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Throat Coat Sweet Orange Fennel Menthol 6 mg/4.2g Lozenge, 1 pouch — NDC 78732-0001-01 package photo

Throat Coat Sweet Orange Fennel Menthol 6 mg/4.2g Lozenge, 1 pouch

by Traditional Medicinals, Inc. · 16 PACKAGE in 1 POUCH (78732-001-01) / 4.2 g in 1 PACKAGE
NDC 78732-0001-01
🏷️ FDA NDC (as labeled) 78732-001-01 billing pads the product segment with a zero
This package
Contains1 pouch Pack sizes2 compare ↓
Also comes in: 4.2 g 78732-0001-30
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

⚠️
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

FDA NDC (as labeled) 78732-001-01
Product NDC 78732-001
11-digit billing NDC 78732000101
UNII L7T10EIP3A
UPC 0032917007001
Application # M012
SPL Set ID a746cef4-1fb4-45cf-e053-2995a90a02c8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-06-04
Marketing end 2028-12-31
Route ORAL
Dosage form LOZENGE
Substance MENTHOL, UNSPECIFIED FORM
Why two NDCs? The FDA registers this code as 78732-001-01 — 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 → 78732-0001-01. 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

LabelerTraditional Medicinals, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code78732
First marketedJun 2020
Product typeHuman Otc Drug
Portfolio4 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

📗 Our plain-language guide HelloPharmacist
  • Menthol is found in a lot of over-the-counter topical products — creams, gels, patches, sprays, and powders. Depending on the product, it's used to temporarily ease minor muscle an...
  • Start with clean, dry skin — free of lotions or creams — before applying the patch. Peel the backing off and press the sticky side firmly to the sore area. Most menthol patches sho...
  • Yes, a mild burning or tingling feeling right after applying a menthol product is common and usually settles down within a few days of regular use. What's not normal is severe burn...
  • Is that burning sensation after I apply it normal?
📖 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.

💊 What it looks like

Color brown
ShapeOval
ImprintT
Size22 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII TRW2FUF47H
    A plant-derived powder from marshmallow root used as a binder and thickener in medicines. It helps hold ingredients together and can soothe irritated surfaces in throat lozenges and syrups.
  • UNII 331KBJ17RK
    Canola oil is a plant-based oil derived from rapeseed. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and may improve how the body absorbs certain medications.
  • UNII 9G5L16BK6N
    A thick, sweet liquid made from corn starch. It acts as a sweetener, thickener, and binder in medicines, helping create the right texture and taste while holding ingredients together.
  • UNII 59AAO5F6HT
    Fennel oil is a natural essential oil extracted from fennel seeds. It's used in medicines as a flavoring agent to improve taste and mask bitter or unpleasant flavors of active ingredients.
  • UNII 61ZBX54883
    Licorice is a natural extract from the licorice plant root. It's used in medicines as a flavoring agent to mask bitter tastes and improve how the medicine tastes.
  • UNII AKN3KSD11B
    Orange oil obtained by cold pressing orange peel. It serves as a flavoring agent and fragrance in medicines to improve taste and aroma.
  • UNII 89NA02M4RX
    Pectin is a natural fiber extracted from fruit and plants. It's used in medicines as a thickener, binder, and gelling agent to create the right texture and help the product hold together.
  • UNII 8M707QY5GH
    A sweetener and bulking agent made from crystallized sugar cane juice. It adds sweetness to the medicine and helps give the tablet or powder its solid form and texture.
  • 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.

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

The official label also statesOrganic fennel oil, organic glucose syrup, organic licorice extract, organic marshmallow extract, organic orange oil, pectin, organic rapeseed oil, organic raw cane sugar, water.

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 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: 4.2 g
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
Throat Coat Sweet Orange Fennel 6 mg/4.2gthis 78732-0001-01 Traditional 1 pouch — — FDA listed —
Throat Coat Eucalyptus Mint 6 mg/4.2g 78732-0002-01 Traditional 1 pouch — — 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 Throat Coat Sweet Orange Fennel (this brand).

Top reported reactions

Dyspnoea85
Fatigue84
Pain81
Pruritus78
Dizziness67
Headache67
Cough65

Age at onset

Infant1
Child1
Adolescent1
Adult95
Elderly90

Reporter sex

990 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Life-threatening45
Disabling26
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 109 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
78732-0001-01 You're viewing this 16 PACKAGE in 1 POUCH (78732-001-01) / 4.2 g in 1 PACKAGE 2020-06-04 Active
78732-0001-30 30 PACKAGE in 1 POUCH (78732-001-30) / 4.2 g in 1 PACKAGE 2025-10-15 Active

Pack size FAQ

What quantity is in NDC 78732-0001-01?
NDC 78732-0001-01 contains 1 pouch — 16 package in 1 pouch / 4.2 g in 1 package.
What is the difference between NDC 78732-0001-01 and NDC 78732-0001-30?
Both are Throat Coat Sweet Orange Fennel Menthol 6 mg/4.2g Lozenge — the drug itself is identical. NDC 78732-0001-01 is the 1 pouch package, while NDC 78732-0001-30 is the 1 pouch package.
What NDC number is used to bill for this package of Throat Coat Sweet Orange Fennel Menthol 6 mg/4.2g Lozenge?
Bill NDC 78732-0001-01 — the 11-digit billing format is 78732000101. 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 78732-001-01, 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: 78732-0001-01, written without dashes as 78732000101. 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 78732-0001-01, the first segment (78732) is the labeler code FDA assigned to Traditional Medicinals, Inc.; the middle segment (0001) 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 it is currently marketed — but Traditional Medicinals, Inc. has reported a marketing end date of 2028-12-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 pouch (78732-0001-30). 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?
Traditional Medicinals, Inc. 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 28 words ▾

Uses Temporarily relieves Cough due to minor throat and bronchial irritation occurring with the common cold and inhaled irritants. Occasional minor irritaions, pain, sore mouth, and sore throat.

⏱️ Dosage and Administration 42 words ▾

Directions Adults and children 12 years and over: Dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor, up to 5 lozenges per day Children under 12 years of age : ask a doctor.

⚠️ Warnings 47 words ▾

Warnings Sore throat warning : Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, or vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 12 years of age unless directed by physician.

🧪 Active Ingredient 10 words ▾

Active ingredient Active ingredient (per drop) Organic menthol 6 mg

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients Organic fennel oil, organic glucose syrup, organic licorice extract, organic marshmallow extract, organic orange oil, pectin, organic rapeseed oil, organic raw cane sugar, water.

🎯 Purpose 7 words ▾

Purpose Purposes cough suppressant / oral anesthetic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 78714-0001-30 · Barbara 78732-0002-01 · Traditional →
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.