolipids, Tetramethyl Acetyloctahydronaphthalenes, Geranyl Acetate, Terpineol, Dimethyl Phenethyl Acetate.

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

LabelerBentley Laboratories, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code54111
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio35 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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

⏱️ Dosage and Administration 103 words ▾

Directions • Apply generously and evenly to face and neck 15-20 minutes before sun exposure. • Reapply at least every 2 hours • Use a water-resistant sunscreen when swimming or sweating. • Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early aging. To reduce this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: - Limiting 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.

⚠️ Warnings 42 words ▾

Warnings Do not use on damaged or broken skin. For external use only. When using this produc t keep out of eyes. If product gets into the eyes, rinse with water to remove Stop use and consult a doctor if rash occurs.

🧪 Active Ingredient 7 words ▾

Drug Facts Active Ingredients Zinc Oxide 19.5%

🧪 Inactive Ingredients 106 words ▾

Inactive ingredients/Ingredients inactifs Isododecane, Water (Aqua/Eau), Coco-Caprylate/ Caprate, Caprylyl Methicone, Propanediol, Glycerin, Polyglyceryl-4 Diisostearate/ Polyhydroxystearate/Sebacate, Cetyl PEG/ PPG-10/1 Dimethicone, Methyl Dihydroabietate, Tapioca Starch, Argania Spinosa Kernel Oil, Sodium Chloride, Tocopheryl Acetate, Dimethicone, Ethyl Ferulate, Disteardimonium Hectorite, Glycine Soja (Soybean) Oil, Hydroxyacetophenone, Isopentyldiol, Zinc Stearate, Propylene Carbonate, Physales Pubescens Fruit Juice, 1,2-Hexanediol, Caprylyl Glycol, Caprylic/Capric Triglyceride, Sodium Gluconate, Polyglyceryl-3 Diisostearate, Bisabolol, Escin, Fragrance (Parfum), Hydroxypropyl Cyclodextrin, Morus Alba Root Extract, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Tetrahexyldecyl Ascorbate, Polyglutamic Acid, Polyglyceryl-6 Laurate, Polycglyceryl-10 Oleate, Trifolium Pratense (Clover) Flower Extract Sorbitan Palmitate, Acetyl Cysteine, Soy Isoflavones, Glycosphingolipids, Tetramethyl Acetyloctahydronaphthalenes, Geranyl Acetate, Terpineol, Dimethyl Phenethyl Acetate.

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Other Information 11 words ▾

Other Information Protect this product from excessive heat and direct sun.

📄 Package Label / Principal Display Panel 65 words ▾

Product Labeling: 111 SKIN SUNSCREEN SPF 50 111SKIN HARLEY ST. LONDON SPF 50 DR YANNIS ALEXANDRIDES SUNSCREEN SPF50 ℮50mL./1.69 Fl.Oz. Made in the USA for: 111 SKIN LTD 111 Harley Street, London, WiG 6AW, UK [email protected] 50 mL Carton 50 mL Bottle 15 mL Carton 15 mL Bottle res 50mL 111 Skin Box 50mL 111 Skin Botl 15mL 111 Skin Box 15mL 111 Skin Botl

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

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 Bentley Laboratories, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (54111-0190-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Bentley Laboratories, LLC 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.
← 54111-0189-20 · Bentley 54111-0191-01 · Bentley →
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.