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: 2027-12-31
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		2026-10-21
excluded package	package	54305-802	54305-802-45	D	Discontinued by firm		2026-10-21

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 153 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
basic care nasal	PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	858648f6-f454-4008-9ea8-ad060c217833	2024-10-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Navajo Manufacturing Company Inc.	f6068011-ad56-59b4-e053-2995a90ac016	2024-10-03	Warnings	Exact identifier application number: M012
Benadryl Ultratabs	DIPHENHYDRAMINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	76433e3c-142c-4704-8b2b-d602f008c377	2024-10-02	Warnings	Exact identifier application number: M012
Afrin	OXYMETAZOLINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	65bf1556-f234-9439-e053-2a91aa0a3194	2024-10-02	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	Proficient Rx LP	4eab4344-d95e-4b19-a21e-9c8ad033863a	2024-10-01	Warnings	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Proficient Rx LP	a910320b-0585-40bd-928c-0406346281d0	2024-10-01	Warnings	Exact identifier application number: M012
CareOne Nasal and Sinus Decongestant	PSEUDOEPHEDRINE HCL	American Sales Company	81b31070-9b03-4ce4-8aac-a334544842ae	2024-10-01	Warnings	Exact identifier application number: M012
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	Proficient Rx LP	20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d	2024-10-01	Warnings	Exact identifier application number: M012
meijer Nighttime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	1bec5167-5fc5-2405-e063-6294a90a5358	2024-09-30	Warnings	Exact identifier application number: M012
good sense tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	A-S Medication Solutions	19b3db33-86d1-48f3-9525-c7c87a4b6899	2024-09-29	Warnings	Exact identifier application number: M012
nasal decongestant maximum strength non drowsy	PSEUDOEPHEDRINE HCL	Meijer Distribution Inc	8a68ca99-fd76-409a-9769-88830e8720a8	2024-09-28	Warnings	Exact identifier application number: M012
good neighbor pharmacy tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amerisource Bergen	58687394-b6d2-4d51-bde0-8f2cfa3fe909	2024-09-27	Warnings	Exact identifier application number: M012
good neighbor pharmacy nasal	OXYMETAZOLINE HYDROCHLORIDE	Amerisource Bergen	faee3aae-e819-4084-a127-3449be353b13	2024-09-27	Warnings	Exact identifier application number: M012
Tesalon Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCL	OPMX LLC	2309620a-ccbc-41e9-e063-6394a90a9520	2024-09-26	Warnings	Exact identifier application number: M012
adult cough and chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Meijer, Inc.	b11c4cee-bbb5-4585-9d38-6787553e13a0	2024-09-26	Warnings	Exact identifier application number: M012
COLD AND FLU NIGHTTIME SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORP	9de9c34e-a0ca-cdf9-e053-2a95a90a93d3	2024-09-25	Warnings	Exact identifier application number: M012
Basic Care Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	8f3317f6-4ae8-474b-93c3-25e256519cb8	2024-09-25	Warnings	Exact identifier application number: M012
berkley and jensen tussin dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	BJWC	b2de91c9-6af0-4881-8d2d-a69d90c8dfcd	2024-09-24	Warnings	Exact identifier application number: M012
Tussin DM Cough and Chest Non Drowsy	DEXTROMETHORPHAN HBR, GUAIFENESIN	WinCo Foods, LLC	13eb459c-3075-4038-8062-9ee7175b2ab9	2024-09-24	Warnings	Exact identifier application number: M012
equaline nasal decongestant non drowsy maximum strength	PSEUDOEPHEDRINE HCL	United Natural Foods, Inc. dba UNFI	8897580a-709a-4643-8264-ad003d90cbff	2024-09-22	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