FDA.reportPublic FDA data

Halls

Manufacturer
Mondelez Global LLC | Mondelez Canada Inc
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:38:14

Label at a glance#

ProductHalls Green Apple
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 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 (per drop)

OTC - ACTIVE INGREDIENT SECTION

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, 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/PHARMACIST 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 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

  • 10 Calories per drop
  • Contains: SOY.

Inactive ingredients

INACTIVE INGREDIENT SECTION

beta carotene, citric acid, eucalyptus oil, FD&C blue 1, flavors, glucose syrup, malic acid, 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

Green Apple ArtGreen Apple Art

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 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
12546-118-30HallsGreen Apple30 in 1 BAGLOZENGE304
12546-118-80HallsGreen Apple80 in 1 BAGLOZENGE804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-118HALLS GREEN APPLE (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]4Current NDC, 2 package rows20241122_1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12546-11812546-118-80, 12546-118-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
MENTHOLL7T10EIP3AACTIB
SUCROSEC151H8M554IACT
BETA CAROTENE01YAE03M7JIACT
EUCALYPTUS OIL2R04ONI662IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CORN SYRUP9G5L16BK6NIACT
MALIC ACID817L1N4CKPIACT
SOYBEAN LECITHIN1DI56QDM62IACT
POTASSIUM CITRATEEE90ONI6FFIACT
WATER059QF0KO0RIACT

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 Green AppleMENTHOLMondelez Global LLC1bb8dcb2-c3a8-a64e-e063-6294a90ae4a22024-11-20WarningsExact identifier
ndc (package): 12546-118-30
ndc (package): 12546-118-80
ndc (product): 12546-118
ndc11 (package): 12546011830
ndc11 (package): 12546011880
spl id: 275a09a6-a98d-6f3c-e063-6394a90ab0a6
spl set id: 1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2

Reported adverse events (FAERS/openFDA)#

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