FDA.reportPublic FDA data

Throat Coat

Product NDC
78732-010
11-digit product format
787320010
Labeler code
78732
Product ID
78732-010_45380791-66da-1518-e063-6394a90ac82c
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Traditional Medicinals, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-04
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
5 mg/4.2g
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
Throat Coat
Brand name suffix
Sweet Orange Fennel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM5 mg/4.2g

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311508Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4538248f-11cc-d6b2-e063-6294a90a652cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78732-010-01Throat CoatSweet Orange Fennel16 in 1 POUCHLOZENGE161
78732-010-01Throat CoatSweet Orange Fennel4.2 g in 1 PACKAGELOZENGE4.21
78732-010-30Throat CoatSweet Orange Fennel30 in 1 POUCHLOZENGE301
78732-010-30Throat CoatSweet Orange Fennel4.2 g in 1 PACKAGELOZENGE4.21

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 152 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Black Cherry Cough DropsMENTHOLBoston Nutraceutical Production SL856f2e1a-2593-99e6-e053-2991aa0ad0392024-10-07WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLBoston Nutraceutical Production SL857363b6-e025-e074-e053-2a91aa0a43792024-10-07WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLBoston Nutraceutical Production SL857365ba-895e-4a63-e053-2991aa0a8b9f2024-10-07WarningsExact identifier
application number: M012
Menthol Vapor Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.La7062db1-8201-b400-e053-2a95a90a55e82024-10-07WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBoston Nutraceutical Production SLb8f48a47-6871-f7ed-e053-2995a90a16f32024-10-07WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBoston Nutraceutical Production SL856f0bd8-354b-a002-e053-2a91aa0a80222024-10-07WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBoston Nutraceutical Production SL83c4928a-eea6-e176-e053-2991aa0a6bb12024-10-07WarningsExact identifier
application number: M012
Natural Herbal Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.Lc2340f56-9a8e-4eea-e053-2995a90a78fc2024-10-07WarningsExact identifier
application number: M012
Natural Herbal Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.La706ee9c-9ed0-d3f1-e053-2a95a90a26d62024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff0b37b-6c08-b687-e053-2a95a90a11a92024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLTopco Associates LLCefcf2edd-21a3-45f9-e053-2995a90a38652024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff65505-8846-35c2-e053-2a95a90a6b792024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLTopco Associates LLCeff0fdfe-695a-4e62-e053-2a95a90ab50f2024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff1a70f-fa71-52b2-e053-2995a90a038c2024-10-07WarningsExact identifier
application number: M012
Honey Lemon Menthol Cough DropsHONEY LEMON MENTHOLTopco Associates LLCf5be283b-524d-26af-e053-2995a90a39722024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff16ba3-7e30-aa93-e053-2995a90a64cb2024-10-07WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLTarget Corporation Inc.ebf6bcf5-9384-052a-e053-2a95a90a30a52024-10-07WarningsExact identifier
application number: M012
Rompe Pecho SF Flu SF FluBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBREfficient Laboratories Inc06eac696-e8f6-ac50-e063-6394a90a2ed62024-10-07WarningsExact identifier
application number: M012
dg health nasal fourPHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLCceeeb016-8e46-40b8-9923-8a4270475f452024-10-04WarningsExact identifier
application number: M012
Topcare Nasal FourPHENYLEPHRINE HYDROCHLORIDETopco Associates LLC99bc8829-167b-4cf8-8421-57da369f24cd2024-10-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311508menthol 5 MG Oral LozengePSN4538248f-11cc-d6b2-e063-6294a90a652c1
311508menthol 5 MG Oral LozengeSCD4538248f-11cc-d6b2-e063-6294a90a652c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78732-010-017873200100116 PACKAGE in 1 POUCH (78732-010-01) / 4.2 g in 1 PACKAGE16 package2020-06-04NoNoCurrent
78732-010-307873200103030 PACKAGE in 1 POUCH (78732-010-30) / 4.2 g in 1 PACKAGE30 package2025-10-15NoNoCurrent