FDA.reportPublic FDA data

Halls

Product NDC
12546-112
11-digit product format
125460112
Labeler code
12546
Product ID
12546-112_29a54d04-41f2-c4b7-e063-6294a90aaed7
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Mondelez Global LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-07
Substance
MENTHOL
Active strength
5.4 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Halls
Brand name suffix
MENTHO-LYPTUS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5.4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui485287, 1250187

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-112-14HallsMENTHO-LYPTUS14 in 1 BAGLOZENGE1410
12546-112-30HallsMENTHO-LYPTUS30 in 1 BAGLOZENGE3010
12546-112-40HallsMENTHO-LYPTUS40 in 1 BAGLOZENGE4010
12546-112-80HallsMENTHO-LYPTUS80 in 1 BAGLOZENGE8010
12546-112-89HallsMENTHO-LYPTUS200 in 1 BAGLOZENGE20010
12546-112-96HallsMENTHO-LYPTUS96 in 1 BAGLOZENGE9610

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AHALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
MENTHOLACTIVE MOIETYL7T10EIP3AHALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RHALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-112HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]10Current NDC, Legacy NDC, 6 package rows20241222_ff21cf0e-9811-4819-bdfc-17a950e9b114.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250187Halls 5.4 MG Oral LozengePSNff21cf0e-9811-4819-bdfc-17a950e9b11410
485287menthol 5.4 MG Oral LozengePSNff21cf0e-9811-4819-bdfc-17a950e9b11410
1250187menthol 5.4 MG Oral Lozenge [Halls]SBDff21cf0e-9811-4819-bdfc-17a950e9b11410
485287menthol 5.4 MG Oral LozengeSCDff21cf0e-9811-4819-bdfc-17a950e9b11410
1250187Halls 5.4 MG Oral LozengeSYff21cf0e-9811-4819-bdfc-17a950e9b11410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12546-112-141254601121414 LOZENGE in 1 BAG (12546-112-14) 14 lozenge2020-09-010000-00-00NoNoCurrent
12546-112-301254601123030 LOZENGE in 1 BAG (12546-112-30) 30 lozenge2019-04-070000-00-00NoNoCurrent
12546-112-401254601124040 LOZENGE in 1 BAG (12546-112-40) 40 lozenge2019-04-070000-00-00NoNoCurrent
12546-112-801254601128080 LOZENGE in 1 BAG (12546-112-80) 80 lozenge2019-04-070000-00-00NoNoCurrent
12546-112-8912546011289200 LOZENGE in 1 BAG (12546-112-89) 200 lozenge2019-04-070000-00-00NoNoCurrent
12546-112-961254601129696 LOZENGE in 1 BAG (12546-112-96) 96 lozenge2019-04-070000-00-00NoNoCurrent