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DERMADIVE ULTRACARE - TETRAID BENZALKONIUM CHLORIDE .13 g/100mL Lotion, 100 mL — NDC 78663-0102-34 package photo

DERMADIVE ULTRACARE - TETRAID BENZALKONIUM CHLORIDE .13 g/100mL Lotion, 100 mL

by Releaf Technologies LLC · 100 mL in 1 TUBE (78663-102-34)
NDC 78663-0102-34
🏷️ FDA NDC (as labeled) 78663-102-34 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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 Benzalkonium Chloride (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 · Apr 8, 2026 — CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0693-2026
Class II · Apr 8, 2026 — CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0699-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0375-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0369-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0365-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0360-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 78663-102-34
Product NDC 78663-102
11-digit billing NDC 78663010234
RxCUI 1046442
UNII F5UM2KM3W7
Application # M003
SPL Set ID 025c0b33-73ca-334b-e063-6394a90ad668
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-07
Route TOPICAL
Dosage form LOTION
Substance BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 78663-102-34 — 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 → 78663-0102-34. 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.

🏷️ RxNorm drug class

This medicine belongs to the Quaternary ammonium compounds class.

Drug family (ATC) Quaternary ammonium compounds, Medicated dressings with antiinfectives, Antiseptics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerReleaf Technologies LLC
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code78663
First marketedAug 2023
Product typeHuman Otc Drug
Portfolio2 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.

🩺 Clinical

🧪 What is this product?

Dermadive Ultracare is a topical lotion applied to the skin that contains benzalkonium chloride, an antimicrobial agent. Benzalkonium chloride is commonly used in skin-care products to help reduce bacteria and other microorganisms on the skin surface. This product is marketed as an over-the-counter monograph drug, meaning it is made according to established FDA guidelines for this ingredient category rather than through an individual product application.

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.

🧪 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 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII CZ227117JE
    A silicone-based compound made of linked silicon and oxygen atoms arranged in a ring structure. It acts as a solvent, carrier, or conditioning agent to help distribute active ingredients evenly and improve product texture and spreadability.
  • UNII 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • UNII A1A1I8X02B
    A clear liquid solvent derived from ethylene glycol. It helps dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • 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 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 CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesPURIFIED WATER, GLYCERYL STEARATE, EMULSIFYING WAX, STEARYL ALCOHOL, CETYL ALCOHOL, CYCLOTETRASILOXANE (AND) CYCLOPENTASILOXANE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, ETHOXYDIGLYCOL, PROPYLENE GLYCOL, WATER, LECITHIN, ALCOHOL, GLYCERIN, TEA TREE OIL, TRIETHANOLAMINE

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Target Up and Up 2-in-1 Hand Sanitizer 1.3 mg/mL 11673-0147-15 TARGET 150 ml — — FDA listed —
Zylast Antiseptic K .13 g/100mL 57362-0468-00 Innovative 59.1 ml — — FDA listed —
I.C. Waterless Hand Cleaner with Micro Scrubbers 1.3 mg/mL 59555-0303-04 R 59 ml — — FDA listed —
I.C. Sanitizer and Re-Moisturizer with Benzalkonium Chloride 1.3 mg/mL 59555-0903-03 R 50 ml — — FDA listed —
Vaseline 1.3 mg/mL 64942-1849-01 Conopco 88.5 ml — — FDA listed —
Dr Lift Antibacterial .156 mg/120mg 68062-2243-01 Spa 120 mg — — FDA listed —
Dermadive Ultracare - Tetraid .13 g/100mLthis 78663-0102-34 Releaf 100 ml — — FDA listed —
Tazza Antiseptic Hand Sanitizing Wipes .13 g/100mL 76370-0018-00 Tazza 320 applicators — — Discontinued —
Tazza King Wipes .13 g/100mL 76370-0024-00 Tazza 950 applicators — — Discontinued —
Moxie Hand Wipes .13 g/100mL 77720-0035-01 Skaffles 1 ml — — FDA listed —
Meijer Antibacterial Amber Hand .13 g/100mL 79481-0156-01 Meijer, 1650 ml — — FDA listed —
XTRA Squeeze Antibacterial Hand Juicy Orange .13 g/100mL 84987-0002-01 Zhejiang 458 ml — — FDA listed —
XTRA Squeeze Antibacterial Hand Fresh Lemon .13 g/100mL 84987-0003-01 Zhejiang 458 ml — — FDA listed —
XTRA Squeeze Antibacterial Hand Fresh Lemon .13 g/100mL 51628-4502-01 MY 458 ml — — FDA listed —
Marvel Bzk Antiseptic Wipe .13 g/100mL 70108-0104-01 Ashtel 1 pouch — — FDA listed —
Pharma-Care Skin Preparation Cloths .13 g/100mL 71884-0015-02 Enviro 1 packet — — FDA listed —
Black Ops Ab Antibacterial Foaming .13 g/100mL 79016-0103-12 Archer 1000 ml — — FDA listed —
XTRA Antibacterial Hand Fresh Lemon .13 g/100mL 84987-0004-01 Zhejiang 399 ml — — FDA listed —
Sanitaxe Antibacterial .13 g/100mL 72197-0033-27 American 800 ml — — FDA listed —
Tazza .13 g/100mL 76370-0009-00 Tazza 500 applicators — — Discontinued —
XTRA Squeeze Antibacterial Hand Juicy Orange .13 g/100mL 51628-4442-01 MY 458 ml — — FDA listed —
Meijer Antibacterial Spring Rain Hand .13 g/100mL 79481-0125-01 Meijer, 1650 ml — — FDA listed —
Club Wipes Usa Sanitizing Wipes .13 g/100mL 80976-0102-01 Bubble 3.15 ml — — FDA listed —
Nurture ANTISEPTIC WIPES .13 g/100mL 81072-0001-01 Devon 1 packet — — FDA listed —
Proheal Benzalkonium Chloride Antiseptic Towelettes .13 g/100mL 86173-0006-12 Click 120 pouches — — FDA listed —
My-Shield Hand Sanitizer Gel .13 g/100mL 71884-0011-01 Enviro 3 tubes — — Discontinued —
Wipes4Health .13 g/100mL 80976-0100-01 Bubble 3.15 ml — — FDA listed —
XTRA Antibacterial Hand Fresh Lemon .13 g/100mL 51628-4503-01 MY 399 ml — — FDA listed —
Tazza .13 g/100mL 76370-0013-00 Tazza 1700 applicators — — Discontinued —
Tazza Optima Sanitizing Wipes .13 g/100mL 76370-0023-01 Tazza 1460 applicators — — Discontinued —
Tork Foam Antibacterial .13 g/100mL 49351-0104-01 Essity 1000 ml — — FDA listed —
Tazza Hand Sanitizer Gym Wipes .13 g/100mL 76370-0017-00 Tazza 1500 applicators — — FDA listed —
Meijer Antibacterial White Tea and Berry Hand .13 g/100mL 79481-0135-01 Meijer, 221 ml — — FDA listed —
Tazza .13 g/100mL 76370-0001-00 Tazza 180 applicators — — FDA listed —
Tazza Antiseptic Hand Sanitizing Wipes .13 g/100mL 76370-0016-00 Tazza 1400 applicators — — FDA listed —
Tazza Antiseptic Hand Sanitizing Wipes .13 g/100mL 76370-0019-00 Tazza 250 applicators — — Discontinued —
Tazza XL Wipes .13 g/100mL 76370-0025-02 Tazza 1500 applicators — — Discontinued —
RHINO Hand Sanitizing Wipes .13 g/100mL 76370-0026-00 Tazza 1500 applicators — — Discontinued —
Complete .13 g/100mL 63900-0101-02 Simoniz 4 bottles — — FDA listed —
Saniclean .13 g/100mL 63900-0110-02 Simoniz 4 bottles — — FDA listed —
Barbie BZK ANTISEPTIC WIPE .13 g/100mL 70108-0107-01 Ashtel 1 pouch — — 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
Aug 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.

🔬 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 DERMADIVE ULTRACARE - TETRAID (this brand).

Top reported reactions

Drug Hypersensitivity118
Condition Aggravated114
Arthralgia112
Musculoskeletal Stiffness111
Pain In Extremity111
Infection110
Hepatotoxicity108

Age at onset

Infant1
Adolescent3
Adult36
Elderly10

Reporter sex

0 reports
Male · 28%
Female · 72%
Unknown · 0%

Serious outcomes

Hospitalization175
Life-threatening27
Disabling18
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 77 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
78663-0102-34 You're viewing this 100 mL in 1 TUBE (78663-102-34) 2023-08-07 Active

🧭 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 FDA registers it as 78663-102-34, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 78663-0102-34, written without dashes as 78663010234. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 78663-0102-34, the first segment (78663) is the labeler code FDA assigned to Releaf Technologies LLC; the middle segment (0102) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (34) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Releaf Technologies LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Releaf Technologies 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.

📄 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
🎯 Indications and Usage 11 words ▾

USES TO PROTECT SKIN AND SPEED HEALING OF WOUNDS AND SORES.

⏱️ Dosage and Administration 7 words ▾

DIRECTIONS APPLY AS NEEDED TO AFFECTED AREAS.

⚠️ Warnings 38 words ▾

WARNING FOR EXTERNAL USE ONLY. DO NOT USE ON DEEP PUNCTURE WOUNDS OR LACERATIONS. WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES. STOP USING AND ASK A DOCTOR IF THE CONDITION WORSENS A RASH OR IRRITATION DEVELOPS.

📦 Storage and Handling 19 words ▾

OTHER INFORMATION PROTECT PRODUCT FROM EXCESSIVE MOISTURE - AVOID STORING IN DIRECT SUNLIGHT - STORE WITH LID TIGHTLY CLOSED.

🧪 Active Ingredient 5 words ▾

ACTIVE INGREDIENT BENZALKONIUM CHLORIDE 0.13%

🧪 Inactive Ingredients 28 words ▾

INACTIVE INGREDIENTS PURIFIED WATER, GLYCERYL STEARATE, EMULSIFYING WAX, STEARYL ALCOHOL, CETYL ALCOHOL, CYCLOTETRASILOXANE (AND) CYCLOPENTASILOXANE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, ETHOXYDIGLYCOL, PROPYLENE GLYCOL, WATER, LECITHIN, ALCOHOL, GLYCERIN, TEA TREE OIL, TRIETHANOLAMINE

🎯 Purpose 2 words ▾

PURPOSE ANTIMICROBIAL

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 78641-0786-67 · Global 78663-0201-34 · Releaf →
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.