FDA.reportPublic FDA data

HALLS Mentholyptus Stick QI

Manufacturer
Mondelēz Global LLC | Mondelēz Canada Inc.
Effective date
2026-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:56:12

Label at a glance#

ProductHALLS Mentholyptus
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

cough due to a cold occasional minor irritation or sore throat

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

<(per drop) Menthol 6.4 mg>

Purposes

OTC - PURPOSE SECTION

<Cough suppressant, Oral anesthetic>

Uses

INDICATIONS & USAGE SECTION

<temporarily relieves:>

  • cough due to a cold
  • occasional minor irritation or sore throat

Warnings

WARNINGS SECTION

<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. These may be serious.>

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

  • 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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

SPL UNCLASSIFIED SECTION

  • 15 calories per drop
  • Contains: SOY.

Inactive ingredients

INACTIVE INGREDIENT SECTION

<citric acid, eucalyptus oil, flavors, glucose syrup, potassium citrate, soy lecithin, sucrose, water>

Questions

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mentho-lyptus Stick.jpgMentho-lyptus Stick.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1857615Halls 6.4 MG Oral LozengePSN2
1857613menthol 6.4 MG Oral LozengePSN2
1857615menthol 6.4 MG Oral Lozenge [Halls]SBD2
1857613menthol 6.4 MG Oral LozengeSCD2
1857615Halls 6.4 MG Oral LozengeSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130312546629707GTIN-13: 0312546629707
EAN-13: 0312546629707
GTIN-12: 312546629707
UPC-A: 312546629707
GTIN storage (14 digits): 00312546629707		Mentho-lyptus Stick.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-721-09HALLSMentholyptus9 in 1 PACKAGELOZENGE92

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12546-72112546-721-09

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EUCALYPTUS OIL2R04ONI662IACT
CORN SYRUP9G5L16BK6NIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT
POTASSIUM CITRATEEE90ONI6FFIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HALLS MentholyptusMENTHOLMondelez Global LLC38d12374-e2c7-444c-e063-6294a90a42b32026-05-06WarningsExact identifier
ndc (package): 12546-721-09
ndc (product): 12546-721
ndc11 (package): 12546072109
spl id: 5126f4d2-fe36-9930-e063-6294a90aab83
spl set id: 38d12374-e2c7-444c-e063-6294a90a42b3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.