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 135 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEAAA PHARMACEUTICAL, INC.19898135-0f7b-45a5-a672-14c49fd210772024-12-02WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corpbb72de5d-d3c0-42fc-ae52-a3ad95214af52024-12-02WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAAA Pharmaceutical, Inc.a242e005-0330-4afb-83b8-13c7d56f5c6d2024-12-02WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETopCo Associates LLC53b15e75-9efd-4b4b-834b-6e9f12c601082024-12-02WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Incf4468840-e17c-6888-e053-2995a90a04a02024-12-02WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corpac8a14ac-7023-1e23-e053-2995a90aea3a2024-11-28WarningsExact identifier
application number: M012
Childrens Benadryl DYE-FREE ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC10d478ff-ddc6-45da-87ff-cfe1b2b07a8e2024-11-27WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepack9cd10af6-a2fa-44f8-8df3-a6d2a95a52932024-11-27WarningsExact identifier
application number: M012
Severe Sinus Congestion Allergy and Cough FormulaACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLC36a4ec1f-50c3-4d61-ada9-987ccad3563c2024-11-26WarningsExact identifier
application number: M012
Daytime Nighttime Childrens Multi-symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores, Inc.177e3247-402d-98e4-e063-6294a90ae0682024-11-26WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold and Flu, CVPCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLETLil' Drug Store Products, Inc.e7a27773-69d6-9e07-e053-2a95a90af8ea2024-11-25WarningsExact identifier
application number: M012
DayTime Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.4361912e-4b56-4743-b11d-acfb94482a2e2024-11-25WarningsExact identifier
application number: M012
NightTime Sinus ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.413d82d3-a896-4f15-9fca-c1b7b9a1ee632024-11-25WarningsExact identifier
application number: M012
Night Cold Flu Cough and AllergyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.590f4f0d-c8b0-412d-be1e-3eb2ccb29ac02024-11-25WarningsExact identifier
application number: M012
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.cbd3a905-1c41-4cb0-8df6-36784430d6272024-11-25WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.7a28d0fe-0e0a-453a-b604-1cc784dd153c2024-11-25WarningsExact identifier
application number: M012
Cough and Cold plusACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltdc483d88f-cb0a-4dd6-b3ae-559521782ba62024-11-25WarningsExact identifier
application number: M012
DayTime SinusACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.a0b01aef-4248-4d41-862c-0c8884dfca5e2024-11-25WarningsExact identifier
application number: M012
DayTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.3af20739-6794-42e0-b404-3f0401d10a6d2024-11-25WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mgDEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.ffc7e1e2-b664-461b-963d-764bad2f983f2024-11-25WarningsExact 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