FDA.reportPublic FDA data

Halls

Manufacturer
Mondelez Global LLC | MSI Express, Inc | Mondelez Canada Inc
Effective date
2025-02-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:55:44

Label at a glance#

ProductHalls Sugar Free Watermelon
Active ingredientMENTHOL
Label structure12 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 2 drops (one at a time) 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 2.5 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, 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

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

SPL UNCLASSIFIED SECTION

  • phenylketonurics: contains phenylalanine 0.5 mg per drop
  • excessive consumption may have a laxative effect
  • <5 calories per drop
  • Contains: SOY.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, aspartame, citric acid, eucalyptus oil, FD&C red 40, flavors (includes cinnamon), isomalt, soy lecithin, 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 SF Mini Watermelon Pouch frontHalls SF Mini Watermelon Pouch front

Halls SF Mini Watermelon Pouch backHalls SF Mini Watermelon Pouch back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
896992Halls 2.5 MG Oral LozengePSN4
616344menthol 2.5 MG Oral LozengePSN4
896992menthol 2.5 MG Oral Lozenge [Halls]SBD4
616344menthol 2.5 MG Oral LozengeSCD4
896992Halls 2.5 MG Oral LozengeSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-351-24HallsSugar Free Watermelon24 in 1 PACKAGELOZENGE244
12546-351-48HallsSugar Free Watermelon2 in 1 BAGLOZENGE24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-351HALLS SUGAR FREE WATERMELON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]4Current NDC, Legacy NDC, 2 package rows20250223_c4c090ca-f083-74e0-e053-2a95a90a9d60.zip

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
12546-35112546-351-24, 12546-351-48

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
ACESULFAME POTASSIUM23OV73Q5G9IACT
ASPARTAMEZ0H242BBR1IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
EUCALYPTUS OIL2R04ONI662IACT
MENTHOLL7T10EIP3AACTIB
FD&C RED NO. 40WZB9127XOAIACT
ISOMALTS870P55O2WIACT

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 Sugar Free WatermelonMENTHOLMondelez Global LLCc4c090ca-f083-74e0-e053-2a95a90a9d602025-02-14WarningsExact identifier
ndc (package): 12546-351-24
ndc (package): 12546-351-48
ndc (product): 12546-351
ndc11 (package): 12546035148
ndc11 (package): 12546035124
spl id: 2e2102c6-02eb-3a8f-e063-6394a90abf5e
spl set id: c4c090ca-f083-74e0-e053-2a95a90a9d60

Reported adverse events (FAERS/openFDA)#

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