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
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	5 mg/4.2g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
4538248f-11cc-d6b2-e063-6294a90a652c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78732-010-01	Throat CoatSweet Orange Fennel	16 in 1 POUCH	LOZENGE	16	1
78732-010-01	Throat CoatSweet Orange Fennel	4.2 g in 1 PACKAGE	LOZENGE	4.2	1
78732-010-30	Throat CoatSweet Orange Fennel	30 in 1 POUCH	LOZENGE	30	1
78732-010-30	Throat CoatSweet Orange Fennel	4.2 g in 1 PACKAGE	LOZENGE	4.2	1

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 162 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Cold and Cough Nighttime	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Safeway, Inc.	cbbec807-f882-4c6a-b1cd-c7fd5ce70cad	2024-05-15	Warnings	Exact identifier application number: M012
Cold and Flu Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	d6ac0d70-0511-4ec8-bb35-8b2e0e3d7742	2024-05-15	Warnings	Exact identifier application number: M012
Night Time Cough	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	f658a03b-6fc2-4b63-b3ab-7e886fbf20b4	2024-05-15	Warnings	Exact identifier application number: M012
AXIV DM Max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	VIVUNT PHARMA LLC	18704e66-ee8f-315d-e063-6294a90a5282	2024-05-14	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Target Corporation Inc.	187622dc-ecde-181d-e063-6294a90a4e8f	2024-05-14	Warnings	Exact identifier application number: M012
Lemon Mint Drops	MENTHOL	Target Corporation Inc.	1876df19-398a-23d8-e063-6394a90ae7e8	2024-05-14	Warnings	Exact identifier application number: M012
Cold Flu and Sore Throat Relief Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Safeway, Inc.	6c952c81-c8b6-4e74-abd8-781f6f44736b	2024-05-14	Warnings	Exact identifier application number: M012
Pain and Sinus Reliever	ACETAMINOPHEN AND PHENYLEPHRINE	JHK DBA American Safety & First Aid	249373c6-f56f-4bd3-9cef-98b7ee73457d	2024-05-14	Warnings	Exact identifier application number: M012
Nasal	PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	fea71cb9-e044-4729-ad26-1db0cdb9dd11	2024-05-14	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	a70ead03-6d2c-44c1-9ae5-f6c4094821ec	2024-05-14	Warnings	Exact identifier application number: M012
Day Time Cold and Flu Relief non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Safeway, Inc.	cc450f89-a156-48e0-82ae-19782f13c2ca	2024-05-13	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Safeway, Inc.	a8df5c04-0f92-4013-b3e5-2b45009a7b8d	2024-05-13	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE	Safeway, Inc.	f762600a-f4b1-4869-a04b-8431c3d8a3e3	2024-05-13	Warnings	Exact identifier application number: M012
Cold and Flu DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Safeway, Inc.	ef0cd436-5e81-47a7-92d6-58495283ab28	2024-05-13	Warnings	Exact identifier application number: M012
Tussin Cough Sugar Free	DEXTROMETHORPHAN HBR GUAIFENESIN	P & L Development, LLC	7ed2fe86-3346-4308-a9b6-6a264f879b02	2024-05-09	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	KROGER COMPANY	10106c90-f2f0-508e-e063-6294a90a544b	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	Kroger	1013ce02-7b12-335e-e063-6394a90af3e6	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	Kroger	10b08ea8-693e-eb18-e063-6394a90af548	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	10b0bcff-d3bc-f70c-e063-6394a90a35ed	2024-05-08	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger	10b0e0a0-b878-0a9a-e063-6394a90a20e0	2024-05-08	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311508	menthol 5 MG Oral Lozenge	PSN	4538248f-11cc-d6b2-e063-6294a90a652c	1
311508	menthol 5 MG Oral Lozenge	SCD	4538248f-11cc-d6b2-e063-6294a90a652c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
78732-010-01	78732001001	16 PACKAGE in 1 POUCH (78732-010-01) / 4.2 g in 1 PACKAGE	16 package	2020-06-04	No	No	Current
78732-010-30	78732001030	30 PACKAGE in 1 POUCH (78732-010-30) / 4.2 g in 1 PACKAGE	30 package	2025-10-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Organic Throat Coat - Sweet Orange Fennel 5 mg	Traditional Medicinals, Inc.	2025-11-21	HUMAN OTC DRUG LABEL	1