Freegells Cough Drops Menthol Honey Lemon

Product NDC
71165-013
11-digit product format
711650013
Labeler code
71165
Product ID
71165-013_08a1dbae-5c73-f0b8-e063-6294a90a44be
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LOZENGE
Route
ORAL
Labeler
Riclan S.A.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-01
Substance
MENTHOL
Active strength
7.5 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
Freegells Cough Drops Menthol Honey Lemon
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL7.5 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
1250189Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6271e85-9ca2-41d3-9bff-a13670ac5b80Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71165-013-00Freegells Cough Drops Menthol Honey Lemon30 in 1 BAGLOZENGE302
71165-013-01Freegells Cough Drops Menthol Honey Lemon200 in 1 BAGLOZENGE2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71165-013FREEGELLS COUGH DROPS MENTHOL HONEY LEMON (MENTHOL) LOZENGE [RICLAN S.A.]2Current NDC, Legacy NDC, 2 package rows20231027_f6271e85-9ca2-41d3-9bff-a13670ac5b80.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 47 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
foster and thrive daytime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESportpharm LLC51e34704-5e6b-4e80-836c-ddbc24a451b22026-03-06WarningsExact identifier
application number: M012
Medi-First Plus Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDESportpharm LLC20f58b0b-c123-477f-a62c-fa5423e23f932026-03-06WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLSportpharm LLC7f4e8d37-8c6b-4849-b86c-4335a0bcac1c2026-03-06WarningsExact identifier
application number: M012
Daytime and Nighttime Cold and Flu KitDAYTIME AND NIGHTTIME COLD AND FLU KITAllegiant Health0533db78-7809-46ea-9998-deb5f6f1d0d92026-03-06WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCLBetter Living Brands, LLC0153294d-7f52-4d92-8db8-daeca3e29a3b2026-03-06WarningsExact identifier
application number: M012
Mucus DMDEXTROMETHORPHAN HBR, GUAIFENESINMeijer Distribution, Inc.87cf4f25-b0e9-4f8b-bde3-0d0f26e2120e2026-03-06WarningsExact identifier
application number: M012
RYNEX PEBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLEDWARDS PHARMACEUTICALS, INC.77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef2026-03-05WarningsExact identifier
application number: M012
Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLBest Choice (Valu Merchandisers Company)042f9449-4af0-4b15-bb3e-236afeb1e11f2026-03-05WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESINAmerisource Bergen087a3a0b-8d3f-45ed-8807-0af47b446cac2026-03-05WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MGNUVICARE LLC6c4bc7d1-09d9-4311-8457-a1d47ab02a5a2026-03-05WarningsExact identifier
application number: M012
Allergy Relief childrensDIPHENHYDRAMINE HCLWALMART INC.dceb99a9-4aa3-4acc-b632-9a4ba8c879192026-03-04WarningsExact identifier
application number: M012
AMAZON Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAMAZON.COM SERVICES LLC26101105-a6cf-4b51-a639-9d078542fea32026-03-04WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLMajor Pharmaceuticals3a976e90-c6af-4414-984e-9987158c9e982026-03-04WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLBest Choice (Valu Merchandisers Company)714e93ec-0aa9-4be2-9311-399e82f148e02026-03-04WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)d1131759-dd2e-4c06-bb73-92dd975f55112026-03-04WarningsExact identifier
application number: M012
AMAZON Maximim Strength Adult Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAMAZON.COM SERVICES LLC6bbe8cc9-7a60-4476-b5cf-b13c5bebff262026-03-04WarningsExact identifier
application number: M012
Severe Cold and Flu Daytime, NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5a1dfaf3-370d-4ac7-a72d-a48863a357412026-03-04WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWalgreen Companyc5cb09d4-c049-461c-8898-2c5bb6a8a1382026-03-04WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLWinCo Foods, LLC3d96d6d0-8c04-43bb-aed0-4cd00cdf34562026-03-04WarningsExact identifier
application number: M012
DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH E Be2994c0f-add8-4f75-a6d2-24cd2af271e42026-03-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250189menthol 7.5 MG Oral LozengePSNf6271e85-9ca2-41d3-9bff-a13670ac5b802
1250189menthol 7.5 MG Oral LozengeSCDf6271e85-9ca2-41d3-9bff-a13670ac5b802

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71165-013-007116500130030 LOZENGE in 1 BAG (71165-013-00) 30 lozenge2022-10-010000-00-00NoNoCurrent
71165-013-0171165001301200 LOZENGE in 1 BAG (71165-013-01) 200 lozenge2022-10-010000-00-00NoNoCurrent