FDA.reportPublic FDA data

THERASTAT

Product NDC
50332-0137
11-digit product format
503320137
Labeler code
50332
Product ID
50332-0137_185393b3-076a-4f6c-841b-50912e97c46b
Type
HUMAN OTC DRUG
Nonproprietary name
Cherry Cough Drops
Dosage form
LOZENGE
Route
ORAL
Labeler
HART Health
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-04
Substance
MENTHOL
Active strength
5.8 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
THERASTAT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5.8 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
476973Internal RxNorm lookup
2548889Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
96bae19a-3337-4199-9b8c-cdf9b368178bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50332-0137-4THERASTAT1 in 1 PACKETLOZENGE11
50332-0137-4THERASTAT50 in 1 BOXLOZENGE501

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 1 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MG DermaSpray 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.153ed8ff-5632-4f21-84de-2b87ac2bef312026-08-04WarningsExact identifier
application number: M
The Original Mane n Tail Daily Control 2 in 1 Anti DandruffPYRITHIONE ZINCStraight Arrow Products Inc68ab55d6-b1a9-46c0-87f0-ec12ad3474bc2026-07-09WarningsExact identifier
application number: M
Stool Softener LaxativeDOCUSATE SODIUMATLANTIC BIOLOGICALS CORP.c1f588d0-4600-4b97-b2d3-2c08ac351e072026-06-30WarningsExact identifier
application number: M
Docusate SodiumDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.66ca7a94-378b-4476-8060-d9c6f82f57fc2026-06-12WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Health3d17aba0-220f-42c4-9e26-5c44857847cd2026-05-20Warnings, Adverse reactionsExact identifier
application number: M
IT Cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep Deep Honey Deep Bronze Neutral Deep Deep Mocha Tan Cool Rich Cool Deep Cool Neutral RichHOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc2a44a019-0cc0-439b-aaa5-37582ec5492e2026-05-14WarningsExact identifier
application number: M
THORACOLHONEY LEMON COUGH DROPSHART Healthfee9f594-c619-4d77-bb52-632078e0254e2026-04-16WarningsExact identifier
application number: M
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Health07d447f1-469c-4e34-b807-ede9a449e6ab2026-04-15WarningsExact identifier
application number: M
HYDROCORTISONEHYDROCORTISONE CREAMHART Healthc76fb030-cbb5-4773-aa52-d038cb41d0af2026-04-15WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEAmazon.com Services LLC55b0d905-fcc0-40ba-a5dd-331a27a3a2092026-04-07Warnings, Adverse reactionsExact identifier
application number: M
Docusate SodiumDOCUSATE SODIUM 100MGPharbest Pharmaceuticals, Inc.025e03e0-e273-47ed-87f7-98e388abe0472026-03-05WarningsExact identifier
application number: M
TEENY TUMMY Gas Relief DropsSIMETHICONEALTANTIC BIOLOGICAS CORP.05eadb73-4468-4dae-a67b-133d893feed22026-02-13WarningsExact identifier
application number: M
Relief-PEACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINEHART Health9475fb51-931b-4a89-be6b-62e715d0883e2026-01-15WarningsExact identifier
application number: M
ASPIRINASPIRINHART Healtha1c73edf-861d-478b-9d3c-0eddcc6879cc2026-01-14WarningsExact identifier
application number: M
HISTAPRINDIPHENHYDRAMINENorMed38786a65-a12b-4479-b63c-b7c15410da042026-01-14WarningsExact identifier
application number: M
Blood ClottingBENZETHONIUM CHLORIDE AND LIDOCAINEHART Health21668731-8b8a-404f-80ab-962a0a9d5f632026-01-14WarningsExact identifier
application number: M
BandageBENZOCAINE AND BENZETHONIUM CHLORIDEHART Health6de57472-6dd0-43b6-8a82-fe459fa99ddb2026-01-14WarningsExact identifier
application number: M
Sooth-a-StingBENZOCAINE, ISOPROPYL ALCOHOLHART Healthc0e7d661-a9c9-4656-a516-57552848ebe82026-01-12WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLHART Health8d01b10b-7916-420e-9d44-ebd3806fe3152026-01-12WarningsExact identifier
application number: M
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476973menthol 5.8 MG Oral LozengePSN96bae19a-3337-4199-9b8c-cdf9b368178b1
2548889Therastat 5.8 MG Oral LozengePSN96bae19a-3337-4199-9b8c-cdf9b368178b1
2548889menthol 5.8 MG Oral Lozenge [Therastat]SBD96bae19a-3337-4199-9b8c-cdf9b368178b1
476973menthol 5.8 MG Oral LozengeSCD96bae19a-3337-4199-9b8c-cdf9b368178b1
2548889Therastat 5.8 MG Oral LozengeSY96bae19a-3337-4199-9b8c-cdf9b368178b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50332-0137-45033201370450 PACKET in 1 BOX (50332-0137-4) / 1 LOZENGE in 1 PACKET50 packet2025-08-04NoNoCurrent