Sugar Free Mountain Herb Cough Suppressant Throat Drops

Product NDC
63667-958
11-digit product format
636670958
Labeler code
63667
Product ID
63667-958_7ac17b95-43d2-4b6d-a1a7-ce7ad6942bb4
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LOZENGE
Route
ORAL
Labeler
Ricola USA Inc.
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63667-95863667-958-24DDiscontinued by firm2026-10-27
excluded packagepackage63667-95863667-958-45DDiscontinued by firm2026-10-27

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 2025-12-0563667-958-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0563667-958-24d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2663667-958-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2663667-958-24f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3163667-958-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3163667-958-242ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2863667-958-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2863667-958-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2163667-958-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2163667-958-24cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1063667-958-45cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1063667-958-24cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3163667-958-45302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3163667-958-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2063667-958-45ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2063667-958-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1063667-958-450efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1063667-958-240efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0863667-958-45ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0863667-958-24ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0363667-958-45367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0363667-958-24367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0963667-958-45557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0963667-958-24557ba5c1ecfa…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 Mountain Herb Cough Suppressant Throat Drops
Listing expiration
2027-12-31

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
c3f3c062-55e5-43c1-a016-ee47a7b388a5Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63667-958-19Sugar Free Mountain Herb Cough Suppressant Throat Drops19 in 1 BAGLOZENGE198
63667-958-24Sugar Free Mountain Herb Cough Suppressant Throat Drops24 in 1 BAGLOZENGE248
63667-958-45Sugar Free Mountain 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
63667-958SUGAR FREE MOUNTAIN HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]8Current NDC, Legacy NDC, 3 package rows20241211_c3f3c062-55e5-43c1-a016-ee47a7b388a5.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 137 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company4b49137c-8fc9-43b7-b1a1-82e318237eb62024-11-12WarningsExact identifier
application number: M012
CVS Original Nasal MistOXYMETAZOLINE HCLCVS PHARMACY, INCe9c551a0-cd78-4272-b42f-36c096d267362024-11-12WarningsExact identifier
application number: M012
up and up cough plus chest congestionDEXTROMETHORPHAN HBR, GUAIFENESINTarget Corporationed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c2024-11-12WarningsExact identifier
application number: M012
DG Health Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp Incb33d104b-0b4d-40c6-8345-c2c7403273312024-11-11WarningsExact identifier
application number: M012
Zephrex DPSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Company5468a7e2-361b-494f-9ca3-1b62f3819f652024-11-11WarningsExact identifier
application number: M012
careone tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINAmerican Sales Company6c90fccf-0e6f-43df-9468-d8ece8ded0092024-11-11WarningsExact identifier
application number: M012
good sense night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company89dc1423-d097-47a8-9025-eab5381cca262024-11-11WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC10f9627b-edda-422a-b01f-7066f9c983352024-11-11WarningsExact identifier
application number: M012
nighttime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED17c3fe42-3c40-4405-80b7-b3f9e4aa83762024-11-11WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEH E B1dd36aa7-f085-4350-8cf2-f9fa29b583e42024-11-11WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCa7f9f1d0-7498-461c-b4e8-4c92cf3feae82024-11-11WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWalgreen Companybd079f5d-0a38-40e6-9661-e8236c88a24d2024-11-11WarningsExact identifier
application number: M012
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANPAI Holdings, LLC dba PAI Pharmaff970fff-d1a3-4322-83b4-34e361431a1c2024-11-11WarningsExact identifier
application number: M012
topcare tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLCe1118592-30ac-4505-9f38-c6d395c4cf5b2024-11-11WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC624b8029-9fdb-4908-a13b-f9dd750301202024-11-11WarningsExact identifier
application number: M012
Biofreeze ColorlessMENTHOLA-S Medication Solutionscc1cba14-da40-4d7d-b522-b5c648798e962024-11-11WarningsExact identifier
application number: M012
foster and thrive nighttime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEStrategic Sourcing Services LLC298b7754-d0d8-496d-9949-4c346cb11e342024-11-11WarningsExact identifier
application number: M012
leader tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leaderb418c10c-528b-4395-944e-af959b639ec22024-11-10WarningsExact identifier
application number: M012
equaline adult tussinDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINUnited Natural Foods, Inc. dba UNFIf7c753f8-4b12-4797-a599-736d597bc1bc2024-11-10WarningsExact identifier
application number: M012
foster and thrive adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINStrategic Sourcing Services LLCf8933226-fbc9-44e3-a90f-4e6c1dbdb7b72024-11-10WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637119menthol 4.8 MG Oral LozengePSNc3f3c062-55e5-43c1-a016-ee47a7b388a58
637119menthol 4.8 MG Oral LozengeSCDc3f3c062-55e5-43c1-a016-ee47a7b388a58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63667-958-196366709581919 LOZENGE in 1 BAG (63667-958-19) 19 lozenge1942-04-120000-00-00NoNoCurrent
63667-958-246366709582424 in 1 BAGHistorical
63667-958-456366709584545 in 1 BAGHistorical