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 111 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pentrexcilina Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe11e5c17-28f2-7186-e053-2995a90a51f62025-07-17WarningsExact identifier
application number: M012
Viro Flu PM ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe1553da8-3a89-e258-e053-2a95a90a47252025-07-17WarningsExact identifier
application number: M012
ACTICON PEDIATRICDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC3052cc67-e6c0-4d3f-9ec9-ffe58d9fae232025-07-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDemoulas Super Markets, Inc397f5acd-31c0-683e-e063-6394a90a7e542025-07-16WarningsExact identifier
application number: M012
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATEKenvue Brands LLC19ad2cca-c1cb-019c-e063-6294a90a56442025-07-16WarningsExact identifier
application number: M012
DG HEALTH COLD FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDolgencorp Inc8ea03891-2fbc-4413-8e6d-de903d426f8d2025-07-16WarningsExact identifier
application number: M012
up and up nighttime flu and severe cold and coughACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationdf488727-b913-440b-9a0b-cce3ae143bf22025-07-15WarningsExact identifier
application number: M012
Topcare DayTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDETopco Associates LLCbb9663e3-fd11-4e72-bf85-fee4841b795f2025-07-15WarningsExact identifier
application number: M012
DG HEALTH COLD FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp Inc320e4f32-66aa-48be-9afd-fa2b2c217dc12025-07-14WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.f29da4ca-443d-7035-e053-2a95a90acab82025-07-14WarningsExact identifier
application number: M012
CVS PHARMACY MS Adult Severe Multi Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS PHARMACYcdc9af7c-3766-4573-9d95-bf217907b9322025-07-11WarningsExact identifier
application number: M012
Health Smart Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUS OILInternational Wholesale Inc398fee3d-7d93-9dbc-e063-6294a90abdcc2025-07-10WarningsExact identifier
application number: M012
HEADACHE RELIEFACETAMINOPHEN, ASPIRIN AND CAFFEINEKroger Companybbed29a1-3c52-3531-e053-2995a90a686c2025-07-10WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY, INCb765c82e-5021-4772-8647-c5ebc596bc0a2025-07-10WarningsExact identifier
application number: M012
Sinus Pressure and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companyc378acaf-389a-4afb-a4f0-e367a907a4682025-07-10WarningsExact identifier
application number: M012
Nasal Decongestant Non-DrowsyPSEUDOEPHEDRINE HCLCVS Pharmacy3330b077-dab7-45c6-acbb-0f91f22712322025-07-09WarningsExact identifier
application number: M012
ACTIDOGESIC DFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEACTIPHARMA, LLCff8e2565-bce3-4c06-a416-6e8f369f057f2025-07-09WarningsExact identifier
application number: M012
ACTINELDEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCLACTIPHARMA, LLCdb0cb6ae-0a4d-4232-805a-f3f3a058261f2025-07-08WarningsExact identifier
application number: M012
HALLS Extra StrongMENTHOLMondelez Global LLC396f93a9-8d2c-2f27-e063-6294a90ab3442025-07-08WarningsExact identifier
application number: M012
ACTICONDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLCaea0335d-75e6-4a90-86a5-f197cf024a112025-07-08WarningsExact 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