FDA.reportPublic FDA data

MEDIQUE Medikoff Drops

Product NDC
47682-050
11-digit product format
476820050
Labeler code
47682
Product ID
47682-050_3e4cb58c-fe20-ca13-e063-6394a90a7244
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LOZENGE
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-12-30
Substance
MENTHOL
Active strength
7.6 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
MEDIQUE Medikoff Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL7.6 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
359751Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0d6b4443-16a1-4851-bb03-d7407167551dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-050-22MEDIQUE Medikoff Drops75 in 1 BOXLOZENGE7514
47682-050-60MEDIQUE Medikoff Drops600 in 1 BOXLOZENGE60014
47682-050-64MEDIQUE Medikoff Drops24 in 1 BOXLOZENGE2414
47682-050-66MEDIQUE Medikoff Drops601 in 1 BOXLOZENGE60114
47682-050-69MEDIQUE Medikoff Drops6 in 1 BOXLOZENGE614

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47682-050-22EA - Each47682-050c22f8e6e-44cd-477a-8a0c-ca5ff1268f7c12012-07-24
47682-050-60EA - Each47682-050e5229762-fb01-4452-8705-0d107c26c97812012-07-24
47682-050-64EA - Each47682-0506d39e7f9-82ca-4706-9a92-8784020e7f9212012-07-24
47682-050-69EA - Each47682-0508762556f-fe53-4815-866f-3bd92d669eb812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AMEDIQUE MEDIKOFF DROPS (MENTHOL) LOZENGE MEDI-FIRST CHERRY COUGH DROPS (MENTHOL) LOZENGE MEDI FIRST PLUS CHERRY COUGH DROPS (MENTHOL) LOZENGE [UNIFIRST FIRST AID CORPORATION]2
MENTHOLACTIVE MOIETYL7T10EIP3AMEDIQUE MEDIKOFF DROPS (MENTHOL) LOZENGE MEDI-FIRST CHERRY COUGH DROPS (MENTHOL) LOZENGE MEDI FIRST PLUS CHERRY COUGH DROPS (MENTHOL) LOZENGE [UNIFIRST FIRST AID CORPORATION]2
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NMEDIQUE MEDIKOFF DROPS (MENTHOL) LOZENGE MEDI-FIRST CHERRY COUGH DROPS (MENTHOL) LOZENGE MEDI FIRST PLUS CHERRY COUGH DROPS (MENTHOL) LOZENGE [UNIFIRST FIRST AID CORPORATION]2
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662MEDIQUE MEDIKOFF DROPS (MENTHOL) LOZENGE MEDI-FIRST CHERRY COUGH DROPS (MENTHOL) LOZENGE MEDI FIRST PLUS CHERRY COUGH DROPS (MENTHOL) LOZENGE [UNIFIRST FIRST AID CORPORATION]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMEDIQUE MEDIKOFF DROPS (MENTHOL) LOZENGE MEDI-FIRST CHERRY COUGH DROPS (MENTHOL) LOZENGE MEDI FIRST PLUS CHERRY COUGH DROPS (MENTHOL) LOZENGE [UNIFIRST FIRST AID CORPORATION]2
SUCROSEINACTIVE INGREDIENTC151H8M554MEDIQUE MEDIKOFF DROPS (MENTHOL) LOZENGE MEDI-FIRST CHERRY COUGH DROPS (MENTHOL) LOZENGE MEDI FIRST PLUS CHERRY COUGH DROPS (MENTHOL) LOZENGE [UNIFIRST FIRST AID CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-050MEDIQUE MEDIKOFF DROPS (MENTHOL) LOZENGE MEDI-FIRST CHERRY COUGH DROPS (MENTHOL) LOZENGE MEDI FIRST PLUS CHERRY COUGH DROPS (MENTHOL) LOZENGE [UNIFIRST FIRST AID CORPORATION]13Current NDC, Legacy NDC, 5 package rows20241120_0d6b4443-16a1-4851-bb03-d7407167551d.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 142 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good neighbor pharmacy adult tussin DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmerisource Bergenced71993-f535-4e28-bc1d-3fcb7d86e9b72024-11-08WarningsExact identifier
application number: M012
adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS Pharmacy2f1dc8f8-79c5-4724-99aa-a55330ed9d5f2024-11-08WarningsExact identifier
application number: M012
good sense day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company4ac6b64a-8214-4b03-8aa5-0d3199cf0b722024-11-08WarningsExact identifier
application number: M012
tussinDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINH E B1dd9afb6-9b58-4274-a557-900a0cb235242024-11-08WarningsExact identifier
application number: M012
DG health sinus severeOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLC7abaa912-be8b-463c-8818-104e79b335392024-11-07WarningsExact identifier
application number: M012
Extra Strength TYLENOL Cold Plus Flu Multi-Action DayACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC7d3266dc-879a-4d28-b8ea-74d238c3020a2024-11-07WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU SEVERE DAY/NIGHTACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC2ddb86a8-e34c-4a03-a60a-d3fedaf906082024-11-07WarningsExact identifier
application number: M012
Tylenol Cold Plus Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCce43e5c2-fe96-4462-882c-d7479318b33d2024-11-07WarningsExact identifier
application number: M012
TYLENOL SINUS PLUS HEADACHE DAYACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCe608d214-cc46-4a24-ac85-1040e36e74032024-11-07WarningsExact identifier
application number: M012
Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLCe83f7911-22b4-4ffc-8f49-68f6acd2ebf52024-11-07WarningsExact identifier
application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE.Kenvue Brands LLCf81d924e-10e9-0e9d-e053-6294a90a2ddf2024-11-07WarningsExact identifier
application number: M012
Childrens TYLENOL COLD Plus FLUACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC8b516736-86ac-47cb-a0ec-038d4c3a00202024-11-07WarningsExact identifier
application number: M012
Tylenol Cold plus Flu plus Cough NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCe85e5eb9-3ecf-4784-999e-111e38e306f52024-11-07WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCef8a846d-4b29-4fd8-a683-fada04d0a2b92024-11-07WarningsExact identifier
application number: M012
Childrens TYLENOL COLD Plus FLUACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC9761c807-75a1-4498-a8c6-1f2b1c9ffde62024-11-07WarningsExact identifier
application number: M012
TYLENOL Cold Plus Mucus SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC24ac94e8-b223-424e-bcd2-9c027c8ff9ed2024-11-07WarningsExact identifier
application number: M012
PrimateneEPHEDRINE HYDROCHLORIDEFoundation Consumer Brands2170f081-c03f-47e8-bc63-4052c5e653fa2024-11-07WarningsExact identifier
application number: M012
Rompe Pecho Max Multi SymptomsACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESINEFFICIENT LABORATORIES INC938e4e47-d2d9-4b0d-bf88-e9f41b5019452024-11-07WarningsExact identifier
application number: M012
topcare sinus nasalOXYMETAZOLINE HYDROCHLORIDETopco Associates LLCca1fefed-e9d7-430a-9da4-972b1a6fb7862024-11-07WarningsExact identifier
application number: M012
Leader Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderdd82a389-9ec5-4b3f-a9ea-1a56871ebd172024-11-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359751menthol 7.6 MG Oral LozengePSN0d6b4443-16a1-4851-bb03-d7407167551d14
359751menthol 7.6 MG Oral LozengeSCD0d6b4443-16a1-4851-bb03-d7407167551d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-050-224768200502275 LOZENGE in 1 BOX (47682-050-22) 75 lozenge2008-12-300000-00-00NoNoCurrent
47682-050-6047682005060600 LOZENGE in 1 BOX (47682-050-60) 600 lozenge2008-12-300000-00-00NoNoCurrent
47682-050-644768200506424 LOZENGE in 1 BOX (47682-050-64) 24 lozenge2008-12-300000-00-00NoNoCurrent
47682-050-6647682005066601 LOZENGE in 1 BOX (47682-050-66) 601 lozenge2008-12-300000-00-00NoNoCurrent
47682-050-69476820050696 LOZENGE in 1 BOX (47682-050-69) 6 lozenge2008-12-300000-00-00NoNoCurrent