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MyCuteness Pet Dental Care Water Additive CHLORHEXIDINE DIGLUCONATE 8 g/100mL Liquid, 500 mL — NDC 87154-001-01 (Billing 87154-0001-01)

by MY CUTENESS LLC · 500 mL in 1 BOTTLE

This is a package of 500 mL of MyCuteness Pet Dental Care Water Additive CHLORHEXIDINE DIGLUCONATE 8 g/100mL Liquid from MY CUTENESS LLC, no longer marketed (first marketed Oct 2025), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 87154-0001-01
🏷️ FDA NDC (as labeled) 87154-001-01 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ 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 →
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87154-001-01
Product NDC 87154-001
11-digit billing NDC 87154000101
UNII MOR84MUD8E
SPL Set ID 4080d4bd-bbd4-d76a-e063-6294a90a1c76
Physiologic effect Decreased Cell Wall Integrity
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2025-10-07
Route DENTAL
Dosage form LIQUID
Substance CHLORHEXIDINE DIGLUCONATE
Why two NDCs? The FDA registers this code as 87154-001-01 — 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 → 87154-0001-01. 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

🧪 What is this product?

This is an unapproved liquid dental care product containing chlorhexidine digluconate, an antimicrobial agent typically used to reduce bacteria in the mouth. The product is intended to be added to drinking water for pets. Chlorhexidine digluconate is commonly found in oral rinses and dental products because of its antimicrobial properties. This product has not received FDA approval.

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
87154-0001-01 You're viewing this Main listing 500 mL in 1 BOTTLE 2025-10-07 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
MyCuteness Pet Dental Care Water Additive 8 g/100mLthis 87154-0001-01 MY 500 ml — — Discontinued —
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
Oct 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerMY CUTENESS LLC
Labeler code87154
First marketedOct 2025
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.

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 13 words ▾

Add 1/2 cap (5ml) per 500m!of fresh water daily. Replacewater regularly for bestresults

⏱️ Dosage and Administration 13 words ▾

Add 1/2 cap (5ml) per 500m!of fresh water daily. Replacewater regularly for bestresults

⚠️ Warnings 15 words ▾

WARNING: For pet use only.Consult a veterinarian before use if yourpet has a medical condition.

🧪 Active Ingredient 1 words ▾

acitve

🧪 Inactive Ingredients 18 words ▾

INGREDIENTS: Purified Water, ChlorhexidineGluconate, Sodium BenzoateGlycerin, Citric Acid, TeaEssence, PEG-60 HydrogenatedSesame Oil. PeppermintExtract, Sodium Phosphate,Acetic Acid, Vegetable Acid

🎯 Purpose 10 words ▾

REDUCES ORALBACTERIAAND TARTAR FRESHENS T FIGHTS PLAQUE BREATH STRENGTHENSTOOTH ENAMEL

📄 Do Not Use 15 words ▾

WARNING: For pet use only.Consult a veterinarian before use if yourpet has a medical condition.

📄 When Using This Product 13 words ▾

Add 1/2 cap (5ml) per 500m!of fresh water daily. Replacewater regularly for bestresults

📄 Stop Use and Ask a Doctor If 14 words ▾

.For pet use only.Consult a veterinarian before use if yourpet has a medical condition.

📄 Keep Out of Reach of Children 15 words ▾

WARNING: For pet use only.Consult a veterinarian before use if yourpet has a medical condition.

📄 Package Label / Principal Display Panel 79 words ▾

WARNING: For pet use only.Consult a veterinarian before use if yourpet has a medical condition. STORAGE INSTRUCTION:Store in a cool, dry place.Avoid direct sunlight. Ingredients provided by My CutenessUSA WWW.MYCUTENESS.COMMADE IN PR.C DIRECTIONS FOR USE: Add 1/2 cap (5ml) per 500mlof fresh water daily.

Replacewater regularly for bestresults. INGREDIENTS: Purified Water, ChlorhexidineGluconate, Sodium Benzoate,Glycerin, Citric Acid, TeaEssence, PEG-60 HydrogenatedSesame Oil. PeppermintExtract, Sodium Phosphate,Acetic Acid, Vegetable Acid PET ORAL CARE ADDITIVE FRESHENS |FIGHTS PLAQUE I REDUCES ORALSTRENGTHENSBREATHAND TARTARBACTERIATOOTH ENAMEL 321

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

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 CHLORHEXIDINE DIGLUCONATE — the ingredient across all brands.

Top reported reactions

Anaphylactic Reaction4
Blood Pressure Increased2
Headache2
Lower Respiratory Tract Infection2
Pruritus2
Acute Graft Versus Host Disease1
Anaphylactic Shock1

Age at onset

Adult3

Reporter sex

24 reports
Male · 55%
Female · 45%

Serious outcomes

Hospitalization12
Life-threatening5
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5 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.

About this NDC listing & data coverage

Over-the-counter (OTC) product Marketed without an FDA application No longer marketed (per FDA listing data)

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 "Unapproved Drug Other". 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
MY CUTENESS 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.
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.