Freegells Cough Drops Honey Lemon 200ct

Product NDC
83002-043
11-digit product format
830020043
Labeler code
83002
Product ID
83002-043_40ab7563-8e54-4f25-e063-6394a90a699d
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LOZENGE
Route
ORAL
Labeler
RL Albert & Son Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-15
Substance
LEVOMENTHOL
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 Honey Lemon 200ct
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOMENTHOL7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BZ1R15MTK7Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ac08274-08d9-4dab-b09a-6e297948a25aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83002-043-01Freegells Cough Drops Honey Lemon 200ct200 in 1 BAGLOZENGE2002
83002-043-01Freegells Cough Drops Honey Lemon 200ct4 in 1 CARTONLOZENGE42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83002-043FREEGELLS COUGH DROPS HONEY LEMON 200CT (MENTHOL) LOZENGE [RL ALBERT & SON INC.]1Current NDC, 2 package rows20240420_3ac08274-08d9-4dab-b09a-6e297948a25a.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 144 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tussin severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E B7cc2c136-d1b7-4658-99bb-73bb1d1402612024-11-04WarningsExact identifier
application number: M012
dg health tussinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp Inca5d0ee70-d528-4a53-bf01-7bb13b364ed02024-11-04WarningsExact identifier
application number: M012
basic care tussin cf severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLCbba9a17d-eb87-46f3-acee-c9dd34e5bfd42024-11-04WarningsExact identifier
application number: M012
topcare tussin cf maxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCb553b7e6-933b-49e3-97d3-22a4643a04b92024-11-04WarningsExact identifier
application number: M012
dg health nasal originalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLCfb209752-705a-4bb0-9298-8b70357f39112024-11-02WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEH E B3c301993-642a-487c-96a2-ebc4ef90dc882024-11-02WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC1341744c-43c3-462b-b93c-1e46476fd9352024-11-01WarningsExact identifier
application number: M012
Nighttime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy43784616-1afd-4ff7-8fee-6ac389f616a22024-11-01WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLC28ef87e8-29e5-444d-b1f7-5c38a7f758d32024-11-01WarningsExact identifier
application number: M012
Good Sense Severe NightTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLL. Perrigo Company0e3c36c9-d45b-41b9-891d-a42d854295f92024-11-01WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company7dc3941a-e5f8-4caa-bae5-6a0d075295cb2024-11-01WarningsExact identifier
application number: M012
DoloMax Cold CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBENARD INDUSTRIES INC520aee75-8b9a-4dcc-8970-75e122640e912024-10-31WarningsExact identifier
application number: M012
Good Sense NasalOXYMETAZOLINE HYDROCHLORIDEA-S Medication Solutionsb6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe2024-10-31WarningsExact identifier
application number: M012
CareOne Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmerican Sales Company819d5c82-0240-4013-9904-c335bd65d03e2024-10-30WarningsExact identifier
application number: M012
Signature Care Nighttime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLSafeway9a0ad5d5-8fd9-468d-be2c-87c14d08b9342024-10-30WarningsExact identifier
application number: M012
Good Sense Severe NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLL. Perrigo Companyf2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd22024-10-30WarningsExact identifier
application number: M012
dg health cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLDolgencorp, LLC81f3ac36-9bae-4f42-92a0-8a2e4bbd09842024-10-30WarningsExact identifier
application number: M012
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLRite Aid Corporation9a71e8eb-4195-4694-bf3e-44f691ff2cef2024-10-30WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLH E Bfe4a95d2-6fb3-43fe-baec-6f22d19653232024-10-30WarningsExact identifier
application number: M012
NightTime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKroger Company2c9ef0d7-3d5b-494a-8f06-9dd42110d78a2024-10-30WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83002-043-01830020043014 BAG in 1 CARTON (83002-043-01) / 200 LOZENGE in 1 BAG4 bag2024-03-15NoNoCurrent