Freegells Cough Drops Menthol 30ct

Product NDC
83002-005
11-digit product format
830020005
Labeler code
83002
Product ID
83002-005_41ebbf77-9a31-8dbf-e063-6394a90a2158
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LOZENGE
Route
ORAL
Labeler
R.L. ALBERT & SON, INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-05
Substance
MENTHOL
Active strength
5.4 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 30ct
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5.4 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
485287Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b174e57c-4e4f-4842-b8f2-f1b067764a68Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83002-005-01Freegells Cough Drops Menthol 30ct30 in 1 BAGLOZENGE303
83002-005-01Freegells Cough Drops Menthol 30ct9 in 1 CARTONLOZENGE93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83002-005FREEGELLS COUGH DROPS MENTHOL 30CT (MENTHOL) LOZENGE [R.L. ALBERT & SON, INC]2Current NDC, 2 package rows20241222_b174e57c-4e4f-4842-b8f2-f1b067764a68.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 125 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HCLMECLIZINE HCL 25MG CHEWABLE TABLETSAphena Pharma Solutions - Tennessee, LLC02d1af4d-d97d-4019-a5bf-3ec3912386762025-01-09WarningsExact identifier
application number: M012
HISTEX PD Drops New FormulationTRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLC0c693f15-5d76-3dbf-e063-6294a90af9ac2025-01-08WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HBR 15 MGDEXTROMETHORPHAN HBR 15 MGAMZ789 LLCe2175017-6a0d-0155-e053-2995a90a65d62025-01-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRHealth Pharma USA LLC29bb7822-76c6-e39d-e063-6294a90a64fb2025-01-07WarningsExact identifier
application number: M012
Childrens Allergy ReliefCHILDRENS ALLERGY RELIEFAllegiant Healthcb6df361-b8e5-4e2f-945f-c20159d76c4f2025-01-06WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLWinCo Foods, LLCbb7a9fed-dc04-4c31-aa7f-4185d955242c2025-01-06WarningsExact identifier
application number: M012
Leader Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDECardinal Health 110, LLC. dba Leader207b2677-aaad-4fe4-a96d-963b7dcfba702025-01-06WarningsExact identifier
application number: M012
Allergy Relief CapletDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC126c05e7-2cd9-47d3-96c3-82305714e1db2025-01-02WarningsExact identifier
application number: M012
Right Remedies Adult Long Lasting Cough Relief SoftgelDEXTROMETHORPHAN HYDROBROMIDEStrive Pharmaceuticals Inc.e3ea468e-4e12-4dae-b222-8e32456b77b82025-01-02WarningsExact identifier
application number: M012
AVON HeXashield Congestion Relief OriginalOXYMETAZOLINE HYDROCHLORIDETai Guk Pharm. Co., Ltd.8f2c152c-c564-0cba-e053-2a95a90ab3c72025-01-01WarningsExact identifier
application number: M012
Multi-Symptom Nighttime Cold and Flu ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRAdvanced Rx LLCa75553bd-f3f0-47bd-b3c3-aeeb0d1a81b42025-01-01WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HYDROBROMIDEAdvanced Rx LLC297e10e3-e740-4434-91a2-2e5c54985d332025-01-01WarningsExact identifier
application number: M012
MUCUS RELIEF DMGUAIFENESIN, DEXTROMETHORPHAN HBRAdvanced Rx LLC64620186-a45b-4c35-a3b9-a347348f93f72025-01-01WarningsExact identifier
application number: M012
DM MaxDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBest Choice57a44bbf-a304-47b9-8adc-4442c77878532025-01-01WarningsExact identifier
application number: M012
Long Acting Cough SoftgelsDEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY, INC322daee6-c61d-43d3-a54d-a354fd3df2422025-01-01WarningsExact identifier
application number: M012
Adult Tussin DM Lil Drug Store ProductsDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINLil' Drug Store Products, Inc1915cf2a-ebaa-4c47-8991-5b741fa01be22024-12-31WarningsExact identifier
application number: M012
Congestion Relief Lil Drug Store ProductsOXYMETAZOLINE HYDROCHLORIDELil' Drug Store Products, Inc8fca348c-ecb6-4a91-89dd-8bd4c05ac7452024-12-31WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU MULTI SYMPTOMDAYTIME COLD AND FLU MULTI SYMPTOMTARGET CORP9dea350d-2f09-b944-e053-2995a90a2b632024-12-30WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreens2b7aa3f5-3bc9-471f-8ff7-3c52719f0acb2024-12-30WarningsExact identifier
application number: M012
Pediacare Childrens Cough and Cold GrapeBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTHfabafdc1-9dd8-4258-af49-bab1e29ad1092024-12-30WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485287menthol 5.4 MG Oral LozengePSNb174e57c-4e4f-4842-b8f2-f1b067764a683
485287menthol 5.4 MG Oral LozengeSCDb174e57c-4e4f-4842-b8f2-f1b067764a683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83002-005-01830020005019 BAG in 1 CARTON (83002-005-01) / 30 LOZENGE in 1 BAG9 bag2023-07-05NoNoCurrent