FDA.reportPublic FDA data

HALLS

Manufacturer
Mondelez Global LLC | Mondelēz Canada Inc
Effective date
2025-07-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:38:54

Label at a glance#

ProductHALLS Extra Strong
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

Temporarily relieves occasional minor irritation and pain associated with: sore mouth 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 18 mg>

Purpose

OTC - PURPOSE SECTION

<Oral Anesthetic>

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves occasional minor irritation and pain associated with:

  • sore mouth
  • 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.>

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • 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, FD&C blue 1, 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>

OTC Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HHHalls Extra Strong 9 count Stick.jpgHalls Extra Strong 9 count Stick.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1422189Halls 18 MG Oral LozengePSN1
1422187Menthol 18 MG Oral LozengePSN1
1422189menthol 18 MG Oral Lozenge [Halls]SBD1
1422187menthol 18 MG Oral LozengeSCD1
1422189Halls 18 MG Oral LozengeSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130312546006867GTIN-13: 0312546006867
EAN-13: 0312546006867
GTIN-12: 312546006867
UPC-A: 312546006867
GTIN storage (14 digits): 00312546006867		Halls Extra Strong 9 count 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
12546-722-09HALLSExtra Strong9 in 1 PACKAGELOZENGE91

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
12546-72212546-722-09

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
WATER059QF0KO0RIACT
CORN SYRUP9G5L16BK6NIACT
SUCROSEC151H8M554IACT
EUCALYPTUS OIL2R04ONI662IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MENTHOLL7T10EIP3AACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM CITRATEEE90ONI6FFIACT
LECITHIN, SOYBEAN1DI56QDM62IACT

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 Extra StrongMENTHOLMondelez Global LLC396f93a9-8d2c-2f27-e063-6294a90ab3442025-07-08WarningsExact identifier
ndc (package): 12546-722-09
ndc (product): 12546-722
ndc11 (package): 12546072209
spl id: 396f93a9-8d2d-2f27-e063-6294a90ab344
spl set id: 396f93a9-8d2c-2f27-e063-6294a90ab344

Reported adverse events (FAERS/openFDA)#

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