ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN 50 mL/100mL Liquid, 355 mL
by My Imports USA, LLC · 355 mL in 1 BOTTLE, PLASTIC (51628-4233-1)
NDC 51628-4233-01
🏷️ FDA NDC (as labeled)
51628-4233-1
billing pads the package segment with a zero
This package
Contains355 mL
Pack sizes3 compare ↓
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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
FDA NDC (as labeled)
51628-4233-1
Product NDC
51628-4233
11-digit billing NDC
51628423301
RxCUI
616456
UNII
ND2M416302
Application #
M003
SPL Set ID
d4d77ec3-4930-74f0-e053-2a95a90a962a
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2020-06-18
Route
TOPICAL
Dosage form
LIQUID
Substance
ISOPROPYL ALCOHOL
Why two NDCs?
The FDA registers this code as 51628-4233-1 — a 5-4-1 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 package segment → 51628-4233-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️ RxNorm drug class
This medicine belongs to the 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.
🏭 Manufacturer & labeler
LabelerMy Imports USA, LLC
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code51628
First marketedJun 2020
Product typeHuman Otc Drug
Portfolio25 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.
🩺 Clinical
🧪 What is this product?
This is a topical liquid rubbing alcohol product containing 50% isopropyl alcohol and wintergreen oil, marketed as an over-the-counter monograph drug. Isopropyl alcohol is typically used as a topical antiseptic and disinfectant on skin. Wintergreen oil is commonly included in these formulations for its cooling and soothing properties. The product is applied directly to the skin surface and is not intended for ingestion.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Isopropyl Alcohol?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
-
UNII I753WB2F1M
FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
-
UNII LAV5U5022Y
Methyl salicylate is a naturally derived liquid compound commonly found in wintergreen plants. In medicines, it's used as a flavoring agent and penetrating solvent to help distribute active ingredients evenly throughout topical products.
-
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.
4 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesInactive ingredient Water, methyl salicylate, FD&C Blue #1, FD&C Yellow #5
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.
💲 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 system | Per mL | Per 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
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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Isopropyl 50 mL/100mL 00869-0211-40 | Vi-Jon, | 355 ml | — | — | Discontinued | — |
| 50% Rubbing 50 mL/100mL 00869-0864-18 | Vi-Jon, | 118 ml | — | — | Discontinued | — |
| Isopropyl Alcohol 50% 50 mL/100mL 10565-0003-04 | Hydrox | 118 ml | — | — | FDA listed | — |
| Isopropyl Alcohol with Wintergreen 50% 50 mL/100mL 10565-0007-04 | Hydrox | 118 ml | — | — | FDA listed | — |
| Isopropyl 50 mL/100mL 11344-0112-43 | Nice-Pak | 473 ml | — | — | FDA listed | — |
| Isopropyl Rubbing Alcohol 50 mL/100mL 30400-0100-01 | Jell | 355 ml | — | — | FDA listed | — |
| Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 30400-0101-01 | Jell | 119 ml | — | — | FDA listed | — |
| Isopropyl 50 mL/100mL 37808-0055-43 | H | 473 ml | — | — | FDA listed | — |
| 50 percent Isopropyl alcohol 50 mL/100mL 42681-6573-01 | Whole | 473 ml | — | — | FDA listed | — |
| Isopropyl alcohol 50 percent 50 mL/100mL 49035-0271-16 | EQUATE | 473 ml | — | — | FDA listed | — |
| Isopropyl alcohol 50 percent 50 mL/100mL 49035-0272-16 | EQUATE | 473 ml | — | — | FDA listed | — |
| Isopropyl alcohol 50 percent Wintergreen ReadyInCase 50 mL/100mL 49580-0272-02 | P | 355 ml | — | — | FDA listed | — |
| 50% Rubbing 50 mL/100mL 50804-0864-43 | Perrigo | 473 ml | — | — | FDA listed | — |
| Isopropyl Rubbing Alcohol 50% 50 mL/100mL 51628-4232-01 | MY | 355 ml | — | — | FDA listed | — |
| Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mLthis 51628-4233-01 | My | 355 ml | — | — | FDA listed | — |
| American Red Cross 50% Isopropyl Rubbing Alcohol 500 mg/mL 51628-4239-01 | MY | 177 ml | — | — | FDA listed | — |
| Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 51628-4240-01 | MY | 177 ml | — | — | FDA listed | — |
| Isopropyl Rubbing Alcohol 50% 50 mL/100mL 52000-0050-01 | Universal | 118 ml | — | — | FDA listed | — |
| Isopropyl Rubbing Alcohol 50% with Wintergreen 50 mL/100mL 52000-0051-01 | Universal | 118 ml | — | — | FDA listed | — |
| Universal 50% Rubbing Alcohol 50 mL/100mL 52000-0410-32 | Universal | 946 ml | — | — | FDA listed | — |
| Universal 50% Rubbing Alcohol with Wintergreen and Glycerin 50 mL/100mL 52000-0412-32 | Universal | 946 ml | — | — | FDA listed | — |
| Isopropyl Rubbing Alcohol 50 mL/100mL 52000-0801-01 | Universal | 355 ml | — | — | FDA listed | — |
| Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 52000-0802-01 | Universal | 119 ml | — | — | FDA listed | — |
| Novita Isopropyl Alcohol 50% 50 mL/100mL 52410-1050-04 | Shield | 355 ml | — | — | FDA listed | — |
| Novita 50% Isopropyl Rubbing Alcohol W/ Wintergreen 50 mL/100mL 52410-1051-04 | Shield | 355 ml | — | — | FDA listed | — |
| Isopropyl Rubbing Alcohol 50% 50 mL/100mL 52862-0022-03 | Home | 119 ml | — | — | FDA listed | — |
| Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 52862-0023-03 | Home | 119 ml | — | — | FDA listed | — |
| Isopropyl alcohol 50 mL/100mL 55319-0569-16 | Family | 473 ml | — | — | FDA listed | — |
| Isopropyl 50 mL/100mL 55910-0211-43 | Old | 473 ml | — | — | FDA listed | — |
| 50% Rubbing 50 mL/100mL 55910-0864-38 | Old | 296 ml | — | — | Discontinued | — |
| Isopropyl Rubbing Alcohol 50 mL/100mL 58037-0002-01 | New | 355 ml | — | — | FDA listed | — |
| Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 58037-0005-01 | New | 355 ml | — | — | FDA listed | — |
| 50% Isopropyl Alcohol 50 mL/100mL 59640-0864-43 | H | 473 ml | — | — | FDA listed | — |
| Isopropyl Rubbing Alcohol Orazen Inc 50 mL/100mL 71927-0025-01 | Orazen | 354 ml | — | — | Discontinued | — |
| Isopropyl Rubbing Alcohol Wintergreen Orazen Inc 50 mL/100mL 71927-0026-01 | Orazen | 354 ml | — | — | Discontinued | — |
| 50% Isopropyl Alcohol 500 mg/mL 72288-0864-43 | Amazon.com | 473 ml | — | — | FDA listed | — |
| Isopropyl Rubbing Alcohol 50 Percent 50 mL/100mL 72520-0315-12 | JC | 355 ml | — | — | FDA listed | — |
| Rubbing Alcohol 50 Percent 50 mL/100mL 76436-0321-12 | Viny | 355 ml | — | — | FDA listed | — |
| Rubbing Alcohol 50 mL/100mL 78440-0009-01 | INTERNATIONAL | 354 ml | — | — | FDA listed | — |
| Nexxgen 50% Rubbing Alcohol 50 mL/100mL 83629-0019-32 | A | 946 ml | — | — | FDA listed | — |
| Wish Rubbing Alcohol 50% 50 mL/100mL 84809-0009-01 | LJ | 12 bottles | — | — | FDA listed | — |
| WISH RUBBING ALCOHOL 50% Winter Green 50 mL/100mL 84809-0010-01 | LJ | 12 bottles | — | — | FDA listed | — |
| Our Brand 50% Isopropyl Rubbing Alcohol 50 mL/100mL 85891-0001-01 | SPARROW | 354 ml | — | — | Discontinued | — |
| Our Brand 50% Isopropyl Rubbing Alcohol With Wintergreen 50 mL/100mL 85891-0002-01 | SPARROW | 354 ml | — | — | Discontinued | — |
| Doue 50% Isopropyl Rubbing Alcohol 50 mL/100mL 87510-0002-01 | ONEST | 355 ml | — | — | FDA listed | — |
| Doue 50% Isopropyl Rubbing Alcohol With Wintergreen 50 mL/100mL 87510-0003-01 | ONEST | 355 ml | — | — | FDA listed | — |
| Isopropyl Alcohol 50 mL/100mL 11344-0864-43 | Nice-Pak | 473 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
Jun 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.
🔬 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 ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 2%
Female · 98%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51628-4233-01 You're viewing this | 355 mL in 1 BOTTLE, PLASTIC (51628-4233-1) | 2020-06-18 | Active |
| 51628-4233-02 | 473 mL in 1 BOTTLE, PLASTIC (51628-4233-2) | 2020-06-18 | Active |
| 51628-4233-03 | 946 mL in 1 BOTTLE, PLASTIC (51628-4233-3) | 2020-06-18 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 51628-4233-01?
NDC 51628-4233-01 contains 355 mL — 355 ml in 1 bottle, plastic.
What is the difference between NDC 51628-4233-01 and NDC 51628-4233-02?
Both are ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN 50 mL/100mL Liquid — the drug itself is identical. NDC 51628-4233-01 is the 355 mL package, while NDC 51628-4233-02 is the 473 ml package.
What NDC number is used to bill for this package of ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN 50 mL/100mL Liquid?
Bill NDC 51628-4233-01 — the 11-digit billing format is 51628423301. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 51628-4233-1, 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: 51628-4233-01, written without dashes as 51628423301. 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 51628-4233-01, the first segment (51628) is the labeler code FDA assigned to My Imports USA, LLC; the middle segment (4233) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 My Imports USA, 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 2 other package presentations of this same product, including 473 ml (51628-4233-02), 946 ml (51628-4233-03). 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?
My Imports USA, 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.
📄 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
🎯 Indications and Usage ▾
Uses to decrease germs in minor cuts and scrapes helps relieve minor muscular aches due to exertion
⏱️ Dosage and Administration ▾
Directions apply to skin directly of with clean gauze, cotton or swab for rubbing apply liberally and rub with hands
⚠️ Warnings ▾
Warnings For external use only flammable, keep away from fire and flame will produce serious gastric disturbances if taken internally
🧪 Active Ingredient ▾
Active ingredient (by volume) Isopropyl alcohol (50% concentrate)
🧪 Inactive Ingredients ▾
Inactive ingredient Water, methyl salicylate, FD&C Blue #1, FD&C Yellow #5
🎯 Purpose ▾
Purpose topical antimicrobial
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.