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CHLORHEXIDINE GLUCONATE 1.2 mg/mL Rinse, 473 mL — NDC 00121-0893-16 package photo

CHLORHEXIDINE GLUCONATE 1.2 mg/mL Rinse, 473 mL

by PAI Holdings, LLC dba PAI Pharma · 473 mL in 1 BOTTLE (0121-0893-16)
NDC 00121-0893-16
🏷️ FDA NDC (as labeled) 0121-0893-16 billing pads the labeler segment with a zero
This package
Contains473 mL Cost per mL$0.0047 NADAC Per package$2.22 / 473 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.0383/unit · Part D plans $0.0247/unit — full pricing hub ↓
Also comes in: 10 cups 00121-0893-00 10 cups 00121-0893-40
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Sep 10, 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 Chlorhexidine Gluconate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 18, 2026 — Cross Contamination with Other Products (Sage Products, LLC) · FDA recall D-0837-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. 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

FDA NDC (as labeled) 0121-0893-16
Product NDC 0121-0893
11-digit billing NDC 00121089316
NCPDP billing unit ML — per mL (volume)
RxCUI 834127
UNII MOR84MUD8E
Application # ANDA074522
SPL Set ID d3c2d8a7-bad5-410f-af83-e78a45e4b93f
Physiologic effect Decreased Cell Wall Integrity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 1995-12-15
Route ORAL
Dosage form RINSE
Substance CHLORHEXIDINE GLUCONATE
GCN Seq No 057959
GCN 23248
HICL code 004297
Ingredient (HICL) Chlorhexidine Gluconate
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D1
Therapeutic class — intermediate (HIC2) Dental Preparations
HIC3 code D1D
Therapeutic class — specific (HIC3) Dental Aids And Preparations
AHFS code 52:04.24.00
AHFS class Astringents (52:04)
FDB label name CHLORHEXIDINE 0.12% RINSE
FDB brand name Chlorhexidine Gluconate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 0121-0893-16 — a 4-4-2 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 labeler segment → 00121-0893-16. 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 and antiseptics for local oral treatment class.

Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Antiinfectives, Biguanides and amidines
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

LabelerPAI Holdings, LLC dba PAI Pharma
Application holderPHARMACEUTICAL ASSOCIATES INC
FDA applicationANDA074522 (ANDA)
Labeler code00121
First marketedDec 1995
Product typeHuman Prescription Drug
Portfolio142 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

Label name CHLORHEXIDINE 0.12% RINSE Ingredient Chlorhexidine Gluconate
📖 What it is MedlinePlus · NLM

Chlorhexidine is used to treat gingivitis (redness and swelling of the gums). Chlorhexidine is in a class of medications called anti-infectant agents. It works by decreasing the amount of bacteria in the mouth.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's actually a prescription-strength antimicrobial rinse, which is different from over-the-counter mouthwash. Your dentist prescribes it specifically to treat gingivitis — that's...
  • What exactly is chlorhexidine rinse for — is it just like a regular mouthwash?
  • Yes, tooth and surface staining is one of the most common side effects of chlorhexidine oral rinse. It can also increase tartar buildup on your teeth. The good news is that this is...
  • My teeth look like they're staining — is that from the rinse?
📖 Read our full Chlorhexidine guide →

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.

💊 What it looks like

Color blue
FlavorPeppermint
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 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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 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 SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • 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.

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

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 $0.005 $2.22 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0383 $18.12 / 473 ml
Medicare drug plans payPart D · Q2 2026 $0.0247 $11.68 / 473 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Apr 2022 Sep 2022 Feb 2024 $0.006 $0.004
▼ Down 16% over the last 15 months.
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
Chlorhexidine Gluconate 1.2 mg/mLthis 00121-0893-16 PAI 473 ml $0.005 AT Discontinued —
Chlorhexidine Gluconate Oral Rinse 1.2 mg/mL 16571-0128-48 Rising 473 ml $0.007 AT Availability likely +56%
Chlorhexidine Gluconate 1.2 mg/mL 00116-2001-04 Xttrium 118 ml $0.017 AT Availability likely +257%
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 [iU]/mL 00116-0003-15 Xttrium 15 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00116-0175-16 Xttrium 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00116-0301-15 Xttrium 15 ml — AT FDA listed —
NUPRO Chlorhexidine Gluconate 1.2 mg/mL 00116-0800-16 Xttrium 473 ml — AT FDA listed —
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 00116-4075-01 Xttrium 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00116-6000-04 Xttrium 118 ml — AT FDA listed —
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 00116-6720-04 Xttrium 118 ml — AT FDA listed —
Periogard Alcohol Free 1.2 mg/mL 00126-0272-16 Colgate 473 ml — AT FDA listed —
Periogard Alcohol Free 1.2 mg/mL 00126-0282-16 Colgate 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00374-5080-01 Lyne 15 ml — AT FDA listed —
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 00404-4075-01 Henry 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00904-7035-80 Major 1500 ml — AT FDA listed —
Periogard Alcohol Free 1.2 mg/mL 17856-0272-01 ATLANTIC 72 cups — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 17856-2001-03 Atlantic 10 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 17856-2002-03 ATLANTIC 15 ml — AT Discontinued —
Peridex 1.2 mg/mL 48878-0620-01 Solventum 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 50090-0722-00 A-S 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 53329-0301-24 Medline 15 ml — AT FDA listed —
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 53462-0003-15 Sage 15 ml — AT FDA listed —
DASH Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 55154-1980-05 Cardinal 5 cups — AT FDA listed —
DASH Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 55154-1981-05 Cardinal 5 cups — AT FDA listed —
Major Oral Rinse 1.2 mg/mL 55154-3573-05 Cardinal 5 cups — AT FDA listed —
Major Oral Rinse 1.2 mg/mL 55154-3574-05 Cardinal 5 cups — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 59883-0175-16 Den-mat 473 ml — AT FDA listed —
Chlorhexidine Gluconate, 0.12% Oral Rinse 1.2 mg/mL 60687-0714-16 American 10 cups — AT FDA listed —
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution 1.2 mg/mL 61037-0469-02 Bajaj 118 ml — AT FDA listed —
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 62135-0649-41 Chartwell 120 ml — AT FDA listed —
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 62135-0650-24 Chartwell 10 cups — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 63187-0685-16 Proficient 473 ml — AT FDA listed —
Sky Oral Rinse 1.2 mg/mL 63739-0052-57 McKesson 600 ml — AT FDA listed —
NUPRO Chlorhexidine Gluconate 1.2 mg/mL 65222-0800-16 Dentsply 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 66467-2560-01 Darby 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 66689-0106-50 VistaPharm, 50 cups — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 66975-0600-04 Benco 118 ml — AT FDA listed —
CleanCare Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 67239-0225-00 Safco 118 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 68071-1837-06 NuCare 473 ml — AT FDA listed —
Chlorhexidine Gluconate Oral Rinse 1.2 mg/mL 68071-3630-06 NuCare 473 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 68788-9546-04 Preferred 473 ml — AT FDA listed —
Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 68999-0650-24 Chartwell 10 cups — AT FDA listed —
DASH Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL 69339-0138-15 Natco 15 ml — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 70518-4494-00 REMEDYREPACK 473 ml — AT FDA listed —
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution 1.2 mg/mL 73141-0512-50 A2A 100 cups — AT FDA listed —
Chlorhexidine Gluconate Oral Rinse 1.2 mg/mL 73614-0203-01 Brisk 118 ml — AT FDA listed —
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution 1.2 mg/mL 81033-0512-50 Kesin 100 cups — AT FDA listed —
Chlorhexidine Gluconate 1.2 mg/mL 00121-1786-16 PAI 473 ml — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
1995
On the market since
Dec 1995
📍
2026
Currently FDA-listed
31 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00121-0893-16, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2K
Units reimbursed last 4 qtrs
974.9K
Gross reimbursed last 4 qtrs
$37.3K
Avg / prescription
$18.39
Avg / unit
$0.0383
Latest quarter Q4 2025
381Rx
Medicaid pays / mL
$0.0383
gross reimbursed
vs
NADAC / mL
$0.0047
acquisition cost
=
Spread
+$0.0336
+715% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
88% FFS 12% MCO
Fee-for-service · 1,785 Rx Managed care · 243 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 5,676 units · 56.6 per 100k residents MI New York: 719,120 units · 3,674 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 8,041 units · 68.2 per 100k residents OH Pennsylvania: 25,489 units · 197 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 5,676 units · 81.1 per 100k residents MA California: 119,538 units · 307 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 43,043 units · 696 per 100k residents MD Connecticut: 6,622 units · 183 per 100k residents CT Rhode Island: no data reported RI Arizona: 2,273 units · 30.6 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 12,771 units · 179 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 26,622 units · 582 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
30.63,674
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 3,674 /100k
2 Maryland 696 /100k
3 Louisiana 582 /100k
4 California 307 /100k
5 Pennsylvania 197 /100k
6 Connecticut 183 /100k
7 Tennessee 179 /100k
8 Massachusetts 81.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
473 ml this page00121-0893-16 2,028 Rx · $37,298
10 cups00121-0893-00 47 Rx · $28,728
10 cups00121-0893-40 38 Rx · $9
Drug total (last 4 qtrs): 2,113 Rx · 975,614 units · $66,036 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Chlorhexidine Gluconate — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Chlorhexidine Gluconate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.96M
Claims incl. refills
658.9K
Beneficiaries
540.1K
Spend / beneficiary
$7.34
Spend / claim
$6.02
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Gluconate — the ingredient across all brands.

Top reported reactions

Fatigue2,139
Rash1,979
Pain1,957
Joint Swelling1,929
Hypersensitivity1,801
Impaired Healing1,786
Folliculitis1,759

Reporter sex

0 reports

Serious outcomes

Death2,815
Disabling2,791
Life-threatening2,632
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 880 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 Per unit Per pack Marketing startStatus
00121-0893-00 10 TRAY in 1 CASE (0121-0893-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-0893-15) — — 2020-09-18 Active
00121-0893-16 You're viewing this 473 mL in 1 BOTTLE (0121-0893-16) $0.0047 / mL $2.22 2020-09-18 Discontinued by firm
00121-0893-40 4 TRAY in 1 CASE (0121-0893-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-0893-15) — — 2020-09-18 Active

In Medicaid, this is the most-dispensed pack of this product — about 96% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00121-0893-16?
NDC 00121-0893-16 contains 473 mL — 473 ml in 1 bottle.
What NDC number is used to bill for this package of CHLORHEXIDINE GLUCONATE 1.2 mg/mL Rinse?
Bill NDC 00121-0893-16 — the 11-digit billing format is 00121089316. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
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) ✓ Available
“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

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 FDA registers it as 0121-0893-16, 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: 00121-0893-16, written without dashes as 00121089316. 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 00121-0893-16, the first segment (00121) is the labeler code FDA assigned to PAI Holdings, LLC dba PAI Pharma; the middle segment (0893) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 10 cups (00121-0893-00), 10 cups (00121-0893-40). 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?
PAI Holdings, LLC dba PAI Pharma 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 65 words ▾

INDICATION Chlorhexidine gluconate oral rinse, 0.12% is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse, 0.12% has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS .

⏱️ Dosage and Administration 106 words ▾

DOSAGE AND ADMINISTRATION Chlorhexidine gluconate oral rinse, 0.12% therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine gluconate oral rinse, 0.12% should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing.

Usual dosage is 15 mL of undiluted chlorhexidine gluconate oral rinse, 0.12%. Patients should be instructed to not rinse with water or other mouthwashes, brush teeth or eat immediately after using chlorhexidine gluconate oral rinse, 0.12%. Chlorhexidine gluconate oral rinse, 0.12% is not intended for ingestion and should be expectorated after rinsing.

⛔ Contraindications 25 words ▾

CONTRAINDICATIONS Chlorhexidine gluconate oral rinse, 0.12% should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

⚠️ Warnings 88 words ▾

WARNINGS The effect of chlorhexidine gluconate oral rinse, 0.12% on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in chlorhexidine gluconate oral rinse users compared with control users. It is not known if chlorhexidine gluconate use results in an increase in subgingival calculus.

Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. (See CONTRAINDICATIONS ) .

🤒 Adverse Reactions 192 words ▾

ADVERSE REACTIONS The most common side effects associated with chlorhexidine gluconate oral rinses are: 1) an increase in staining of teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception, see WARNINGS and PRECAUTIONS . Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with the use of chlorhexidine gluconate oral rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum.

Each occurred at a frequency of less than 1%. Among postmarketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinse.

There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse. To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🤰 Pregnancy 68 words ▾

Pregnancy Teratogenic Effects Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, and have not revealed evidence of harm to the fetus. However, adequate and well-controlled studies in pregnant women have not been done. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 23 words ▾

Pediatric Use Clinical effectiveness and safety of chlorhexidine gluconate oral rinse, 0.12% have not been established in children under the age of 18.

🆘 Overdosage 62 words ▾

OVERDOSAGE Ingestion of 1 or 2 ounces of chlorhexidine gluconate oral rinse, 0.12% by a small child (~10 kg body weight) might result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces of chlorhexidine gluconate oral rinse, 0.12% is ingested by a small child or if signs of alcohol intoxication develop.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Chlorhexidine gluconate oral rinse, 0.12% provides antimicrobial activity during oral rinsing. The clinical significance of chlorhexidine gluconate oral rinse, 0.12% antimicrobial activities is not clear. Microbiological sampling of plaque has shown a general reduction of counts of certain assayed bacteria, both aerobic and anaerobic, ranging from 54-97% through six months use.

Use of chlorhexidine gluconate oral rinse in a six month clinical study did not result in any significant changes in bacteria resistance, overgrowth of potentially opportunistic organisms or other adverse changes in the oral microbial ecosystem. Three months after chlorhexidine gluconate oral rinse use was discontinued, the number of bacteria in plaque had returned to baseline levels and resistance of plaque bacteria to chlorhexidine gluconate was equal to that at baseline. Pharmacokinetics Pharmacokinetic studies with chlorhexidine gluconate oral rinse indicate approximately 30% of the active ingredient, chlorhexidine gluconate, is retained in the oral cavity following rinsing.

This retained drug is slowly released into the oral fluids. Studies conducted on human subjects and animals demonstrate chlorhexidine gluconate is poorly absorbed from the gastrointestinal tract. The mean plasma level of chlorhexidine gluconate reached a peak of 0.206 µg/g in humans 30 minutes after they ingested a 300 mg dose of the drug.

Detectable levels of chlorhexidine gluconate were not present in the plasma of these subjects 12 hours after the compound was administered. Excretion of chlorhexidine gluconate occurred primarily through the feces (~90%). Less than 1% of the chlorhexidine gluconate ingested by these subjects was excreted in the urine.

📦 How Supplied / Storage and Handling 111 words ▾

HOW SUPPLIED Chlorhexidine gluconate oral rinse, USP 0.12% is a clear, light blue, peppermint flavored liquid and is supplied as: NDC 0121-0893-04: 4 fl oz (118mL) NDC 0121-1786-16: 16 fl oz (473 mL) NDC 0121-0893-15: 15 mL unit dose cup. Case contains 40 unit dose cups of 15 mL (NDC 0121-0893-40), packaged in 4 trays of 10 unit dose cups each and 100 unit dose cups of 15 mL (NDC 0121-0893-00) packaged in 10 trays of 10 unit dose cups each. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Rx only Keep out of reach of children Dispense in bottle as provided with a child-resistant closure.

📦 Storage and Handling 30 words ▾

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Rx only Keep out of reach of children Dispense in bottle as provided with a child-resistant closure.

📋 Description 83 words ▾

DESCRIPTION Chlorhexidine gluconate oral rinse, USP 0.12% is an oral rinse containing 0.12% chlorhexidine gluconate (1,1’-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-D-gluconate) in a base containing 11.6% alcohol, FD&C Blue No. 1, glycerin, peppermint flavor, polysorbate 80, purified water, and saccharin sodium. Chlorhexidine Gluconate Oral Rinse, 0.12% is a near-neutral solution (pH range 5-7).

Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is: C 22 H 30 Cl 2 N 10 •2C 6 H 12 O 7 M.W. 897.72 Chemical Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00121-0892-50 · PAI 00121-0904-94 · PAI →
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.