FDA.reportPublic FDA data

EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT

Product NDC
63667-503
11-digit product format
636670503
Labeler code
63667
Product ID
63667-503_ebff7e9e-acbb-4ce0-bc94-1d85221d45a5
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
2013-05-27
Substance
MENTHOL
Active strength
8.3 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 packagepackage63667-50363667-503-04DDiscontinued by firm2026-10-21

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
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL8.3 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
1424614Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0baf383c-886d-47ca-8a6d-221298c79446Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63667-503-042020-02-10EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT
63667-503-192020-02-10EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT
63667-503-262020-02-10EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT
63667-503-042020-01-31EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT
63667-503-192020-01-31EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT
63667-503-262020-01-31EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63667-503-04EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT4 in 1 PACKAGELOZENGE46
63667-503-19EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT19 in 1 BAGLOZENGE196
63667-503-26EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT26 in 1 BAGLOZENGE266

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AEXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA USA INC.]2
MENTHOLACTIVE MOIETYL7T10EIP3AEXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA USA INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA USA INC.]2
INVERT SUGARINACTIVE INGREDIENTED959S6ACYEXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA USA INC.]2
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BEXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA USA INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA USA INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63667-503EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA USA INC.]6Current NDC, Legacy NDC, 3 package rows20241211_0baf383c-886d-47ca-8a6d-221298c79446.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 99 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freegells Cough Drops Menthol Honey Lemon 80ctMENTHOLR.L. ALBERT & SON, INC61deea94-d0a9-4563-926b-53f255a7c4252025-10-08WarningsExact identifier
application number: M012
FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPSMENTHOLR.L. ALBERT & SON, INCc6b36350-386b-4346-bef0-a37ec11319c02025-10-08WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC3314b174-d5bb-4843-9288-9b9c5fce79d52025-10-08WarningsExact identifier
application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral SolutionDIPHENHYDRAMINE HCLMEDWISE LIFESCIENCES INC.407b7cbb-7ebd-7b7e-e063-6394a90af5012025-10-06WarningsExact identifier
application number: M012
Quality Choice Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc2025-10-06WarningsExact identifier
application number: M012
Halls Sugar Free Honey LemonMENTHOLMondelez Global LLC2b19fdd2-8088-47f2-be20-f220a6b825fc2025-10-06WarningsExact identifier
application number: M012
Giltuss Childrens Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories, Inc40802fb6-c1ec-d7b0-e063-6394a90ab4232025-10-06WarningsExact identifier
application number: M012
Giltuss DiabeticDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories, Inc3f64c81a-bbfc-4575-e063-6294a90a6ed72025-10-06WarningsExact identifier
application number: M012
TexaClear Severe Cough, Cold and FluCHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGM Pharmaceuticals, INCcb99e5b3-1908-43c9-b31f-d35e7ce58b442025-10-06WarningsExact identifier
application number: M012
RoboHBr Cough SUPPRESSANTDEXTROMETHORPHAN HBRDXM Pharmaceutical, Inc0af624ce-191f-45e1-882b-e8acb90cc77b2025-10-06WarningsExact identifier
application number: M012
RoboTabletsDEXTROMETHORPHANDXM Pharmaceutical, Incb92cf698-032d-4d8d-b19c-456c6338b0942025-10-06WarningsExact identifier
application number: M012
SinuLiefLORATADINERoseWell Pharmaceuticals LLC32619143-a782-3497-e063-6394a90aaaec2025-10-06WarningsExact identifier
application number: M012
STAHIST ADCHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEMagna Pharmaceuticals, Inc.ccedbc38-2479-4c35-9f86-a9f29bcfab3f2025-10-03WarningsExact identifier
application number: M012
Childrens PediaClear 8PYRILAMINE MALEATEGM Pharmaceuticals, INC8e524967-d01c-4c93-9198-c42f15fe3fe02025-10-03WarningsExact identifier
application number: M012
Childrens PediaClear PDTRIPROLIDINE HYDROCHLORIDEGM Pharmaceuticals, INCf3ede5b7-1b0f-493a-b647-4459affc7e542025-10-03WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEInvaTech Pharma Solutions LLC40288ecf-043d-eb9e-e063-6394a90ac0a72025-10-02WarningsExact identifier
application number: M012
Guaifenesin 400GUAIFENESIN TABLETS 400InvaTech Pharma Solutions LLC40291505-55ca-0759-e063-6394a90acee12025-10-02Exact identifier
application number: M012
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3dd5b783-5b64-24b5-e063-6394a90ab4ee2025-10-02WarningsExact identifier
application number: M012
Acetaminophen and Diphenhydramine citrateACETAMINOPHEN AND DIPHENHYDRAMINE CITRATEInvaTech Pharma Solutions LLC403a88fa-e06b-9b6e-e063-6394a90a97b82025-10-02WarningsExact identifier
application number: M012
Equaline childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEUnited Natural Foods, Inc. dba UNFI3053f6d7-0eff-488c-8901-770dcc62af062025-10-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1424614menthol 8.3 MG Oral LozengePSN0baf383c-886d-47ca-8a6d-221298c794466
1424614menthol 8.3 MG Oral LozengeSCD0baf383c-886d-47ca-8a6d-221298c794466

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63667-503-04636670503044 in 1 PACKAGEHistorical
63667-503-196366705031919 LOZENGE in 1 BAG (63667-503-19) 19 lozenge2013-05-270000-00-00NoNoCurrent
63667-503-266366705032626 LOZENGE in 1 BAG (63667-503-26) 26 lozenge2013-05-270000-00-00NoNoCurrent