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Chlorhexidine Gluconate Solution 1 g/mL Liquid, 500 mL — NDC 49452-1947-1 (Billing 49452-1947-01)

by Spectrum Laboratory Products, Inc. · 500 mL in 1 BOTTLE

This is a package of 500 mL of Chlorhexidine Gluconate Solution 1 g/mL Liquid from Spectrum Laboratory Products, Inc., marketed since May 1993 and currently FDA-listed. It is the main listing for this product, which comes in 5 package sizes.

NDC 49452-1947-01
🏷️ FDA NDC (as labeled) 49452-1947-1 billing pads the package segment with a zero
This package
Contains500 mL Pack sizes5 compare ↓
Main listing for product 49452-1947 · Also comes in: 100 ml 49452-1947-3 4000 ml 49452-1947-2 20000 ml 49452-1947-4 200000 ml 49452-1947-5
On market Non-controlled ⇄ 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 →

NDC database record

One package, one record: these facts belong to NDC 49452-1947-1 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
49452 labeler · 1947 product · 1 package
Package marketed since
May 1, 1993
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4945219471 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49452-1947-1
Product NDC 49452-1947
11-digit billing NDC 49452194701
SPL Set ID 092e3e92-88fd-9f5c-e063-6394a90a7db5
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1993-05-01
Dosage form LIQUID
Substance CHLORHEXIDINE GLUCONATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 96200034302000
GPI class Chlorhexidine Gluconate
GCN Seq No 022520
GCN 80931
HICL code 004297
Ingredient (HICL) Chlorhexidine Gluconate
HIC1 code U
Therapeutic class — broad (HIC1) Miscell. Drugs/ Pharmaceutical Adjuvants
HIC2 code U6
Therapeutic class — intermediate (HIC2) Pharmaceutical Adjuvants
HIC3 code U6W
Therapeutic class — specific (HIC3) Bulk Chemicals
AHFS code 84:04.92.00
AHFS class Local Anti-Infectives, Miscellaneous
FDB label name CHLORHEXIDINE GLUC 20% SOLN
FDB brand name Chlorhexidine Gluconate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 022520
  • GCN: 80931
  • GPI-14 (Medi-Span): 96200034302000
  • HICL (First Databank): 004297
  • AHFS class code: 84:04.92.00
Why two NDCs? The FDA registers this code as 49452-1947-1 — a 5-4-1 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 package segment → 49452-1947-01. 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

Label name CHLORHEXIDINE GLUC 20% SOLN Ingredient Chlorhexidine Gluconate
📖 What it is MedlinePlus · NLM

Chlorhexidine topical is used to reduce the number of bacteria on the skin. It is usually used as needed to clean the skin or wounds. It also is used as a handwash for healthcare providers, especially before surgery or procedures. Chlorhexidine is in a class of medications called anti-infectant agents. It works by reducing the amount of bacteria on the skin.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats gingivitis, which means red, swollen gums that may bleed. You use it between dental visits as part of a program with your dentist. It has not been tested in people with A...
  • It can. Staining of teeth and other mouth surfaces is one of the most common side effects. You may also notice more tartar and changes in taste. Your dentist should remove tartar a...
  • Anyone allergic to chlorhexidine gluconate or any ingredient in the product should avoid it. Serious allergic reactions, including anaphylaxis, have been reported with dental produ...
  • Keep it out of reach of children. A small child who swallows 1 or 2 ounces may have stomach upset, nausea or signs of alcohol intoxication. Get medical help if more than 4 ounces i...
📖 Read our full Chlorhexidine guide →
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.
Try another pack size: 100 ml 4000 ml 20000 ml 200000 ml
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
49452-1947-01 You're viewing this Main listing 500 mL in 1 BOTTLE — — Active
49452-1947-02 49452-1947-2 4000 mL in 1 BOTTLE — — Active
49452-1947-03 49452-1947-3 100 mL in 1 BOTTLE — — Active
49452-1947-04 49452-1947-4 20000 mL in 1 BOTTLE — — Active
49452-1947-05 49452-1947-5 200000 mL in 1 BOTTLE — — Active

You're viewing one of 5 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 500 mL — 500 ml in 1 bottle.
How does this package differ from NDC 49452-1947-03?
Both are Chlorhexidine Gluconate Solution 1 g/mL Liquid — the drug itself is identical. This page's package is the 500 mL one, while NDC 49452-1947-03 is the 100 ml package.
What NDC number is used to bill for this package of Chlorhexidine Gluconate Solution 1 g/mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlorhexidine Gluconate Solution 1 g/mLthis 49452-1947-01 Spectrum 500 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

🏛️
1993
On the market since
May 1993
📍
2026
Currently FDA-listed
33 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.

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

LabelerSpectrum Laboratory Products, Inc.
Labeler code49452
First marketedMay 1993
Product typeDrug For Further Processing
Portfolio234 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.

Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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 Gluconate Solution — the ingredient across all brands.

Top reported reactions

Erythema1
Hypersensitivity1
Oedema1
Pruritus1

Age at onset

Adult1

Reporter sex

1 reports
Male · 100%
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 1 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

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Spectrum Laboratory Products, Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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 "Drug For Further Processing". 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 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.
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 Spectrum Laboratory Products, Inc.. 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 4 other package presentations of this same product, including 100 ml (49452-1947-03), 4000 ml (49452-1947-02), 20000 ml (49452-1947-04). 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?
Spectrum Laboratory Products, 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.
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.