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 firm2026-10-23

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 102 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AXIV DayTime - NightTime 48 SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC1320e243-344f-98ed-e063-6294a90a00922025-09-17WarningsExact identifier
application number: M012
AXIV Sinus Severe MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDEVIVUNT PHARMA LLC13245298-8b78-e177-e063-6294a90a6bec2025-09-17WarningsExact identifier
application number: M012
GoodSense Tussin CF Multi-Symptom Cold, RaspberryDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.3f05cf84-d485-7688-e063-6394a90ae7402025-09-17WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)5d7466b4-fdb7-432b-880d-e7aa4a4acbda2025-09-17WarningsExact identifier
application number: M012
allergy relief ChildrensDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFIe34d8bf5-e12e-453c-93ea-9c7988c4f13d2025-09-16WarningsExact identifier
application number: M012
DayTime Cold Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHarris Teeter, LLC67beb9f6-4e0a-4f7b-b50a-4bcd3a01354f2025-09-16WarningsExact identifier
application number: M012
DOMETUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEDomel Laboratories3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe2025-09-16WarningsExact identifier
application number: M012
CareOne Severe Congestion NasalOXYMETAZOLINE HYDROCHLORIDEAmerican Sales Companyd1dba68b-c4e1-4afc-9aee-6a51341b89f52025-09-16WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFSA Store Inc. (Caring Mills)e69ef8dc-09d2-46de-aebf-ba735f4cc7ea2025-09-16WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Lemon FlavorMENTHOL HONEY LEMON FLAVORCVS Pharmacy3ea9a1f2-75b3-c67a-e063-6294a90a8caf2025-09-13WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Lemon FlavorMENTHOL HONEY LEMON FLAVORCVS Pharmacy3eab4cf9-6fdc-a6fb-e063-6394a90a86332025-09-13WarningsExact identifier
application number: M012
COLD AND FLU DAYTIME-NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORP9de9fab3-890a-158d-e053-2a95a90af4232025-09-13WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPrecision Dose, Inc.4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea42025-09-12WarningsExact identifier
application number: M012
Nasal Spray, Circle KOXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTIONLil' Drug Store Products, Inc.3ea06e88-a2c6-621b-e063-6294a90a10752025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHarris Teeter, LLCa0090dc6-0fe5-4ab2-a2cf-6ed19892f3632025-09-12WarningsExact identifier
application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCICVS Pharmacyebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e2025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFSA Store Inc. (Caring Mills)8d7bb31b-a47d-4252-a0a7-79d286179fb92025-09-12WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)150e5c3a-7c86-4b66-af30-a376df6974012025-09-12WarningsExact identifier
application number: M012
SEVERE COUGH COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED67f8d405-a2ad-4ade-93b4-9b09a0d81d8e2025-09-11WarningsExact identifier
application number: M012
equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.3862aaa5-2281-e8f9-e063-6294a90a0f7e2025-09-09WarningsExact 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