Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Pure Protect Mineral Sunscreen Stick SPF50 Zinc Oxide 23.8 g/100g Stick, 20 g — NDC 84130-010-07 (Billing 84130-0010-07)
by Koco Life LLC · 20 g in 1 CONTAINER
This is a package of 20 g of Pure Protect Mineral Sunscreen Stick SPF50 Zinc Oxide 23.8 g/100g Stick from Koco Life LLC, marketed since Sep 2024 and currently FDA-listed. It is this product's only package size.
NDC 84130-0010-07
🏷️ FDA NDC (as labeled)
84130-010-07
billing pads the product segment with a zero
🗂️ 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 84130-010-07 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 84130 labeler · 010 product · 07 package
- Package marketed since
- Sep 23, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0850056558785
- 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)
84130-010-07
Product NDC
84130-010
11-digit billing NDC
84130001007
UNII
SOI2LOH54Z
UPC
0850056558785
Application #
M020
SPL Set ID
22cd5999-9b9a-91a3-e063-6394a90a0da5
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-09-23
Route
TOPICAL
Dosage form
STICK
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 84130-010-07 — 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 → 84130-0010-07. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
🧪 What is this product?
This is an over-the-counter sunscreen stick containing zinc oxide, a mineral UV filter. Applied topically to the skin, zinc oxide works by reflecting and scattering ultraviolet rays from the sun. This product is marketed as an OTC monograph drug under the FDA's established rules for sunscreen products. The stick form (SPF 50) is typically used to help protect exposed skin from sun damage.
Patient education
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
💬 Questions about Zinc Oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 7, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 84130-0010-07 You're viewing this Main listing | 20 g in 1 CONTAINER | 2024-09-23 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Banana Boat 23.8 g/100g 63354-0164-61 | Edgewell | 14.2 g | — | — | FDA listed | — |
| Pure Protect Mineral Sunscreen Stick SPF50 23.8 g/100gthis 84130-0010-07 | Koco | 20 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2024
On the market since
Sep 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.
- FDA Orange Book · refreshed Oct 3, 2026
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 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 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 K8NU647RJ0
Behenyl behenate is a waxy ester derived from behenic acid. It acts as a lubricant and glidant in tablets and capsules to reduce friction during manufacturing and improve powder flow.
-
UNII WW4FVB2PEM
A waxy compound made from fatty acids, used as an emulsifier and thickener to help blend oil and water ingredients together and give the medicine a smooth, stable texture.
-
UNII WL0328HX19
A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
-
UNII 331KBJ17RK
Canola oil is a plant-based oil derived from rapeseed. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and may improve how the body absorbs certain medications.
-
UNII R12CBM0EIZ
A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
-
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 4828G836N6
A plant-derived oil mixture from coconut that acts as an emollient and solvent. It helps dissolve or carry active ingredients and improves how the medicine spreads or absorbs in topical formulations.
-
UNII 609A3V1SUA
A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
-
UNII 74J1X57U42
A waxy, fatty substance derived from stearic acid that helps bind ingredients together and improves the texture and spreadability of topical products and formulations.
-
UNII ANA2NCS6V1
A natural oil derived from macadamia nuts, used as an emollient and conditioning agent. It helps soften the product's texture and improve how it spreads or absorbs on skin or mucous membranes.
-
UNII EB41QIU6JL
Farnesol is a natural fragrant compound found in plants. It's used in medicines as a preservative and flavoring agent to improve taste and help prevent microbial growth.
-
UNII G7036X8B5H
A dark iron compound that gives medicine its color. Used as a colorant in tablets and capsules to help identify the medication and make it visually distinctive.
-
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 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 724GKU717M
Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
-
UNII 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
-
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 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 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 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 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 8KQ7I65XZE
A waxy compound derived from stearic acid, used as a thickener and emulsifier to help blend oil and water-based ingredients. It improves the texture and stability of the medicine formulation.
-
UNII 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 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 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.
30 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesHelianthus Annuus (Sunflower) Seed Cera/Wax/Cire, Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Coco-Caprylate, C12-15 Alkyl Benzoate, Ethyl Macadamiate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecanol, Argania Spinosa Kernel Oil, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Copernicia Cerifera Cera (Copernicia Cerifera (Carnauba) Wax, Cire de Carnauba), Methyl Dihydroabietate, Helianthus Annuus (Sunflower) Seed Oil, Candelilla Cera (Euphorbia Cerifera (Candelilla) Wax, Cire de Candelilla), Tocopherol, Jojoba Esters, Behenyl Behenate, Polyhydroxystearic Acid, C18-38 Alkyl Hydroxystearoyl Stearate, Sorbitan Sesquioleate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Bisabolol, Malic Acid, Citric Acid, Canola Oil (Huile de Colza) CI 77491/77492 (Iron Oxides), Farnesol
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerKoco Life LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84130
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio27 products on file
More NDCs from Koco Life LLC labeler code 84130
- Sun Shield On-the-Glow Sheer Stick SPF40 Avobenzone, Homosalate, Octocrylene, Octisalate 10 g/100g; 5 g/100g; 3 g/100g; 10 g/100g Stick NDC 84130-004-10
- Bright as Day Mineral SPF50 Zinc Oxide 100 mg/mL Cream NDC 84130-005-03
- Sun Shield Soft Glow Daily Face SPF30 Homosalate, Octisalate, Octocrylene, Avobenzone 30 mg/mL; 50 mg/mL; 40 mg/mL; 100 mg/mL Cream NDC 84130-006-12
- Antioxidant Face Shield Mineral SPF30 Zinc Oxide 141.4 mg/mL Cream NDC 84130-007-12
- Sun Essentials SPF Duo Kit Avobenzone, Homosalate, Octocrylene, Octisalate Kit NDC 84130-008-99
- Sun on the Run Kit Avobenzone, Homosalate, Octocrylene, Octisalate Kit NDC 84130-009-98
- Sunglaze Sheer Setting Mist Sunscreen SPF50 Avobenzone, Homosalate, Octisalate, Octyocrylene 5 mg/mL; 50 mg/mL; 100 mg/mL; 30 mg/mL Spray NDC 84130-011-13
- Golden Sunglaze Sheer Body Mist Sunscreen SPF50 Avobenzone, Homosalate, Octisalate, Octocrylene 30 mg/mL; 5 mg/mL; 50 mg/mL; 100 mg/mL Spray NDC 84130-012-50
- Sun Voyage Kit Avobenzone, Homosalate, Octocrylene, Octisalate Kit NDC 84130-013-97
- Lip Love Moisture Balm SPF30 - Pink Strawberry Zinc Oxide 10.88 g/100g Gel NDC 84130-014-36
- Lip Love Moisture Balm SPF30 - Nude Beige Zinc Oxide 10.88 g/100g Gel NDC 84130-015-36
- Lip Love Moisture Balm SPF30 - Watermelon Zinc Oxide 10.88 g/100g Gel NDC 84130-016-36
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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 ▾
Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer & early skin aging caused by the sun.
⏱️ Dosage and Administration ▾
Directions Apply (liberally or generously) to face, neck, and body 15 minutes before sun exposure. Reapply: At least every 2 hour. Use a water resistant sunscreen if swimming or sweating.
Sun Protection Measures Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher & 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.
Children under 6 months of age: Ask a Doctor.
⚠️ Warnings ▾
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 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 ▾
Other information Protect the product in this container from excessive heat and direct sun.
🧪 Active Ingredient ▾
Active ingredients Zinc Oxide 23.8%
🧪 Inactive Ingredients ▾
Inactive ingredients Helianthus Annuus (Sunflower) Seed Cera/Wax/Cire, Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Coco-Caprylate, C12-15 Alkyl Benzoate, Ethyl Macadamiate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecanol, Argania Spinosa Kernel Oil, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Copernicia Cerifera Cera (Copernicia Cerifera (Carnauba) Wax, Cire de Carnauba), Methyl Dihydroabietate, Helianthus Annuus (Sunflower) Seed Oil, Candelilla Cera (Euphorbia Cerifera (Candelilla) Wax, Cire de Candelilla), Tocopherol, Jojoba Esters, Behenyl Behenate, Polyhydroxystearic Acid, C18-38 Alkyl Hydroxystearoyl Stearate, Sorbitan Sesquioleate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Bisabolol, Malic Acid, Citric Acid, Canola Oil (Huile de Colza) CI 77491/77492 (Iron Oxides), Farnesol
🎯 Purpose ▾
Purpose Zinc Oxide 23.8%................Sunscreen
📄 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 If ▾
Stop use and ask a doctor if rash occurs.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions/Comments Call (858) 252-0099
📄 Package Label / Principal Display Panel ▾
Kopari Pure Protect Mineral Sunscreen Stick SPF 50+ Pure Protect Ecran Solaire Mineral En Stick FPS 50+ Net Wt. 0.7 oz. | Poids Net 20 G 1 2
No label section mentions that — try another word, or open the full label on DailyMed below.
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 Pure Protect Mineral Sunscreen Stick SPF50 (this brand).
Top reported reactions
Reporter sex
Male · 37%
Female · 63%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 Koco Life LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Koco Life 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.