FDA.reportPublic FDA data

THORACOL

Product NDC
50332-0156
11-digit product format
503320156
Labeler code
50332
Product ID
50332-0156_5886d208-5a40-4ca9-ae63-c2817f891cc9
Type
HUMAN OTC DRUG
Nonproprietary name
Honey Lemon Cough Drops
Dosage form
LOZENGE
Route
ORAL
Labeler
HART Health
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-09
Substance
MENTHOL
Active strength
8.6 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
THORACOL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL8.6 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
433194Internal RxNorm lookup
2699389Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fee9f594-c619-4d77-bb52-632078e0254eAvailable on FDA.report

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0156THORACOL (HONEY LEMON COUGH DROPS) LOZENGE [HART HEALTH]1Current NDC20241211_fee9f594-c619-4d77-bb52-632078e0254e.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 2 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
application number: M
NUTRALOXCALCIUM CARBONATEHART Health3941b84e-3b4b-46eb-851b-979bac1ae9972025-12-31WarningsExact identifier
application number: M
PVP IodinePOVIDONE-IODINEHART Health06b085dd-934d-40e9-aa0d-2dd9cdccd5352025-12-31WarningsExact identifier
application number: M
WOUND WIPESBENZALKONIUM CHLORIDEHART Health4942195e-2941-4111-8ab7-2891c316bd272025-12-31WarningsExact identifier
application number: M
MG DermaGel 62ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.e6b2cc57-11a6-4808-a30f-8118a8de9fc62025-12-29WarningsExact identifier
application number: M
MG FoamSanBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.c5311836-674a-400b-a0d3-92f959d926822025-12-29WarningsExact identifier
application number: M
CETAFEN EXTRAACETAMINOPHENHART Health38db0b09-37f8-4fed-903e-81e89486b39b2025-12-24WarningsExact identifier
application number: M
CETAFENACETAMINOPHENHART Healthc1162bab-377d-4e17-9417-ccd20d29148b2025-12-24WarningsExact identifier
application number: M
CETAFEN COUGH and COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,HART Health44da0d8c-4a12-4122-99da-781e2809e1a82025-12-24WarningsExact identifier
application number: M
Adult Low Dose AspirinASPIRINPharbest Pharmaceuticals, Inc.4522f745-b88d-4021-a5dc-0161f1967dc92025-12-24WarningsExact identifier
application number: M
MG DermaFoamBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.4a43a605-f333-4c76-a476-476a9cc2e13a2025-12-23WarningsExact identifier
application number: M
MG DermaGel 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.56ac723b-3ede-4c94-bf4a-0572a7b42b592025-12-23WarningsExact identifier
application number: M
MG DermaSan 72ISOPROPYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.cccdefbc-09ef-417f-9b7a-1b254ae6e4382025-12-23WarningsExact identifier
application number: M
MG FoamSan 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.11fc23dd-80e1-4df1-8c19-f759ecb34f1a2025-12-23WarningsExact identifier
application number: M
Hand Sanitizer Solution 101BENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.81fa10d3-6dbb-4a72-bfff-2dd795f949682025-12-23WarningsExact identifier
application number: M
MG DermaWashBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.0bb37363-418f-46c7-8c39-9ef9aa5023f72025-12-23WarningsExact identifier
application number: M
MG DermaGel 62 LVETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.437a508d-31ba-49b4-b821-4bf57b596e332025-12-23WarningsExact identifier
application number: M
Antibacterial Liquid HandBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.ea0a5970-e95f-4090-bbe3-7df9e04393b52025-12-23WarningsExact identifier
application number: M
MG DermaCleanN/AMorgan Gallacher Inc.ed3d983e-0a6e-4de4-832a-0020f77110112025-12-23WarningsExact identifier
application number: M
MG DermaSanN/AMorgan Gallacher Inc.d4c0de39-8570-4a05-a5e3-3752545ed95f2025-12-23WarningsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433194menthol 8.6 MG Oral LozengePSNfee9f594-c619-4d77-bb52-632078e0254e5
2699389THORACOL 8.6 MG Oral LozengePSNfee9f594-c619-4d77-bb52-632078e0254e5
2699389menthol 8.6 MG Oral Lozenge [Thoracol]SBDfee9f594-c619-4d77-bb52-632078e0254e5
433194menthol 8.6 MG Oral LozengeSCDfee9f594-c619-4d77-bb52-632078e0254e5
2699389Thoracol 8.6 MG Oral LozengeSYfee9f594-c619-4d77-bb52-632078e0254e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50332-0156-45033201560450 PACKET in 1 BOX (50332-0156-4) / 1 LOZENGE in 1 PACKET50 packet2024-12-09NoNoCurrent
50332-0156-750332015607125 PACKET in 1 BOX (50332-0156-7) / 1 LOZENGE in 1 PACKET125 packet2024-12-09NoNoCurrent