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Leader Cough Drops Vanilla Honey Menthol 2.5 mg Lozenge, 30-count — NDC 83698-692-30 (Billing 83698-0692-30)

by Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · 30 LOZENGE in 1 BAG

This is a package of 30 lozenges of Leader Cough Drops Vanilla Honey Menthol 2.5 mg Lozenge from Xiamen Kang Zhongyuan Biotechnology Co., Ltd., marketed since Jul 2024 and currently FDA-listed. It is this product's only package size.

NDC 83698-0692-30
🏷️ FDA NDC (as labeled) 83698-692-30 billing pads the product segment with a zero
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

NDC database record

One package, one record: these facts belong to NDC 83698-692-30 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83698 labeler · 692 product · 30 package
Package marketed since
Jul 10, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0096295143591
FDA record last changed
Jul 24, 2026
⚠️
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) 83698-692-30
Product NDC 83698-692
11-digit billing NDC 83698069230
RxCUI 616344
UNII L7T10EIP3A
UPC 0096295143591
Application # M012
SPL Set ID 26a93c2c-a663-e3d1-e063-6394a90ad859
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-07-10
Route ORAL
Dosage form LOZENGE
Substance MENTHOL, UNSPECIFIED FORM
Quick answers
  • RxCUI (RxNorm): 616344
Why two NDCs? The FDA registers this code as 83698-692-30 — 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 → 83698-0692-30. 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.
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
83698-0692-30 You're viewing this Main listing 30 LOZENGE in 1 BAG 2024-07-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Menthol Cough Drops Honey Vanilla Flavor 2.5 mg 10202-0013-09 7-ELEVEN 9 lozenges — — FDA listed —
Halls Green Apple 2.5 mg 12546-0118-80 Mondelez 80 lozenges — — FDA listed —
Halls Blueberry 2.5 mg 12546-0119-80 Mondelez 80 lozenges — — FDA listed —
Halls Honey Vanilla 2.5 mg 12546-0338-30 Mondelez 30 lozenges — — FDA listed —
Halls Sugar Free Honey Lemon 2.5 mg 12546-0347-24 Mondelez 24 lozenges — — FDA listed —
Halls Sugar Free Watermelon 2.5 mg 12546-0351-24 Mondelez 24 lozenges — — FDA listed —
Leader Cough Drops Vanilla Honey 2.5 mg 70000-0692-01 Cardinal 30 lozenges — — FDA listed —
MGC Health 2.5 mg 83173-0128-30 Medical 30 lozenges — — FDA listed —
QUALITY CHOICE Cough Drops Vanilla Honey 2.5 mg 83324-0308-30 Chain 30 lozenges — — FDA listed —
Menthol Cough Drops Honey Vanilla Flavor 2.5 mg 83698-0013-09 Xiamen 9 lozenges — — FDA listed —
MGC Health 2.5 mg 83698-0128-30 Xiamen 30 lozenges — — FDA listed —
QUALITY CHOICE Cough Drops Vanilla Honey 2.5 mg 83698-0620-30 Xiamen 30 lozenges — — FDA listed —
Leader Cough Drops Vanilla Honey 2.5 mgthis 83698-0692-30 Xiamen 30 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

🏛️
2024
On the market since
Jul 2024
📍
2026
Currently FDA-listed
2 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.

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.

🧪 Avoiding an ingredient? See Menthol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

LabelerXiamen Kang Zhongyuan Biotechnology Co., Ltd.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code83698
First marketedJul 2024
Product typeHuman Otc Drug
Portfolio68 products on file

More NDCs from Xiamen Kang Zhongyuan Biotechnology Co., Ltd. labeler code 83698

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

Uses temporarily relieves: • cough due to a cold • occasional minor irritation, pain, sore mouth, and sore throat

⏱️ Dosage and Administration 37 words ▾

Directions • adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor • children under 2 years of age: ask a doctor

⚠️ Warnings 136 words ▾

Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. Ask a doctor before use if you have • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema • cough accompanied by excessive phlegm (mucus) When using this product do not exceed recommended dosage Stop use and ask a doctor if • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.

A persistent cough may be a sign of a serious condition • sore mouth symptoms do not improve in 7 days • irritation, pain, or redness persists or worsens Keep this and all drugs out of the reach of children.

📦 Storage and Handling 31 words ▾

Other information • store at room temperature. • keep away from excessive heat or sunlight • do not use if primary bag seal has been torn or broken. • contains: SOY

🧪 Active Ingredient 8 words ▾

Active ingredient (in each lozenge) Menthol 2.5 mg

🧪 Inactive Ingredients 13 words ▾

Inactive ingredients beta carotene, corn syrup, honey, soy lecithin, sucrose, vanilla flavor, water.

🎯 Purpose 4 words ▾

Purposes Cough suppressant/oral anesthetic

📄 Keep Out of Reach of Children 11 words ▾

Keep this and all drugs out of the reach of children.

📄 Questions or Comments 23 words ▾

Questions or comments? Call +1-866-306-9136 You may also report concerns to this phone number Monday to Friday, 9 AM -5 PM Eastern Time

📄 Package Label / Principal Display Panel 3 words ▾

Packaging Vanilla Honey

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 — the ingredient across all brands.

Top reported reactions

Pain3,545
Fatigue3,324
Nausea3,269
Headache3,025
Dyspnoea2,471
Diarrhoea2,208
Pneumonia2,151

Age at onset

Neonate144
Infant64
Child375
Adolescent265
Adult5,396
Elderly3,493

Reporter sex

54,495 reports
Male · 36%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization18,793
Death5,294
Life-threatening4,358
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,728 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.

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 — Not published for this NDC No photo available yet for this listing.
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 Xiamen Kang Zhongyuan Biotechnology Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 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.
← 83698-0675-30 · Xiamen 83698-0711-30 · Xiamen →
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.