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DYNA-HEX 2 Chlorhexidine gluconate 2 g/100mL Liquid, 15142 mL — NDC 00116-1021-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

DYNA-HEX 2 Chlorhexidine gluconate 2 g/100mL Liquid, 15142 mL — NDC 0116-1021-01 (Billing 00116-1021-01)

by Xttrium Laboratories, Inc. · 15142 mL in 1 JUG

This is a package of 15,142 mL of DYNA-HEX 2 Chlorhexidine gluconate 2 g/100mL Liquid from Xttrium Laboratories, Inc., no longer marketed (first marketed Jan 2014), no longer in the FDA NDC Directory.

NDC 00116-1021-01
🏷️ FDA NDC (as labeled) 0116-1021-01 billing pads the labeler segment with a zero
This package
Contains15142 mL Pack sizes7 compare ↓
Product page 00116-1021-04 Also comes in: 118 ml 0116-1021-04 237 ml 0116-1021-08 250 ml 0116-1021-85 473 ml 0116-1021-16 473 ml 0116-1021-17 946 ml 0116-1021-32
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 0116-1021-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0116 labeler · 1021 product · 01 package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0011610211601, 0301161021089, 0011610211700
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0116-1021-01
Product NDC 0116-1021
11-digit billing NDC 00116102101
RxCUI 834160, 1245230
UNII MOR84MUD8E
UPC 0011610211601, 0301161021089, 0011610211700
Application # NDA019422
SPL Set ID 6cc89ac1-baef-40bb-85a3-d9ae9e3e7a63
Physiologic effect Decreased Cell Wall Integrity
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2014-01-01
Marketing end 2027-02-28
Route TOPICAL
Dosage form LIQUID
Substance CHLORHEXIDINE GLUCONATE

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

GPI-14 92100030102015
GPI class Dyna-Hex 2
Quick answers
  • GPI-14 (Medi-Span): 92100030102015
  • RxCUI (RxNorm): 834160
Why two NDCs? The FDA registers this code as 0116-1021-01 — 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 → 00116-1021-01. 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.

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: 118 ml 237 ml 250 ml 473 ml 473 ml 946 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 Per unit Per pack Marketing startMarketing endStatus
00116-1021-01 You're viewing this 15142 mL in 1 JUG — — 2014-01-01 — Discontinued by firm
00116-1021-08 0116-1021-08 237 mL in 1 BOTTLE, PLASTIC — — 2014-01-01 — Discontinued by firm
00116-1021-16 0116-1021-16 473 mL in 1 BOTTLE, PLASTIC — — 2014-01-01 — Discontinued by firm
00116-1021-17 0116-1021-17 473 mL in 1 BOTTLE, PLASTIC — — 2014-01-01 — Discontinued by firm
00116-1021-32 0116-1021-32 946 mL in 1 BOTTLE, PLASTIC — — 2014-01-01 Feb 28, 2027 Active
00116-1021-85 0116-1021-85 250 mL in 1 BOTTLE, PUMP — — 2020-10-01 — Discontinued by firm
00116-1021-04 0116-1021-04 Main listing 118 mL in 1 BOTTLE, PLASTIC $0.0240 / mL $2.83 2014-01-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 15142 mL — 15142 ml in 1 jug.
How does this package differ from NDC 00116-1021-04?
Both are DYNA-HEX 2 Chlorhexidine gluconate 2 g/100mL Liquid — the drug itself is identical. This page's package is the 15142 mL one, while NDC 00116-1021-04 is the 118 ml package.
What NDC number is used to bill for this package of DYNA-HEX 2 Chlorhexidine gluconate 2 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.

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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dyna-Hex 2 2 g/100mLthis 00116-1021-01 Xttrium 15142 ml — — Discontinued —
Dyna-Hex 2 20 mg/mL 00116-1022-18 Xttrium 535 ml — — FDA listed —
Provon Antimicrobial Foam Handwash 20 mg/mL 00116-8500-89 Xttrium 1200 ml — — FDA listed —
Bactoshield CHG Chlorhexidine Gluconate 20 mg/mL 11084-0038-03 SC 118 ml — — FDA listed —
Bactoshield CHG 20 mg/mL 11084-0126-03 SC 118 ml — — FDA listed —
Antimicrobial Skin Cleanser 20 mg/mL 21749-0106-32 Gojo 946 ml — — FDA listed —
Purell Antimicrobial Foam 20 mg/mL 21749-0225-53 GOJO 535 ml — — FDA listed —
Antimicrobial Foam Handwash 20 mg/mL 21749-0416-89 GOJO 1200 ml — — FDA listed —
Antiseptic Foam Handwash 20 mg/mL 21749-0461-89 GOJO 1200 ml — — FDA listed —
Provon Antimicrobial Foam Handwash 20 mg/mL 21749-0850-53 Gojo 535 ml — — FDA listed —
Scrub, Scrub-Stat, Foam Safe, Micro-Guard 20 mg/mL 42939-0124-19 AVA, 946 ml — — FDA listed —
Scrub, Scrub-Stat, Foam Safe, Micro-Guard 20 mg/mL 42939-0127-01 AVA, 118 ml — — FDA listed —
Scrub-Stat 20 mg/mL 47593-0463-11 Ecolab 3780 ml — — FDA listed —
Scrub-Stat 20 mg/mL 47593-0467-21 Ecolab 208000 ml — — Discontinued —
foaming hand wash 20 mg/mL 53329-0994-84 Medline 1000 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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 92005F972D
    A foaming and thickening agent derived from coconut oil. It's used in liquid medicines to improve texture, help distribute active ingredients evenly, and create a pleasant consistency for easier swallowing or application.
  • UNII S38J6RZN16
    Hydroxyethyl cellulose is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust product texture, and a film-former to create smooth coatings on tablets.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 4F6FC4MI8W
    Lauramine oxide is a surfactant, a substance that helps mix oil and water together. It's used in medicines to improve how ingredients blend and to help the product dissolve or spread properly.
  • 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.

The official label also statescitric add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerXttrium Laboratories, Inc.
Application holderXTTRIUM LABORATORIES INC
FDA applicationNDA019422 (NDA)
Labeler code00116
First marketedJan 2014
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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 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 skin wound and general skin cleansing

⏱️ Dosage and Administration 164 words ▾

Directions 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 under running water for 30 seconds.

Clean fingernails using a nailstick or similar cleaner. scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers rinse thoroughly under running water for 30 seconds wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds 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 Skin wound and general skin cleaning: 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 38 words ▾

Warnings For external use only Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away.

🧪 Active Ingredient 6 words ▾

Active ingredient chlorhexidine gluconate 2% solution

🧪 Inactive Ingredients 13 words ▾

Inactive ingredients citric add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

🎯 Purpose 2 words ▾

Purpose Antiseptic

📄 Do Not Use 28 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

📄 When Using This Product 129 words ▾

When using this product keep out of eyes, ears and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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 wounds that 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.

📄 Stop Use and Ask a Doctor If 42 words ▾

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

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 38 words ▾

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

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

📄 Questions or Comments 14 words ▾

Questions or comments? call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

📄 Package Label / Principal Display Panel ~1 min read ▾

DYNA-HEX 2® NDC 0116-1021-08 Chlorhexidine Gluconate 2% Solution Antiseptic Foam Handwash Distributed by: Xttrium Laboratories, Inc. Mount Prospect, IL 60056 2BLDY08BTLLBLC Net Wt 8 fl oz (237 mL) NDC 0116-1021-85 DYNA-HEX 2®ANTIMICROBIAL HAND SOAP Chlorhexidine Gluconate 2% Solution Antiseptic Contains: 2% Chlorhxidine Gluconate FOR EXTERNAL USE ONLY FDA approved formula Helps Reduce Bacteria Fragrance-Free Used by Healthcare personnel in hospitals Net Contents: 8.5 fl oz (251 mL) 2DYN85FLBL NDC 0116-1021-16 Dyna-Hex 2 ® Chlorhexidine Gluconate 2% Solution Antiseptic Foam Handwash Distributed by: Xttrium Laboratories, Inc.

Mount Prospect, IL 60056 2DYN16BTLLBLD Net Wt 16 fl oz (473 mL) NDC 0116-1021-17 Dyna-Hex 2® Chlorhexidine Gluconate 2% Solution Antiseptic Foam Handwash Distributed by: Xttrium Laboratories, Inc. Mount Prospect, IL 60056 2BLDYNATLBLD Net Wt 16 fl oz (473 mL) NDC 0116-1021-32 Dyna-Hex 2® Chlorhexidine Gluconate 2% Solution Antiseptic Foam Handwash Distributed by: Xttrium Laboratories, Inc. Mount Prospect, IL 60056 2DYN32BTLLBLA Net Wt 32 fl oz (946 mL) NDC 0116-1021-01 Dyna-Hex 2® Chlorhexidine Gluconate 2% Solution Antiseptic Foam Handwash Distributed by: Xttrium Laboratories, Inc.

Mount Prospect, IL 60056 2DYN1GBTLLBLB Net Wt 128 fl oz (1 gal) Dyna-Hex 2 8oz single panel 2DYN85 Front 2DYN85 DF1 2DYN85 DF2 2DYN85 DF3 Dyna-Hex 2 16oz single panel Nat 1 Nat 2 nat 3 nat 4 PDP 32-oz Page 1 PDP 32-oz Page 2 PDP 32-oz Page 3 Dyna-Hex 1 Gallon

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

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

Medicare Part D (outpatient prescription) spending for Chlorhexidine Gluconate (matched by generic name) — 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. CMS lists 2 products for this generic; we show the highest-spend one. 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.

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 ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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 6 other package presentations of this same product, including 118 ml (00116-1021-04), 237 ml (00116-1021-08), 250 ml (00116-1021-85). 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.
← 00116-0901-05 · Xttrium 00116-1022-18 · 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.