FDA.reportPublic FDA data

Menthol

Product NDC
68599-0464
11-digit product format
685990464
Labeler code
68599
Product ID
68599-0464_24241327-4250-104a-e063-6294a90a41e7
Type
HUMAN OTC DRUG
Nonproprietary name
Cough Suppressant
Dosage form
LOZENGE
Route
ORAL
Labeler
McKesson
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-29
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
.7 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68599-0464-9IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68599-0464-9IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68599-0464-9IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductEExcluded after deficient or non-compliant submission was not corrected8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68599-0464-9EExcluded after deficient or non-compliant submission was not corrected8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductYUnknown FDA exclusion code: Ye2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68599-0464-9YUnknown FDA exclusion code: Ye2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductYUnknown FDA exclusion code: Y9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68599-0464-9YUnknown FDA exclusion code: Y9bebd1f3094a…5416666fcb17…

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
Menthol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM.7 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d4def70-480f-f2fa-e053-2995a90a9877Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68599-0464-92022-10-24C16284748780-1d6a99b39-4d89-a426-e053-dadaa90af4c2Menthol Eucalyptus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-0464-9Menthol0.7 g in 1 JARLOZENGE0.78

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-0464MENTHOL (COUGH SUPPRESSANT) LOZENGE [MCKESSON]8Current NDC, Legacy NDC, 1 package rows20241012_9d4def70-480f-f2fa-e053-2995a90a9877.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 129 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mentholatum No Mess Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Companyf4675bc1-01cc-4a33-a3bf-bfc99230fe322024-12-17WarningsExact identifier
application number: M012
Mentholatum Cherry Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Companyde01225a-eabb-4972-bf3a-3e5a0e44abef2024-12-17WarningsExact identifier
application number: M012
Rite Aid Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLRite Aid Corporation198a666a-3f34-4e4f-89e8-ec7f412f00af2024-12-17WarningsExact identifier
application number: M012
Equate Childrens VaporizingCAMPHOR, EUCALYPTUS OIL, MENTHOLWal-Mart Stores Inc372e66a6-1f1f-4aa3-a2ed-d215fafee9b92024-12-17WarningsExact identifier
application number: M012
Caring Mill Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLFSA Store Inc.caa83419-c332-4b92-b151-22da2fa852892024-12-17WarningsExact identifier
application number: M012
Always Save Chest Congestion Relief GUAFGUAIFENESINValu Merch9d81d88b-2db9-4891-942b-fecb1be961dd2024-12-17WarningsExact identifier
application number: M012
Kroger EXTRA STRENGTH Acetaminophen PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEThe Kroger Co.24a75ffa-c2a7-71a9-e063-6394a90a0e252024-12-17WarningsExact identifier
application number: M012
Allergy 36ct, Caseys 4goodDIPHENHYDRAMINE HCL 25MGLil' Drug Store Products, Inc.04b78b23-424d-9762-e063-6394a90a52e32024-12-16WarningsExact identifier
application number: M012
Sinus Relief, Caseys 4goodACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATEDLil' Drug Store Products, Inc.033837c0-fa68-a38d-e063-6394a90a98322024-12-16WarningsExact identifier
application number: M012
DayQuil Severe plus VapoCOOL Cold and Flu, Travel BASIXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.cfab9b80-0580-4482-b6e3-0aab875b57972024-12-16WarningsExact identifier
application number: M012
Allergy Relief, 24-7 Lift by 7-ElevenDIPHENHYDRAMINE HCL 25MGLil' Drug Store products, Inc.04c9db9a-95ef-3a48-e063-6294a90a4e8e2024-12-16WarningsExact identifier
application number: M012
Cold and Flu Daytime Severe, 24/7 LifeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLETLil' Drug Store Products, Inc.05cc7185-d49d-82a3-e063-6294a90a568e2024-12-16WarningsExact identifier
application number: M012
Cold and Flu Nighttime Severe, 24-7 LifeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLLil' Drug Store products, Inc.05d0410f-164e-e7ee-e063-6394a90a2aaa2024-12-16WarningsExact identifier
application number: M012
tussin dm max daytime nighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESINCVS Pharmacy6feaf29e-de06-4c94-912c-a76ea2cbd8c12024-12-16WarningsExact identifier
application number: M012
Leader Childrens Multi Symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER169ff9cf-fcf5-46a6-b460-259421f2ec072024-12-16WarningsExact identifier
application number: M012
Childrens Mucus and Cough ReliefDEXTROMETHORPHAN HBR, GUAIFENESINCARDINAL HEALTH 110, LLC. DBA LEADER125eeb3d-0ee2-45bb-81c0-4ca6999798862024-12-16WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mg Liquid GelsDEXTROMETHORPHAN HBRRUGBY LABORATORIEScf3cc387-6642-43fd-999d-688fdaf65d4f2024-12-14WarningsExact identifier
application number: M012
Allergy Relief Dye-Free SoftgelDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACY, INC60b1bb79-3ed1-438b-a27f-f7fbc108d1142024-12-14WarningsExact identifier
application number: M012
Rycontuss Cherry FlavorCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOkendpharma, Inc.c91798fa-48ab-47a0-92da-4d44c2aafde02024-12-13WarningsExact identifier
application number: M012
Mentholatum Lavender Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company6f208c05-617d-492a-a016-e9d6be3c971f2024-12-13WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68599-0464-968599046409.7 g in 1 JAR (68599-0464-9) 2020-01-290000-00-00NoNoCurrent