HomeNDC LookupIngredientsIsopropyl Alcohol › 58037-0005-01
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN 50 mL/100mL Liquid, 355 mL — NDC 58037-0005-01 package photo

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN 50 mL/100mL Liquid, 355 mL

by New Pride Corp · 355 mL in 1 BOTTLE, PLASTIC (58037-005-01)
NDC 58037-0005-01
🏷️ FDA NDC (as labeled) 58037-005-01 billing pads the product segment with a zero
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) 58037-005-01
Product NDC 58037-005
11-digit billing NDC 58037000501
RxCUI 616456
UNII ND2M416302
UPC 0818159010012
Application # M003
SPL Set ID f159051c-27de-52a9-e053-2995a90aeb72
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 58037-005-01 — 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 → 58037-0005-01. 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

LabelerNew Pride Corp
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code58037
First marketedJun 2020
Product typeHuman Otc Drug
Portfolio10 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 an over-the-counter topical liquid containing isopropyl alcohol at 50% concentration, marketed under FDA's OTC monograph rules. Isopropyl alcohol is commonly used as an antimicrobial and rubefacient agent in liniments and rubbing alcohol products applied to the skin. The product also contains wintergreen oil, which is typically included in topical preparations for its cooling and mild counterirritant properties. This type of product is generally intended for external application only.

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.

🧪 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 09179OX7TB
    PEG-75 Lanolin is a waxy substance derived from sheep's wool that has been chemically modified to mix easily with water and oil. It acts as an emulsifier and moisturizer in topical formulations, helping blend different ingredients and soften the skin.
  • UNII 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 statesInactive ingredient Water, methyl salicylate, laneth-75, 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 DailyMedingredient 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 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.
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

ProductLabelerPackNADAC/unitTEStatusPrice 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/100mL 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/100mLthis 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

Pemphigus1,529
Glossodynia1,527
Hand Deformity1,508
Joint Swelling1,506
Helicobacter Infection1,501
Infusion Related Reaction1,494
Systemic Lupus Erythematosus1,490

Age at onset

Neonate24
Adolescent1
Adult604
Elderly23

Reporter sex

3,540 reports
Male · 2%
Female · 98%
Unknown · 0%

Serious outcomes

Hospitalization2,411
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,319 109
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 NDCDescription Marketing startStatus
58037-0005-01 You're viewing this 355 mL in 1 BOTTLE, PLASTIC (58037-005-01) 2020-06-18 Active

🧭 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 58037-005-01, 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: 58037-0005-01, written without dashes as 58037000501. 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 58037-0005-01, the first segment (58037) is the labeler code FDA assigned to New Pride Corp; the middle segment (0005) 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 New Pride Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
New Pride Corp 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 17 words

Uses to decrease germs in minor cuts and scrapes helps relieve minor muscular aches due to exertion

⏱️ Dosage and Administration 20 words

Directions apply to skin directly of with clean gauze, cotton or swab for rubbing apply liberally and rub with hands

⚠️ Warnings 20 words

Warnings For external use only flammable, keep away from fire and flame will produce serious gastric disturbances if taken internally

🧪 Active Ingredient 8 words

Active ingredient (by volume) Isopropyl alcohol (50% concentrate)

🧪 Inactive Ingredients 12 words

Inactive ingredient Water, methyl salicylate, laneth-75, FD&C Blue #1, FD&C Yellow #5

🎯 Purpose 3 words

Purpose topical antimicrobial

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.