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Isopropyl Alcohol 91 mL/100mL Liquid, 473 mL — NDC 36800-0804-43 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Isopropyl Alcohol 91 mL/100mL Liquid, 473 mL — NDC 36800-804-43 (Billing 36800-0804-43)

by Topco Associates LLC · .473 mL in 1 BOTTLE, PLASTIC

This is a package of 473 mL of Isopropyl Alcohol 91 mL/100mL Liquid from Topco Associates LLC, marketed since Mar 1991 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 36800-0804-43
🏷️ FDA NDC (as labeled) 36800-804-43 billing pads the product segment with a zero
This package
Contains473 mL Pack sizes2 compare ↓
Main listing for product 36800-804 · Also comes in: 946 ml 36800-804-45
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 36800-804-43 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
36800 labeler · 804 product · 43 package
Package marketed since
Mar 15, 1991
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 3680080443 3
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Isopropyl Alcohol (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0373-2026
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0604-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0601-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0602-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0600-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0605-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 36800-804-43
Product NDC 36800-804
11-digit billing NDC 36800080443
RxCUI 582901
UNII ND2M416302
Application # M003
SPL Set ID ad1ef2ea-bfc3-4a8a-acd2-55e7f52813d4
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1991-03-15
Route TOPICAL
Dosage form LIQUID
Substance ISOPROPYL ALCOHOL
Quick answers
  • RxCUI (RxNorm): 582901
Why two NDCs? The FDA registers this code as 36800-804-43 — 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 → 36800-0804-43. 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
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?

This is a topical liquid containing 91% isopropyl alcohol, marketed as an over-the-counter monograph product. Isopropyl alcohol is commonly used on the skin as an antiseptic and disinfectant to help reduce bacteria before minor procedures or on small cuts and scrapes. This product is applied directly to the skin surface and is not meant to be swallowed.

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: 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
36800-0804-43 You're viewing this Main listing .473 mL in 1 BOTTLE, PLASTIC 1991-03-15 — Active
36800-0804-45 36800-804-45 946 mL in 1 BOTTLE, PLASTIC 2024-10-29 — Active

Pack size FAQ

What quantity is in this package?
This package contains 473 mL — .473 ml in 1 bottle, plastic.
How does this package differ from NDC 36800-0804-45?
Both are Isopropyl Alcohol 91 mL/100mL Liquid — the drug itself is identical. This page's package is the 473 mL one, while NDC 36800-0804-45 is the 946 ml package.
What NDC number is used to bill for this package of Isopropyl Alcohol 91 mL/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
Sunmark Isopropyl Alcohol 91 Percent 910 mg/mL 49348-0174-38 Strategic 473 ml $0.005 — FDA listed —
Isopropyl alcohol 91 mL/100mL 46122-0772-34 AmerisourceBergen 473 ml $0.054 — Availability likely —
Health Mart Isopropyl Alcohol 91 Percent 910 mg/mL 62011-0272-01 Strategic 473 ml $0.054 — Availability likely —
Isopropyl alcohol 91 mL/100mL 70677-1250-01 Strategic 473 ml $0.054 — Availability likely —
Isopropyl alcohol 91 percent 91 mL/100mL 00363-0277-10 Walgreens 296 ml — — FDA listed —
Walgreens 91% Isopropyl Alcohol .91 mL/mL 00363-0381-16 Walgreens 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 00363-0804-43 Walgreens 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 00869-0804-43 Vi-Jon, 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 10565-0071-04 Hydrox 118 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 11344-0408-08 Nice-Pak 3785 ml — — FDA listed —
Isopropyl alcohol 91 percent 91 mL/100mL 11673-0077-32 TARGET 946 ml — — FDA listed —
Isopropyl Alcohol .91 mg/mL 11673-0804-43 Target 473 ml — — Discontinued —
Isopropyl Alcohol 91 mL/100mL 21130-0804-43 Better 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 21130-0969-32 Safeway, 946 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 21130-0976-16 Safeway, 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 30142-0804-43 The 473 ml — — FDA listed —
Isopropyl alcohol 91 percent 91 mL/100mL 30400-0505-01 Jell 946 ml — — FDA listed —
91% Isopropyl Rubbing Alcohol 91 mL/100mL 30400-0601-01 Jell 355 ml — — FDA listed —
Isopropyl Alcohol 91 percent 91 mL/100mL 36800-0077-16 TOP 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mLthis 36800-0804-43 Topco 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 37808-0804-43 H 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 41163-0804-43 United 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 41250-0804-43 Meijer, 473 ml — — Discontinued —
91% Isopropyl Alcohol 91 mL/100mL 42507-0820-43 Hy-Vee, 473 ml — — FDA listed —
Isopropyl alcohol 91 percent 91 mL/100mL 49035-0277-16 EQUATE 473 ml — — Discontinued —
Isopropyl alcohol 91 percent ReadyInCase 91 mL/100mL 49580-0277-06 P 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 50594-0804-45 Big 946 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 50804-0804-43 Perrigo 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 51316-0277-32 CVS 946 ml — — FDA listed —
American Red Cross Isopropyl Alcohol First Aid Antiseptic 91 mL/100mL 51628-0341-00 My 473 ml — — FDA listed —
91% Isopropyl Rubbing Alcohol 91 mL/100mL 51628-4236-01 MY 355 ml — — FDA listed —
American Redcross 91% Isopropyl Rubbing Alcohol With Wintergreen 91 mL/100mL 51628-4237-01 MY 355 ml — — FDA listed —
Universal Rubbing Alcohol 91 mL/100mL 52000-0406-35 Universal 355 ml — — FDA listed —
Isopropyl alcohol 91 mL/100mL 52000-0804-01 Universal 355 ml — — FDA listed —
MedPride 91% Rubbing Alcohol 91 mL/100mL 52410-4091-05 Shield 475 ml — — FDA listed —
91% Isopropyl Rubbing Alcohol 91 mL/100mL 52862-0028-01 Home 355 ml — — FDA listed —
Isopropyl Rubbing Alcohol 99% With Wintergreen 91 mL/100mL 52862-0029-01 Home 119 ml — — FDA listed —
Isopropyl alcohol 91 mL/100mL 53329-0797-06 Medline 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 53943-0091-16 Discount 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 53943-0804-43 Discount 473 ml — — Discontinued —
Isopropyl alcohol 91 mL/100mL 55319-0571-16 Family 473 ml — — FDA listed —
Isopropyl alcohol 91 percent 91 mL/100mL 55910-0277-16 Dolgencorp, 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 55910-0804-43 Old 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 56062-0804-43 Publix 473 ml — — FDA listed —
91% Isopropyl Rubbing Alcohol 91 mL/100mL 58037-0004-01 New 355 ml — — FDA listed —
91% Isopropyl Rubbing Alcohol With Wintergreen 91 mL/100mL 58037-0007-01 New 355 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 59779-0804-38 CVS 295 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 63941-0804-43 Valu 473 ml — — FDA listed —
Germ Attack 91% Isopropyl Alcohol .91 mL/mL 66902-0091-16 Natural 473 ml — — FDA listed —
Rubbing Alcohol 91 percent isopropyl 91 mL/100mL 67091-0307-16 WinCo 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 67091-0804-43 WinCo 473 ml — — FDA listed —
Isopropyl Alcohol .91 mL/mL 67326-0035-00 Degasa, 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 68016-0804-43 Pharmacy 473 ml — — FDA listed —
Isopropyl alcohol 91 percent 91 mL/100mL 68196-0277-32 Sam's 946 ml — — FDA listed —
Isopropyl alcohol 91 percent 91 mL/100mL 69256-0277-16 Harris 473 ml — — FDA listed —
Isopropyl Rubbing Alcohol 91 percent 91 mL/100mL 70000-0498-01 Cardinal 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 70000-0691-01 Cardinal 946 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 72036-0804-43 HARRIS 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 72288-0904-45 Amazon.com 946 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 72476-0804-43 ADUSA 473 ml — — FDA listed —
Isopropyl Alcohol 91 Percent 910 mg/mL 82645-0914-16 Pharma 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 82749-0004-16 Epic 473 ml — — FDA listed —
91% Isopropyl Alcohol 91 mL/100mL 83324-0173-16 Chain 473 ml — — FDA listed —
Nexxgen 91% Rubbing Alcohol 91 mL/100mL 83629-0016-12 A 355 ml — — FDA listed —
NEXXGEN 91% RUBBING ALCOHOL with Wintergreen 91 mL/100mL 83629-0018-12 A 355 ml — — FDA listed —
Wish Rubbing Alcohol 91% 91 mL/100mL 84809-0011-01 LJ 12 bottles — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 85828-0804-43 Grocery 473 ml — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 87251-0005-16 4 473 ml — — FDA listed —
Wish 91% Isopropyl Rubbing Alcohol 91 mL/100mL 84809-0006-01 LJ 12 bottles — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 79903-0285-10 Walmart 295 ml — — FDA listed —
Isopropyl alcohol 91 percent 91 mL/100mL 49580-4162-02 P 2 bottles — — FDA listed —
Isopropyl Alcohol 91 mL/100mL 87251-0012-08 4 236 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

🏛️
1991
On the market since
Mar 1991
📍
2026
Currently FDA-listed
35 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 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.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also stateswater

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

LabelerTopco Associates LLC
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedMar 1991
Product typeHuman Otc Drug
Portfolio408 products on file

More NDCs from Topco Associates LLC labeler code 36800

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 and Cautions ⚠️ Warnings 🤒 Adverse Reactions 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Use first aid to help prevent the risk of infection in: minor cuts scrapes burns

⏱️ Dosage and Administration 32 words ▾

Directions clean the affected area apply a small amount of this product on the area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first

⚠️ Warnings and Cautions 37 words ▾

Caution Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.

⚠️ Warnings 13 words ▾

Warnings For external use only. If taken internally serious gastric disturbances will result.

🤒 Adverse Reactions 26 words ▾

Adverse Reaction DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143 ©TOPCO QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrands.com Visit here for more information: http://topbrnds.com QUALITY GUARANTEED Pat. D675, 101

🧪 Active Ingredient 5 words ▾

Active Ingredient Isopropyl alcohol 91%

🧪 Inactive Ingredients 3 words ▾

Inactive ingredient water

🎯 Purpose 4 words ▾

Purpose First aid antiseptic

📄 Ask a Doctor Before Use If 15 words ▾

Ask a doctor before use for deep or puncture wounds, animal bites or serious burns

📄 When Using This Product 32 words ▾

When using this product do not get into eyes do not inhale do not apply over large areas of the body do not use longer than 1 week use only as directed

📄 Stop Use and Ask a Doctor If 12 words ▾

Stop use and ask a doctor if condition persists or gets worse

📄 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 16 words ▾

Other information does not contain, nor is intended as a substitute for grain or ethyl alcohol

📄 Questions or Comments 2 words ▾

Questions? 1-888-423-0139

📄 Package Label / Principal Display Panel 97 words ▾

principal display panel TopCare ® health 91% Isopropyl Alcohol FIRST AID ANTISEPTIC Helps Prevent the Risk of Infection in: Minor Cuts Minor Scrapes Minor Burns WARNING FLAMMABLE Keep away from heat, spark, electrical, fire or flame DANGER: DO NOT USE AS A FUEL SOURCE. If exposed to a heat source, vapors may ignite, resulting in severe burns, serious injury, or death. CAUTION: Do not point at self or others; product will squirt whe squeezed.

Use only as directed, in a well-ventilated area; fumes can be harmful. 32 FL OZ (1 QT) 946 mL image description image description

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 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 Topco Associates LLC. 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 1 other package presentation of this same product, including 946 ml (36800-0804-45). 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?
Topco Associates LLC 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.
← 36800-0803-43 · Topco 36800-0805-25 · TOPCO →
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.