FDA.reportPublic FDA data

Throat Coat

Product NDC
78732-100
11-digit product format
787320100
Labeler code
78732
Product ID
78732-100_44f86312-ab4d-44ba-e063-6294a90a9f40
Type
HUMAN OTC DRUG
Nonproprietary name
Pectin
Dosage form
LOZENGE
Route
ORAL
Labeler
Traditional Medicinals, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-04
Substance
PECTIN
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
Lemon Ginger Echinacea
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PECTIN5 mg/4.2g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89NA02M4RXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7a92a52-9ace-66d1-e053-2a95a90a8d8eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78732-100-00Throat CoatLemon Ginger Echinacea2 in 1 POUCHLOZENGE24
78732-100-00Throat CoatLemon Ginger Echinacea4.2 g in 1 PACKAGELOZENGE4.24
78732-100-01Throat CoatLemon Ginger Echinacea4.2 g in 1 PACKAGELOZENGE4.24
78732-100-01Throat CoatLemon Ginger Echinacea16 in 1 POUCHLOZENGE164
78732-100-30Throat CoatLemon Ginger Echinacea30 in 1 POUCHLOZENGE304
78732-100-30Throat CoatLemon Ginger Echinacea4.2 g in 1 PACKAGELOZENGE4.24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78732-100THROAT COAT LEMON GINGER ECHINACEA (PECTIN) LOZENGE [TRADITIONAL MEDICINALS, INC.]2Current NDC, Legacy NDC, 6 package rows20231109_a7a92a52-9ace-66d1-e053-2a95a90a8d8e.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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78732-100-00787320100002 PACKAGE in 1 POUCH (78732-100-00) / 4.2 g in 1 PACKAGE2 package2023-10-27YesNoCurrent
78732-100-017873201000116 PACKAGE in 1 POUCH (78732-100-01) / 4.2 g in 1 PACKAGE16 package2020-06-040000-00-00NoNoCurrent
78732-100-307873201003030 PACKAGE in 1 POUCH (78732-100-30) / 4.2 g in 1 PACKAGE30 package2023-10-19NoNoCurrent