FDA.reportPublic FDA data

Green Guard Honey Lemon Cough Drop

Product NDC
47682-040
11-digit product format
476820040
Labeler code
47682
Product ID
47682-040_3e4c84e3-f679-5eca-e063-6294a90a031c
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 8.6 mg
Dosage form
LOZENGE
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-01
Substance
MENTHOL
Active strength
8.6 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
Green Guard Honey Lemon Cough Drop
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL8.6 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
433194Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8a94f090-61d6-4909-e053-2995a90aee38Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-040-25Green Guard Honey Lemon Cough Drop125 in 1 BOXLOZENGE1259
47682-040-50Green Guard Honey Lemon Cough Drop50 in 1 BOXLOZENGE509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-040GREEN GUARD HONEY LEMON COUGH DROP (MENTHOL 8.6 MG) LOZENGE [UNIFIRST FIRST AID CORPORATION]8Current NDC, Legacy NDC, 2 package rows20241116_8a94f090-61d6-4909-e053-2995a90aee38.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 114 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Sinus Max Clear and CoolACETAMINOPHEN AND GUAIFENESINRB Health (US) LLC37de813a-54b7-672a-e063-6294a90a374e2025-06-18WarningsExact identifier
application number: M012
childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4a1aeb41-a8fa-4116-8068-e11acd608e582025-06-18WarningsExact identifier
application number: M012
NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIXACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATEDLil' Drug Store Products, Inc.37c768f5-dabd-22d0-e063-6394a90af9e52025-06-17WarningsExact identifier
application number: M012
DISCOUNT DRUG MART Childrens Allergy ChewableDIPHENHYDRAMINE HCLDISCOUNT DRUG MART51de95da-e8e8-48f0-9fa4-6191aa4a247b2025-06-16WarningsExact identifier
application number: M012
Halls CherryMENTHOLMondelez Global LLC5f4af8e8-8550-45c7-a199-694efac9e7be2025-06-16WarningsExact identifier
application number: M012
Halls Honey LemonMENTHOLMondelez Global LLC25eaae85-d516-40da-a472-70736ea2b75d2025-06-16WarningsExact identifier
application number: M012
Halls CherryMENTHOLMondelez Global LLCbad89968-22a7-4287-a57c-9e6206e574fe2025-06-16WarningsExact identifier
application number: M012
Herbal Throat DropsLEMON MINT HERBALMeijer, Inc.37dd58ad-95d1-568c-e063-6394a90a94332025-06-16WarningsExact identifier
application number: M012
topcare childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDETopco Associates LLC40a6a7e3-6ec9-4005-9406-9d5b044b3c212025-06-16WarningsExact identifier
application number: M012
Daytime Nighttime Sinus ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLTarget Corporation23f50b88-52c3-2029-e063-6394a90ac73e2025-06-14WarningsExact identifier
application number: M012
Cough Drops Dollar General Berries Flavor 25ctPECTINDollar General Corporationc53c19a9-5984-4b08-ae46-a53dc8bb7d742025-06-13WarningsExact identifier
application number: M012
Cough Drops Dollar General Strawberry Flavor 25ctPECTINDollar General Corporationd82034ca-b7fd-48c8-ab4a-8e1e564183242025-06-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLBelleview Biosciences1db57d86-39f0-f8ca-e063-6394a90a63972025-06-12WarningsExact identifier
application number: M012
TARGET Cold and Cough and Nighttime Value PackBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL,TARGET CORPORATIONce536313-7265-405c-88b7-f45e62781da52025-06-11WarningsExact identifier
application number: M012
Capron MaxDEXTROMETHORPHAN HBR AND PYRILAMINE MALEATECapital Pharmaceutical, LLC3756812b-f128-8946-e063-6294a90a59ba2025-06-11WarningsExact identifier
application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestionDEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES60311ca3-8544-417e-aa29-e9f65c6692ba2025-06-11WarningsExact identifier
application number: M012
Cold Max NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.e65d2815-6932-123c-e053-2a95a90a2cf92025-06-10WarningsExact identifier
application number: M012
Cold Head Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmerican Sales Company0cc66c6c-db26-4bb2-a97d-c4106210d70c2025-06-10WarningsExact identifier
application number: M012
Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL.N.K. International, Inc.75a9c736-bc7e-4b7f-84ea-9474a37508ec2025-06-10WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINKJD Pharma Private Limited8877bb8d-479f-4968-8033-5c269d449a462025-06-10WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433194menthol 8.6 MG Oral LozengePSN8a94f090-61d6-4909-e053-2995a90aee389
433194menthol 8.6 MG Oral LozengeSCD8a94f090-61d6-4909-e053-2995a90aee389

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-040-2547682004025125 LOZENGE in 1 BOX (47682-040-25) 125 lozenge2019-07-010000-00-00NoNoCurrent
47682-040-504768200405050 LOZENGE in 1 BOX (47682-040-50) 50 lozenge2019-07-010000-00-00NoNoCurrent