FDA.reportPublic FDA data

Halls

Manufacturer
Mondelēz Global LLC | Mondelēz Canada Inc.
Effective date
2019-07-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:19:19

Label at a glance#

ProductHalls Ice Peppermint
Active ingredientMenthol
Label structure12 sections

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 10 mg>

Purposes

OTC - PURPOSE SECTION

<Cough suppressant, Oral anesthetic>

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Enter section text here

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

<eucalyptus oil, FDC blue 1, flavors, glucose syrup, soy lecithin, sucrose, water>

Questions?

OTC - QUESTIONS SECTION

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

OTC Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

<NDC 12546-101-09 Halls Ice Peppermint 9ct stick>

MM1MM1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3A2
MentholACTIVE MOIETYL7T10EIP3A2
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6622
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM622
SUCROSEINACTIVE INGREDIENTC151H8M5542
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12546-10112546-101-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
MentholL7T10EIP3AACTIB
EUCALYPTUS OIL2R04ONI662IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 93 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
7 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDDOUCHE / VAGINALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM, SOLUBLE / ORAL0.04 mgExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOAP / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62AEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, FILM COATED, EXTENDED RELEASE / ORAL119.12 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDMOUTHWASH / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CREAM / VAGINAL1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / SUBLINGUAL0.03 mgExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTABLE, LIPOSOMAL / INTRAVENOUS7560 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LOZENGE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCREAM / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLOTION / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM / SUBLINGUAL0.07 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate

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
e8d29a1d-d66a-78f2-e053-2995a90a5bbc3e3e899d-6074-4c75-8ffa-0273fe7216b32022-09-16WarningsExact identifier
spl set id: 3e3e899d-6074-4c75-8ffa-0273fe7216b3

Reported adverse events (FAERS/openFDA)#

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