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 88 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aprodine	PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL	Major Pharmaceuticals	6612e514-2690-4f5b-8a82-0e54d362758f	2025-11-19	Warnings	Exact identifier application number: M012
Cough Drops Gems Flawless Cherry Flavor 30ct	MENTHOL	Riclan S.A.	0f0260df-89ac-4b83-afea-3aff56ff1b43	2025-11-18	Warnings	Exact identifier application number: M012
Cough Drops Gems Flawless Honey Lemon Flavor 30ct	MENTHOL	Riclan S.A.	16f6d531-9298-4172-8d08-ecd87d6add76	2025-11-18	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Haleon US Holdings LLC	a6f750c8-8738-4965-a3ad-612c24611056	2025-11-18	Warnings	Exact identifier application number: M012
YINCHIAO	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.	09ba45f6-03e1-46b9-83ab-a618b2626716	2025-11-18	Warnings	Exact identifier application number: M012
GANMAOLING	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.	c757a03e-59ea-469c-970d-4bc62e73f36f	2025-11-18	Warnings	Exact identifier application number: M012
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	e1d545dc-9222-4d61-964d-1c781215d7d2	2025-11-18	Warnings	Exact identifier application number: M012
Goodnow cold flu day relief cold flu night relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Gobrands, Inc	7590d0c6-121e-4016-b6bb-534c5d0a7970	2025-11-17	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	R J General Corporation	d786ae07-ce57-44c7-9ba5-f4c87df115de	2025-11-17	Warnings	Exact identifier application number: M012
Benadryl Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	R J General Corporation	c46c01c0-29f4-400c-bef5-14b3eb944c51	2025-11-17	Warnings	Exact identifier application number: M012
TYLENOL COLD AND FLU	ACETAMINPHEN	R J General Corporation	b618877b-9dbc-4ba2-be2c-bf1922c646cc	2025-11-17	Warnings	Exact identifier application number: M012
TYLENOL SINUS SEVERE	ACETAMINOPHEN	R J General Corporation	2cbf7954-b28f-4d7b-b142-6c6c5c58b25d	2025-11-17	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	R J General Corporation	8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc	2025-11-17	Warnings	Exact identifier application number: M012
Quality Choice Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	QUALITY CHOICE (Chain Drug Marketing Association)	c0e3c959-bed6-2ce5-e053-2995a90a0be9	2025-11-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	c5ea5a7a-c806-e5e0-e053-2995a90a15e9	2025-11-17	Warnings	Exact identifier application number: M012
Multi-Symptom Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	50f3157b-5788-4b63-835a-e60c8dc33df9	2025-11-17	Warnings	Exact identifier application number: M012
Day and Night Sinus	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	a9d809f5-63a1-4f80-8b4d-33e8e052c7bd	2025-11-15	Warnings	Exact identifier application number: M012
Cold and Flu Day, Night	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	937b481a-e0b7-4d34-a8a1-0bfb2b867c2b	2025-11-15	Warnings	Exact identifier application number: M012
Sinus Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	f701a6ae-200d-48dc-94e4-6bd3228f50d4	2025-11-15	Warnings	Exact identifier application number: M012
MULTI-SYMPTOM COLD	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar Services Inc	b1fae7cc-4033-44bc-aa7c-ca3ceea51c7d	2025-11-15	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