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Zinctral Zinc Oxide 20 g/100g Paste, 57 g — NDC 59088-0627-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Zinctral Zinc Oxide 20 g/100g Paste, 57 g — NDC 59088-627-05 (Billing 59088-0627-05)

by PureTek Corporation · 57 g in 1 TUBE

This is a package of 57 g of Zinctral Zinc Oxide 20 g/100g Paste from PureTek Corporation, marketed since Mar 2023 and currently FDA-listed. It is this product's only package size.

NDC 59088-0627-05
🏷️ FDA NDC (as labeled) 59088-627-05 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

⚠️
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) 59088-627-05
Product NDC 59088-627
11-digit billing NDC 59088062705
NCPDP billing unit GM — per gram (weight)
RxCUI 416684
UNII SOI2LOH54Z
Application # M016
SPL Set ID de990834-00da-0c7a-e053-2995a90a7c37
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-03-24
Route TOPICAL
Dosage form PASTE
Substance ZINC OXIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 038762
GCN 09488
HICL code 002361
Ingredient (HICL) Zinc Oxide
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L3
Therapeutic class — intermediate (HIC2) Protectives
HIC3 code L3A
Therapeutic class — specific (HIC3) Protectives
AHFS code 84:24.12.00
AHFS class Basic Ointments And Protectants
FDB label name ZINCTRAL 20% PASTE
FDB brand name Zinctral
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 038762
  • GCN: 09488
  • HICL (First Databank): 002361
  • AHFS class code: 84:24.12.00
  • RxCUI (RxNorm): 416684
Why two NDCs? The FDA registers this code as 59088-627-05 — 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 → 59088-0627-05. 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

Label name ZINCTRAL 20% PASTE Ingredient Zinc Oxide
🧪 What is this product?

Zinctral is an over-the-counter topical paste containing zinc oxide at a concentration of 20 grams per 100 grams. Zinc oxide is commonly used in skin-care products as a barrier agent and mild astringent. This OTC monograph product is applied directly to the skin to help protect and soothe minor skin irritation.

Supplement & herbal interactions

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

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer 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
59088-0627-05 You're viewing this Main listing 57 g in 1 TUBE 2023-03-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Critic Aid Skin 200 mg/g 11701-0050-32 Coloplast 170 g — — FDA listed —
Medline 200 mg/g 53329-0255-05 Medline 170 g — — FDA listed —
DermacinRx Zinc Oxide Skin Healing 200 mg/g 59088-0563-01 PureTek 4 g — — FDA listed —
Zinctral 20 g/100gthis 59088-0627-05 PureTek 57 g — — FDA listed —
restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex 20 g/100g 57670-0000-00 RESTORSEA 1 tube — — FDA listed —
SPF 50 Mineral Sunscreen 20 g/100g 72667-0101-01 Inspec 50 g — — FDA listed —
Radically Rejuvenating SPF Day Cream 20 g/100g 54136-0152-52 Better 52 g — — FDA listed —
Seriously Soothing SPF Day Cream 20 g/100g 54136-0179-52 Better 52 g — — FDA listed —
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0100-60 9055-7588 60 g — — FDA listed —
Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30 20 g/100g 61649-0162-75 9055-7588 75 g — — FDA listed —
Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30 20 g/100g 61649-0165-15 9055-7588 150 g — — FDA listed —
Zinc Oxide 20 g/100g 69771-0109-38 Geri-Gentle 1 tube — — FDA listed —
Aloe UP SPF 33 Mineral 20 g/100g 61477-0231-01 Aloe 30 g — — FDA listed —
Attitude mineral sunscreen orange blossom SPF 30 20 g/100g 61649-0022-15 9055-7588 150 g — — FDA listed —
Attitude mineral sunscreen unscented SPF 30 20 g/100g 61649-0030-85 Attitude 85 g — — Discontinued —
Attitude mineral sunscreen tropical SPF 30 20 g/100g 61649-0031-85 Attitude 85 g — — Discontinued —
ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0098-60 9055-7588 60 g — — FDA listed —
ATTITUDE Sunly Tinted Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0097-20 9055-7588 20 g — — FDA listed —
All Good Mineral Sport Sunscreen Sunstick SPF 30 20 g/100g 75786-0220-01 Elemental 17 g — — FDA listed —
Mackenzies SPF 40 Ocean Safe Sunscreen 20 g/100g 80325-0040-02 Naturally 80 g — — FDA listed —
Aloe Up SPF 50 Mineral 20 g/100g 61477-0234-01 Aloe 89 g — — FDA listed —
Aloe Up SPF 50 Kids Mineral 20 g/100g 61477-0236-01 Aloe 89 g — — FDA listed —
Attitude mineral sunscreen tropical SPF 30 20 g/100g 61649-0021-15 9055-7588 150 g — — FDA listed —
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Terracotta 20 g/100g 61649-0046-08 9055-7588 8.5 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0090-60 9055-7588 60 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30 20 g/100g 61649-0092-60 9055-7588 60 g — — FDA listed —
Attitude Kids mineral sunscreen unscented SPF 30 20 g/100g 61649-0160-15 9055-7588 150 g — — FDA listed —
Mineral Defense Sport Ceramide Spf-30 20 g/100g 73054-0108-11 SOLARA 1 applicator — — FDA listed —
ProCure Zinc Oxide 20 g/100g 55681-0017-01 Twin 28.3 g — — FDA listed —
Attitude Kids mineral sunscreen unscented SPF 30 20 g/100g 61649-0038-85 Attitude 85 g — — Discontinued —
Attitude tinted mineral sunscreen face unscented SPF 30 20 g/100g 61649-0041-30 Attitude 30 g — — Discontinued —
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0101-20 9055-7588 20 g — — FDA listed —
All Good Coconut Mineral Sunscreen Sunstick SPF 30 20 g/100g 75786-0221-01 Elemental 17 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0094-20 9055-7588 20 g — — FDA listed —
Medpride 20 g/100g 52410-3040-03 Shield 28 g — — FDA listed —
Medline 20 g/100g 53329-0220-07 Medline 14 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Stick Tropical SPF 30 20 g/100g 61649-0091-60 9055-7588 60 g — — FDA listed —
Bio Spectra Attitude 20 g/100g 61649-0120-01 9055-7588 75 g — — FDA listed —
BLDG Active Skin Repair Sun Stick Performance Sunscreen 20 g/100g 70489-1423-01 Innovacyn, 15 g — — FDA listed —
Stream2Sea SPF 50 20 g/100g 69555-0050-01 Stream2Sea 1 jar — — FDA listed —
Stream2Sea Sport Lip Balm SPF 50 20 g/100g 69555-0500-01 Stream2Sea, 4 g — — FDA listed —
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0099-20 9055-7588 20 g — — FDA listed —
Bio Spectra Attitude 20 g/100g 61649-0110-15 9055-7588 150 g — — FDA listed —
dabur 20 g/100g 68747-3040-03 Dabur 28 g — — FDA listed —
New Kid on the Block 20 g/100g 84568-0552-12 Dimples 106.8 g — — FDA listed —
Lasso Tallow Sunscreen Spf 50 20 g/100g 87761-0004-01 Moes 140 g — — FDA listed —
Procure 20 g/100g 55681-0304-03 TWIN 28.3 g — — FDA listed —
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose 20 g/100g 61649-0045-08 9055-7588 8.5 g — — FDA listed —
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Peachy Shell 20 g/100g 61649-0047-08 9055-7588 8.5 g — — FDA listed —
Endit Zinc Oxide Skin Protectant 20 g/100g 64068-0402-01 Endit 454 g — — FDA listed —
Stream2Sea Reef Safer Mineral Sunscreen SPF40 20 g/100g 69555-0400-10 Stream2Sea, 1 jar — — FDA listed —
365 Whole Foods Market Sport Mineral Spf 30 20 g/100g 42681-0062-01 Whole 44 g — — FDA listed —
Stream2Sea Ecostock SPF 40 Sunscreen 20 g/100g 69555-0401-01 Stream2Sea, 14 g — — FDA listed —
Utu Broad Spectrum SPF 30 Moisturizing Body Sunscreen 20 g/100g 87952-0004-02 Utu 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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 WR1WPI7EW8
    A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
  • 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 I9PJ0O6294
    A modified starch derived from corn or potato starch with aluminum salt and octenylsuccinic acid added. It acts as a binder to hold tablet ingredients together and as a thickening agent in liquid formulations.
  • UNII 568ET80C3D
    Calcium pantothenate is a salt form of pantothenic acid, a B-vitamin derivative. It's used as a nutritional supplement or vitamin fortification ingredient in medicines and formulations.
  • UNII 9S60Q72309
    A plant-derived ingredient made from safflower seed components. It acts as an emulsifier and carrier to help distribute oils and active ingredients evenly throughout the medicine.
  • UNII C5529G5JPQ
    Ginger is a plant-derived ingredient used as a flavoring agent to add taste and aroma to medicines. It may also provide mild soothing properties to support product palatability.
  • 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 TP11QR7B8R
    A natural oil extracted from kukui nuts, used as an emollient and skin-conditioning agent in topical medicines. It helps soften the formulation and improve how the product spreads and absorbs into skin.
  • 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 68Y4CF58BV
    Pyridoxine hydrochloride is a form of vitamin B6, added to medicines as a nutritional supplement or to meet dietary requirements. It supports the body's metabolism and nerve function.
  • 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 836SJG51DR
    Sodium ascorbyl phosphate is a derivative of vitamin C that acts as an antioxidant and preservative in medications. It helps protect the drug's active ingredients from degradation caused by air and light exposure.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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

The official label also statesAleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Carthamus Tinctorius (Safflower) Seed Oil, Fragrance (Contains: Alpha-Isomethyl Ionone, Butylphenyl Methylpropional, Coumarin, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool), GenRx Complex® [Consisting of: Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, DL-Alpha-Tocopheryl Acetate (Vitamin E), Zingiber Officinale (Ginger) Root Extract], Petrolatum, Phenoxyethanol, Zea Mays (Corn) Starch.

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

LabelerPureTek Corporation
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code59088
First marketedMar 2023
Product typeHuman Otc Drug
Portfolio178 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 words ▾

Uses dries the oozing and weeping of poison: ivy oak sumac Helps treat and prevent diaper rash. Protects minor skin irritations due to diaper rash and helps protect from wetness.

⏱️ Dosage and Administration 54 words ▾

Directions Cleanse skin with DiaSinc All Purpose Cleansing Spray and apply paste to area as needed. Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

⚠️ Warnings 58 words ▾

Warnings For external use only When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of childern. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 21 words ▾

Other information protect from freezing avoid excessive heat Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

🧪 Active Ingredient 11 words ▾

Active ingredient Zinc Oxide 20.0% (3.0% as Calamine) Purpose Skin Protectant

🧪 Inactive Ingredients 79 words ▾

Inactive ingredients: Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Carthamus Tinctorius (Safflower) Seed Oil, Fragrance (Contains: Alpha-Isomethyl Ionone, Butylphenyl Methylpropional, Coumarin, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool), GenRx Complex® [Consisting of: Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, DL-Alpha-Tocopheryl Acetate (Vitamin E), Zingiber Officinale (Ginger) Root Extract ], Petrolatum, Phenoxyethanol, Zea Mays (Corn) Starch.

🎯 Purpose 3 words ▾

Purpose Skin Protectant

📄 When Using This Product 9 words ▾

When using this product do not get into eyes

📄 Stop Use and Ask a Doctor If 25 words ▾

Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Package Label / Principal Display Panel 20 words ▾

Zinctral™ Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 Label

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 PureTek Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PureTek Corporation 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.
← 59088-0623-08 · PureTek 59088-0630-00 · PureTek →
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.