THE ORIGINAL NATURAL HERB COUGH DROPS

Product NDC
54305-175
11-digit product format
543050175
Labeler code
54305
Product ID
54305-175_2a21c3ec-7b7a-4268-9531-db2bf7c75d66
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LOZENGE
Route
ORAL
Labeler
Ricola Ag
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1942-01-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54305-17554305-175-26DDiscontinued by firm2026-10-20

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
THE ORIGINAL NATURAL HERB COUGH DROPS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4.8 mg/1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
54305-175-212020-02-10THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-212020-02-10THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-262020-02-10THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-262020-02-10THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-272020-02-10THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-272020-02-10THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-502020-02-10THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-502020-02-10THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-932020-02-10THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-932020-02-10THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-212020-01-31THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-212020-01-31THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-262020-01-31THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-262020-01-31THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-272020-01-31THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-272020-01-31THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-502020-01-31THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-502020-01-31THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-932020-01-31THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS
54305-175-932020-01-31THE ORIGINAL NATURAL HERB COUGH DROPS COUGH SUPPRESSANT THROAT DROPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54305-175-10THE ORIGINAL NATURAL HERB COUGH DROPS10 in 1 BAGLOZENGE1013
54305-175-15THE ORIGINAL NATURAL HERB COUGH DROPS115 in 1 BAGLOZENGE11513
54305-175-21THE ORIGINAL NATURAL HERB COUGH DROPS21 in 1 BAGLOZENGE2113
54305-175-26THE ORIGINAL NATURAL HERB COUGH DROPS26 in 1 BAGLOZENGE2613
54305-175-27THE ORIGINAL NATURAL HERB COUGH DROPS27 in 1 BAGLOZENGE2713
54305-175-45THE ORIGINAL NATURAL HERB COUGH DROPS45 in 1 BAGLOZENGE4513
54305-175-50THE ORIGINAL NATURAL HERB COUGH DROPS50 in 1 BAGLOZENGE5013
54305-175-65THE ORIGINAL NATURAL HERB COUGH DROPS65 in 1 BAGLOZENGE6513
54305-175-90THE ORIGINAL NATURAL HERB COUGH DROPS90 in 1 BAGLOZENGE9013
54305-175-93THE ORIGINAL NATURAL HERB COUGH DROPS130 in 1 BAGLOZENGE13013
54305-175-95THE ORIGINAL NATURAL HERB COUGH DROPS105 in 1 BAGLOZENGE10513

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54305-175THE ORIGINAL NATURAL HERB COUGH DROPS (MENTHOL) LOZENGE [RICOLA AG]13Current NDC, Legacy NDC, 11 package rows20250424_db2f8e7b-77dd-4a5d-a8cc-019a76507fc7.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 31 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCINEX Rapid Clear Day Night and Clear and Cool NasalACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC37dcb0ed-df56-1bec-e063-6394a90a695e2026-05-13WarningsExact identifier
application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and CoolOXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC373e0d75-8def-4b98-e063-6394a90a5e472026-05-13WarningsExact identifier
application number: M012
MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASALOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC5a397466-8721-4060-a178-5ebfd7069cc92026-05-13WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC350764de-7801-b24e-e063-6394a90ab3c32026-05-13WarningsExact identifier
application number: M012
Cepacol Extra Strength Sore Throat and CoughBENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCc0cc32db-90f0-4106-8538-89821083ece12026-05-13WarningsExact identifier
application number: M012
Mucinex Cold and FluACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLCe8bc4131-f7b0-926a-e053-2995a90a40ac2026-05-13WarningsExact identifier
application number: M012
Mucinex Cold, Flu, and Sore ThroatACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC37ded76a-ee8d-f22c-e063-6394a90a00c22026-05-13WarningsExact identifier
application number: M012
Mucinex Night Time Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCfdb5c937-c148-eb46-e053-6394a90a8bed2026-05-13WarningsExact identifier
application number: M012
Mucinex Cough Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINReckitt Benckiser LLCe9c32d81-cd9b-4ff2-e053-2995a90aa4992026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC316b5569-b66f-f30c-e063-6394a90ae1472026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCd9467ca2-df75-4fa1-92b3-d2101eb54a772026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC12420092-3ef6-464b-9106-2d56cd6ef2002026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC09fdf96f-345f-43f2-9f0f-8303ac70849e2026-05-13WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Night Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC2ce31244-9c6c-b7dd-e063-6394a90a31a82026-05-13WarningsExact identifier
application number: M012
equate daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc2ac53cc7-000f-41fd-b799-4e6d6886fe622026-05-13WarningsExact identifier
application number: M012
nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Inc2201d5c0-bd51-47a7-9775-916b185736232026-05-13WarningsExact identifier
application number: M012
topcare nite time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLCf868e4a0-e9fb-4e6a-9984-29a2182462412026-05-13WarningsExact identifier
application number: M012
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEMeijer Distribution Inc582fa36b-6d0c-4ff3-80ab-6e0da4b209e42026-05-13WarningsExact identifier
application number: M012
SudoGestPSEUDOEPHEDRINE HYDROCHLORIDEMajor Pharmaceuticals78faa497-6743-b85b-e053-2a91aa0ae8222026-05-12WarningsExact identifier
application number: M012
Allergy Relief mini SoftgelsDIPHENHYDRAMINE HCI 25 MGCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdf1c620b-ff59-4126-99a5-1d6750888f2b2026-05-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637119menthol 4.8 MG Oral LozengePSNdb2f8e7b-77dd-4a5d-a8cc-019a76507fc713
637119menthol 4.8 MG Oral LozengeSCDdb2f8e7b-77dd-4a5d-a8cc-019a76507fc713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54305-175-09543050175099 LOZENGE in 1 BAG (54305-175-09) 9 lozenge2026-01-01NoNoCurrent
54305-175-105430501751010 LOZENGE in 1 BAG (54305-175-10) 10 lozenge1942-01-010000-00-00NoNoCurrent
54305-175-1554305017515115 LOZENGE in 1 BAG (54305-175-15) 115 lozenge1942-01-01NoNoCurrent
54305-175-215430501752121 LOZENGE in 1 BAG (54305-175-21) 21 lozenge1942-01-010000-00-00NoNoCurrent
54305-175-265430501752626 in 1 BAGHistorical
54305-175-275430501752727 LOZENGE in 1 BAG (54305-175-27) 27 lozenge1942-01-010000-00-00NoNoCurrent
54305-175-455430501754545 LOZENGE in 1 BAG (54305-175-45) 45 lozenge1942-01-01NoNoCurrent
54305-175-505430501755050 LOZENGE in 1 BAG (54305-175-50) 50 lozenge1942-01-010000-00-00NoNoCurrent
54305-175-655430501756565 LOZENGE in 1 BAG (54305-175-65) 65 lozenge1942-01-01NoNoCurrent
54305-175-905430501759090 LOZENGE in 1 BAG (54305-175-90) 90 lozenge2024-06-01NoNoCurrent
54305-175-9354305017593130 LOZENGE in 1 BAG (54305-175-93) 130 lozenge1942-01-010000-00-00NoNoCurrent
54305-175-9554305017595105 LOZENGE in 1 BAG (54305-175-95) 105 lozenge1942-01-01NoNoCurrent