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Altra Antimicrobial Foaming Hand Wash with 0.3% PCMX CHLOROXYLENOL .3 g/100mL Solution, 550 mL — NDC 30805-0016-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Altra Antimicrobial Foaming Hand Wash with 0.3% PCMX CHLOROXYLENOL .3 g/100mL Solution, 550 mL — NDC 30805-016-07 (Billing 30805-0016-07)

by Buckeye International, Inc. · 550 mL in 1 BOTTLE

This is a package of 550 mL of Altra Antimicrobial Foaming Hand Wash with 0.3% PCMX CHLOROXYLENOL .3 g/100mL Solution from Buckeye International, Inc., marketed since Apr 2020 and currently FDA-listed.

NDC 30805-0016-07
🏷️ FDA NDC (as labeled) 30805-016-07 billing pads the product segment with a zero
This package
Contains550 mL Pack sizes3 compare ↓
Product page 30805-0016-02 Also comes in: 1000 ml 30805-016-13 1250 ml 30805-016-02
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 30805-016-07 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
30805 labeler · 016 product · 07 package
Package marketed since
Apr 15, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 3080501607 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 30805-016-07
Product NDC 30805-016
11-digit billing NDC 30805001607
RxCUI 413261
UNII 0F32U78V2Q
Application # 505G(a)(3)
SPL Set ID a3ce509c-d919-0752-e053-2995a90a8ac4
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-04-15
Route TOPICAL
Dosage form SOLUTION
Substance CHLOROXYLENOL
Quick answers
  • RxCUI (RxNorm): 413261
Why two NDCs? The FDA registers this code as 30805-016-07 — a 5-3-2 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 product segment → 30805-0016-07. 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 Phenol and derivatives class.

Drug family (ATC) Phenol and derivatives
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

🧪 What is this product?

Altra Antimicrobial Foaming Hand Wash is a topical foaming solution containing chloroxylenol, an antimicrobial ingredient commonly used in hand-washing products. Chloroxylenol is typically included to help reduce bacteria and other microorganisms on the skin. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established category rules for antimicrobial hand soaps rather than as an individually reviewed product application.

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: 1000 ml 1250 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
30805-0016-02 30805-016-02 Main listing 1250 mL in 1 BAG 2020-04-15 — Discontinued by firm
30805-0016-07 You're viewing this 550 mL in 1 BOTTLE 2020-04-15 — Active
30805-0016-13 30805-016-13 1000 mL in 1 BAG 2020-04-15 — Active

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

Pack size FAQ

What quantity is in this package?
This package contains 550 mL — 550 ml in 1 bottle.
How does this package differ from NDC 30805-0016-13?
Both are Altra Antimicrobial Foaming Hand Wash with 0.3% PCMX CHLOROXYLENOL .3 g/100mL Solution — the drug itself is identical. This page's package is the 550 mL one, while NDC 30805-0016-13 is the 1000 ml package.
What NDC number is used to bill for this package of Altra Antimicrobial Foaming Hand Wash with 0.3% PCMX CHLOROXYLENOL .3 g/100mL Solution?
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
Lemon Drop Gentle Antiseptic 3 mg/mL 11429-1006-01 Woodbine 118 ml — — FDA listed —
Simplify Antibacterial Hand Apple Blossom Scent .3 g/100mL 11822-0281-01 Rite 573 ml — — Discontinued —
Antiseptic Hand 3 mg/mL 16496-0544-14 Image 3785 ml — — FDA listed —
Renown Antibacterial Hand 3000 mg/L 18949-0051-00 HD 3.78 l — — FDA listed —
Symmetry Antimicrobial Foaming Hand Wash .3 g/100mL 30805-0006-02 Buckeye 1250 ml — — FDA listed —
Altra Antimicrobial Foaming Hand Wash with 0.3% PCMX .3 g/100mLthis 30805-0016-07 Buckeye 550 ml — — FDA listed —
Sentry Antiseptic Handsoap 3 mg/mL 31507-0544-14 Wechem, 3785 ml — — FDA listed —
Hand Guard High Foaming Antiseptic Hand and Body Wash 3 mg/mL 31507-0876-01 Wechem, 1200 ml — — Discontinued —
Chloroxylenol 0.30 % 3 mg/mL 42669-0028-03 Davion, 828 ml — — FDA listed —
Fm-24 Foaming 3 mg/mL 43097-0876-01 People's 1200 ml — — Discontinued —
Sani Foam Mango Antiseptic Hand and Body Wash 3 mg/mL 43374-0876-10 Delta 1000 ml — — Discontinued —
Pearl Antimicrobial Hand Item 1027Ab-01 .3 g/100mL 50536-0127-01 AMERICAN 3785 ml — — FDA listed —
Soft Touch Plus Antibacterial Hand Item 1039 .3 g/100mL 50536-0139-01 AMERICAN 3785 ml — — FDA listed —
Super Suds Antibacterial Hand Item 1063 .3 g/100mL 50536-0163-01 AMERICAN 3785 ml — — FDA listed —
E-2 Hand Item 1095 .3 g/100mL 50536-0195-01 AMERICAN 3785 ml — — FDA listed —
Golden Medicated .3 g/100mL 50865-0060-09 Kutol 3785 ml — — FDA listed —
Xtra Antibacterial Hand Juicy Orange 3 mg/mL 51628-0033-00 MY 709 ml — — FDA listed —
Ultra 3 mg/mL 55910-0589-44 Old 532 ml — — Discontinued —
Triclosan Free Antibacterial Antibacterial .3 g/100mL 57337-0086-01 Rejoice 443 ml — — FDA listed —
Triclosan Free Antibacterial 7.5 oz original Antibacterial .3 g/100mL 57337-0087-01 Rejoice 221 ml — — FDA listed —
Triclosan Free Antibacterial 7.5 oz (Ocean) Antibacterial .3 g/100mL 57337-0088-01 Rejoice 221 ml — — FDA listed —
Triclosan Free Antibacterial 7.5 oz (Strawberry Pomegranate) Antibacterial .3 g/100mL 57337-0089-01 Rejoice 221 ml — — FDA listed —
Triclosan Free Antibacterial 7.5 oz (Fresh Citrus) Antibacterial .3 g/100mL 57337-0090-01 Rejoice 221 ml — — FDA listed —
Chemseptic 3 mg/mL 59503-0544-01 Rochester 532 ml — — Discontinued —
Antibacterial Foamy Mango High Foaming Antiseptic Hand and Body Wash 3 mg/mL 60456-0876-01 Carpet 1200 ml — — Discontinued —
Franklin cleaning technology antibacterial hand 3 mg/mL 60933-0056-00 Fuller 3790 ml — — FDA listed —
1012 Antimicrobial 3 mg/mL 62257-0012-06 ABC 800 ml — — Discontinued —
Lynx Antibacterial 3 mg/mL 62257-0160-01 ABC 1200 ml — — Discontinued —
Lynx Foamy PCMX Antiseptic Hand and Body Wash 6876 3 mg/mL 62257-0161-01 ABC 1200 ml — — Discontinued —
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380 3 mg/mL 62257-0380-12 ABC 1000 ml — — FDA listed —
Palm 3 mg/mL 62257-0544-06 ABC 800 ml — — FDA listed —
Lynx LX0864 peachy-foam antiseptic handsoap 3 mg/mL 62257-0686-12 ABC 1000 ml — — FDA listed —
Sani Mango Antiseptic Hand and Body Wash 3 mg/mL 62257-0875-01 ABC 1200 ml — — Discontinued —
Sani Mango Antiseptic Hand and Body Wash 3 mg/mL 62257-0876-01 ABC 1200 ml — — FDA listed —
Handtastic Foamy Mango Antiseptic Hand and Body Wash 3 mg/mL 63533-0876-01 Momar 1200 ml — — Discontinued —
Suds High Foaming Antiseptic Hand and Body Wash 3 mg/mL 63830-0876-01 Pro 1200 ml — — Discontinued —
Fresh Start 3 mg/mL 63830-0950-06 Pro 800 ml — — FDA listed —
Surgent Antiseptic 3 mg/mL 66155-0544-01 SunCoast 1200 ml — — Discontinued —
Zep Applaud AB .3 g/100mL 66949-0123-01 Zep 11400 ml — — FDA listed —
Inoderm Style Antibacterial 3 mg/.001L 73062-0055-00 Avro 3.8 l — — FDA listed —
Inoderm Choice Antibacterial 3 mg/mL 73062-0523-42 Avro 3800 ml — — FDA listed —
Kroger Antibacterial Green Apple Hand .3 g/100mL 73487-0001-01 Korex 709 ml — — Discontinued —
Power Force Antibacterial Handsoap Green Apple Scent .3 g/100mL 73487-0008-01 Korex 709 ml — — FDA listed —
Power Force Antibacterial Handsoap Citrus Scent .3 g/100mL 73487-0009-01 KOREX 709 ml — — FDA listed —
Freshands Premium Foamy Antibacterial Handsoap 6876 3 mg/mL 75632-0876-14 Consolidated 3785 ml — — Discontinued —
Satin Foam High Foaming Antiseptic Hand Wash 3 mg/mL 75990-0914-03 Certus 750 ml — — FDA listed —
Green Antibacterial Dish and HandSoap 30 mg/10mL 79481-0200-02 Meijer, 709 ml — — FDA listed —
TOTO Antibacterial Foam HandSoap 3 mg/mL 84791-0686-05 Toto 18927 ml — — FDA listed —
Great Value ULTRA DISH Liquid Antibacterial HANDSOAP crisp apple .3 g/100mL 79903-0136-28 WALMART 828 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

🏛️
2020
On the market since
Apr 2020
📍
2026
Currently FDA-listed
6 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.

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

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 896SJ235FN
    A synthetic cleanser derived from lauryl alcohol and sulfate chemistry. It helps break down oils and reduce surface tension in liquid formulations, acting as a surfactant to improve mixing and dispersion of ingredients.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII 40U37V505D
    A fatty acid derived from coconut oil. It acts as an emulsifier to help mix water and oil-based ingredients, and may also serve as a surfactant or lubricant in tablet and capsule formulations.
  • UNII 9G34HU7RV0
    EDTA is a chemical compound that binds to metals and other substances in medicines. It's used as a preservative and stabilizer to prevent discoloration and extend shelf life.
  • UNII 5KV86114PT
    A chemical compound used in medicines as a pH buffer and neutralizing agent. It helps maintain the proper acidity level in liquid formulations to improve stability and make the medicine easier to take.
  • UNII 2UMI9U37CP
    Oleic acid is a naturally occurring fatty acid derived from plant or animal oils. It functions as an emulsifier and solvent in medicines, helping blend water and oil-based ingredients together and dissolving other components.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII BPV390UAP0
    Sodium laureth sulfate is a mild detergent and surfactant derived from coconut oil or petroleum. It helps mix oil and water in formulations and is often used as a cleaning or foaming agent in topical products like shampoos and cleansers.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.

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

The official label also statesWater (Aqua), Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Coconut Acid C-110, Oleic Acid, Ammonium Laureth Sulfate, Ethanolamine, Cocamidopropyl Betaine, EDTA, Fragrance (Parfum), Propylene Glycol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

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

LabelerBuckeye International, Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code30805
First marketedApr 2020
Product typeHuman Otc Drug
Portfolio15 products on file

More NDCs from Buckeye International, Inc. labeler code 30805

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 📄 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 14 words ▾

Uses Hand wash to help reduce bacteria on the skin Recommended for repeated use

⏱️ Dosage and Administration 21 words ▾

Directions Wet hands and wrists Dispense an adequate amount of soap and vigorously wash hands Rinse hands thoroughly Dry hands completely

⚠️ Warnings 54 words ▾

Warnings For external use only. When using this product do not use in or near eyes. If in eyes, flush thoroughly with water. If irritation or rash appears and persists , stop use and see a physician. Keep out of reach of children . If swallowed, call a physician or Poison control Center immediately.

🧪 Active Ingredient 4 words ▾

Active ingredient Chloroxylenol 0.3%

🧪 Inactive Ingredients 32 words ▾

Inactive ingredients Water (Aqua), Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Coconut Acid C-110, Oleic Acid, Ammonium Laureth Sulfate, Ethanolamine, Cocamidopropyl Betaine, EDTA, Fragrance (Parfum), Propylene Glycol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

🎯 Purpose 2 words ▾

Purpose Antibacterial

📄 When Using This Product 18 words ▾

When using this product do not use in or near eyes. If in eyes, flush thoroughly with water.

📄 Stop Use and Ask a Doctor If 14 words ▾

If irritation or rash appears and persists , stop use and see a physician.

📄 Keep Out of Reach of Children 17 words ▾

Keep out of reach of children . If swallowed, call a physician or Poison control Center immediately.

📄 Questions or Comments 14 words ▾

Questions? Call Buckeye International, Inc. 314-291-1900 Monday through Friday 8:00 a.m. to 5:00p.m. CST

📄 Package Label / Principal Display Panel 36 words ▾

ALTRA Antimicrobial Foaming Hand Wash with 0.3% PCMX Hand Hygiene Manufactured by: Buckeye International 2700 Wagner Place Maryland Heights MO 63043 USA (314) 291-1900 Product # 71031120 net Contents 1250 mL (42.2 fl oz) container label

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 Altra Antimicrobial Foaming Hand Wash with 0.3% PCMX (this brand).

Top reported reactions

Vomiting2
Abdominal Pain Lower1
Abdominal Pain Upper1
Anaemia1
Cholecystitis1
Cystitis1
Drug Effect Decreased1

Age at onset

Elderly1

Reporter sex

7 reports
Male · 14%
Female · 86%

Serious outcomes

Hospitalization3
Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
2025 2026 2 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
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

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 "Otc Monograph Drug". 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 Buckeye International, 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 1000 ml (30805-0016-13), 1250 ml (30805-0016-02). 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?
Buckeye International, 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.
← 30805-0015-02 · Buckeye 30805-0017-02 · Buckeye →
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.