FDA.reportPublic FDA data

Halls

Product NDC
12546-334
11-digit product format
125460334
Labeler code
12546
Product ID
12546-334_1bc29960-5e7b-e8ab-e063-6294a90a3f80
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
6.4 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL6.4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1857613Internal RxNorm lookup
1857615Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5292c5b-5608-4e13-afc2-4f3d7133da88Available on FDA.report

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
12546-334-09HallsMentholyptus9 in 1 PACKAGELOZENGE93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-334HALLS MENTHOLYPTUS (MENTHOL) LOZENGE [MONDELĒZ GLOBAL LLC]3Current NDC, Legacy NDC, 1 package rows20240627_f5292c5b-5608-4e13-afc2-4f3d7133da88.zip

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 15 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense allergyDIPHENHYDRAMINE HCLL. Perrigo Companybf5039a0-2109-41a2-84a9-b5167d0a93da2026-07-22WarningsExact identifier
application number: M012
Congestion and HeadacheACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY432c3ec4-7595-4213-94e3-ce41af91804e2026-07-21WarningsExact identifier
application number: M012
SKAPEMED ORIGINAL NASALNAPHAZOLINE HCL 0.05% ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a208a1f-f6e8-0b4a-e063-6294a90a10c82026-07-21WarningsExact identifier
application number: M012
SERYNTH FAST RELIEF NASALNAPHAZOLINE HCL 0.05% FAST RELIEF NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4abdc0-aded-1b8a-e063-6394a90a9b562026-07-21WarningsExact identifier
application number: M012
DERMFREE ORIGINAL NASALNAPHAZOLINE HCL0.05%ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4d0c03-7d8f-76cb-e063-6394a90a938c2026-07-21WarningsExact identifier
application number: M012
DERMFREE ORIGINAL NASALNAPHAZOLINE HCL 0.05%ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4d3a2b-a4ed-c736-e063-6394a90a96df2026-07-21WarningsExact identifier
application number: M012
Severe Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY791eaac1-ddb5-40e2-9040-52dfadc30e062026-07-21WarningsExact identifier
application number: M012
DRx Choice DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERaritan Pharmaceuticals Inc.9ab47b10-b1ed-4ae1-94e8-09d50e952bb02026-07-21WarningsExact identifier
application number: M012
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLP & L Development, LLC17639c3b-5d36-41f5-bd0d-da29075abd092026-07-21WarningsExact identifier
application number: M012
NATUHEAL ORIGINAL NASALNAPHAZOLINE HCL 0.05% ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a470b9e-c83f-fb20-e063-6294a90a2f132026-07-20WarningsExact identifier
application number: M012
TYLENOL Cold plus Flu Multi-Symptom Liquid Gels DayACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC1c444202-19e9-8d04-e063-6394a90a92942026-07-20WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONDISCOUNT DRUG MART5565a581-e2b5-81a5-e063-6394a90af4092026-07-20WarningsExact identifier
application number: M012
Best Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)40e0b17a-5704-4203-8f0a-11b2fcf81f8f2026-07-17WarningsExact identifier
application number: M012
Equate Daytime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.ee1ef41d-b8be-42f3-9918-ccf1c0a802412026-07-17WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.879a7804-f3d4-4a3d-bc92-b473499d6c952026-07-17WarningsExact identifier
application number: M012
Best ChoiceOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)95007785-ddf6-4386-af5f-84dac1066b402026-07-17WarningsExact identifier
application number: M012
BEST CHOICE No DripALLERGY SINUSBEST CHOICE (VALU MERCHANDISERS COMPANY)d5f95b56-8201-4d97-82ab-e23761bfe7202026-07-17WarningsExact identifier
application number: M012
Best Choice Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)7d19fdba-35b0-424a-ba11-315521d3256d2026-07-17WarningsExact identifier
application number: M012
Best Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)badb15ac-91e8-4962-96f5-beb2509775602026-07-17WarningsExact identifier
application number: M012
Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0839c07b-f692-4af1-85b8-da60fb281d492026-07-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1857615Halls 6.4 MG Oral LozengePSNf5292c5b-5608-4e13-afc2-4f3d7133da883
1857613menthol 6.4 MG Oral LozengePSNf5292c5b-5608-4e13-afc2-4f3d7133da883
1857615menthol 6.4 MG Oral Lozenge [Halls]SBDf5292c5b-5608-4e13-afc2-4f3d7133da883
1857613menthol 6.4 MG Oral LozengeSCDf5292c5b-5608-4e13-afc2-4f3d7133da883
1857615Halls 6.4 MG Oral LozengeSYf5292c5b-5608-4e13-afc2-4f3d7133da883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12546-334-09125460334099 LOZENGE in 1 PACKAGE (12546-334-09) 9 lozenge2019-04-070000-00-00NoNoCurrent