FDA.reportPublic FDA data

MEDIQUE Medikoff Drops

Product NDC
47682-050
Requested package NDC
47682-050-64
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 30 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Fast-Max Severe Congestion and CoughGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC1991d5ee-fc90-4070-8965-cd6f4abc45cf2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3ba2cc08-acad-79a8-e063-6394a90af17f2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCa3523aa3-9ed1-472d-9986-438440d0a3eb2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC2ed3c844-0532-40d9-beba-738d196de34d2026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion and PainACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC1e243dbe-138f-4346-ba22-ceea01e970522026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCa14bc0d1-9b05-4a21-aaa8-95d4d073b9ed2026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC128f3442-9802-4303-80be-aead092379362026-05-13WarningsExact identifier
application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and CoolOXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC33f0d9bb-c67d-92ba-e063-6294a90a99432026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion and Pain, Maximum StrengthACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC2c01962d-74e3-4dfa-b7cb-a91a687711d52026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCf5365c6d-9296-41a5-953a-d1008954e67f2026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC8905706b-b9da-4520-8cf2-87d7c125edf32026-05-13WarningsExact identifier
application number: M012
MUCINEX Rapid Clear Day Night and Clear and Cool NasalACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC37dcb0ed-df56-1bec-e063-6394a90a695e2026-05-13WarningsExact identifier
application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and CoolOXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC373e0d75-8def-4b98-e063-6394a90a5e472026-05-13WarningsExact identifier
application number: M012
MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASALOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC5a397466-8721-4060-a178-5ebfd7069cc92026-05-13WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC350764de-7801-b24e-e063-6394a90ab3c32026-05-13WarningsExact identifier
application number: M012
Cepacol Extra Strength Sore Throat and CoughBENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCc0cc32db-90f0-4106-8538-89821083ece12026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC316b5569-b66f-f30c-e063-6394a90ae1472026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCd9467ca2-df75-4fa1-92b3-d2101eb54a772026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC12420092-3ef6-464b-9106-2d56cd6ef2002026-05-13WarningsExact 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
47682-050-644768200506424 LOZENGE in 1 BOX (47682-050-64) 24 lozenge2008-12-300000-00-00NoNoCurrent