Home › NDC Lookup › Ingredients › Cetylpyridinium Chloride › 87594-0100-00
🧴image loading
(from DailyMed)

AHLO PRO Healthy Gums Cetylpyridinium Chloride .075 g/100mL Liquid, 473 mL

by Gervest USA Inc · 473 mL in 1 BOTTLE (87594-100-00)
NDC 87594-0100-00
🏷️ FDA NDC (as labeled) 87594-100-00 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 Cetylpyridinium Chloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Dec 26, 2025 — Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. (Haleon US Holdings LLC) · FDA recall D-0297-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 87594-100-00
Product NDC 87594-100
11-digit billing NDC 87594010000
RxCUI 1599135
UNII D9OM4SK49P
Application # M022
SPL Set ID 4f5a0ccb-26e5-ebb6-e063-6394a90abbc5
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-20
Route TOPICAL
Dosage form LIQUID
Substance CETYLPYRIDINIUM CHLORIDE
Why two NDCs? The FDA registers this code as 87594-100-00 — 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 → 87594-0100-00. 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 Antiinfectives class.

Drug family (ATC) Antiinfectives, Quaternary ammonium compounds, Medicated dressings with antiinfectives
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

LabelerGervest USA Inc
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code87594
First marketedApr 2026
Product typeHuman Otc Drug
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?

AHLO PRO Healthy Gums is a liquid rinse for oral use containing cetylpyridinium chloride, an antimicrobial agent. This over-the-counter monograph product is typically used as a mouthwash to help reduce bacteria in the mouth. Cetylpyridinium chloride is commonly included in oral rinses to help support gum health and oral hygiene as part of a daily dental care routine.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 083X55C543
    A natural extract from pomelo seeds that acts as a binder and helps hold tablet ingredients together. It may also provide antioxidant properties to help preserve the medicine's stability.
  • UNII D982V7VT3P
    A plant extract from the narrow-leafed coneflower root, used as a natural flavor, color, or botanical ingredient in some formulations to add taste and appearance to the medicine.
  • 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 ZW3Z11D0JV
    A plant extract from goldenseal root, used as a natural colorant and flavoring agent in some medicines. It may also have mild preservative properties in certain formulations.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII EE90ONI6FF
    Potassium citrate is a salt derived from citric acid and potassium. In medicines, it acts as a buffer to adjust and maintain the pH balance of the product, helping keep it stable and palatable.
  • 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 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.

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

The official label also statesInactive Ingredients Water, Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Sodium Benzoate, Potassium Citrate, Polysorbate 80, Flavor, Citric Acid, Citrus Grandis (Grapefruit) Seed Extract, Hydrastis Canadensis (Goldenseal) Root Extract, Echinacea Angustifolia Root Extract, Calendula Officinalis Flower Extract.

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 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
Colgate Total Active Prevention Peppermint 15 mg/20mL 35000-0279-16 COLGATE 500 ml — — FDA listed —
Colgate Total Active Prevention Spearmint 15 mg/20mL 35000-0280-16 Colgate-Palmolive 500 ml — — FDA listed —
Colgate Total Active Prevention Gum Health 15 mg/20mL 35000-0281-16 Colgate-Palmolive 500 ml — — FDA listed —
Hello Clean Mint with aloe vera 15 mg/20mL 35000-0510-12 Colgate-Palmolive 520 ml — — FDA listed —
Hello Extra Minty with extra cooling 15 mg/20mL 35000-0511-12 Colgate-Palmolive 520 ml — — FDA listed —
Hello Peace Out Plaque peace out, plaque antigingivitis 15 mg/20mL 35000-0683-10 Colgate-Palmolive 473 ml — — FDA listed —
Hello empower mint 15 mg/20mL 35000-0690-10 Colgate-Palmolive 473 ml — — FDA listed —
Colgate Total Advanced Pro-Shield Peppermint Blast 15 mg/20mL 35000-0720-02 Colgate-Palmolive 60 ml — — FDA listed —
Colgate Total Advanced Gum Health Mouthwash .75 mg/mL 35000-0723-02 Colgate-Palmolive 60 ml — — Discontinued —
Colgate Total 12 Hr Pro-Shield Spearmint Surge 15 mg/20mL 35000-0731-02 Colgate-Palmolive 60 ml — — FDA listed —
Hello Peace Out Plaque 15 mg/20mL 44038-0683-01 Accupac 473 ml — — FDA listed —
TheraStom .075 mg/.1mL 70275-0936-16 Forward 473 ml — — FDA listed —
AHLO PRO Healthy Gums .075 g/100mLthis 87594-0100-00 Gervest 473 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

🏛️
2026
On the market since
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 AHLO PRO Healthy Gums (this brand).

Top reported reactions

Nausea21
Vomiting17
Fatigue15
Back Pain14
Sepsis14
Pain13
Rash12

Age at onset

Adolescent2
Adult20
Elderly29

Reporter sex

169 reports
Male · 28%
Female · 72%

Serious outcomes

Hospitalization100
Death25
Life-threatening19
Disabling4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 16 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
87594-0100-00 You're viewing this 473 mL in 1 BOTTLE (87594-100-00) 2026-04-20 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 — Not published for this NDC No photo available yet for this listing.
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 87594-100-00, 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: 87594-0100-00, written without dashes as 87594010000. 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 87594-0100-00, the first segment (87594) is the labeler code FDA assigned to Gervest USA Inc; the middle segment (0100) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 Gervest USA Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Gervest USA Inc 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 9 words ▾

Uses Uses Helps control plaque that leads to gingivitis

⏱️ Dosage and Administration 96 words ▾

Directions Directions Adults 18 and older: Rinse and gargle with 10 mL (2 teaspoons) for 90 seconds twice daily after brushing. Do not swallow. Wait 5 minutes before eating or drinking.

Children 12-17: Rinse and gargle with 10 mL (2 teaspoons) for 90 seconds once daily after brushing. Do not swallow. Wait 5 minutes before eating or drinking.

Children 6-11: Rinse and gargle with 10 mL (2 teaspoons) for 60 seconds once daily after brushing. Do not swallow. Adult supervision recommended.

Wait 30 minutes before eating or drinking. Children under 6: Use only under adult supervision.

⚠️ Warnings 82 words ▾

Warnings Stop use and ask a dentist if Gingivitis, bleeding, or redness persists for more than 2 weeks You have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease Keep out of reach of children under 6 years of age. If more than used for rinsing is accidently swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active Ingredient Active Ingredient Purpose Cetylpyridinium Chloride 0.075% Antigingivitis, Antiplaque

🧪 Inactive Ingredients 37 words ▾

Inactive Ingredients Water, Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Sodium Benzoate, Potassium Citrate, Polysorbate 80, Flavor, Citric Acid, Citrus Grandis (Grapefruit) Seed Extract, Hydrastis Canadensis (Goldenseal) Root Extract, Echinacea Angustifolia Root Extract, Calendula Officinalis Flower Extract.

🎯 Purpose 8 words ▾

Active Ingredient Purpose Cetylpyridinium Chloride 0.075% Antigingivitis, Antiplaque

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 87593-0101-50 · Lance 87596-0001-02 · Frankly →
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.