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Vicks VapoCOOL Severe WINTERFROST Menthol 20 mg Lozenge, 45-count — NDC 37000-0597-45 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Vicks VapoCOOL Severe WINTERFROST Menthol 20 mg Lozenge, 45-count — NDC 37000-597-45 (Billing 37000-0597-45)

by The Procter & Gamble Manufacturing Company · 45 POUCH in 1 BAG / 1 LOZENGE in 1 POUCH

This is a package of 45 lozenges of Vicks VapoCOOL Severe WINTERFROST Menthol 20 mg Lozenge from The Procter & Gamble Manufacturing Company, marketed since Dec 2017 and currently FDA-listed.

NDC 37000-0597-45
🏷️ FDA NDC (as labeled) 37000-597-45 billing pads the product segment with a zero
This package
Contains45-count Pack sizes4 compare ↓
Product page 37000-0597-18 Also comes in: 18 lozenges 37000-597-18 70 lozenges 37000-597-70 200 lozenges 37000-597-20
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

⚠️
Other active recalls for Menthol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 20, 2026 — This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. (Xiamen Kang Zhongyuan Biotechnology Co., Ltd.) · FDA recall D-0458-2026
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) 37000-597-45
Product NDC 37000-597
11-digit billing NDC 37000059745
RxCUI 1995300
UNII L7T10EIP3A
UPC 0323900045682
Application # M022
SPL Set ID 06579fc7-7d91-2a7b-e063-6394a90ae516
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-12-29
Route ORAL
Dosage form LOZENGE
Substance MENTHOL
Quick answers
  • RxCUI (RxNorm): 1995300
Why two NDCs? The FDA registers this code as 37000-597-45 — 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 → 37000-0597-45. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Mostly for temporary relief of minor aches and pains in muscles and joints, like those from arthritis, backache, strains, sprains and bruises. Some products are for other things, s...
  • It depends on the product. Many creams, gels and patches are limited to about 3 to 4 times a day, and patches also have a time limit, often 8 hours. Follow your product label and a...
  • A brief burning feeling can happen when you first apply it and usually fades in several days. But if you get severe burning pain, swelling or blistering, stop using it and call you...
  • No. Don't use menthol products with a heating pad, and avoid local heat or direct sunlight on the area. Rare cases of serious burns have been reported.
📖 Read our full Menthol 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 eachPer 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: 18 lozenges 70 lozenges 200 lozenges
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
37000-0597-18 37000-597-18 Main listing 18 POUCH in 1 BAG / 1 LOZENGE in 1 POUCH 2017-12-29 — Active
37000-0597-20 37000-597-20 200 POUCH in 1 BAG / 1 LOZENGE in 1 POUCH 2019-07-09 — Active
37000-0597-45 You're viewing this 45 POUCH in 1 BAG / 1 LOZENGE in 1 POUCH 2017-12-29 — Active
37000-0597-70 37000-597-70 70 POUCH in 1 BAG / 1 LOZENGE in 1 POUCH 2025-05-12 — Active

Pack size FAQ

What quantity is in this package?
This is a 45-count package — 45 pouch in 1 bag / 1 lozenge in 1 pouch.
How does this package differ from NDC 37000-0597-18?
Both are Vicks VapoCOOL Severe WINTERFROST Menthol 20 mg Lozenge — the drug itself is identical. This page's package is the 45-count one, while NDC 37000-0597-18 is the 18 lozenges package.
What NDC number is used to bill for this package of Vicks VapoCOOL Severe WINTERFROST Menthol 20 mg Lozenge?
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
Walgreens Severe Menthol Throat Drops 20 mg 00363-9956-45 Walgreens 45 lozenges — — FDA listed —
Walgreens Severe Honey Lemon Throat Drops 20 mg 00363-9961-45 Walgreens 45 lozenges — — FDA listed —
Vicks VapoCOOL Severe WINTERFROST 20 mgthis 37000-0597-45 The 45 lozenges — — FDA listed —
Vicks VapoCool SEVERE 20 mg 69423-0796-05 The 225 lozenges — — FDA listed —
Vicks VapoCOOL SEVERE 20 mg 69423-0797-18 The 18 lozenges — — FDA listed —
Menthol Vapor Cough Drops 20 mg 72628-0108-01 BOSTON 45 pastilles — — FDA listed —
Menthol Drops Dollar General Severe Honey Lemon 45ct 20 mg 75712-0016-01 Dollar 405 lozenges — — FDA listed —
Menthol Drops Dollar General Severe 45ct 20 mg 75712-0024-01 Dollar 405 lozenges — — FDA listed —
Meijer Severe Menthol Throat Drops 20 mg 79481-0092-01 Meijer 45 lozenges — — FDA listed —
Equate Severe Menthol Throat Drop 20 mg 79903-0254-45 Walmart 45 lozenges — — FDA listed —
Severe Throat Drops 20 mg 82442-0201-01 Target 45 pastilles — — FDA listed —
Menthol Drops Freegells Extra Strong Eucalyptus 30ct 20 mg 83002-0011-01 R.L. 540 lozenges — — FDA listed —
Menthol Drops Freegells Extra Strong Honey Lemon 30ct 20 mg 83002-0012-01 R.L. 540 lozenges — — FDA listed —
Vicks VapoCOOL Severe Sugar-Free 20 mg 84126-0313-30 The 30 lozenges — — FDA listed —
Vicks Vapo Breathers 20 mg 84126-0320-40 The 40 lozenges — — FDA listed —
Vicks VapoCOOL 20 mg 84126-0341-12 The 12 lozenges — — 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

🏛️
2017
On the market since
Dec 2017
📍
2026
Currently FDA-listed
9 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.

What it looks like

Color white
ShapeOval
Imprintvapor
Size23 mm
ScoringNot scored
FlavorMenthol
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerThe Procter & Gamble Manufacturing Company
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code37000
First marketedDec 2017
Product typeHuman Otc Drug
Portfolio850 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 🆘 Overdosage 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

Uses temporarily relieves occasional minor irritation and pain due to sore throat sore mouth

⏱️ Dosage and Administration 35 words ▾

Directions adults and children 12 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor. children 12 years and under: do not use

⚠️ Warnings 42 words ▾

Warnings Sore Throat Warning- Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

🆘 Overdosage 15 words ▾

In case of overdose, get medical help or contact a Poison Control Center right away

📦 Storage and Handling 11 words ▾

Other information Store at no greater than 25°C (77°F) contains soy

🧪 Active Ingredient 7 words ▾

Active ingredient (per drop) Menthol 20 mg

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients corn syrup, eucalyptol, FD&C Blue No. 1, flavors, glycerin, gum arabic, potassium sorbate, sucrose, water

🎯 Purpose 3 words ▾

Purpose Oral anesthetic

📄 Ask a Doctor Before Use If 36 words ▾

Ask a doctor before use if you have a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting

📄 Stop Use and Ask a Doctor If 25 words ▾

Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Questions or Comments 2 words ▾

Questions? 1-800-707-1709

📄 Package Label / Principal Display Panel 30 words ▾

PRINCIPAL DISPLAY PANEL - 70 drops in a bag VALUE PACK VICKS® VapoCOOL™ SEVERE MENTHOL ·ORAL ANESTHETIC MAX STRENGTH • FAST RELIEF SOOTHES SORE THROAT WINTERFROST 70 MEDICATED DROPS 597

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 The Procter & Gamble Manufacturing Company. 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 3 other package presentations of this same product, including 18 lozenges (37000-0597-18), 70 lozenges (37000-0597-70), 200 lozenges (37000-0597-20). 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?
The Procter & Gamble Manufacturing Company 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.
← 37000-0576-01 · The 37000-0598-12 · The →
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.