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Halls Sugar Free Watermelon Menthol 2.5 mg Lozenge, 24-count — NDC 12546-0351-24 package photo

Halls Sugar Free Watermelon Menthol 2.5 mg Lozenge, 24-count

by Mondelez Global LLC · 24 LOZENGE in 1 PACKAGE (12546-351-24)
NDC 12546-0351-24
🏷️ FDA NDC (as labeled) 12546-351-24 billing pads the product segment with a zero
This package
Contains24-count Pack sizes2 compare ↓
Also comes in: 48 lozenges 12546-0351-48
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) 12546-351-24
Product NDC 12546-351
11-digit billing NDC 12546035124
RxCUI 616344, 896992
UNII L7T10EIP3A
Application # M012
SPL Set ID c4c090ca-f083-74e0-e053-2a95a90a9d60
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-12-13
Route ORAL
Dosage form LOZENGE
Substance MENTHOL
Why two NDCs? The FDA registers this code as 12546-351-24 — 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 → 12546-0351-24. 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

LabelerMondelez Global LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code12546
First marketedDec 2021
Product typeHuman Otc Drug
Portfolio27 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.

🧪 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 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII S870P55O2W
    Isomalt is a sugar alcohol made from sugar that's used as a sweetener and bulking agent in medicines. It helps give tablets and powders the right texture and sweetness while having minimal calories.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • 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 statesacesulfame potassium, aspartame, citric acid, eucalyptus oil, FD&C red 40, flavors (includes cinnamon), isomalt, soy lecithin, 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: 48 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.

🔁 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 mgthis 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 mg 83698-0692-30 Xiamen 30 lozenges — — FDA listed —
Best Health Pumpkin Spice Cough Drops 2.5 mg 52642-0062-30 Bestco 30 lozenges — — FDA listed —
Best Health Maple Spice Cough Drops 2.5 mg 52642-0063-30 Bestco 30 lozenges — — FDA listed —
Best Health Bourbon Honey Cough Drops 2.5 mg 52642-0064-30 Bestco 30 lozenges — — FDA listed —
Best Health Caramel Apple Cough Drops 2.5 mg 52642-0061-30 Bestco 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

🏛️
2021
On the market since
Dec 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
12546-0351-24 You're viewing this 24 LOZENGE in 1 PACKAGE (12546-351-24) 2021-12-13 Active
12546-0351-48 2 PACKAGE in 1 BAG (12546-351-48) / 24 LOZENGE in 1 PACKAGE (12546-351-24) 2025-06-01 Active

Pack size FAQ

What quantity is in NDC 12546-0351-24?
NDC 12546-0351-24 is a 24-count package — 24 lozenge in 1 package.
What is the difference between NDC 12546-0351-24 and NDC 12546-0351-48?
Both are Halls Sugar Free Watermelon Menthol 2.5 mg Lozenge — the drug itself is identical. NDC 12546-0351-24 is the 24-count package, while NDC 12546-0351-48 is the 48 lozenges package.
What NDC number is used to bill for this package of Halls Sugar Free Watermelon Menthol 2.5 mg Lozenge?
Bill NDC 12546-0351-24 — the 11-digit billing format is 12546035124. 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 12546-351-24, 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: 12546-0351-24, written without dashes as 12546035124. 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 12546-0351-24, the first segment (12546) is the labeler code FDA assigned to Mondelez Global LLC; the middle segment (0351) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (24) 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 Mondelez Global LLC. 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 1 other package presentation of this same product, including 48 lozenges (12546-0351-48). 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?
Mondelez Global LLC 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 14 words ▾

Uses temporarily relieves: cough due to a cold occasional minor irritation or sore throat

⏱️ Dosage and Administration 32 words ▾

Directions adults and children 5 years and over: dissolve 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed. children under 5 years: ask a doctor

⚠️ Warnings 35 words ▾

Warnings Sore throat warning: if sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious

🧪 Active Ingredient 7 words ▾

Active Ingredient (per drop) Menthol 2.5 mg

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients acesulfame potassium, aspartame, citric acid, eucalyptus oil, FD&C red 40, flavors (includes cinnamon), isomalt, soy lecithin, water

🎯 Purpose 5 words ▾

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 ↗
← 12546-0349-24 · Mondelez 12546-0352-25 · Mondelez →
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.