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Brush On Block Quick Stick SPF 40 Mineral Stick zinc oxide 17.5 g/100g Stick, 18 g — NDC 58274-0012-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Brush On Block Quick Stick SPF 40 Mineral Stick zinc oxide 17.5 g/100g Stick, 18 g — NDC 58274-012-01 (Billing 58274-0012-01)

by SPF Ventures LLC · 18 g in 1 CONTAINER

This is a package of 18 g of Brush On Block Quick Stick SPF 40 Mineral Stick zinc oxide 17.5 g/100g Stick from SPF Ventures LLC, marketed since Mar 2024 and currently FDA-listed. It is this product's only package size.

NDC 58274-0012-01
🏷️ FDA NDC (as labeled) 58274-012-01 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 →

NDC database record

One package, one record: these facts belong to NDC 58274-012-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58274 labeler · 012 product · 01 package
Package marketed since
Mar 4, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5827401201 5
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) 58274-012-01
Product NDC 58274-012
11-digit billing NDC 58274001201
UNII SOI2LOH54Z
Application # M020
SPL Set ID 12d10ec9-847a-7483-e063-6294a90a42a7
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-03-04
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 58274-012-01 — 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 → 58274-0012-01. 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?

Brush On Block Quick Stick SPF 40 Mineral Stick is a topical sunscreen product sold as an over-the-counter drug under FDA's monograph rules for sunscreen active ingredients. It contains zinc oxide, a mineral UV filter commonly used in sunscreens to help reflect and scatter ultraviolet rays from the sun. The stick form allows for convenient, direct application to the skin.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

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 eachPer 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
58274-0012-01 You're viewing this Main listing 18 g in 1 CONTAINER 2024-03-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lipshade SPF 30 High Five 17.5 g/100g 75936-0616-02 Supergoop, 1 tube — — FDA listed —
Lipshade SPF 30 Lucky Me 17.5 g/100g 75936-0618-02 Supergoop, 1 tube — — FDA listed —
Os-01 Face Spf Bs Spf 30 Tinted Deep 17.5 g/100g 84451-0005-02 ONESKIN 1 tube — — FDA listed —
Os-01 Face Spf Bs Spf 30 Tinted Deep 17.5 g/100g 62742-4271-02 Allure 1 tube — — FDA listed —
OS-01 Face SPF BS SPF30 Untinted 17.5 g/100g 84451-0003-02 ONESKIN 1 tube — — FDA listed —
Brush On Block Quick Stick SPF 40 Mineral Stick 17.5 g/100gthis 58274-0012-01 SPF 18 g — — FDA listed —
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Untinted 17.5 g/100g 62742-4229-02 Allure 1 tube — — FDA listed —
OS-01 Face SPF BS SPF30 Tinted 17.5 g/100g 62742-4266-02 Allure 1 tube — — FDA listed —
Lipshade SPF 30 Love You More 17.5 g/100g 75936-0617-02 Supergoop, 1 tube — — FDA listed —
OS-01 Face SPF BS SPF30 Tinted 17.5 g/100g 84451-0002-02 ONESKIN 1 tube — — FDA listed —
Os-01 Face Spf Bd Spf 30 Tinted Medium/Deep 17.5 g/100g 84451-0006-02 ONESKIN 1 tube — — FDA listed —
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted 17.5 g/100g 62742-4228-02 Allure 1 tube — — FDA listed —
OS-01 Face SPF BS SPF30 Untinted 17.5 g/100g 62742-4267-02 Allure 1 tube — — FDA listed —
Lipshade SPF 30 Obsessed 17.5 g/100g 75936-0619-02 Supergoop, 1 tube — — FDA listed —
Os-01 Face Spf Bd Spf 30 Tinted Medium/Deep 17.5 g/100g 62742-4272-02 Allure 1 tube — — FDA listed —
Lipshade SPF 30 Hey Yall 17.5 g/100g 75936-0615-02 Supergoop, 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

🏛️
2024
On the market since
Mar 2024
📍
2026
Currently FDA-listed
2 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 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 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 3JRB8A35M0
    A mineral compound made from calcium, aluminum, boron, and silicon. It's used as a colorant and opacifying agent to give medicines their appearance and color, and sometimes helps protect ingredients from light damage.
  • 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 QBS8A3XZGQ
    A synthetic oil made from diisostearyl alcohol and malic acid. It serves as an emollient and solvent in formulations, helping to dissolve and deliver active ingredients while improving texture and spreadability.
  • 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 42DG15CHXV
    A natural plant wax derived from sunflower seeds. It serves as a lubricant and glidant to help powders flow smoothly during manufacturing and tablet formation.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII X33R8U0062
    Isostearic acid is a fatty acid derived from vegetable oils. It acts as an emulsifier and lubricant in medicines, helping blend ingredients together and reducing friction during tablet or capsule manufacturing.
  • UNII IV0Z586Z4Y
    A synthetic oil derived from isostearic acid, used as an emollient and lubricant in topical formulations to soften the skin and improve the texture and spreadability of creams, lotions, and ointments.
  • UNII 36W3E5TAMG
    Glucomannan is a natural soluble fiber derived from the konjac plant. In medications, it acts as a binder and bulking agent, helping hold ingredients together and add volume to the formulation.
  • UNII 834K0WOS5G
    A natural fat extracted from sunflower seeds. It acts as an emulsifier and lubricant in medicines, helping mix ingredients that don't normally blend together and allowing the product to flow smoothly during manufacturing.
  • UNII 817L1N4CKP
    Malic acid is a naturally occurring organic acid found in fruits. It works as a buffer and flavor agent to maintain the medicine's pH balance and add tartness to the product.
  • 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 3G168G2S4C
    Naringi crenulata is a plant extract used as a natural flavoring and coloring agent in medicines. It adds taste and visual appeal to the formulation.
  • UNII 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • 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 7Q0OK5DOT4
    A plant-derived emulsifier made from glycerin and ricinoleic acid (from castor oil). It helps blend oil and water-based ingredients together in formulations and improves product texture and stability.
  • 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 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 65UEH262IS
    Safflower oil is a plant-based oil extracted from safflower seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and sometimes as an emollient to improve texture.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 OLX698AH5P
    A clay mineral processed with a quaternary ammonium compound. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
  • 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 8OC9U7TQZ0
    Tribehenin is a waxy, plant-derived substance that acts as a lubricant and glidant in tablets and capsules. It helps the medicine flow smoothly during manufacturing and prevents sticking during production and packaging.
  • UNII 06YD7896S3
    A waxy, fatty substance derived from stearic acid. It acts as a thickener and texture modifier in medicines, helping control how quickly the drug dissolves and improving the product's firmness and consistency.

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

The official label also statesC12-15 ALKYL BENZOATE CAPRYLIC/CAPRIC TRIGLYCERIDE HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX ISOSTEARYL ISOSTEARATE BUTYLOCTYL SALICYLATE TRIBEHENIN DIISOSTEARYL MALATE SILICA OCTYLDODECANOL CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL POLYHYDROXYSTEARIC ACID STEARALKONIUM BENTONITE CALCIUM ALUMINUM BOROSILICATE CAPRYLYL GLYCOL ETHYLHEXYL PALMITATE GLUCOMANNAN GLYCINE SOJA (SOYBEAN) OIL HESPERETHUSA CRENULATA BARK EXTRACT ISOSTEARIC ACID LECITHIN MALIC ACID ORYZA SATIVA (RICE) EXTRACT ORYZA SATIVA (RICE) GERM EXTRACT POLYGLYCERYL-3 DIISOSTEARATE POLYGLYCERYL-3 POLYRICINOLEATE PROPYLENE CARBONATE SODIUM HYALURONATE TOCOPHEROL TRIHYDROXYSTEARIN

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

LabelerSPF Ventures LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code58274
First marketedMar 2024
Product typeHuman Otc Drug
Portfolio6 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 29 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 88 words ▾

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. Sunprotection 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 69 words ▾

Warnings For external use only Do not use Do not use on damaged or broken skin When using this product When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor Stop use and ask a doctor if rash occurs. Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 14 words ▾

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

🧪 Active Ingredient 5 words ▾

Active ingredient Zinc Oxide 17.5%

🧪 Inactive Ingredients 70 words ▾

Inactive Ingredients C12-15 ALKYL BENZOATE CAPRYLIC/CAPRIC TRIGLYCERIDE HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX ISOSTEARYL ISOSTEARATE BUTYLOCTYL SALICYLATE TRIBEHENIN DIISOSTEARYL MALATE SILICA OCTYLDODECANOL CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL POLYHYDROXYSTEARIC ACID STEARALKONIUM BENTONITE CALCIUM ALUMINUM BOROSILICATE CAPRYLYL GLYCOL ETHYLHEXYL PALMITATE GLUCOMANNAN GLYCINE SOJA (SOYBEAN) OIL HESPERETHUSA CRENULATA BARK EXTRACT ISOSTEARIC ACID LECITHIN MALIC ACID ORYZA SATIVA (RICE) EXTRACT ORYZA SATIVA (RICE) GERM EXTRACT POLYGLYCERYL-3 DIISOSTEARATE POLYGLYCERYL-3 POLYRICINOLEATE PROPYLENE CARBONATE SODIUM HYALURONATE TOCOPHEROL TRIHYDROXYSTEARIN

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 11 words ▾

Do not use Do not use on damaged or broken skin

📄 When Using This Product 17 words ▾

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

📄 Stop Use and Ask a Doctor If 15 words ▾

Stop use and ask a doctor Stop use and ask a doctor if rash occurs.

📄 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.

📄 Package Label / Principal Display Panel 2 words ▾

label label

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 Brush On Block Quick Stick SPF 40 Mineral Stick (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
Death204
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 272 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 SPF Ventures LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SPF Ventures 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.
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.