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Halls MENTHO-LYPTUS Menthol 5.4 mg Lozenge, 14-count — NDC 12546-0112-14 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Halls MENTHO-LYPTUS Menthol 5.4 mg Lozenge, 14-count — NDC 12546-112-14 (Billing 12546-0112-14)

by Mondelez Global LLC · 14 LOZENGE in 1 BAG

This is a package of 14 lozenges of Halls MENTHO-LYPTUS Menthol 5.4 mg Lozenge from Mondelez Global LLC, no longer marketed (first marketed Apr 2019), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 5 package sizes.

NDC 12546-0112-14
🏷️ FDA NDC (as labeled) 12546-112-14 billing pads the product segment with a zero
This package
Contains14-count Pack sizes5 compare ↓
Main listing for product 12546-112 · Also comes in: 30 lozenges 12546-112-30 40 lozenges 12546-112-40 80 lozenges 12546-112-80 200 lozenges 12546-112-89
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 12546-112-14
Product NDC 12546-112
11-digit billing NDC 12546011214
RxCUI 485287, 1250187
UNII L7T10EIP3A
Application # M012
SPL Set ID ff21cf0e-9811-4819-bdfc-17a950e9b114
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2019-04-07
Route ORAL
Dosage form LOZENGE
Substance MENTHOL
Quick answers
  • RxCUI (RxNorm): 485287
Why two NDCs? The FDA registers this code as 12546-112-14 — 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 → 12546-0112-14. 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.
Try another pack size: 30 lozenges 40 lozenges 80 lozenges 200 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
12546-0112-14 You're viewing this Main listing 14 LOZENGE in 1 BAG 2020-09-01 — Discontinued by firm
12546-0112-30 12546-112-30 30 LOZENGE in 1 BAG 2019-04-07 — Active
12546-0112-40 12546-112-40 40 LOZENGE in 1 BAG 2019-04-07 — Discontinued by firm
12546-0112-80 12546-112-80 80 LOZENGE in 1 BAG 2019-04-07 — Active
12546-0112-89 12546-112-89 200 LOZENGE in 1 BAG 2019-04-07 — Active

You're viewing the smallest of 5 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 14-count package — 14 lozenge in 1 bag.
How does this package differ from NDC 12546-0112-30?
Both are Halls MENTHO-LYPTUS Menthol 5.4 mg Lozenge — the drug itself is identical. This page's package is the 14-count one, while NDC 12546-0112-30 is the 30 lozenges package.
What NDC number is used to bill for this package of Halls MENTHO-LYPTUS Menthol 5.4 mg Lozenge?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cough Drops Menthol 5.4 mg 70000-0638-01 Cardinal 30 pastilles $0.034 — Availability likely —
Menthol Cough Drop 5.4 mg 00363-1070-30 Walgreens 30 lozenges — — FDA listed —
Walgreens Menthol Cough Drops 5.4 mg 00363-9957-40 Walgreens 40 lozenges — — FDA listed —
Halls MENTHO-LYPTUS 5.4 mgthis 12546-0112-14 Mondelez 14 lozenges — — Discontinued —
HALLS Mentholyptus 5.4 mg 12546-0116-30 Mondelez 30 lozenges — — FDA listed —
Menthol Cough Drop 5.4 mg 21130-0265-30 Safeway 30 lozenges — — FDA listed —
Menthol cough drop 5.4 mg 30142-0031-30 The 30 lozenges — — FDA listed —
menthol cough drops 5.4 mg 36800-0814-30 Topco 30 lozenges — — FDA listed —
Menthol Cough Drop 5.4 mg 37808-0032-30 HEB 30 lozenges — — FDA listed —
HEB Menthol Cough Drops 5.4 mg 37808-0475-60 HEB 160 lozenges — — FDA listed —
Menthol Cough Drops 5.4 mg 41250-0082-00 Meijer 200 lozenges — — FDA listed —
menthol cough drops 5.4 mg 41250-0149-04 Meijer 30 lozenges — — FDA listed —
menthol cough drops 5.4 mg 41520-0009-30 American 30 lozenges — — FDA listed —
HyVee Cough Drops Menthol 5.4 mg 42507-0905-30 HY-VEE, 30 lozenges — — FDA listed —
GoodSense Menthol Cough Drops 5.4 mg 50804-0013-30 Geiss, 30 lozenges — — FDA listed —
Cough Drops 5.4 mg 50804-0592-01 Perrigo 30 pastilles — — FDA listed —
Menthol Cough Drops 5.4 mg 52642-0042-30 Bestco 30 lozenges — — FDA listed —
Best Health Menthol Cough Drops 5.4 mg 52642-0055-80 Bestco 80 lozenges — — FDA listed —
Discount Drug Mart 5.4 mg 53943-0102-30 DISCOUNT 30 lozenges — — FDA listed —
Menthol Flavor Cough Drop 5.4 mg 55301-0581-30 Army 30 lozenges — — FDA listed —
Exchange Select Cough Drops Menthol Sugar Free 5.4 mg 55301-0584-25 Army 25 lozenges — — FDA listed —
Menthol cough drops 5.4 mg 55319-0006-30 Family 30 lozenges — — FDA listed —
Cough Drops 5.4 mg 59450-0713-01 The 30 pastilles — — FDA listed —
Cough Drops 5.4 mg 59450-0714-01 The 200 pastilles — — FDA listed —
menthol cough drops 5.4 mg 67091-0300-80 Winco 80 lozenges — — FDA listed —
Premier Value 5.4 mg 68016-0885-30 Pharmacy 4 lozenges — — FDA listed —
CVS Menthol Cough Drops 5.4 mg 69842-0536-60 CVS 160 lozenges — — FDA listed —
Freegells Cough Drops Menthol Eucalyptus 5.4 mg 71165-0012-00 Riclan 30 lozenges — — FDA listed —
Harris Teeter Menthol Cough Drops 5.4 mg 72036-0085-30 Harris 30 lozenges — — FDA listed —
Menthol Cough Drops 5.4 mg 72628-0118-01 BOSTON 30 pastilles — — FDA listed —
Cough Drops Dollar General Menthol 30ct 5.4 mg 75712-0017-01 Dollar 270 lozenges — — FDA listed —
Cough Drops Dollar General Menthol 80ct 5.4 mg 75712-0021-01 Dollar 480 lozenges — — FDA listed —
Cough Drops Dollar General Menthol 160ct 5.4 mg 75712-0023-01 Dollar 640 lozenges — — FDA listed —
Cough Drops 5.4 mg 76162-0011-01 Topco 30 pastilles — — FDA listed —
Equate Menthol Cough Drops 5.4 mg 79903-0253-30 Walmart 30 lozenges — — FDA listed —
Freegells Cough Drops Menthol 80ct 5.4 mg 83002-0004-01 R.L. 480 lozenges — — FDA listed —
Freegells Cough Drops Menthol 30ct 5.4 mg 83002-0005-01 R.L. 270 lozenges — — FDA listed —
MGC Cough Drops 5.4 mg 83173-0109-30 Medical 30 lozenges — — FDA listed —
MGC Health 5.4 mg 83173-0113-25 Medical 25 lozenges — — FDA listed —
Quality Choice Menthol Cough Drops 5.4 mg 83324-0265-30 Chain 30 lozenges — — FDA listed —
Cough Drops 5.4 mg 83455-0206-01 United 30 pastilles — — FDA listed —
Discount Drug Mart 5.4 mg 83698-0102-30 Xiamen 30 lozenges — — FDA listed —
MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops 5.4 mg 83698-0110-30 Xiamen 30 lozenges — — FDA listed —
MGC Health 5.4 mg 83698-0113-25 Xiamen 25 lozenges — — FDA listed —
Menthol Flavor Cough Drop 5.4 mg 83698-0581-30 Xiamen 30 lozenges — — FDA listed —
Exchange Select Cough Drops Menthol Sugar Free 5.4 mg 83698-0584-25 Xiamen 25 lozenges — — FDA listed —
Quality Choice 5.4 mg 83698-0675-30 Xiamen 30 lozenges — — FDA listed —
Premier Value 5.4 mg 83698-0885-30 Xiamen 4 lozenges — — FDA listed —
HyVee Cough Drops Menthol 5.4 mg 83698-0901-30 Xiamen 30 lozenges — — FDA listed —
Sanatos 5.4 mg 55758-0518-30 Pharmadel 900 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

🏛️
2019
On the market since
Apr 2019
📍
2026
Currently FDA-listed
7 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
ShapeOval
ImprintH
Size21 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.

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 marketedApr 2019
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.

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 28 words ▾

Directions adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed. children under 5 years: ask a doctor

⚠️ Warnings 33 words ▾

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

🧪 Active Ingredient 7 words ▾

Active Ingredient <(per drop) Menthol 5.4 mg>

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients <citric acid, eucalyptus oil, FDC blue 1, FDC red 40, flavors, glucose syrup, potassium citrate, soy lecithin, sucrose, 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 ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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) — 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 30 lozenges (12546-0112-30), 40 lozenges (12546-0112-40), 80 lozenges (12546-0112-80). 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.
← 12546-0110-00 · Mondelez 12546-0114-30 · 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.