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Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% 4 mg/100mL Liquid, 473 mL — NDC 00116-0161-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% 4 mg/100mL Liquid, 473 mL — NDC 0116-0161-16 (Billing 00116-0161-16)

by Xttrium Laboratories, Inc. · 473 mL in 1 BOTTLE, PUMP

This is a package of 473 mL of Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% 4 mg/100mL Liquid from Xttrium Laboratories, Inc., marketed since May 2011 and currently FDA-listed.

NDC 00116-0161-16
🏷️ FDA NDC (as labeled) 0116-0161-16 billing pads the labeler segment with a zero
This package
Contains473 mL Pack sizes3 compare ↓
Product page 00116-0161-08 Also comes in: 15 ml 0116-0161-15 237 ml 0116-0161-08
OTC Brand 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 →

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 0116-0161-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0116 labeler · 0161 product · 16 package
Package marketed since
May 1, 2011
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0311917182728
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0116-0161-16
Product NDC 0116-0161
11-digit billing NDC 00116016116
RxCUI 211365
UNII MOR84MUD8E
UPC 0311917182728
Application # NDA019125
SPL Set ID 4ab2cfc2-7adb-20c4-e054-00144ff8d46c
Physiologic effect Decreased Cell Wall Integrity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-05-01
Route TOPICAL
Dosage form LIQUID
Substance CHLORHEXIDINE GLUCONATE
Quick answers
  • RxCUI (RxNorm): 211365
Why two NDCs? The FDA registers this code as 0116-0161-16 — 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 → 00116-0161-16. 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.

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: 15 ml 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
00116-0161-08 0116-0161-08 Main listing 237 mL in 1 BOTTLE, PLASTIC 2011-05-01 — Active
00116-0161-15 0116-0161-15 15 mL in 1 KIT 2017-01-01 — Active
00116-0161-16 You're viewing this 473 mL in 1 BOTTLE, PUMP 2011-05-01 — Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 473 mL — 473 ml in 1 bottle, pump.
How does this package differ from NDC 00116-0161-15?
Both are Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% 4 mg/100mL Liquid — the drug itself is identical. This page's package is the 473 mL one, while NDC 00116-0161-15 is the 15 ml package.
What NDC number is used to bill for this package of Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% 4 mg/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/100mL 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/100mLthis 00116-0161-16 Xttrium 473 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 —
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

🏛️
2011
On the market since
May 2011
📍
2026
Currently FDA-listed
15 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 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 WQ29KQ9POT
    Gluconolactone is a mild organic acid derived from glucose. It functions as a buffer and pH regulator in medicines, helping maintain stable acidity levels and improve product stability.
  • 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 09179OX7TB
    PEG-75 Lanolin is a waxy substance derived from sheep's wool that has been chemically modified to mix easily with water and oil. It acts as an emulsifier and moisturizer in topical formulations, helping blend different ingredients and soften the skin.
  • UNII 8I9428H868
    Tridecyl alcohol is a fatty alcohol derived from natural oils or made synthetically. In medicines, it works as an emulsifier and surfactant to help mix oil and water-based ingredients together smoothly.
  • 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.

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

The official label also statescocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

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 applicationNDA019125 (NDA)
Labeler code00116
First marketedMay 2011
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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

Uses healthcare personnel handwash : helps reduce bacteria that potentially can cause disease skin wound and general skin cleansing

⏱️ Dosage and Administration 87 words ▾

Directions use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. Healthcare personnel handwash: wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for about 15 seconds rinse and dry thoroughly Skin wound and normal 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 194 words ▾

Warnings For external use only Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing 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 When using this product keep out of eyes, ears, and mouth.

May cause serious and permanent eye injury if pemitted to ener and remain in the eye or may cause deafness when instilled in the middle eat through perforated eardrums.. if solution should contact these areas, rinse out promptly and thoroughly with water wounds 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 13 words ▾

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

🧪 Active Ingredient 6 words ▾

Active Ingredient 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 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 89 words ▾

When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if pemitted to ener and remain in the eye or may cause deafness when instilled in the middle eat through perforated eardrums.. if solution should contact these areas, rinse out promptly and thoroughly with water wounds 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 21 words ▾

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 19 words ▾

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

📄 Other Information 81 words ▾

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine-releasing products. Rinse completely and use only non-chlorine detergents. W ARNING: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer. ‡Walgreens Pharmacist Survey Study, November 2014 ‡‡This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.

Distributed by: Walgreen Co. 200 Wilmot RD., Deerfield, IL 60015 100% Satisfaction Guaranteed walgreens.com ©2015 Walgreen Co. Made in USA

📄 Questions or Comments 2 words ▾

Questions? 1-800-587-3721

📄 Recent Major Changes 3 words ▾

Surgical handscrub removed

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

Package label and principal display panel Walgreens Compare to the Hibiclens® active ingredient NDC 0363-1061-08 Dye-Free Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4% SOLUTION / ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER DYE FREE TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING 8 FL OZ (237 mL) NDC 0363-1061-18 Walgreens Compare to Hibiclens® active ingredient Dye-Free Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4% SOLUTION / ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING 18 FL OZ (532 mL) NDC 0363-1061-16 Walgreens Compare to Hibiclens® active ingredient Dye-Free Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4% SOLUTION / ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING 16 FL OZ (473 mL) Wal 8oz wal 18oz wal 16oz

Carton NDC 0363-1061-15 Walgreens, Co. Chlorhexidine Gluconate 4% Solution Antiseptic Skin Cleansing Kit Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056 4WAL15INNERCTNA

0.5 FL OZ (15 mL) CTN Page 1 CTN Page 2 CTN Page 3

Lidstock NDC 0363-1061-15 Walgreens, Co. Chlorhexidine Gluconate 4% Solution Antiseptic Skin Cleansing Kit Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056 4WAL15LIDSTOCKA

0.5 FL OZ (15 mL) LDSK

Packet NDC 0363-1061-15 Walgreens, Co. Chlorhexidine Gluconate 4% Solution Antiseptic Skin Cleansing Convenience Kit Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056 4WAL15PACKETA

0.5 FL OZ (15 mL) PP Page 1 PP Page 2

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

About this NDC listing & data coverage

Over-the-counter (OTC) product
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.
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 Xttrium Laboratories, 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 2 other package presentations of this same product, including 15 ml (00116-0161-15), 237 ml (00116-0161-08). 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.
← 00116-0137-34 · Xttrium 00116-0175-16 · 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.