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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54305-80254305-802-24DDiscontinued by firm2026-10-12
excluded packagepackage54305-80254305-802-45DDiscontinued by firm2026-10-12

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 datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0554305-802-24d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0554305-802-45d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2654305-802-24f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2654305-802-45f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3154305-802-242ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3154305-802-452ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2854305-802-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2854305-802-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2154305-802-24cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2154305-802-45cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1054305-802-24cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1054305-802-45cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3154305-802-24302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3154305-802-45302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2054305-802-24ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2054305-802-45ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1054305-802-240efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1054305-802-450efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0854305-802-24ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0854305-802-45ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0354305-802-24367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0354305-802-45367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0954305-802-24557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0954305-802-45557ba5c1ecfa…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
IngredientStrength
MENTHOL4.8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637119Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b790a91c-33be-4bc3-bdeb-eae6f366f085Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54305-802-19SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS19 in 1 BAGLOZENGE198
54305-802-24SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS24 in 1 BAGLOZENGE248
54305-802-45SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS45 in 1 BAGLOZENGE458

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54305-802SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]8Current NDC, Legacy NDC, 3 package rows20241207_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 19 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Kids Pain and FeverACETAMINOPHENCalmCo LLC2ee6df99-727a-34c6-e063-6294a90a6bbc2026-07-06WarningsExact identifier
application number: M012
Dr Kids Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC28ec213e-fabb-28ec-e063-6394a90ad1022026-07-06WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRSelect Consumer Group55fc7d6f-cc44-b4c0-e063-6294a90ae4fc2026-07-06WarningsExact identifier
application number: M012
Allergy Plus Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLDOLGENCORP, LLCf2eacb1b-8b29-41ec-828a-c1f902ac09342026-07-06WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDESelect Consumer Group55d10292-e673-9896-e063-6294a90a56742026-07-04WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group55bddbea-5ad9-6a18-e063-6394a90a461d2026-07-03WarningsExact identifier
application number: M012
CONTAC COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEVESPYR BRANDS LLCf72d510b-e370-4137-8d4f-d9afd5d19a192026-07-03WarningsExact identifier
application number: M012
Nite time Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incf8f84be1-e3b1-4e93-8e1c-ee93e1f4af132026-07-02WarningsExact identifier
application number: M012
COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMeijer, Inc.9d355bf8-6398-4f3a-902a-c41cf5840c152026-07-02WarningsExact identifier
application number: M012
TUSSIN CF SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmazon.com Services LLC01d6c897-619d-4a6d-8950-4d6d32346b9b2026-07-01WarningsExact identifier
application number: M012
NITE TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.161c34b4-3cd2-40b4-b13e-ad980ad4249c2026-07-01WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)437cd589-f5da-4390-b178-609d4537eaab2026-07-01WarningsExact identifier
application number: M012
Cold and Flu Nighttime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLL.N.K. International, Inc.9167a80e-fcf0-4b64-97e6-8a8ac566f1342026-06-29WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS CHERRYDISCOUNT DRUG MART55653790-9400-e63b-e063-6394a90ae5f72026-06-29WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS MENTHOLDISCOUNT DRUG MART55656a74-9721-62cf-e063-6394a90a7eb72026-06-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CHERRYMedical Group Care LLC5565f02b-ce38-339f-e063-6294a90a671c2026-06-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.b3be2068-39e8-45f8-950e-afaee2c2520f2026-06-29WarningsExact identifier
application number: M012
NIGHTTIME COUGH DMDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED646f65f4-b9e4-4291-aadc-d2070848d35c2026-06-29WarningsExact identifier
application number: M012
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLC259b6f12-50c0-4e7a-9a44-bdf7e9a20a562026-06-29WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLC31755678-825c-b84a-e063-6294a90a5a832026-06-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637119menthol 4.8 MG Oral LozengePSNb790a91c-33be-4bc3-bdeb-eae6f366f0858
637119menthol 4.8 MG Oral LozengeSCDb790a91c-33be-4bc3-bdeb-eae6f366f0858

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54305-802-195430508021919 LOZENGE in 1 BAG (54305-802-19) 19 lozenge1942-04-120000-00-00NoNoCurrent
54305-802-245430508022424 in 1 BAGHistorical
54305-802-455430508024545 in 1 BAGHistorical