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 150 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI08fda81a-bedd-4ff3-9c32-2066d2cea3f92024-10-17WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINAmerican Health Packaging2fd702ea-3069-472c-b99e-c527f13757052024-10-17WarningsExact identifier
application number: M012
Mucus Relief XpectGUAIFENSIN, DEXTROMETHORPHANSelder, S.A. de C.V.c2b49d10-b60f-3072-e053-2a95a90af0042024-10-17WarningsExact identifier
application number: M012
Head Congestion plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI1db914d3-8bba-405e-9bf9-9b1a5806284c2024-10-17WarningsExact identifier
application number: M012
Cold Medicine XL3ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.e2c35fae-9dd6-51f2-e053-2995a90a1e9e2024-10-17WarningsExact identifier
application number: M012
Cough and Cold XL3 XtraACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.da5b31dd-becd-471a-9392-d0ee4b8f95392024-10-17WarningsExact identifier
application number: M012
Cold Medicine XL3 FORTEACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDEMIDWAY IMPORTING INC.58252f15-485c-3061-e053-2a91aa0a23202024-10-17WarningsExact identifier
application number: M012
Cold Medicine XL3ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDEMidway Importing, Inc.e41b9beb-e274-5c02-e053-2995a90ad0f82024-10-17WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC38e70a28-eff2-4a48-b829-8cd68e80beef2024-10-17WarningsExact identifier
application number: M012
Mucus Relief XpectGUAIFENSIN, DEXTROMETHORPHANMidway Importing Inc.c2c8bd26-bbf1-c2e6-e053-2995a90a86a72024-10-17WarningsExact identifier
application number: M012
Antiflu Des Cough and FluACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATEProductos Farmaceuticos, S.A. de C.V.dcf3897a-a793-6df7-e053-2995a90a25f82024-10-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEFSA STORE INC.ec6aef90-ece1-4fe6-e053-2995a90a93102024-10-16WarningsExact identifier
application number: M012
Tukol MAX ACTION Cold, Sore Throat and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGenomma Lab USA, Incc8eebe64-00bf-436d-a9fc-1623401bebfa2024-10-16WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart4f42c8d2-0538-4bcd-aac0-e26103a304992024-10-16WarningsExact identifier
application number: M012
Tukol MAX ACTION Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGenomma Lab USA, Inc9ac3e24a-d18a-48fc-8005-55393085d57b2024-10-16WarningsExact identifier
application number: M012
Nighttime CoughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED45471fdd-c4cd-46ad-a932-aa37327e8a412024-10-16WarningsExact identifier
application number: M012
DG Health Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc8cb15a8d-c836-4167-bc6b-dd20a34076e82024-10-16WarningsExact identifier
application number: M012
basic care nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLCf4497e56-c69d-4ae9-bd81-80bf2ee1b17f2024-10-15WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEFOODHOLD U.S.A., LLC8256c1fb-683d-56ab-e053-2a91aa0ac1972024-10-15WarningsExact identifier
application number: M012
SINUS SEVREACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f9586e3-a8b4-4060-e053-2995a90aa0682024-10-15WarningsExact 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