SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS

Product NDC: 54305-802
11-digit product format: 543050802
Labeler code: 54305
Product ID: 54305-802_2f7f3ce7-2f0b-4982-9aa0-f858d0e64179
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: LOZENGE
Route: ORAL
Labeler: Ricola Ag
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1942-04-12
Substance: MENTHOL
Active strength: 4.8 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	54305-802	54305-802-24	D	Discontinued by firm		2026-10-16
excluded package	package	54305-802	54305-802-45	D	Discontinued by firm		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	54305-802-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	54305-802-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	54305-802-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	54305-802-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	54305-802-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	54305-802-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	54305-802-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	54305-802-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	54305-802-24	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	54305-802-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	54305-802-24	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	54305-802-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	54305-802-24	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	54305-802-45	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	54305-802-24	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	54305-802-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	54305-802-24	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	54305-802-45	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	54305-802-24	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	54305-802-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	54305-802-24	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	54305-802-45	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	54305-802-24	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	54305-802-45	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	4.8 mg/1

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
637119	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
b790a91c-33be-4bc3-bdeb-eae6f366f085	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
54305-802-19	2020-02-10	ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS SUGAR FREE
54305-802-24	2020-02-10	ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS SUGAR FREE
54305-802-19	2020-01-31	ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS SUGAR FREE
54305-802-24	2020-01-31	ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS SUGAR FREE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54305-802-19	SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS	19 in 1 BAG	LOZENGE	19	8
54305-802-24	SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS	24 in 1 BAG	LOZENGE	24	8
54305-802-45	SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS	45 in 1 BAG	LOZENGE	45	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]	2
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]	2
ISOMALT	INACTIVE INGREDIENT	S870P55O2W	SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54305-802	SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]	8	Current NDC, Legacy NDC, 3 package rows	20241207_b790a91c-33be-4bc3-bdeb-eae6f366f085.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 102 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MGC Health Cough Drops Honey Herb	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3fa17272-fd7f-9ab4-e063-6394a90a585f	2025-09-25	Warnings	Exact identifier application number: M012
MGC Health Throat Soothing Drops Creamy Strawberry	PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3fa2e438-2ff3-a2df-e063-6394a90ac7b5	2025-09-25	Warnings	Exact identifier application number: M012
QUALITY CHOICE ADULT TUSSIN EXPECTORANT	GUAIFENESIN	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	63dad603-fe2f-42a6-a626-5c8048a42c10	2025-09-25	Warnings	Exact identifier application number: M012
Giltuss Childrens Allergy Plus	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3fa5220f-38bb-9ef6-e063-6294a90aeff8	2025-09-25	Warnings	Exact identifier application number: M012
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Health Pharma USA LLC	a03befb4-d86d-43e4-8097-eda5c8bb25be	2025-09-24	Warnings	Exact identifier application number: M012
Childrens Giltuss EX Expectorant	GUAIFENESIN	Dextrum Laboratories Inc.	3f8d7d47-f14c-888c-e063-6394a90a5cdd	2025-09-24	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Dextrum Laboratories, Inc	3f909bc2-eb84-a19d-e063-6294a90ae04e	2025-09-24	Warnings	Exact identifier application number: M012
Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Dextrum Laboratories, Inc	3f79137f-f0b0-d22c-e063-6394a90a7245	2025-09-23	Warnings	Exact identifier application number: M012
GoodSense Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	GOOD SENSE	240bb6af-9d38-49fe-9011-3016246b0986	2025-09-23	Warnings	Exact identifier application number: M012
Xpect Honey Lemon Cough Drops	HONEY LEMON COUGH DROPS	Cintas Corporation	79e0b7c1-4acc-41d2-89cd-d075a8bac0c9	2025-09-23	Warnings	Exact identifier application number: M012
Topcare NiteTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	b2b3c450-e988-41d1-9e53-cc8e30d75cb4	2025-09-23	Warnings	Exact identifier application number: M012
Xpect Cherry Cough Drops	CHERRY COUGH DROPS	Cintas Corporation	d1fd2f23-5435-405d-a7fd-644691f79e80	2025-09-23	Warnings	Exact identifier application number: M012
Topcare DayTime NiteTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	560fb22b-391f-4d7b-a6fd-38d577d404b0	2025-09-23	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GUAIFENESIN	Dextrum Laboratories Inc.	3f67ac3d-1503-3418-e063-6394a90a938f	2025-09-22	Warnings	Exact identifier application number: M012
Giltuss HBP Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dextrum Laboratories Inc.	3f68e68a-cf32-9df8-e063-6394a90a3012	2025-09-22	Warnings	Exact identifier application number: M012
SUPRESS A	DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kramer Novis	f0bec5f5-4d76-471e-9024-557eba848b93	2025-09-22	Warnings	Exact identifier application number: M012
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	9f050fb0-6100-4b14-b82f-1d5fcbf16540	2025-09-22	Warnings	Exact identifier application number: M012
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	c6392ace-c7d1-4450-8b71-4dccc60b4f02	2025-09-22	Warnings	Exact identifier application number: M012
Giltuss Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3f12ee8f-d1c6-d73a-e063-6394a90a9199	2025-09-18	Warnings	Exact identifier application number: M012
CVS Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy	3d71d306-893a-e73a-e063-6394a90a0a3b	2025-09-18	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
637119	menthol 4.8 MG Oral Lozenge	PSN	b790a91c-33be-4bc3-bdeb-eae6f366f085	8
637119	menthol 4.8 MG Oral Lozenge	SCD	b790a91c-33be-4bc3-bdeb-eae6f366f085	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54305-802-19	54305080219	19 LOZENGE in 1 BAG (54305-802-19)	19 lozenge	1942-04-12	0000-00-00	No	No	Current
54305-802-24	54305080224	24 in 1 BAG						Historical
54305-802-45	54305080245	45 in 1 BAG						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS SUGAR FREE	Ricola Ag	2024-12-05	HUMAN OTC DRUG LABEL	8