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 157 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	445e49a2-6ed0-434c-aaea-3ce14bc7df59	2024-08-12	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	d49b42ad-0ae0-48c9-adba-5fc2ced97764	2024-08-12	Warnings	Exact identifier application number: M012
RYMED	DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE	EDWARDS PHARMACEUTICALS, INC.	c1d6e914-74cc-4cdf-9587-7eaaa4a386e5	2024-08-12	Warnings	Exact identifier application number: M012
WesTussin DM NF	WESTUSSIN DM NF	Westminster Pharmaceuticals, LLC	4e0f9f97-a31c-41ac-9d6c-d81efd20fcef	2024-08-08	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	2f2a2864-af11-4240-bdad-a54aca58d01b	2024-08-07	Warnings	Exact identifier application number: M012
Cold plus Flu Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	0199aea2-a9c1-4c9d-8786-28b9dadc832e	2024-08-07	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	32d1ce6e-2617-4b50-a9e6-2e1941465dff	2024-08-07	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	07362db5-a372-4463-af8b-06e8783ca865	2024-08-07	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	1fb11d90-48bf-4baa-9b3a-5d64d81e3a06	2024-08-07	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	574774b2-9813-4799-9cd4-27e296dd8584	2024-08-07	Warnings	Exact identifier application number: M012
Cold Max Day and NIght	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	a92bcefb-ba29-4b3f-a60b-b4476ca8cf04	2024-08-07	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	778f1f5a-fd04-456f-90d0-998b93e774a5	2024-08-07	Warnings	Exact identifier application number: M012
Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	990f3232-bc75-45cf-8a50-cd7861d83f98	2024-08-07	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	0f5f25c6-7389-4285-b8d5-463cb7b6fcc4	2024-08-07	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	Care One (Retail Business Services, LLC.)	a9a5b39d-b4c8-414e-8fe7-4c0601f75197	2024-08-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	American Health Packaging	b94feeb6-f33f-410d-a9b0-776b1ccf34a9	2024-08-04	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	American Health Packaging	4cd8aee3-5522-434b-a1b1-9591bed3e9a6	2024-08-04	Warnings	Exact identifier application number: M012
Guaifenesin DM	GUAIFENESIN AND DEXTROMETHORPHAN	American Health Packaging	8632a655-7f5b-450f-95fa-62478a174e9c	2024-08-04	Warnings	Exact identifier application number: M012
Guaifenesin DM	GUAIFENESIN AND DEXTROMETHORPHAN	American Health Packaging	990906b3-c566-4f35-923c-060202ba48e0	2024-08-04	Warnings	Exact identifier application number: M012
Honey Lemon Flavor Cough Drops	HONEY LEMON FLAVOR MENTHOL	WHOLE FOODS MARKET, INC.	1eb7abdc-061f-0e18-e063-6294a90a3a65	2024-08-02	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