HomeNDC LookupIngredientsBenzalkonium Chloride › 35000-0760-05
Bright Amber Antibacterial Benzalkonium chloride 1.33 mg/mL Liquid, 170 mL — NDC 35000-0760-05 package photo

Bright Amber Antibacterial Benzalkonium chloride 1.33 mg/mL Liquid, 170 mL

by Colgate-Palmolive Company · 170 mL in 1 BOTTLE (35000-760-05)
NDC 35000-0760-05
🏷️ FDA NDC (as labeled) 35000-760-05 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 →
⚠️
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) 35000-760-05
Product NDC 35000-760
11-digit billing NDC 35000076005
UNII F5UM2KM3W7
UPC 0827854027379
Application # 505G(a)(3)
SPL Set ID 44f9cf18-dd2d-4637-a5e1-3db82a1904ff
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-09
Route TOPICAL
Dosage form LIQUID
Substance BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 35000-760-05 — 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 → 35000-0760-05. 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.

🏭 Manufacturer & labeler

LabelerColgate-Palmolive Company
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code35000
First marketedDec 2025
Product typeHuman Otc Drug
Portfolio183 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?

Bright Amber Antibacterial is a topical liquid containing benzalkonium chloride, an over-the-counter monograph product marketed under FDA's established guidelines for this category. Benzalkonium chloride is an antimicrobial agent commonly used in topical antiseptic and disinfectant products to reduce bacteria on skin and surfaces. This liquid formulation is typically applied to the skin or other areas where an antibacterial effect is desired.

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.

💊 What it looks like

Color Orange
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII UC9PE95IBP
    A synthetic compound that works as a preservative and antimicrobial agent in medicines. It helps prevent bacterial and fungal growth, extending the shelf life of liquid formulations like eye drops and topical solutions.
  • UNII C80684146D
    A foaming agent and thickener derived from coconut oil. It helps create a smooth texture and stable foam in liquid or semi-solid medicines, improving how the product feels and applies.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 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 I6KX160QTV
    A cleaning agent and surfactant derived from coconut oil. It helps reduce foam and improves the flow and mixing of powder ingredients in the formulation.
  • UNII YM0K64F20V
    A synthetic emulsifier derived from polyethylene glycol and glucose. It helps blend oil and water-based ingredients together and improves the texture and spreadability of the product.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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.

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

The official label also statesWater, Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Cocamide MEA, Citric Acid, Sodium Benzoate, PEG-120 Methyl Glucose Dioleate, Fragrance, Sodium Chloride, Tetrasodium EDTA, Yellow 5, Red 33.

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 DailyMedingredient 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
SoftSoap Antibacterial with moisturizers Crisp Clean 1.33 mg/mL 35000-0086-11 Colgate-Palmolive 332 ml FDA listed
SoftSoap Antibacterial Kitchen Fresh Hands 1.33 mg/mL 35000-0677-11 COLGATE 332 ml Discontinued
Bright Amber Antibacterial 1.33 mg/mLthis 35000-0760-05 Colgate-Palmolive 170 ml FDA listed
ECOLAB Antiseptic 1.33 mg/mL 71338-0225-71 Ecolab 20 packets FDA listed
SoftSoap Antibacterial with moisturizers Fresh Citrus 1.33 mg/mL 35000-0087-11 Colgate-Palmolive 332 ml FDA listed
Softsoap Antibacterial with Moisturizers White Tea and Berry 1.33 mg/mL 35000-0243-11 COLGATE 332 ml FDA listed
Softsoap Antibacterial with Moisturizers Crisp Clean LHS 1.33 mg/mL 35000-0251-11 Colgate-Palmolive 332 ml FDA listed
Softsoap Antibacterial Sparkling Pear 1.33 mg/mL 35000-0252-11 COLGATE 332 ml FDA listed
Softsoap Antibacterial Clean and Protect Cool Splash 1.33 mg/mL 35000-0254-11 COLGATE 332 ml FDA listed
SoftSoap Antibacterial Hand Citrus Cheer 1.33 mg/mL 35000-0733-26 COLGATE 162 ml Discontinued
SoftSoap Antibacterial Kitchen Fresh Hands 1.33 mg/mL 35000-0088-11 COLGATE 332 ml Discontinued
SoftSoap Antibacterial Kitchen Fresh Hands 1.33 mg/mL 35000-0253-11 Colgate-Palmolive 332 ml FDA listed
Softsoap AB Sensitive Rose Water and Aloe LHS 1.33 mg/mL 35000-0256-11 Colgate-Palmolive 332 ml FDA listed
Protex Balance antibacterial hand 1.33 mg/mL 35000-0675-12 Colgate-Palmolive 3780 ml Discontinued
SoftSoap Antibacterial with moisturizers White Tea and Berry Fusion 1.33 mg/mL 35000-0081-11 Colgate-Palmolive 332 ml Discontinued
Softsoap Antibacterial Sparkling Pear 1.33 mg/mL 35000-0102-11 COLGATE 332 ml Discontinued
Softsoap Antibacterial with Moisturizers Fresh Citrus LHS 1.33 mg/mL 35000-0250-11 COLGATE 332 ml FDA listed
Softsoap Antibacterial Clean and Protect Cool Splash 1.33 mg/mL 35000-0096-11 COLGATE 332 ml Discontinued
Softsoap Antibacterial With Moisturizers White Tea And Berry Lhs 1.33 mg/mL 35000-0249-11 Colgate-Palmolive 332 ml Discontinued
Protex Balance antibacterial hand 1.33 mg/mL 35000-0255-75 Colgate-Palmolive 221 ml 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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
35000-0760-05 You're viewing this 170 mL in 1 BOTTLE (35000-760-05) 2025-12-09 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 35000-760-05, 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: 35000-0760-05, written without dashes as 35000076005. 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 35000-0760-05, the first segment (35000) is the labeler code FDA assigned to Colgate-Palmolive Company; the middle segment (0760) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Colgate-Palmolive Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Colgate-Palmolive Company 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 6 words

Use helps eliminate bacteria on hands

⏱️ Dosage and Administration 5 words

Directions wash hands and rinse

⚠️ Warnings 43 words

Warnings For external use only. When using this product, avoid contact with eyes. In case of contact, flush with water. Keep out of reach of children, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words

Active ingredient Benzalkonium Chloride 0.13%

🧪 Inactive Ingredients 27 words

Inactive ingredients Water, Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Cocamide MEA, Citric Acid, Sodium Benzoate, PEG-120 Methyl Glucose Dioleate, Fragrance, Sodium Chloride, Tetrasodium EDTA, Yellow 5, Red 33.

🎯 Purpose 2 words

Purpose Antibacterial

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.