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Cardinal Health CHLORHEXIDINE GLUCONATE 4% 4 g/100mL Liquid, 118 mL — NDC 0116-0061-04 (Billing 00116-0061-04)

by Xttrium Laboratories, Inc. · 118 mL in 1 BOTTLE, PLASTIC

This is a package of 118 mL of Cardinal Health CHLORHEXIDINE GLUCONATE 4% 4 g/100mL Liquid from Xttrium Laboratories, Inc., no longer marketed (first marketed Jul 2015), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 2 package sizes.

NDC 00116-0061-04
🏷️ FDA NDC (as labeled) 0116-0061-04 billing pads the labeler segment with a zero
This package
Contains118 mL Pack sizes2 compare ↓
Main listing for product 0116-0061 · Also comes in: 237 ml 0116-0061-08
OTC Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0116-0061-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0116 labeler · 0061 product · 04 package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0116006104 8
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0116-0061-04
Product NDC 0116-0061
11-digit billing NDC 00116006104
RxCUI 211365
UNII MOR84MUD8E
Application # NDA019125
SPL Set ID 4a645652-ae2f-3811-e054-00144ff8d46c
Physiologic effect Decreased Cell Wall Integrity
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2015-07-24
Route TOPICAL
Dosage form LIQUID
Substance CHLORHEXIDINE GLUCONATE
Quick answers
  • RxCUI (RxNorm): 211365
Why two NDCs? The FDA registers this code as 0116-0061-04 — 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 → 00116-0061-04. 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.

Clinical

📗 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 →

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.

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: 237 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
00116-0061-04 You're viewing this Main listing 118 mL in 1 BOTTLE, PLASTIC 2015-07-24 — Discontinued by firm
00116-0061-08 0116-0061-08 237 mL in 1 BOTTLE, PLASTIC 2015-07-24 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 118 mL — 118 ml in 1 bottle, plastic.
How does this package differ from NDC 00116-0061-08?
Both are Cardinal Health CHLORHEXIDINE GLUCONATE 4% 4 g/100mL Liquid — the drug itself is identical. This page's package is the 118 mL one, while NDC 00116-0061-08 is the 237 ml package.
What NDC number is used to bill for this package of Cardinal Health CHLORHEXIDINE GLUCONATE 4% 4 g/100mL 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
Antiseptic Skin Cleanser 4 g/100mL 70000-0407-01 Cardinal 237 ml $0.025 — FDA listed —
Antiseptic Skin Cleanser 4 g/100mL 00116-1061-04 Xttrium 118 ml $0.034 — Availability likely —
Antiseptic Skin Cleanser 4 mg/100mL 46122-0137-34 AmerisourceBergen 237 ml $0.037 — Availability likely —
Foster and Thrive 4 g/100mL 70677-1221-01 McKesson 237 ml $0.037 — Availability likely —
Chlorhexidine Gluconate 40 mg/mL 16571-0111-12 Rising 118 ml $0.040 — Availability likely —
Betasept .04 mg/mL 67618-0200-04 Atlantis 118 ml $0.040 — Availability likely —
Cardinal Health 4 g/100mLthis 00116-0061-04 Xttrium 118 ml — — Discontinued —
Antiseptic Skin Cleanser 4 mg/100mL 00116-0137-34 Xttrium 237 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 00116-0161-08 Xttrium 237 ml — — FDA listed —
Betasept .04 mg/mL 00116-0200-01 Xttrium 3785 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 00116-0401-50 Xttrium 237 ml — — FDA listed —
Antiseptic Skin Cleanser 4 g/100mL 00116-0407-01 Xttrium 237 ml — — FDA listed —
Antiseptic Skin Cleanser 4 g/100mL 00116-0767-08 Xttrium 237 ml — — FDA listed —
CliniClean 4 g/100mL 00116-0901-05 Xttrium 118 ml — — Discontinued —
Dyna-Hex 4 4 g/100mL 00116-1060-18 Xttrium 535 ml — — FDA listed —
Foster and Thrive 4 g/100mL 00116-1221-01 Xttrium 237 ml — — FDA listed —
Bactoshield CHG 40 mg/mL 00116-1344-08 Xttrium 3780 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 00116-3678-07 Xttrium 473 ml — — FDA listed —
Hibiclens 4 g/100mL 00234-0575-40 Molnlycke 118 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 00363-1061-08 Walgreen 237 ml — — FDA listed —
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% 40 mg/mL 00404-0219-01 Henry 118 ml — — FDA listed —
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% 40 mg/mL 00404-0220-03 Henry 236 ml — — FDA listed —
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% 40 mg/mL 00404-0221-04 Henry 473 ml — — FDA listed —
Bactoshield CHG 40 mg/mL 11084-0039-03 SC 118 ml — — FDA listed —
Bactoshield CHG 40 mg/mL 11084-0128-03 SC 118 ml — — FDA listed —
Antiseptic Skin Cleanser 4 g/100mL 11822-0116-05 Rite 237 ml — — FDA listed —
Antiseptic Skin Cleanser 4 g/100mL 11822-0891-02 Rite 532 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 11822-3678-07 Rite 473 ml — — FDA listed —
BD E-Z Scrub 107 40 g/1000mL 17271-0107-03 Becton 18 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 36800-0401-50 Topco 237 ml — — FDA listed —
Halyard Chlorhexidine Gluconate 40 mg/mL 39892-0960-01 Owens 118 ml — — FDA listed —
Halyard Chlorhexidine Gluconate 40 mg/mL 39892-0961-01 Owens 118 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 41250-0162-08 Meijer 237 ml — — Discontinued —
Scrub, Scrub-Stat, Foam Safe, Micro-Guard 40 mg/mL 42939-0125-19 AVA, 946 ml — — FDA listed —
Scrub, Scrub-Stat, Foam Safe, Micro-Guard 40 mg/mL 42939-0128-01 AVA, 118 ml — — FDA listed —
Scrub-Stat 40 mg/mL 47593-0464-11 Ecolab 3780 ml — — FDA listed —
Scrub-Stat 40 mg/mL 47593-0468-21 Ecolab 208000 ml — — Discontinued —
Antiseptic Skin Cleanser 4 g/100mL 59779-0767-08 CVS 237 ml — — FDA listed —
Antiseptic Skin Cleanser 4 mg/100mL 63868-0940-08 Chain 237 ml — — FDA listed —
Antiseptic Skin Cleanser 4 g/100mL 68599-5401-00 McKesson 4 bottles — — FDA listed —
CliniClean 4 g/100mL 69464-0901-05 HR 118 ml — — Discontinued —
Hibiclens 4 g/100mL 76420-0535-08 Asclemed 236 ml — — FDA listed —
Surgical Scrub Brush/Sponge With Nail Cleaner 4% CHG 4 g/100mL 84128-0003-01 Xinxiang 30 patches — — FDA listed —
Antiseptic Solution 4 g/100mL 11701-0172-52 Coloplast 118 ml — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2015
On the market since
Jul 2015
📍
2026
Currently FDA-listed
11 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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

LabelerXttrium Laboratories, Inc.
Application holderXTTRIUM LABORATORIES INC
FDA applicationNDA019125 (NDA)
Labeler code00116
First marketedJul 2015
Product typeHuman Otc Drug
Portfolio35 products on file

More NDCs from Xttrium Laboratories, Inc. labeler code 00116

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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 54 words ▾

Uses surgical hand scrub : significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash : helps reduce bacteria that potentially can cause disease patient preoperative skin preparation : for the preparation of the patient's skin prior to surgery skin wound and general cleansing

⏱️ Dosage and Administration 182 words ▾

Direction use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrub: wet hands and forearms with water. scrub for 3 minutes with about 5 mL of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces a separate nail cleaner may be used rinse throughly wash for an additional 3 minutes with 5 mL of product and rinse under running water dry thoroughly Healthcare personnel handwash: wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly Patient preoperative skin preparation: apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel repeat procecedure for an additional 2 minutes and dry with a sterile towel Skin wound and general skin cleansing: thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessary to cover the skin or wound area and wash gently rinse again thoroughly

⚠️ Warnings 206 words ▾

Warnings For external use only Allergy alert: ​This product may cause a severe allergic reation. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product in contact with meninges in the genital area as a preoperative skin preparation of the head or face When using this product keep out of eyes, ears, and mouth.

May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water wound which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when advised by a health care provider Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs.

These may be signs of a serious condition. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 16 words ▾

other information store at 20-25 C (68-77 F) avoid excessive heat above 40 C (104 F)

🧪 Active Ingredient 4 words ▾

Chlorhexidine gluconate 4% Solution

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

🎯 Purpose 2 words ▾

Purpose Antiseptic

📄 Do Not Use 38 words ▾

Do not use if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product in contact with meninges in the genital area as a preoperative skin preparation of the head or face

📄 Ask a Doctor Before Use If 21 words ▾

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

📄 When Using This Product 90 words ▾

When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water wound which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when advised by a health care provider

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 116 words ▾

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents. WARNING: This product can expose you to chemicals including cocamide DEA, which is known to the State of California to cause cancer.

For more informationm, go to P65Warnings.ca.gov For Professional and Hospital Use Only You may report serious side effects to 1-877-227-3642 Not Made with Natural Rubber Latex Distributed by Cardinal Health Waukegan, IL 60085 USA Rev. D 2019-07 • cardinalhealth.com ©2019 Cardinal Health. All Rights Reserved.

CARDINAL HEALTH and the Cardinal Health LOGO are trademarks of Cardinal Health and may be registered in the US and/or in other countries.

📄 Package Label / Principal Display Panel 51 words ▾

Package Label NDC: 63517-061-04 AS-4CHGL4 Cardinal Health Chlorhexidine Gluconate 4% Solution Single-Use Antiseptic Non Sterile Solution 4 fl oz (118mL) NDC: 63517-061-08 AS-4CHGL8 Cardinal Health Chlorhexidine Gluconate 4% Solution Antiseptic 8 fl oz (237 mL) 4CHA04 PDP 4CHA04 DF1 4CHA04 DF2 4CHA04 DF3 4CHA08 PDP 4CHA08 DF1 4CHA08 DF2 4CHA08 DF3

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 Cardinal Health (this brand).

Top reported reactions

Burkholderia Infection2
Eye Irritation2
Hypersensitivity2
Sepsis2
Sputum Culture Positive2
Ageusia1
Alopecia1

Age at onset

Elderly1

Reporter sex

14 reports
Male · 36%
Female · 64%

Serious outcomes

Life-threatening2
Disabling2
Hospitalization1
Death1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4 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 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 — 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

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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 237 ml (00116-0061-08). 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?
Xttrium Laboratories, 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.
← 00116-0039-03 · Xttrium 00116-0100-55 · Xttrium →
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.