FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS

Product NDC
83002-001
11-digit product format
830020001
Labeler code
83002
Product ID
83002-001_40abcd12-fa40-c457-e063-6394a90a2ac3
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
R.L. ALBERT & SON, INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-15
Substance
MENTHOL
Active strength
2.7 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage83002-001-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage83002-001-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage83002-001-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage83002-001-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage83002-001-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage83002-001-011332a3947898…d4bfe170f9cd…

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 STRAWBERRY 30 DROPS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2.7 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
433196Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c6b36350-386b-4346-bef0-a37ec11319c0Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-12-20Drug Facts
2024-12-20Drug Facts
2024-01-30Drug Facts
2024-01-30Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83002-001-01FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS30 in 1 BAGSUSPENSION/ DROPS303
83002-001-01FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS9 in 1 CARTONSUSPENSION/ DROPS93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83002-001FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS (MENTHOL) SUSPENSION/ DROPS [R.L. ALBERT & SON, INC]2Current NDC, Legacy NDC, 2 package rows20241222_c6b36350-386b-4346-bef0-a37ec11319c0.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 173 of 174 · 3,464 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUAIFENESINGUAIFENESINPAI Holdings, LLC dba PAI Pharmac2e53fb5-2798-47c8-9285-d1077d46e6292022-06-14WarningsExact identifier
application number: M012
Mucus Relief DMMUCUS RELIEF DMTopCo Associates, LLC71674a9b-89ed-43d1-aadb-b9311fdfbdf92022-06-07WarningsExact identifier
application number: M012
Daytime Nighttime Cold and Flu Relief Combo PackDAYTIME NIGHTTIME COLD AND FLUAllegiant Healthfa7ed5db-4da7-46b4-a08d-1d79cb7a56742022-05-19WarningsExact identifier
application number: M012
Mucus Relief DM Immediate ReleaseMUCUS RELIEF DMGood Sense26a199bf-57e5-4f36-b40c-83a1187e48702022-05-18WarningsExact identifier
application number: M012
Mucus Relief DM Immediate ReleaseMUCUS RELIEF DMAllegiant Health731f8608-ad5b-491e-a4d4-2bb0c423fed52022-05-18WarningsExact identifier
application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HClACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb3c229a4-c772-70fb-e053-2a95a90a72db2022-03-11WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEGood Sensef88e2654-8e97-4cf6-9c36-01aeb51a91022021-11-30WarningsExact identifier
application number: M012
Cold MedicineCOLD MEDICINEAllegiant Health443fbc44-2c33-4316-ad31-dcc5a5aa8f522021-11-23WarningsExact identifier
application number: M012
Decongestant PE Non DrowsyPHENYLEPHRINE HCLAllegiant Health7a3098b4-381c-4f32-97a7-87b53fd644282021-06-16WarningsExact identifier
application number: M012
Mucus Relief Immediate ReleaseGUAIFENESIN 400MGGood Sensee7c68746-7ec0-46cf-b4a3-174fab819b5e2021-05-05WarningsExact identifier
application number: M012
Mucus Relief Immediate ReleaseGUAIFENESIN 400MGTopCo Associates, LLC7d91c6ab-d161-42b9-b353-0aa8f59619f82021-01-21WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MGAllegiant Healthbed5f9dc-45ea-4e90-86c6-86599b6f38612020-11-16WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHENAllegiant Healthb97126d7-847d-483e-b3d1-e2b61ab1743f2020-11-11WarningsExact identifier
application number: M012
Cold and AllergyPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEAllegiant Health7af63769-fa56-4f1f-a2ad-5b4c108c8e4f2019-12-12WarningsExact identifier
application number: M012
Mucus Relief Immediate ReleaseGUAIFENESINAllegiant Health221d64a2-b8c7-435a-aae4-fb58fd38108f2019-03-26WarningsExact identifier
application number: M012
Sleep Tabs For Nighttime useDIPHENHYDRAMINE HCL TABLETSAllegiant Health566e40b1-e9d7-44e4-b971-eef2b7cf0a7d2018-12-26WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEAllegiant Health4305ad50-d2a5-4d3e-9d92-cbf26e856a162018-12-26WarningsExact identifier
application number: M012
Sleep AidDIPHENHYDRAMINE HCL 25 MGAllegiant Healthdbbc535f-515a-4d9b-b799-34e60f5230bb2018-12-21WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCLAllegiant Healthc2823bad-540f-4662-8dcc-58e9f0d94efb2018-11-07WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum Strength Non-DrowsyPHENYLEPHRINE 10 MGAllegiant Health7aef00df-816a-4ea2-a2ad-beed66dd2fe42018-11-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433196menthol 2.7 MG Oral LozengePSNc6b36350-386b-4346-bef0-a37ec11319c03
433196menthol 2.7 MG Oral LozengeSCDc6b36350-386b-4346-bef0-a37ec11319c03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83002-001-01830020001019 BAG in 1 CARTON (83002-001-01) / 30 BAG in 1 BAG / 1 SUSPENSION/ DROPS in 1 BAG9 bag2022-11-150000-00-00NoNoCurrent