FDA.reportPublic FDA data

Halls

Manufacturer
Mondelez Global LLC | Mondelēz Canada Inc
Effective date
2025-06-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:03:12

Label at a glance#

ProductHalls Honey Lemon
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

temporarily relieves 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 8.8 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 severs, 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

<beta carotene, eucalyptus oil, flavors, glucose syrup, honey, soy lecithin, sucralose, sucrose, water>

Questions

OTC - QUESTIONS SECTION

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

OTC Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Halls Honey Lemon 9 count Stick.jpgHalls Honey Lemon 9 count Stick.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1811176Halls 8.8 MG Oral LozengePSN4
1811174menthol 8.8 MG Oral LozengePSN4
1811176menthol 8.8 MG Oral Lozenge [Halls]SBD4
1811174menthol 8.8 MG Oral LozengeSCD4
1811176Halls 8.8 MG Oral LozengeSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-320-09HallsHoney Lemon9 in 1 PACKAGELOZENGE94

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12546-32012546-320-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
.BETA.-CAROTENE01YAE03M7JIACT
EUCALYPTUS OIL2R04ONI662IACT
HONEYY9H1V576FHIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
CORN SYRUP9G5L16BK6NIACT

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 Honey LemonMENTHOLMondelez Global LLC25eaae85-d516-40da-a472-70736ea2b75d2025-06-16WarningsExact identifier
ndc (package): 12546-320-09
ndc (product): 12546-320
ndc11 (package): 12546032009
spl id: 37b45686-b73a-5d88-e063-6394a90af12a
spl set id: 25eaae85-d516-40da-a472-70736ea2b75d

Reported adverse events (FAERS/openFDA)#

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