FDA.reportPublic FDA data

MEDIQUE Medikoff Drops

Product NDC
47682-050
Requested package NDC
47682-050-69
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 89 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TUSICOFDEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINEKramer Novise966b75c-4bb4-4216-8247-baada8f5d7592025-11-12WarningsExact identifier
application number: M012
Fast Acting Mucus Relief Maximum Strength Severe Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)52327ed0-ea49-4d1c-b928-20ab381be9f22025-11-11WarningsExact identifier
application number: M012
TOPCO Childrens Cough ReliefDEXTROMETHORPHAN HBR AND GUAIFENESINTopco Associates, LLCee0f5627-5104-4990-88ee-2fb46965bc1e2025-11-11WarningsExact identifier
application number: M012
TOPCARE Childrens Cold and Cough and Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDETopco Associates, LLC8931d4ca-c599-49be-87e1-8c0598f38b772025-11-11WarningsExact identifier
application number: M012
TOPCARE Multi Symptom Flu Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLC01c517e5-d693-4926-9eb5-4b894a2f69172025-11-11WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435b4a2a-d6bf-ec25-e063-6294a90a3f062025-11-11WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435e6387-1ee0-c20f-e063-6294a90adac52025-11-11WarningsExact identifier
application number: M012
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLC10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b2025-11-10WarningsExact identifier
application number: M012
TOPCARE Childrens Allergy ChewsDIPHENHYDRAMINE HCLTopco Associates, LLCb5e15dd1-6e99-411c-9183-8a4265eae4042025-11-08WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corp103de130-ef12-4c58-bbcf-234b3f3b2cbf2025-11-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Strawberry 30ctMENTHOLDollar General Corporation2b3fbab9-92b5-42a7-b27b-ff46350ce0552025-11-07WarningsExact identifier
application number: M012
Robitussin Day and Night Maximum Strength Cough DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCb43d8fbd-1977-4465-aa64-79e7b7f54e092025-11-07WarningsExact identifier
application number: M012
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp093649a4-f968-49bd-83af-bb7e0f448ecf2025-11-07WarningsExact identifier
application number: M012
TARGET Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTARGET CORPORATIONbfc91c71-0506-4e94-8bfe-dc9e4bf959da2025-11-07WarningsExact identifier
application number: M012
CHILDRENS COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEH E B08f4785a-c628-4e9b-9412-b2a817f9be602025-11-07WarningsExact identifier
application number: M012
G-TUSICOFDEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINEKramer Novisd169585f-b4f4-4831-8c71-e1533ae7e7c42025-11-07WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)1d512053-7a54-4691-a657-77da4c627cb82025-11-07WarningsExact identifier
application number: M012
Allergy and HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdc249163-26dd-42ca-b423-2f16299f2d652025-11-07WarningsExact identifier
application number: M012
Sinus CongestionPSEUDOEPHEDRINE HCLChain Drug Marketing Association, Inc.9744d04d-298d-4acd-9470-db9e7f2901e72025-11-07WarningsExact identifier
application number: M012
Daytime, Nighttime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc3b7fab1-f7fe-41be-a1c4-7ba4ba23c1592025-11-07WarningsExact 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
47682-050-69476820050696 LOZENGE in 1 BOX (47682-050-69) 6 lozenge2008-12-300000-00-00NoNoCurrent