Honey Lemon Menthol Cough Drops

Product NDC
76162-024
11-digit product format
761620024
Labeler code
76162
Product ID
76162-024_23e6fb6c-0b9f-3900-e063-6394a90a5fe6
Type
HUMAN OTC DRUG
Nonproprietary name
Honey Lemon Menthol
Dosage form
PASTILLE
Route
ORAL
Labeler
Topco Associates LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-08
Substance
MENTHOL
Active strength
7.5 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
Honey Lemon Menthol Cough Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL7.5 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
1250189Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5be283b-524d-26af-e053-2995a90a3972Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-024-01Honey Lemon Menthol Cough Drops30 in 1 BAGPASTILLE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-024HONEY LEMON MENTHOL COUGH DROPS (HONEY LEMON MENTHOL) PASTILLE [TOPCO ASSOCIATES LLC]3Current NDC, 1 package rows20241010_f5be283b-524d-26af-e053-2995a90a3972.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 162 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Halls MentholyptusMENTHOLMondelez Global LLCf5292c5b-5608-4e13-afc2-4f3d7133da882024-06-25WarningsExact identifier
application number: M012
Halls StrawberryMENTHOLMondelez Global LLC75638f29-7f2a-46b0-b8a0-e87bc7d6eba12024-06-25WarningsExact identifier
application number: M012
Good Sense Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEA-S Medication Solutions5396a9cf-16eb-4628-9432-f49c67ffe2ce2024-06-25WarningsExact identifier
application number: M012
Nighttime Cold and Flu LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETARGET CORPORATION130ca5f1-2951-ec6f-e063-6394a90a754f2024-06-24WarningsExact identifier
application number: M012
Daytime and Nighttime Severe Honey Cold and FluDAYTIME - ACETAMINOPHEN. DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND NIGHTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATETARGET CORPORATION08fd1513-30ab-15da-e063-6394a90ab57d2024-06-21WarningsExact identifier
application number: M012
Daytime Severe and Nighttime Severe cold and fluDAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORPORATION0c0caa59-0637-bc33-e063-6294a90ae2442024-06-21WarningsExact identifier
application number: M012
Halls StrawberryMENTHOLMondelez Global LLCde401eb4-3282-4298-8a51-15d2682534642024-06-21WarningsExact identifier
application number: M012
Cough and Chest Congestion DM Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINWalgreense4515d0e-c12b-40cd-8218-6d91476cfebd2024-06-21WarningsExact identifier
application number: M012
SUDOGESTPSEUDOEPHEDRINE HCLA-S Medication Solutions1811199f-bf88-475f-8f94-b372db4bead32024-06-20WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Soft ChewsACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC91dbb541-6a86-4803-a1fe-1bf61b457c342024-06-19WarningsExact identifier
application number: M012
Tukol Max Action Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAaedce1f9-4902-4c51-92e0-6056196394c22024-06-14WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIdbc71f58-0704-4d2b-aed1-0dc01f9800062024-06-11WarningsExact identifier
application number: M012
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDETARGET CORPORATION135d2212-2122-b7a1-e063-6294a90aa5f52024-06-07WarningsExact identifier
application number: M012
up and up daytime honey cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETarget Corporation29da4b94-8f8e-48e8-909f-8476e3b39d782024-06-06WarningsExact identifier
application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCITARGET Corporatione3da3003-88e3-4431-8b65-e61e177289012024-06-04WarningsExact identifier
application number: M012
Dimetapp Cold and AllergyBROMPHENIRAMINE MALEATEFoundation Consumer Healthcare15c3570c-bd00-8e43-e063-6294a90a86832024-06-01WarningsExact identifier
application number: M012
Dimetapp Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Healthcare176be362-5237-edd8-e063-6294a90a4aef2024-06-01WarningsExact identifier
application number: M012
Dimetapp Nighttime Cold and CoughDIPHENHYDRAMINE HYDROCHLORIDEFoundation Consumer Healthcare179115ad-d610-99b2-e063-6294a90ae7112024-06-01WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Nighttime Cold and CoughDIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Healthcare179259a9-231e-df03-e063-6294a90a145e2024-06-01WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and CoughBROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDEFoundation Consumer Healthcare1820e7c7-bc11-9061-e063-6394a90ae5812024-06-01WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250189menthol 7.5 MG Oral LozengePSNf5be283b-524d-26af-e053-2995a90a39723
1250189menthol 7.5 MG Oral LozengeSCDf5be283b-524d-26af-e053-2995a90a39723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-024-017616200240130 PASTILLE in 1 BAG (76162-024-01) 30 pastille2023-06-08NoNoCurrent