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 firm2026-10-15

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 5 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corp5afb242f-fac9-dc81-e063-6394a90a84482026-08-27WarningsExact identifier
application number: M012
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEAmazon.com Services LLC6de619d3-0ab0-43e7-8dac-7bbd5368ac652026-08-27WarningsExact identifier
application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCIWalgreens366ddac8-9e8a-41bd-a7f7-48213485a5f82026-08-27WarningsExact identifier
application number: M012
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens37896933-3ed3-457f-8a32-ee0d784a19e82026-08-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC298e9164-e378-4b39-a944-bfc8f8baa4de2026-08-27WarningsExact identifier
application number: M012
DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum StrengthDAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, NIGHTTIME ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens3b4b3b04-eff9-4e06-8b37-f6729671d07f2026-08-27WarningsExact identifier
application number: M012
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpdfb0fe2e-b0c7-409a-bd1a-fd12485665ba2026-08-26WarningsExact identifier
application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp70c5517d-be4e-4317-b4f4-df660c71c6992026-08-26WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d2026-08-26WarningsExact identifier
application number: M012
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSEACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5b95905e-b729-4caf-921a-fc4ef815289c2026-08-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Incc88e93d4-66b6-4327-b9e5-0e0a95a18d662026-08-25WarningsExact identifier
application number: M012
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
application number: M012
Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATEKenvue Brands LLC594f515c-b369-816d-e063-6294a90a59a12026-08-21WarningsExact identifier
application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
application number: M012
COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEHyVee Inc82ead335-d38e-40c3-8031-222bf985a3022026-08-20WarningsExact identifier
application number: M012
HyVee Nighttime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc49818610-bf4a-fb86-e063-6294a90ae5982026-08-20WarningsExact 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