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 158 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Herbal Flavor Menthol Cough Drops	HERBAL FLAVOR MENTHOL COUGH DROPS	WHOLE FOODS MARKET, INC.	1eb848b6-3dec-5b5f-e063-6394a90aea14	2024-08-02	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL COUGH DROPS	WHOLE FOODS MARKET, INC.	1eb8927b-22c5-2ca3-e063-6294a90aa563	2024-08-02	Warnings	Exact identifier application number: M012
No Drip Severe Anefrin Nasal	0.05% OXYMETAZOLINE HCL	Walgreens Company	c126e969-56f3-47b4-a011-02ff150eccb8	2024-08-02	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	90e0426b-654f-4bcd-8b1d-cf56d1fc0c68	2024-07-27	Warnings	Exact identifier application number: M012
nasal decongestant	OXYMETAZOLINE HCL	A-S Medication Solutions	0e81a937-59e5-4869-8ffb-c758fb37230d	2024-07-23	Warnings	Exact identifier application number: M012
WesTussin DM	DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Westminster Pharmaceuticals, LLC	68a0cd44-3fdd-430e-af1a-498d4415ab78	2024-07-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Lil' Drug Store Products, Inc.	edc244d6-eb0b-d3c9-e053-2a95a90a2622	2024-07-22	Warnings	Exact identifier application number: M012
Night Time Sleep Aid	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	1f3eeb6c-4c44-4e2a-ad72-12c95e6589c9	2024-07-22	Warnings	Exact identifier application number: M012
CareOne Childrens Allergy Relief	DIPHENHYDRAMINE HCL	American Sales Company	bb78ef2c-4f42-4e8f-b38d-f9b2965a384b	2024-07-19	Warnings	Exact identifier application number: M012
dg health allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp, LLC	71445443-34bd-4d8c-b9c8-e7c3b8d4c832	2024-07-19	Warnings	Exact identifier application number: M012
basic care childrens allergy relief	DIPHENHYDRAMINE HCL	Amazon.com Services LLC	75b9ee90-ad26-433e-8b90-97441b8d1e15	2024-07-19	Warnings	Exact identifier application number: M012
Cold and Flu Severe Day and Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC	9b74dd00-8f84-4fce-b5ea-df886b595326	2024-07-18	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	4872dfdd-0df6-47ae-87f2-8049191cd482	2024-07-18	Warnings	Exact identifier application number: M012
equate allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Wal-Mart Stores Inc	b05acd16-21cb-4ee0-afa0-8f7d59166435	2024-07-18	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Publix Super Markets Inc	cc6e4e26-84f5-4003-b1eb-f0e06d3e294e	2024-07-18	Warnings	Exact identifier application number: M012
childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Kroger Company	10ebc7f8-dc8a-4640-8f87-d0d073998fd5	2024-07-18	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Amerisource Bergen	b173cc2c-7c4c-4f9e-a920-c71bc256ec1e	2024-07-18	Warnings	Exact identifier application number: M012
ALLERGY	CHLORPHENIRAMINE MALEATE	A-S Medication Solutions	b199b5ee-fff3-4746-be68-a04060586f8e	2024-07-18	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL	H E B	2d1715b3-b1cf-455d-9909-f6d58c97db40	2024-07-18	Warnings	Exact identifier application number: M012
careone allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	American Sales Company	ed4038fc-ab39-4567-9961-2b390b91b126	2024-07-17	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