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Alcohol 62 mL/100mL Liquid, 59 mL — NDC 41163-0975-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Alcohol 62 mL/100mL Liquid, 59 mL — NDC 41163-975-16 (Billing 41163-0975-16)

by United Natural Foods, Inc. dba UNFI · 59 mL in 1 BOTTLE, PLASTIC (41163-975-16)

NDC 41163-975-16 (billing 41163-0975-16) is a package of 59 mL of Alcohol 62 mL/100mL Liquid from United Natural Foods, Inc. dba UNFI, marketed since Feb 2023 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 41163-0975-16
🏷️ FDA NDC (as labeled) 41163-975-16 billing pads the product segment with a zero
This package
Contains59 mL Pack sizes3 compare ↓
Main listing for product 41163-975 · Also comes in: 236 ml 41163-975-34 946 ml 41163-975-45
OTC 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 41163-975-16
Product NDC 41163-975
11-digit billing NDC 41163097516
RxCUI 247835
UNII 3K9958V90M
Application # 505G(a)(3)
SPL Set ID ccf505f6-2b34-4a18-af07-92ed505644ff
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-02-02
Route TOPICAL
Dosage form LIQUID
Substance ALCOHOL
Quick answers for NDC 41163-975-16
  • RxCUI (RxNorm): 247835
  • 11-digit billing NDC: 41163097516
Why two NDCs? The FDA registers this code as 41163-975-16 — 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 → 41163-0975-16. 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 Other antiseptics and disinfectants class.

Drug family (ATC) Other antiseptics and disinfectants, Antidotes, Nerve depressants
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 depends on the product. Hand sanitizers and wipes help reduce bacteria on your skin, and alcohol pads prepare skin before an injection. A separate injected form is used by heart...
  • Most directions say to cover all surfaces of your hands and rub until dry. Sprays and wipes follow similar steps. Check your product's label, since directions differ a bit between...
  • Children under 6 should use hand sanitizer only with adult supervision to avoid swallowing. Keep all products out of reach of children. If someone swallows it, get medical help or...
  • Stop using it and ask a doctor if you get irritation and redness, or if your condition lasts more than 72 hours. Avoid broken skin and keep it out of your eyes. If it gets in your...
📖 Read our full Alcohol 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: 236 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 Marketing startMarketing endStatus
41163-0975-16 41163-975-16 You're viewing this Main listing 59 mL in 1 BOTTLE, PLASTIC (41163-975-16) 2023-02-02 — Active
41163-0975-34 41163-975-34 236 mL in 1 BOTTLE, PLASTIC (41163-975-34) 2023-02-02 — Active
41163-0975-45 41163-975-45 946 mL in 1 BOTTLE, PLASTIC (41163-975-45) 2023-02-02 — Active

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

Pack size FAQ

What quantity is in NDC 41163-0975-16?
NDC 41163-0975-16 contains 59 mL — 59 ml in 1 bottle, plastic.
What is the difference between NDC 41163-0975-16 and NDC 41163-0975-34?
Both are Alcohol 62 mL/100mL Liquid — the drug itself is identical. NDC 41163-0975-16 is the 59 mL package, while NDC 41163-0975-34 is the 236 ml package.
What NDC number is used to bill for this package of Alcohol 62 mL/100mL Liquid?
Bill NDC 41163-0975-16 — the 11-digit billing format is 41163097516. 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
Alcohol 62 mL/100mL 00363-0046-16 Walgreen 59 ml — — FDA listed —
Alcohol 62 mL/100mL 11344-0849-16 Nice-Pak 59 ml — — FDA listed —
Alcohol 62 mL/100mL 11673-0826-16 Target 59 ml — — FDA listed —
Alcohol 62 mL/100mL 30142-0849-16 The 59 ml — — FDA listed —
Symmetry Hand Sanitizer 62 mL/100mL 30805-0001-01 Buckeye 9 ml — — FDA listed —
Altra Hand Sanitizer with Aloe and Vitamin E 62 mL/100mL 30805-0014-06 Buckeye 59.2 ml — — FDA listed —
Alcohol 62 mL/100mL 41163-0826-16 United 59 ml — — FDA listed —
Alcohol 62 mL/100mLthis 41163-0975-16 United 59 ml — — FDA listed —
Alcohol 62 mg/mL 41190-0849-16 Wakefern 59 ml — — FDA listed —
Ecolab 620 mg/mL 47593-0489-33 Ecolab 118 ml — — FDA listed —
Facilipro 620 mg/mL 47593-0563-56 Ecolab 1200 ml — — FDA listed —
Safety 1st Oh Sh t Kit 50428-0033-01 Dorel 1 kit — — FDA listed —
Alcohol 62 mL/100mL 55910-0889-48 Old 1005 ml — — Discontinued —
XtraCare Instant Hand Sanitizer 37 g/60g 57337-0058-02 Rejoice 60 g — — FDA listed —
XtraCare Instant Hand Sanitizer 37 g/60g 57337-0059-02 Rejoice 60 g — — FDA listed —
Alcohol 62 mL/100mL 59450-0471-16 The 89 ml — — Discontinued —
Lacura Moisturizing Hand Sanitizer 62 g/100mL 64024-0008-08 Aldi 236 ml — — FDA listed —
Antibacterial Hand Sanitizer 62 mL/100mL 71160-0188-12 TEKWELD 12 ml — — FDA listed —
Freeman Packaging Hand Sanitizer 62 mL/100mL 71734-0201-01 JIANGMEN 7.5 ml — — FDA listed —
KidzStuff Hand Sanitizer 62 g/100g 71734-0204-01 JIANGMEN 2 g — — FDA listed —
Afassco Hand Sanitizer 62 mL/100mL 71734-0206-01 JIANGMEN 2 ml — — FDA listed —
Hand Sanitizer 62 g/100g 71734-0348-01 JIANGMEN 4.2 g — — FDA listed —
Mrs. Meyers Clean Day Hand Sanitizer Basil Scent .62 mL/mL 71763-0101-01 The 59 ml — — FDA listed —
Mrs. Meyers Clean Day Hand Sanitizer Lavender Scent .62 mL/mL 71763-0201-01 The 59 ml — — FDA listed —
Alcohol 62 mL/100mL 72288-0826-32 Amazon.com 354 ml — — FDA listed —
Alcohol 62 mL/100mL 72288-0849-32 Amazon.com 354 ml — — FDA listed —
Hand Sanitizer Fresh Linen 62 mL/100mL 73928-0065-02 Kingkey 35 ml — — FDA listed —
Hand Sanitizer Strawberry Fizz 62 mL/100mL 73928-0066-02 Kingkey 35 ml — — FDA listed —
Hand Sanitizer Pink Sugar 62 mL/100mL 73928-0067-01 Kingkey 30 ml — — FDA listed —
Hand Sanitizer Vanilla 62 mL/100mL 73928-0068-02 Kingkey 35 ml — — FDA listed —
Hand Sanitizer 62 mL/100mL 73928-0079-02 Kingkey 35 ml — — FDA listed —
Hand Sanitizer 62 mL/100mL 73928-0081-01 Kingkey 35 ml — — FDA listed —
Jolly Rancher Hand Sanitizer Set Cherry 62 mL/100mL 73928-0112-01 Kingkey 35 ml — — FDA listed —
Smarties Orange Hand Santizer Set Orange Creamsicle 62 mL/100mL 73928-0113-01 Kingkey 35 ml — — FDA listed —
Sourpatch Kids Hand Sanitizer Set Watermelon 62 mL/100mL 73928-0114-01 Kingkey 35 ml — — FDA listed —
Jolly Rancher Hand Sanitizer Blue Raspberry 62 mL/100mL 73928-0115-01 Kingkey 35 ml — — FDA listed —
Jolly Rancher Hand Sanitizer Cherry 62 mL/100mL 73928-0117-01 Kingkey 35 ml — — FDA listed —
Smarties Hand Sanitizer Orange Creamsicle 62 mL/100mL 73928-0118-01 Kingkey 35 ml — — FDA listed —
Smarties Orange Hand Sanitizer Raspberry Cream 62 mL/100mL 73928-0119-01 Kingkey 35 ml — — FDA listed —
Smarties Orange Hand Sanitizer Mix Berry 62 mL/100mL 73928-0121-01 Kingkey 35 ml — — FDA listed —
Sourpatch Kids Hand Sanitizer Strawberry 62 mL/100mL 73928-0122-01 Kingkey 35 ml — — FDA listed —
Sour Patch Kids Hand Sanitizer Blue Raspberry 62 mL/100mL 73928-0123-01 Kingkey 35 ml — — FDA listed —
Sour Patch Kids Hand Sanitizer Watermelon 62 mL/100mL 73928-0124-01 Kingkey 35 ml — — FDA listed —
Dasiy Hand Sanitizer 62 mL/100mL 73928-0125-01 Kingkey 35 ml — — FDA listed —
Dasiy Hand Sanitizer 62 mL/100mL 73928-0126-01 Kingkey 35 ml — — FDA listed —
Kool Aid Ppink Lemonade Hydrating Hand Sanitizer 62 mL/100mL 73928-0187-01 Kingkey 35 ml — — FDA listed —
Pesi Vanilla Hydratiing Hand Sanitizer 62 mL/100mL 73928-0188-01 Kingkey 35 ml — — FDA listed —
Icee Cherry Hydrating Hand Sanitizer 62 mL/100mL 73928-0189-01 Kingkey 35 ml — — FDA listed —
Jolly Rancher Blue Raspberry Hydrating Hand Sanitizer 62 mL/100mL 73928-0191-01 Kingkey 35 ml — — FDA listed —
Mountain Dew Hydrating Hand Sanitizer 62 mL/100mL 73928-0210-01 Kingkey 35 ml — — FDA listed —
Liquid death hand sanitizer 62 mL/100mL 73928-0211-01 Kingkey 35 ml — — FDA listed —
Dubble Bubble Original Flavor Bubble Gum Hydrating Hand Sanitizer 62 mL/100mL 73928-0217-01 Kingkey 35 ml — — FDA listed —
Sourpatchkids Strawberry Hydrating Hand Sanitizer 62 mL/100mL 73928-0311-01 Kingkey 35 ml — — FDA listed —
Ethyl Alcohol 62 mL/100mL 75712-0849-16 Old 59 ml — — FDA listed —
Alcohol 62 mL/100mL 79481-0826-01 Meijer, 59 ml — — FDA listed —
Alcohol 62 mL/100mL 79481-0849-01 Meijer, 59 ml — — FDA listed —
Antibacterial Hand Sanitizer 62 mL/100mL 82953-0001-01 Cosmuses 10 ml — — FDA listed —
antiseptic hand sanitizer 01 62 mL/100mL 82953-0007-01 Cosmuses 10 ml — — FDA listed —
Antibacterial Hand Sanitizer 62 mL/100mL 82953-0008-01 Cosmuses 15 ml — — FDA listed —
hand sanitizer 01 62 mL/100mL 82953-0015-01 Cosmuses 10 ml — — FDA listed —
Antiseptic Hand Sanitizer 620 mg/g 82996-0005-01 Hubei 9 g — — FDA listed —
Antiseptic Hand Sanitizer 62 mL/100mL 83165-0000-00 Hubei 1.03 ml — — FDA listed —
Ethyl Alcohol 62 mL/100mL 83986-0471-16 UpLift 59 ml — — FDA listed —
Ethyl Alcohol 62 mL/100mL 83986-0973-16 UpLift 59 ml — — FDA listed —
Antiseptic Hand Sanitizer Ethyl Alcohol 62 g/100g 84219-0005-00 M-star 9 g — — FDA listed —
Huanggang Antiseptic Hand Sanitizer 62 mL/100mL 85426-0001-01 Huanggang 9 ml — — Discontinued —
CleanGenic Foaming Hand Sanitizer 62 mL/100mL 81385-0000-01 CleanGenic, 3790 ml — — FDA listed —
CleanGenic 1 GALLON HAND SANITIZER 62 mL/100mL 81385-0001-04 CleanGenic, 24 bottles — — FDA listed —
CleanGenic Foaming Hand Sanitizer 62 mL/100mL 81385-0002-08 CleanGenic, 237 ml — — FDA listed —
CleanGenic 8 OZ HAND SANITIZER 62 mL/100mL 81385-0003-08 CleanGenic, 24 bottles — — FDA listed —
Symmetry Foaming Hand Sanitizer-Fragrance Free with Aloe and Vitamin E 62 mL/100mL 30805-0009-04 Buckeye 1200 ml — — FDA listed —
Soft Care Foam Instant Hand Sanitizer 62 mL/100mL 64536-7295-04 Diversey, 532 ml — — FDA listed —
Transcend Alco-Foam Hand Sanitizer 62 mL/100mL 81792-0001-01 Von 1250 ml — — FDA listed —
Hand Sanitizer 62 mL/100mL 87001-0006-01 HAIAN 35 ml — — FDA listed —
Alpet E3 Hand Sanitizer Foam 62 mL/100mL 59900-0125-02 Best 208197 ml — — FDA listed —
Altra Foaming Hand Sanitizer Fragrance Free with Aloe and Vitamin E 62 mL/100mL 30805-0013-04 Buckeye 1200 ml — — FDA listed —
Avant Foaming Hand Sanitizer 62 mL/100mL 68306-0109-01 B4 530 ml — — FDA listed —
Hillyard Foaming Instant Hand Sanitizer 62 mL/100mL 76402-0410-02 Hillyard 1000 ml — — FDA listed —
FoamFresh Alco-Foam Hand Sanitizer 62 mL/100mL 11429-1004-00 Woodbine 400 ml — — FDA listed —
Symmetry Foaming Hand Sanitizer 62 mL/100mL 30805-0003-03 Buckeye 2000 ml — — FDA listed —
Servo Stat-Foam 62 mL/100mL 76378-0011-01 Enzyme 59 ml — — FDA listed —
Harbor Mist Alco-Foam Hand Sanitizer 62 mL/100mL 81792-0003-01 Von 1250 ml — — FDA listed —
Hydrating and Moisturizing Hand Sanitizer 62 mL/100mL 75112-0010-01 Zhejiang 35 ml — — Discontinued —
Altra Foaming Hand Sanitizer with Aloe and Vitamin E 62 mL/100mL 30805-0012-04 Buckeye 1200 ml — — FDA listed —
Scott Moisturizing Foam Hand Sanitizer 62 mL/100mL 55118-0546-63 Kimberly-Clark 6 bottles — — FDA listed —
GenRx Anti-Bacterial Gel 62 mL/100mL 59088-0299-08 PureTek 118 ml — — FDA listed —
Ecolab 62 mL/100mL 47593-0472-41 Ecolab 750 ml — — FDA listed —
Instant Hand Sanitizer 62 mL/100mL 59898-0420-01 Water-Jel 1728 packets — — 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

🏛️
2023
On the market since
Feb 2023
📍
2026
Currently FDA-listed
3 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 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • 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.

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

The official label also stateswater, carbomer and/or acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, glycerin, isopropyl myristate, tocopheryl acetate

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

LabelerUnited Natural Foods, Inc. dba UNFI
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code41163
First marketedFeb 2023
Product typeHuman Otc Drug
Portfolio211 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

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 🤒 Adverse Reactions 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 15 words ▾

Uses to decrease bacteria on the skin that could cause disease recommended for repeated use

⏱️ Dosage and Administration 25 words ▾

Directions wet hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision not recommended for infants

⚠️ Warnings 13 words ▾

Warnings For external use only: hands Flammable, keep away from fire or flame.

🤒 Adverse Reactions 24 words ▾

ADVERSE REACTION Like it or let us make it right. That's our quality promise. 855-423-2630 DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA DSP-TN-21091 DSP-MO-20087

🧪 Active Ingredient 5 words ▾

Active ingredient Ethyl Alcohol 62%

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients water, carbomer and/or acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, glycerin, isopropyl myristate, tocopheryl acetate

🎯 Purpose 2 words ▾

Purpose Antiseptic

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

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 FDA registers it as 41163-975-16, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 41163-0975-16, written without dashes as 41163097516. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 41163-0975-16, the first segment (41163) is the labeler code FDA assigned to United Natural Foods, Inc. dba UNFI; the middle segment (0975) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) identifies this exact package size and type. Together they name one specific package of one specific product.
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 United Natural Foods, Inc. dba UNFI. 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 236 ml (41163-0975-34), 946 ml (41163-0975-45). 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?
United Natural Foods, Inc. dba UNFI 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.
← 41163-0973-64 · United 41163-0986-22 · United →
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.