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Halls Sugar Free Mentho-Lyptus Menthol 2.7 mg Lozenge, 24-count — NDC 12546-349-24 (Billing 12546-0349-24)

by Mondelez Global LLC · 24 LOZENGE in 1 PACKAGE

This is a package of 24 lozenges of Halls Sugar Free Mentho-Lyptus Menthol 2.7 mg Lozenge from Mondelez Global LLC, marketed since Oct 2020 and currently FDA-listed. It is this product's only package size.

NDC 12546-0349-24
🏷️ FDA NDC (as labeled) 12546-349-24 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 12546-349-24 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
12546 labeler · 349 product · 24 package
Package marketed since
Oct 21, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1254634924 7
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) 12546-349-24
Product NDC 12546-349
11-digit billing NDC 12546034924
RxCUI 433196, 1250183
UNII L7T10EIP3A
Application # M012
SPL Set ID 96046858-c57b-426e-8279-91b35e05bcdb
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-10-21
Route ORAL
Dosage form LOZENGE
Substance MENTHOL
Quick answers
  • RxCUI (RxNorm): 433196
Why two NDCs? The FDA registers this code as 12546-349-24 — 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 → 12546-0349-24. 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.

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
12546-0349-24 You're viewing this Main listing 24 LOZENGE in 1 PACKAGE 2020-10-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Strawberry Cough Drop 2.7 mg 00363-1073-30 Walgreen 30 lozenges — — FDA listed —
Halls Strawberry 2.7 mg 12546-0114-30 Mondelez 30 lozenges — — Discontinued —
Halls Sugar Free Mentho-Lyptus 2.7 mgthis 12546-0349-24 Mondelez 24 lozenges — — FDA listed —
Strawberry Cough Drops 2.7 mg 37808-0113-30 HEB 30 lozenges — — FDA listed —
Strawberry Cough Drops 2.7 mg 52642-0020-30 BestCo 30 lozenges — — FDA listed —
Discount Drug Mart 2.7 mg 53943-0509-25 DISCOUNT 25 lozenges — — FDA listed —
Family Wellness Strawberry Cough Drops 2.7 mg 55319-0048-30 Family 30 lozenges — — FDA listed —
Freegells Cough Drops Menthol Strawberry 2.7 mg 71165-0014-00 Riclan 30 lozenges — — FDA listed —
Cough Drops Dollar General Strawberry 30ct 2.7 mg 75712-0022-01 Dollar 270 lozenges — — FDA listed —
Meijer Strawberry Cough Drops 2.7 mg 79481-0091-01 Meijer 80 lozenges — — FDA listed —
Freegells Cough Drops Menthol Strawberry 30 Drops 2.7 mg 83002-0001-01 R.L. 1 suspension — — FDA listed —
Cough Drops Freegells Strawberry 30ct 2.7 mg 83002-0010-01 R.L. 270 lozenges — — FDA listed —
MGC Health 2.7 mg 83173-0126-30 Medical 30 lozenges — — FDA listed —
MGC Health 2.7 mg 83698-0126-30 Xiamen 30 lozenges — — FDA listed —
Discount Drug Mart 2.7 mg 83698-0509-25 Xiamen 25 lozenges — — FDA listed —
Quality Choice 2.7 mg 83698-0673-30 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

🏛️
2020
On the market since
Oct 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.

What it looks like

Color blue
ShapeRound
ImprintH
Size9 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.

🧪 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

LabelerMondelez Global LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code12546
First marketedOct 2020
Product typeHuman Otc Drug
Portfolio27 products on file

More NDCs from Mondelez Global LLC labeler code 12546

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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 2.7 mg>

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients <acesulfame potassium, aspartame, citric acid, eucalyptus oil, FD&C blue 1, FD&C red 40, flavors, isomalt, soy lecithin, water>

🎯 Purpose 5 words ▾

Purposes <Cough Suppressant, Oral Anesthetic>

📄 Ask a Doctor Before Use If 26 words ▾

Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough accompanied by excessive phlegm (mucus)

📄 Stop Use and Ask a Doctor If 49 words ▾

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. These could be signs of a serious condition. sore mouth does not improve in 7 days irritation, pain, or redness persists or worsens

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

📄 Questions or Comments 16 words ▾

Questions <Call 1-800-524-2854, Monday to Friday, 9 AM-6PM Eastern Time or visit our website at www.gethalls.com>

📄 Package Label / Principal Display Panel 18 words ▾

OTC Principal Display Panel Halls minis sugar free mentho-lyptus 24ct front Halls Minis sugar free mentho-lyptus 24ct back

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 Halls Sugar Free Mentho-Lyptus (this brand).

Top reported reactions

Dyspnoea88
Fatigue86
Pain81
Pruritus81
Headache70
Cough68
Dizziness67

Age at onset

Infant1
Child1
Adolescent1
Adult98
Elderly92

Reporter sex

1,032 reports

Serious outcomes

Hospitalization344
Death125
Life-threatening45
Disabling28
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 96 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 Mondelez Global LLC. Listing status can change — the directory data on this page refreshes weekly.
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.
← 12546-0348-24 · Mondelez 12546-0351-24 · 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.