FDA.reportPublic FDA data

menthol cough drops

Product NDC
41520-009
11-digit product format
415200009
Labeler code
41520
Product ID
41520-009_455336bc-9589-9e89-e063-6394a90a95e4
Type
HUMAN OTC DRUG
Nonproprietary name
menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
American Sales
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-06-09
Substance
MENTHOL
Active strength
5.4 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 cough drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5.4 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
485287Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
34dd34d1-1a08-3470-e054-00144ff8d46cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-009-30menthol cough drops30 in 1 BAGLOZENGE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-009MENTHOL COUGH DROPS (MENTHOL) LOZENGE [AMERICAN SALES]7Current NDC, Legacy NDC, 1 package rows20241202_34dd34d1-1a08-3470-e054-00144ff8d46c.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 122 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger DayTime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEThe Kroger Co.2499210b-c162-76b9-e063-6294a90adbc32025-01-17WarningsExact identifier
application number: M012
Childrens Multi Symptom Cold Very BerryDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS2a849ae9-338f-4642-e063-6394a90a1ca42025-01-17WarningsExact identifier
application number: M012
Kroger NightTime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Kroger Co.24a73de3-e9eb-4cd4-e063-6394a90aa2632025-01-17WarningsExact identifier
application number: M012
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HCL ORALEverpharm LLCd7aaf874-69ac-49cf-93be-6d4a38b9a5572025-01-16WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HBRBest Choice (Valu Merchandisers Company)204a7fc4-142d-45fd-8a77-0612857132be2025-01-16WarningsExact identifier
application number: M012
daytime cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEMeijer, Inc.df31056b-d0eb-4094-98d9-3d444210d50d2025-01-16WarningsExact identifier
application number: M012
Childrens Ibuprofen Oral SuspensionIBUPROFENReliable 1 Laboratories LLC28dd9baa-43bd-b60a-e063-6394a90a8cf72025-01-15WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINReliable 1 Laboratories LLCae469d4f-91c4-cff0-e053-2995a90a04972025-01-15WarningsExact identifier
application number: M012
Diphenhydramine HCL 25 mgDIPHENHYDRAMINE HCLReliable 1 Laboratories LLC32f58cb3-941f-263b-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M012
Diphenhydramine HCl 25 mgDIPHENHYDRAMINE HCLReliable 1 Laboratories LLC32fa40ad-fed5-586f-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M012
CVS Health Chest Congestion and Cough HBP SOFTGELDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS Pharmacy, Inc2741ba44-1cc7-1812-e063-6394a90a8faa2025-01-14WarningsExact identifier
application number: M012
DAY COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORPORATION2b941963-8a8c-4148-e063-6294a90a1dfb2025-01-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLSDA Laboratories, Inc.437e6a13-a4ff-4f98-8973-042f224ee85e2025-01-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLSDA Laboratories, Inc.6a520986-1004-4ee6-9a47-1dfd90bb1b2c2025-01-13WarningsExact identifier
application number: M012
good sense daytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company5ddf3283-94e4-465d-842a-471ee946c3302025-01-10WarningsExact identifier
application number: M012
Vicks VapoSteamCAMPHOR (SYNTHETIC)Kaz USA, Incc28da455-07ad-4053-8b9e-fc559f9a3f722025-01-10WarningsExact identifier
application number: M012
Guaifenesin 200mgGUAIFENESINAphena Pharma Solutions - Tennessee, LLC45ac210a-8c54-4469-8e10-e6fe52b89cb52025-01-09WarningsExact identifier
application number: M012
Meclizine HCLMECLIZINE HCL 25MG CHEWABLE TABLETSAphena Pharma Solutions - Tennessee, LLC02d1af4d-d97d-4019-a5bf-3ec3912386762025-01-09WarningsExact identifier
application number: M012
HISTEX PD Drops New FormulationTRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLC0c693f15-5d76-3dbf-e063-6294a90af9ac2025-01-08WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HBR 15 MGDEXTROMETHORPHAN HBR 15 MGAMZ789 LLCe2175017-6a0d-0155-e053-2995a90a65d62025-01-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485287menthol 5.4 MG Oral LozengePSN34dd34d1-1a08-3470-e054-00144ff8d46c8
485287menthol 5.4 MG Oral LozengeSCD34dd34d1-1a08-3470-e054-00144ff8d46c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-009-304152000093030 LOZENGE in 1 BAG (41520-009-30) 30 lozenge2016-06-090000-00-00NoNoCurrent