Dial refresh and renew Antibacterial Mountain Fresh Benzalkonium Chloride .1 g/100g Soap
by Henkel Corporation · 3 PACKET in 1 PACKAGE (54340-017-03) / 113 g in 1 PACKET
NDC 54340-0017-03
🏷️ FDA NDC (as labeled)
54340-017-03
billing pads the product segment with a zero
This package
Contains113 g in 1 packet
Pack sizes2 compare ↓
Also comes in:
8 packets 54340-0017-08
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-0374-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
54340-017-03
Product NDC
54340-017
11-digit billing NDC
54340001703
RxCUI
1926450
UNII
F5UM2KM3W7
UPC
0017000003245
Application #
505G(a)(3)
SPL Set ID
f9a347aa-808c-2095-e053-6394a90a58b1
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2022-11-22
Route
TOPICAL
Dosage form
SOAP
Substance
BENZALKONIUM CHLORIDE
Why two NDCs?
The FDA registers this code as 54340-017-03 — 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 → 54340-0017-03. 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
LabelerHenkel Corporation
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code54340
First marketedNov 2022
Product typeHuman Otc Drug
Portfolio57 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?
Dial Refresh and Renew is an over-the-counter antibacterial soap containing benzalkonium chloride as its active ingredient. This topical soap is marketed as an OTC monograph product, meaning it follows FDA's established rules for antibacterial soaps rather than undergoing individual approval. Benzalkonium chloride is commonly used in antibacterial hand and body soaps as an antimicrobial agent. The product is intended for routine cleansing and is available in a mountain fresh scent variety.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Benzalkonium Chloride — 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.
💬 Questions about Benzalkonium Chloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 40U37V505D
A fatty acid derived from coconut oil. It acts as an emulsifier to help mix water and oil-based ingredients, and may also serve as a surfactant or lubricant in tablet and capsule formulations.
-
UNII 3P3ONR6O1S
A synthetic green dye approved by the FDA for use in medicines and foods. It serves as a colorant to make the pill or liquid visually distinctive and help with product identification.
-
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 B6G0Y5Z616
Palm acid is a natural fatty acid derived from palm oil. It acts as an emulsifier and lubricant in medications, helping to blend ingredients together and prevent sticking during manufacturing.
-
UNII 79P21R4317
Palm kernel acid is a fatty acid derived from palm kernel oil. It's used in medicines as an emulsifier to help mix oil and water-based ingredients together, and sometimes as a lubricant to improve how a tablet flows during manufacturing.
-
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 R1TQH25F4I
Sodium cocoate is a salt derived from coconut oil. It acts as an emulsifier and surfactant in medicines, helping to mix ingredients that normally don't blend together and improve product texture and stability.
-
UNII 6H91L1NXTW
A processed palm kernel oil derivative used as an emulsifier and surfactant in medications. It helps mix oil and water-based ingredients together and improves how the medicine spreads and dissolves in the body.
-
UNII S0A6004K3Z
Sodium palmate is a salt made from palm oil. It acts as an emulsifier and surfactant in medicines, helping mix ingredients that normally don't blend well together and improving product texture and consistency.
-
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
-
UNII 5EHL50I4MY
A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
-
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 statesSoap [sodium palmate* • sodium palm kernelate* • sodium cocoate*] • water • glycerin • stearic acid* • coconut acid* • palm acid* • palm kernel acid* • fragrance • titanium dioxide • sortibol • sodium chloride • tetrasodium glutamate diacetate • alcohol • yellow 5 • green 3 *contains one or more of these ingredients
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 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.
Try another pack size:
8 packets
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dial refresh and renew Antibacterial Mountain Fresh .1 g/100gthis 54340-0017-03 | Henkel | 3 packets | — | — | FDA listed | — |
| Dial Antibacterial with Vitamins .1 g/100g 54340-0020-01 | Henkel | 113 g | — | — | FDA listed | — |
| Dial refresh and renew Antibacterial white .1 g/100g 54340-0260-01 | Henkel | 113 g | — | — | FDA listed | — |
| Dial advanced clean Antibacterial gold .1 g/100g 54340-0262-01 | Henkel | 113 g | — | — | FDA listed | — |
| Dial Antibacterial Calm and Soothe .1 g/100g 54340-0266-03 | Henkel | 3 packets | — | — | FDA listed | — |
| Dial Antibacterial and Sensitive Aloe .1 g/100g 54340-0267-03 | Henkel | 16 cellos | — | — | FDA listed | — |
| Dial Complete Antibacterial Bar Spring Water .1 g/100g 54340-0270-08 | Henkel | 8 packets | — | — | FDA listed | — |
| Dial Antibacterial Bar .1 g/100g 54340-0272-20 | Henkel | 99 g | — | — | FDA listed | — |
| Dial Antibacterial Bar .1 g/100g 54340-0274-01 | Henkel | 180 g | — | — | Discontinued | — |
| Dial Antibacterial Bar .1 g/100g 54340-0278-04 | Henkel | 678 g | — | — | Discontinued | — |
| Dial antibacterial and sensitive hypoallergenic bar .1 g/100g 54340-0283-30 | Henkel | 1 cello | — | — | FDA listed | — |
| Dial Antibacterial Vitamin Bar .1 g/100g 54340-0286-02 | Henkel | 72 cellos | — | — | FDA listed | — |
| Dial refresh and renew Antibacterial Bar Spring Water .1 g/100g 54340-0300-01 | Henkel | 113 g | — | — | FDA listed | — |
| DK12 Oatmeal Antibacterial and Moisturizing .1 g/110g 62476-0104-15 | Industria | 140 g | — | — | FDA listed | — |
| DK12 Creamy Antibacterial and Moisturizing .1 g/110g 62476-0105-15 | Industria | 140 g | — | — | FDA listed | — |
| DK12 Fresh Energy Antibacterial and Moisturizing .1 g/110g 62476-0106-15 | Industria | 140 g | — | — | FDA listed | — |
| Escudo Ultra-Protect Original .1 g/100g 84529-0001-01 | Indelpa, | 115 g | — | — | FDA listed | — |
| Escudo Ultra-Protect Soft Care .1 g/100g 84529-0002-01 | Indelpa, | 115 g | — | — | FDA listed | — |
| Gelle-N-Detox Ice Mint And Eucalyptus Massage .1 g/100g 49283-0014-07 | CHEMCO | 20 g | — | — | Discontinued | — |
| Gelle-N-Detox - Lavender And Rosemary Massage .1 g/100g 49283-0001-07 | CHEMCO | 20 g | — | — | FDA listed | — |
| Gelle-N-Detox Ice Mint And Eucalyptus Massage .1 g/100g 49283-0110-07 | CHEMCO | 20 g | — | — | FDA listed | — |
| Klean-Them Hand Sanitizing Towels .1 g/100g 73943-0953-01 | Rite-Kem, | 400 g | — | — | FDA listed | — |
| 5EWA5 Antibacterial Hand Sanitizer Wipes .1 g/100g 40096-1909-01 | W.W. | 6 canisters | — | — | Discontinued | — |
| Gelle-N-Detox - Lavender And Rosemary Massage .1 g/100g 49283-0015-07 | CHEMCO | 20 g | — | — | Discontinued | — |
| SCRUBS Hand Sanitizer Wipes .1 g/100g 51239-2909-01 | ITW | 400 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.
⏳ Availability & generic status
🏛️
2022
On the market since
Nov 2022
📍
2026
Currently FDA-listed
4 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 Benzalkonium Chloride — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 32%
Female · 68%
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 54340-0017-03 You're viewing this | 3 PACKET in 1 PACKAGE (54340-017-03) / 113 g in 1 PACKET | 2022-11-22 | Active |
| 54340-0017-08 | 8 PACKET in 1 PACKAGE (54340-017-08) / 113 g in 1 PACKET | 2022-11-22 | Active |
Pack size FAQ
What quantity is in NDC 54340-0017-03?
NDC 54340-0017-03 is listed by the FDA — 3 packet in 1 package / 113 g in 1 packet.
What NDC number is used to bill for this package of Dial refresh and renew Antibacterial Mountain Fresh Benzalkonium Chloride .1 g/100g Soap?
Bill NDC 54340-0017-03 — the 11-digit billing format is 54340001703. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 54340-017-03, 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: 54340-0017-03, written without dashes as 54340001703. 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 54340-0017-03, the first segment (54340) is the labeler code FDA assigned to Henkel Corporation; the middle segment (0017) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Henkel Corporation. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 8 packets (54340-0017-08). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Henkel 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.
📄 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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Use • for washing to decrease bacteria on the skin.
⏱️ Dosage and Administration ▾
Directions • wet bar with water • lather vigorously and wash skin • rinse and dry thoroughly
⚠️ Warnings ▾
Warnings For external use only When using this product • avoid contact with eyes. In case of eye contact, flush with water. Stop use and ask a doctor if • irritation or redness develops. Keep out of reach of chlidren. If swallowed, get medical help or contact a Poison Control Center right away.
🧪 Active Ingredient ▾
Active ingredient Benzalkonium chloride 0.10%
🧪 Inactive Ingredients ▾
Inactive ingredients Soap [sodium palmate* • sodium palm kernelate* • sodium cocoate*] • water • glycerin • stearic acid* • coconut acid* • palm acid* • palm kernel acid* • fragrance • titanium dioxide • sortibol • sodium chloride • tetrasodium glutamate diacetate • alcohol • yellow 5 • green 3 *contains one or more of these ingredients
🎯 Purpose ▾
Purpose Antibacterial
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 ↗
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.