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365 Whole Foods Market Kids Clear Sunscreen Spf 50 Octocrylene, Octisalate, Avobenzone, and Homosalate 10 g/100g; 5 g/100g; 3 g/100g; 15 g/100g Aerosol, Spray, 147 g — NDC 42681-0065-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

365 Whole Foods Market Kids Clear Sunscreen Spf 50 Octocrylene, Octisalate, Avobenzone, and Homosalate 10 g/100g; 5 g/100g; 3 g/100g; 15 g/100g Aerosol, Spray, 147 g — NDC 42681-0065-1 (Billing 42681-0065-01)

by Whole Foods Market, Inc. · 147 g in 1 BOTTLE, SPRAY

This is a package of 147 g of 365 Whole Foods Market Kids Clear Sunscreen Spf 50 Octocrylene, Octisalate, Avobenzone, and Homosalate 10 g/100g; 5 g/100g; 3 g/100g; 15 g/100g Aerosol, Spray from Whole Foods Market, Inc., marketed since Jul 2026 and currently FDA-listed. It is this product's only package size.

NDC 42681-0065-01
🏷️ FDA NDC (as labeled) 42681-0065-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 42681-0065-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
42681 labeler · 0065 product · 1 package
Package marketed since
Jul 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0099482551087, 0099482551070
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42681-0065-1
Product NDC 42681-0065
11-digit billing NDC 42681006501
UNII G63QQF2NOX, 5A68WGF6WM, V06SV4M95S, 4X49Y0596W
UPC 0099482551087, 0099482551070
Application # M020
SPL Set ID 82771f22-0197-40ba-97d2-2386152790ed
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 AEROSOL, SPRAY
Substance OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE
Why two NDCs? The FDA registers this code as 42681-0065-1 — a 5-4-1 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 package segment → 42681-0065-01. 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 spray sunscreen lotion marketed for children, containing four active ultraviolet (UV) light filters: avobenzone, homosalate, octisalate, and octocrylene. These ingredients are commonly used together in sunscreen products to absorb and scatter UV radiation from the sun. The product is formulated as an aerosol spray applied to the skin and is regulated as an over-the-counter monograph drug, meaning it follows FDA's established rules for sunscreen ingredients and labeling rather than undergoing individual product review.

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 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.
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
42681-0065-01 You're viewing this Main listing 147 g in 1 BOTTLE, SPRAY 2026-07-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
365 Whole Foods Market Kids Clear Sunscreen Spf 50 10 g/100g; 5 g/100g; 3 g/100g; 15 g/100gthis 42681-0065-01 Whole 147 g — — FDA listed —
365 Whole Foods Market Sunscreen Clear Coconut Vanilla Spf 50 10 g/100g; 5 g/100g; 3 g/100g; 15 g/100g 42681-0064-01 Whole 147 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
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.

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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • UNII 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • UNII 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 N7YC58165T
    A synthetic polymer made from glycerin and sebacic acid, used as a film-former and binder in medications. It helps hold tablet or capsule ingredients together and may coat the product for controlled release.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • 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 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • 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 W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII A23O709X8O
    A synthetic compound derived from rosin that acts as a film-forming agent and binder. It helps create a protective coating on tablets or capsules and improves how the medicine holds together during manufacturing and storage.
  • 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 CR7307M3QZ
    Rosa canina fruit oil is a natural oil extracted from rosehip fruit. It's used in medicines as an emollient and skin-conditioning agent to help soften and smooth the product's texture or skin contact surface.
  • 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 0W8RRI5W5A
    A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII AZQ08K38Z1
    A synthetic oily liquid derived from salicylic acid. It works as an emollient and penetration enhancer in topical formulations, helping active ingredients absorb into skin while conditioning and softening the application area.

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

The official label also statesAlcohol, Aloe Barbadensis (Aloe Vera) Leaf Juice Organic Ingredients, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Capryloyl Glycerin/Sebacic Acid Copolymer, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexyl Palmitate, Fragrance (Natural) COMPLIES WITH ISO 9235, SEE www.wholefoodsmarket.com FOR MORE INFORMATION. AVOID OVERSPRAY ONTO FABRICS AND OTHER SURFACES AS IT COULD RESULT IN DISCOLORATION., Glycerin, Hydrogenated Methyl Abietate, Rosa Canina (Rosehip) Fruit Oil, Sorbitan Sesquioleate, Tocopherol, Tridecyl Salicylate Alcohol, Aloe Barbadensis (Aloe Vera) Leaf Juice Organic Ingredients, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Capryloyl Glycerin/Sebacic Acid Copolymer, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexyl Palmitate, Glycerin, Hydrogenated Methyl Abietate, Sorbitan Sesquioleate, Tocopherol, Tridecyl Salicylate

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

LabelerWhole Foods Market, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code42681
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio46 products on file

More NDCs from Whole Foods Market, Inc. labeler code 42681

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 60 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

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 ~1 min read ▾

Directions SHAKE WELL before use spray liberally and spread evenly by hand 15 minutes before sun exposure and as needed. Hold container 4 to 6 inches from skin to apply. Do not spray directly into face.

Spray on hands then apply to face. Do not apply in windy conditions. Use in a well-ventilated area.

Avoid breathing mist. reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses

Directions SHAKE WELL before use spray liberally and spread evenly by hand 15 minutes before sun exposure and as needed. Hold container 4 to 6 inches from skin to apply. Do not spray directly into face.

Spray on hands then apply to face. Do not apply in windy conditions. Use in a well-ventilated area.

Avoid breathing mist. reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses

⚠️ Warnings 166 words ▾

Warnings For external use only. Flammable Do not use near heat, sparks, flames or while smoking. Contents under pressure.

Do not puncture or incinerate container. Do not store at temperatures above 120°F (49°C). Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove. Stop use and contact a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Warnings For external use only. Flammable Do not use near heat, sparks, flames or while smoking. Contents under pressure.

Do not puncture or incinerate container. Do not store at temperatures above 120°F (49°C). Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove. Stop use and contact a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📦 Storage and Handling 28 words ▾

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

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

🧪 Active Ingredient 30 words ▾

Active ingredients Purpose Homosalate 15% Sunscreen Octocrylene 10% Sunscreen Octisalate 5% Sunscreen Avobenzone 3% Sunscreen

Active ingredients Purpose Homosalate 15% Sunscreen Octocrylene 10% Sunscreen Octisalate 5% Sunscreen Avobenzone 3% Sunscreen

🧪 Inactive Ingredients 153 words ▾

Inactive ingredients Alcohol, Aloe Barbadensis (Aloe Vera) Leaf Juice Organic Ingredients , Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter , C12-15 Alkyl Benzoate, Calendula Officinalis (Marigold) Flower Extract , Camellia Sinensis (Green Tea) Leaf Extract , Capryloyl Glycerin/Sebacic Acid Copolymer, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract , Ethylhexyl Palmitate, Fragrance (Natural) COMPLIES WITH ISO 9235, SEE www.wholefoodsmarket.com FOR MORE INFORMATION. AVOID OVERSPRAY ONTO FABRICS AND OTHER SURFACES AS IT COULD RESULT IN DISCOLORATION. , Glycerin, Hydrogenated Methyl Abietate, Rosa Canina (Rosehip) Fruit Oil , Sorbitan Sesquioleate, Tocopherol, Tridecyl Salicylate

Inactive ingredients Alcohol, Aloe Barbadensis (Aloe Vera) Leaf Juice Organic Ingredients , Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter , C12-15 Alkyl Benzoate, Calendula Officinalis (Marigold) Flower Extract , Camellia Sinensis (Green Tea) Leaf Extract , Capryloyl Glycerin/Sebacic Acid Copolymer, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract , Ethylhexyl Palmitate, Glycerin, Hydrogenated Methyl Abietate, Sorbitan Sesquioleate, Tocopherol, Tridecyl Salicylate

🎯 Purpose 30 words ▾

Active ingredients Purpose Homosalate 15% Sunscreen Octocrylene 10% Sunscreen Octisalate 5% Sunscreen Avobenzone 3% Sunscreen

Active ingredients Purpose Homosalate 15% Sunscreen Octocrylene 10% Sunscreen Octisalate 5% Sunscreen Avobenzone 3% Sunscreen

📄 Do Not Use 16 words ▾

Do not use on damaged or broken skin.

Do not use on damaged or broken skin.

📄 When Using This Product 26 words ▾

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

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

📄 Stop Use and Ask a Doctor If 18 words ▾

Stop use and contact a doctor if rash occurs.

Stop use and contact a doctor if rash occurs.

📄 Keep Out of Reach of Children 40 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Questions or Comments 12 words ▾

Questions, Comments? [email protected] 1 (844) 936-8255

Questions, Comments? [email protected] 1 (844) 936-8255

📄 Package Label / Principal Display Panel 124 words ▾

PRINCIPAL DISPLAY PANEL - 147 g Bottle Label - Clear Spray NDC 42681-0064-1 365 WHOLE FOODS MARKET Shake Well BEFORE USE SUNSCREEN Clear Spray Coconut Vanilla Scented Formulated without Octinoxate, Oxybenzone or PABA 50 Water Resistant (80 Minutes) BROAD SPECTRUM SPF 50 UVA/UVB Protection NET WT

5.2 OZ (147g) PRINCIPAL DISPLAY PANEL - 147 g Bottle Label - Clear Spray

PRINCIPAL DISPLAY PANEL - 147 g Bottle Label - Kid's Clear Spray NDC 42681-0065-1 365 WHOLE FOODS MARKET Shake Well BEFORE USE kid's SUNSCREEN Clear Spray Fragrance Free Pediatrician Tested Formulated without Octinoxate, Oxybenzone or PABA 50 Water Resistant (80 Minutes) BROAD SPECTRUM SPF 50 UVA/UVB Protection NET WT

5.2 OZ (147g) PRINCIPAL DISPLAY PANEL - 147 g Bottle Label - Kid's Clear Spray

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 Whole Foods Market, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Whole Foods Market, 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.
← 42681-0064-01 · Whole 42681-0066-01 · Whole →
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.