Home › NDC Lookup › Ingredients › Zinc Oxide 18.2% › 79753-0042-01
Coola Bare Republic Mineral Body Gel-Lotion SPF 30 ZINC OXIDE 18.2% 18.2 g/100mL Lotion, 118 mL — NDC 79753-0042-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Coola Bare Republic Mineral Body Gel-Lotion SPF 30 ZINC OXIDE 18.2% 18.2 g/100mL Lotion, 118 mL — NDC 79753-042-01 (Billing 79753-0042-01)

by COOLA LLC · 118 mL in 1 TUBE

This is a package of 118 mL of Coola Bare Republic Mineral Body Gel-Lotion SPF 30 ZINC OXIDE 18.2% 18.2 g/100mL Lotion from COOLA LLC, marketed since Mar 2020 and currently FDA-listed. It is this product's only package size.

NDC 79753-0042-01
🏷️ FDA NDC (as labeled) 79753-042-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 79753-042-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
79753 labeler · 042 product · 01 package
Package marketed since
Mar 2, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7975304201 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 79753-042-01
Product NDC 79753-042
11-digit billing NDC 79753004201
UNII SOI2LOH54Z
Application # M020
SPL Set ID d745d12e-8741-4bf2-89ec-c6f72a8d548b
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 2020-03-02
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 79753-042-01 — 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 → 79753-0042-01. 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 lotion sunscreen containing zinc oxide, an inorganic mineral UV filter. Zinc oxide is commonly used in sunscreens to reflect and scatter ultraviolet radiation away from the skin. Products containing zinc oxide are typically applied to exposed skin areas as part of sun protection routines. This product is marketed under the FDA's over-the-counter monograph rules for sunscreen ingredients.

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
79753-0042-01 You're viewing this Main listing 118 mL in 1 TUBE 2020-03-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Coola Bare Republic Mineral Body Gel-Lotion SPF 30 18.2 g/100mLthis 79753-0042-01 COOLA 118 ml — — FDA listed —
Coola Bare Republic Mineral Face Gel-Lotion SPF 30 18.2 g/100mL 79753-0043-01 COOLA 1 tube — — 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

🏛️
2020
On the market since
Mar 2020
📍
2026
Currently FDA-listed
6 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 I9V075M61R
    A fragrant organic compound used as a flavoring agent and aroma enhancer in medicines. It adds pleasant taste and smell to make the medication more palatable.
  • UNII 33DIC582TL
    Delta-dodecalactone is a naturally occurring compound with a pleasant, creamy odor. It functions as a flavoring agent in medicines to improve taste and make products more palatable for patients.
  • UNII I1XGH66S8P
    A naturally-derived liquid compound used as a flavoring agent in medicines. It provides a creamy, coconut-like taste to mask bitter drug flavors and improve how the medication tastes to patients.
  • UNII UHD6M52X0K
    Gamma-octalactone is a natural flavoring compound derived from plants. It's added to medicines to mask unpleasant tastes and improve palatability, particularly in liquid formulations.
  • UNII QB1T0AG2YL
    A naturally occurring compound used in medicines as a flavoring agent to mask bitter or unpleasant tastes. It may also serve as a fragrance component in certain formulations.
  • UNII Z331YX9EL9
    A synthetic fragrance compound used as a flavoring agent in medicines. It provides taste and aroma to make oral medications more palatable, particularly in liquid formulations or chewable products.
  • UNII V14F8G75P4
    A fragrant alcohol compound derived from plants or made synthetically. It's used as a flavor and aroma agent to improve the taste and smell of medicines.
  • UNII 575DY8C1ER
    Aloe vera flower is a natural plant extract used in medicines as a skin-soothing agent and emollient. It helps soften and moisturize formulations, particularly in topical products like creams and lotions.
  • 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 Q7UI015FF9
    A synthetic polymer material used as a thickener and stabilizer in liquid formulations. It helps create the right texture and prevents separation of ingredients in medicines and topical products.
  • UNII 3TE8A92UPM
    Azadirachta indica flower is a botanical extract from the neem plant. It may be used in formulations for its traditional preservative or antioxidant properties to help maintain product stability.
  • UNII HKY915780T
    A plant extract from the neem tree, used as a natural flavoring agent and preservative in medicines. It may help maintain product stability and add bitter taste characteristics.
  • UNII JZ1374NL9E
    A synthetic polymer made from acrylic compounds that forms a flexible coating. It's used to coat tablets and capsules to control where and how the medicine dissolves in the digestive system, or to protect the ingredient from moisture and stomach acid.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • 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 595AO13F11
    Carrot seed oil is a plant-based oil extracted from carrot seeds. It's used in medicines as a flavor and fragrance component, and may help distribute active ingredients evenly throughout the formulation.
  • 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 VLJ6WOT3K5
    A plant extract from the Coccinia indica fruit, used in herbal and traditional formulations. It may serve as a natural flavoring agent, colorant, or active botanical component depending on the product's intended use.
  • UNII 4004498D06
    A red algae extract used as a natural colorant and pH buffer in medicines. It provides reddish tones to tablets and capsules while helping maintain stable acidity levels in the formulation.
  • UNII 31Z90Q7KQJ
    Decanal is a natural aldehyde compound used as a fragrance and flavoring ingredient. It adds aroma and taste to medicines, helping mask unpleasant flavors or odors in the formulation.
  • UNII JXN40O9Y9B
    A synthetic antimicrobial agent used as a preservative in liquid medicines and topical products. It helps prevent bacterial and fungal growth to maintain product stability and safety during storage.
  • 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 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 W5K7RAS4VK
    A purple vegetable extract used as a natural colorant in some medicines. It provides color to tablets or capsules without affecting how the drug works.
  • 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 FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • UNII 930MLC8XGG
    A plant oil extracted from grape seeds, used as an emollient and solvent in medicines. It helps dissolve active ingredients and improve the texture and absorption of topical or liquid formulations.
  • UNII 7U7KU3MWT0
    Hexyl acetate is a synthetic liquid compound used as a solvent and flavoring agent in medicines. It helps dissolve other ingredients and can contribute to the taste or aroma of the formulation.
  • UNII SCJ765569P
    Holy basil leaf is a plant-derived ingredient used in some formulations as a flavoring agent or botanical additive. It may contribute taste and aroma to the medicine.
  • UNII PAD4FN7P2G
    A fragrant essential oil from juniper wood, used primarily as a flavoring agent and fragrance component to mask tastes and add aroma to medicines.
  • UNII 76LN7P7UCU
    Lauryl glucoside is a mild plant-based cleansing agent made from coconut oil and glucose. It's used in medicines as a surfactant to help dissolve and distribute ingredients evenly throughout the formulation.
  • 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 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 N8F53B3R4R
    A synthetic humectant and solvent derived from propane. It draws and holds moisture in the formulation, helping keep the medicine stable and improving texture or flow in liquid and semi-solid products.
  • UNII 7SAB275FP2
    A plant extract made from basil flowers and leaves. It's used in medicines as a flavoring agent and may help preserve the product by providing natural antimicrobial properties.
  • UNII 4KDO9AFM9I
    A plant-derived emulsifier made from olive oil and polyglycerols. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • 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 991Z19V2OD
    Propylheptyl caprylate is a synthetic oily liquid made from fatty acids. It's used in medicines as an emollient and solvent to help dissolve active ingredients and improve how the product spreads or absorbs.
  • UNII 9S8867952A
    A plant-derived oil from raspberry seeds used as an emollient and skin-conditioning agent in topical formulations. It helps soften the product texture and improve skin feel.
  • 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 NVZ4I0H58X
    A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
  • UNII 23XPH3M9LR
    Sorbityl laurate is a synthetic emulsifier derived from sorbitol and lauric acid. It helps mix oil and water ingredients together and may also act as a surfactant in the formulation.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII A3LZF0L939
    Tridecane is a clear, colorless liquid hydrocarbon derived from petroleum. It acts as a solvent and lubricant in medicines, helping distribute active ingredients evenly and reducing friction during manufacturing and tablet compression.
  • UNII LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
  • UNII 856YO1Z64F
    Turmeric is a natural spice derived from the turmeric plant root. It serves as a colorant in medicines, giving products a yellow or golden appearance, and may also provide mild flavoring.
  • UNII JV0QT00NUE
    Undecane is a clear liquid hydrocarbon derived from petroleum. It functions as a solvent and processing aid in medicines, helping dissolve or suspend active ingredients and improve how the drug is manufactured and delivered.
  • 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.

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

The official label also statesInactive Ingredients Acrylates Copolymer, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice, Alpha-Ionone*, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Caprylic/capric Triglyceride, Caprylyl Glycol, Citric Acid, Coccinia Indica Fruit Extract, Corallina Officinalis Extract, Curcuma Longa (Turmeric) Root Extract, Daucus Carota Sativa (Carrot) Seed Oil, Decanal*, Delta-Dodecalactone*, Didecyldimonium Chloride, Dimethicone, Dimethyl Heptenal*, Ethyl Ferulate, Gamma-Nonalactone*, Gamma-Octalactone*, Gamma-Undecalactone*, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Seed Oil, 3-Hexenol*, Hexyl Acetate*, Juniperus Virginiana Oil*, Lauryl Glucoside, Melia Azadirachta Flower Extract, Melia Azadirachta Leaf Extract, Methyl Dihydroabietate, Methlypropanediol, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Olive Oil Polyglyceryl-6 Esters, Polyacrylate Crosspolymer-6, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Polyquaternium-80, Polysilicone-11, Propylheptyl Caprylate, Rubus Idaeus (Raspberry) Seed Oil, Solanum Melongena (Eggplant) Fruit Extract, Sorbitan Stearate, Sorbityl Laurate, Tridecane, Triethoxycaprylylsilane, Triethyl Citrate*, Undecane, Vitis Vinifera (Grape) Seed Oil, Water, Xanthan Gum

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

LabelerCOOLA LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code79753
First marketedMar 2020
Product typeHuman Otc Drug
Portfolio25 products on file

More NDCs from COOLA LLC labeler code 79753

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 32 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 103 words ▾

Directions ● Shake well. Apply liberally 15 minutes before sun exposure ● reapply: ● after 40 minutes of swimming or sweating ● immediately after towel drying ● at least every 2 hours ● 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 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-sleeve shirts, pants, hats, and sunglasses ● Children under 6 months: Ask a doctor

⚠️ Warnings 35 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 doctor if skin rash occurs

🧪 Active Ingredient 9 words ▾

Drug Facts Active Ingredients Zinc Oxide 18.2% Purpose Suncreen

🧪 Inactive Ingredients 133 words ▾

Inactive Ingredients Acrylates Copolymer, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice, Alpha-Ionone*, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Caprylic/capric Triglyceride, Caprylyl Glycol, Citric Acid, Coccinia Indica Fruit Extract, Corallina Officinalis Extract, Curcuma Longa (Turmeric) Root Extract, Daucus Carota Sativa (Carrot) Seed Oil, Decanal*, Delta-Dodecalactone*, Didecyldimonium Chloride, Dimethicone, Dimethyl Heptenal*, Ethyl Ferulate, Gamma-Nonalactone*, Gamma-Octalactone*, Gamma-Undecalactone*, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Seed Oil, 3-Hexenol*, Hexyl Acetate*, Juniperus Virginiana Oil*, Lauryl Glucoside, Melia Azadirachta Flower Extract, Melia Azadirachta Leaf Extract, Methyl Dihydroabietate, Methlypropanediol, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Olive Oil Polyglyceryl-6 Esters, Polyacrylate Crosspolymer-6, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Polyquaternium-80, Polysilicone-11, Propylheptyl Caprylate, Rubus Idaeus (Raspberry) Seed Oil, Solanum Melongena (Eggplant) Fruit Extract, Sorbitan Stearate, Sorbityl Laurate, Tridecane, Triethoxycaprylylsilane, Triethyl Citrate*, Undecane, Vitis Vinifera (Grape) Seed Oil, Water, Xanthan Gum

🎯 Purpose 2 words ▾

Purpose Suncreen

📄 Keep Out of Reach of Children 21 words ▾

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

📄 Other Information 11 words ▾

Other information protect this product from excessive heat and direct sun

📄 Package Label / Principal Display Panel 56 words ▾

COOLA Label SPF 30 BARE REPUBLIC MINERAL Sunscreen Non-Nano Zinc Oxide Gel-Lotion Sheer, Ultra-Light Hydration Broad Spectrum SPF 30 Water Resistant (40 Minutes)

4.0FL OZ / 118 mL *Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free ©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool San Diego, CA 92010. WWW.GOBAREOUTSIDE.COM res 042 ltube

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 COOLA LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
COOLA 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.
← 79753-0041-01 · COOLA 79753-0043-01 · COOLA →
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.