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RAYO BREATH CHAMOMILE MENTHOL, CAMPHOR 1 g/g; 1 g/g Ointment — NDC 83033-1606-01 package photo

RAYO BREATH CHAMOMILE MENTHOL, CAMPHOR 1 g/g; 1 g/g Ointment

by Quimicas Handal de Centroamerica SA de CV · 1 TUBE in 1 BOX (83033-1606-1) / 50 g in 1 TUBE
NDC 83033-1606-01
🏷️ FDA NDC (as labeled) 83033-1606-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 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

🆔 Identity & classification

FDA NDC (as labeled) 83033-1606-1
Product NDC 83033-1606
11-digit billing NDC 83033160601
UNII 5TJD82A1ET, L7T10EIP3A, LAV5U5022Y
UPC 0734474714162, 0734474714216, 0734474714049, 0734474714018 +9 more
Application # M017
SPL Set ID 09e4a36b-020a-c5b1-e063-6394a90a3e31
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-11-01
Route TOPICAL
Dosage form OINTMENT
Substance MENTHOL; CAMPHOR (SYNTHETIC)
Why two NDCs? The FDA registers this code as 83033-1606-1 — 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 → 83033-1606-01. 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.

🏭 Manufacturer & labeler

LabelerQuimicas Handal de Centroamerica SA de CV
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code83033
First marketedNov 2023
Product typeHuman Otc Drug
Portfolio24 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?

Rayo Breath Chamomile Menthol is a topical ointment marketed as an over-the-counter monograph product. It contains menthol and camphor as active ingredients, which are commonly used in topical products for their cooling and soothing sensations when applied to the skin. These ingredients are typically included in products intended to provide temporary relief and a refreshing feeling on localized areas. This product is sold without a prescription under FDA's established rules for over-the-counter ointments in this category.

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 g / 1 g UNII FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • 1 g / 1 g UNII RV6J6604TK
    Eucalyptol is a natural oil compound extracted from eucalyptus plants. In medicines, it serves as a flavoring agent and aromatic component to improve taste and smell.
  • 1 g / 1 g UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • 1 g / 1 g UNII XJ6RUH0O4G
    Turpentine is a volatile liquid derived from pine tree resin. It's used in medicines as a solvent and penetrating agent to help active ingredients dissolve and absorb into the skin or body.

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

The official label also statesT

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 gPer 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
Rayo Breath Chamomile 1 g/g; 1 g/g 83033-1620-01 Quimicas 1 tube — — FDA listed —
Rayo Breath Chamomile 1 g/g; 1 g/g 83033-1612-01 Quimicas 1 pouch — — FDA listed —
Rayo Active Ice 1 g/g; 1 g/g 83033-1594-01 Quimicas 1 tube — — FDA listed —
Rayo Breath Menthol 1 g/g; 1 g/g 83033-1605-01 Quimicas 1 tube — — FDA listed —
Rayo Breath Chamomile 1 g/g; 1 g/gthis 83033-1606-01 Quimicas 1 tube — — FDA listed —
Rayo Active Ice Sachet 1 g/g; 1 g/g 83033-1609-01 Quimicas 1 pouch — — FDA listed —
Rayo Active Ice 1 g/g; 1 g/g 83033-1600-01 Quimicas 1 tube — — FDA listed —
Rayo Breath Menthol 1 g/g; 1 g/g 83033-1611-01 Quimicas 1 pouch — — FDA listed —
Rayo Active Ice 1 g/g; 1 g/g 83033-1598-01 Quimicas 1 tube — — 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

🏛️
2023
On the market since
Nov 2023
📍
2026
Currently FDA-listed
3 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 MENTHOL, CAMPHOR — the ingredient across all brands.

Top reported reactions

Application Site Burn2
Application Site Vesicles2
Blister2
Chemical Injury2
Drug Reaction With Eosinophilia And Systemic Symptoms2
Tubulointerstitial Nephritis2
Application Site Infection1

Age at onset

Adult1
Elderly3

Reporter sex

20 reports
Male · 35%
Female · 65%

Serious outcomes

Hospitalization5
Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 5 0
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
83033-1606-01 You're viewing this 1 TUBE in 1 BOX (83033-1606-1) / 50 g in 1 TUBE 2023-11-01 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 83033-1606-1, 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: 83033-1606-01, written without dashes as 83033160601. 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 83033-1606-01, the first segment (83033) is the labeler code FDA assigned to Quimicas Handal de Centroamerica SA de CV; the middle segment (1606) 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 Quimicas Handal de Centroamerica SA de CV. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Quimicas Handal de Centroamerica SA de CV 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 64 words ▾

Directions Adults and children 2 years of age and older: Rub a thick layer well over throat and chest Use 3 to 4 times daily Keep clothes loose about throat and chest to help vapors reach nose and mouth For muscle and joint minor aches apply to affected area no more than 3 to 4 times daily Children under 2 years: do not use.

⏱️ Dosage and Administration 64 words ▾

Directions Adults and children 2 years of age and older: Rub a thick layer well over throat and chest Use 3 to 4 times daily Keep clothes loose about throat and chest to help vapors reach nose and mouth For muscle and joint minor aches apply to affected area no more than 3 to 4 times daily Children under 2 years: do not use.

⚠️ Warnings 84 words ▾

For external use only; avoid contact with eyes Ask a doctor before if you have: sensitive skin Do not use by mouth in nostrils on wounds or damaged skin When using this product Avoid contact with the ayes or muccus membranes Wash hands after use with cool water Do not microwave Stop use and ask a doctor if: Cough occurs with too much mucus (phlegm), or if symptoms persist for more than 7 days or clear up and occur again within a few days.

🧪 Active Ingredient 3 words ▾

Mentol, Camphor (synthetic)

🧪 Inactive Ingredients 1 words ▾

T

🎯 Purpose 20 words ▾

When applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associated with common cold.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83033-1605-01 · Quimicas 83033-1609-01 · Quimicas →
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.