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Rohto Cool Relief Naphazoline hydrochloride, Polysorbate 80 .12 mg/mL; 80 2 mg/mL Liquid — NDC 10742-8141-01 package photo

Rohto Cool Relief Naphazoline hydrochloride, Polysorbate 80 .12 mg/mL; 80 2 mg/mL Liquid

by The Mentholatum Company · 1 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8141-1) / 13 mL in 1 BOTTLE, WITH APPLICATOR
NDC 10742-8141-01
🏷️ FDA NDC (as labeled) 10742-8141-1 billing pads the package 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🚨
Active recall for this product.
Class II · Jul 14, 2026 — Lack of Assurance of Sterility (Rohto-Mentholatum (Vietnam) Co., Ltd.) · FDA recall D-0722-2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Naphazoline Hydrochloride, Polysorbate 80 (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 14, 2026 — Lack of Assurance of Sterility (Rohto-Mentholatum (Vietnam) Co., Ltd.) · FDA recall D-0716-2026
Class II · Jul 14, 2026 — Lack of Assurance of Sterility (Rohto-Mentholatum (Vietnam) Co., Ltd.) · FDA recall D-0717-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 10742-8141-1
Product NDC 10742-8141
11-digit billing NDC 10742814101
RxCUI 1098362
UNII MZ1131787D, 6OZP39ZG8H
UPC 0310742010749
Application # M018
SPL Set ID dc8f1ff3-87ae-47ca-815f-5a0e34f8cf30
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-21
Route OPHTHALMIC
Dosage form LIQUID
Substance NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80
Why two NDCs? The FDA registers this code as 10742-8141-1 — 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 → 10742-8141-01. 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 Sympathomimetics, plain class.

Drug family (ATC) Sympathomimetics, plain, Sympathomimetics used as decongestants
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

LabelerThe Mentholatum Company
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code10742
First marketedJun 2021
Product typeHuman Otc Drug
Portfolio108 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?

Rohto Cool Relief is an over-the-counter liquid eye drop marketed under FDA's monograph rules for ophthalmic products. The main active ingredient, naphazoline hydrochloride, is a decongestant typically used to help relieve redness and minor eye irritation. Polysorbate 80 is an inactive ingredient that functions as a solubilizer and preservative aid in the formulation. This product is meant to be applied directly to the eye surface.

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.

🧪 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.

  • 1 mg / 1 mL UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • UNII HM4YQM8WRC
    Chlorobutanol is a colorless crystalline chemical used as a preservative in medicines. It prevents bacterial and fungal growth to maintain product safety and shelf life.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII 91MBZ8H3QO
    Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical formulations.
  • 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.

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

The official label also statesalcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, purified water, sodium borate

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 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
Rohto Cool Relief .12 mg/mL; 80 2 mg/mLthis 10742-8141-01 The 1 bottle — — FDA listed —
Rohto Cool .12 mg/mL; 80 2 mg/mL 10742-8142-01 The 1 bottle — — Discontinued —
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

🏛️
2021
On the market since
Jun 2021
📍
2026
Currently FDA-listed
5 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
10742-8141-01 You're viewing this 1 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8141-1) / 13 mL in 1 BOTTLE, WITH APPLICATOR 2021-06-21 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 10742-8141-1, 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: 10742-8141-01, written without dashes as 10742814101. 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 10742-8141-01, the first segment (10742) is the labeler code FDA assigned to The Mentholatum Company; the middle segment (8141) 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 The Mentholatum Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
The Mentholatum 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.

📄 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 32 words ▾

Uses relieves redness of the eye due to minor eye irritations for use as a lubricant to prevent further irritation or to relieve dryness of the eye for protection against further irritation

⏱️ Dosage and Administration 29 words ▾

Directions put 1 or 2 drops in the affected eye(s) up to 4 times daily tightly snap on cap to seal Other information do not store above 25°C (77°F)

⚠️ Warnings and Cautions 47 words ▾

When using this product do not touch tip of container to any surface to avoid contamination replace cap after each use do not use if solution changes color or becomes cloudy overuse may cause more eye redness pupils may become enlarged temporarily remove contact lenses before using

⚠️ Warnings 112 words ▾

Warnings For external use only Ask a doctor before use if you have narrow angle glaucoma When using this product do not touch tip of container to any surface to avoid contamination replace cap after each use do not use if solution changes color or becomes cloudy overuse may cause more eye redness pupils may become enlarged temporarily remove contact lenses before using Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eyes lasts condition worsens or lasts more than 72 hours Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 8 words ▾

Active ingredients Naphazoline hydrochloride 0.012% Polysorbate 80 0.2%

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, purified water, sodium borate

🎯 Purpose 10 words ▾

Purpose Naphazoline hydrochloride - Redness reliever Polysorbate 80 - Lubricant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 10742-8140-01 · The 10742-8142-01 · 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.