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

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
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 3 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERASTAT, CHERRYCHERRY COUGH DROPSHART Healthe3fdd1de-8f28-4063-a590-6c44507dead12025-12-23WarningsExact identifier
application number: M
Crystal Clean Antibacterial HandSoapBENZALKONIUM CHLORIDEChemcor Chemical Corporation308969b5-5ab2-44ef-ac70-9518a5dfbee22025-12-22WarningsExact identifier
application number: M
Foaming Antibacterial HandsoapBENZALKONIUM CHLORIDEChemcor Chemical Corporationeed9b007-0dc1-4954-891f-a7a042e763aa2025-12-22WarningsExact identifier
application number: M
Antibacterial HandsoapBENZALKONIUM CHLORIDEChemcor Chemical Corporation1022be5e-d515-4a06-bf2b-65774ec29a0b2025-12-22WarningsExact identifier
application number: M
Healthy Hands Foaming Hand SanitizerN/AMaintex746650b8-74b7-43f0-bdfc-62a68764f9362025-12-22WarningsExact identifier
application number: M
Chemcor Chemical Foaming Hand SanitizerBENZALKONIUM CHLORIDEChemcor Chemical Corporation5c9d90c1-0381-4237-9529-398fa51b3ab42025-12-22WarningsExact identifier
application number: M
Fresh HandsBENZALKONIUM CHLORIDEMaintexe174083a-8820-4fa7-8cc2-0a2c86f27cd62025-12-22WarningsExact identifier
application number: M
Aluminum HydroxideALUMINUM HYDROXIDEATLANTIC BIOLOGICALS CORP.60a54d4e-89c2-4329-86bf-a288527f37b52025-12-15WarningsExact identifier
application number: M
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.ff1f6f82-0c7c-4e3f-a2bd-3185e16fa7702025-12-10WarningsExact identifier
application number: M
Health One Pain Relief Cream with Lidocaine 4%PAIN RELIEF CREAM WITH LIDOCAINE 4%ONE2ZEE LIMITED LIABILITY COMPANY46a2276f-9da0-4e41-92f0-b17c302c72222025-12-03WarningsExact identifier
application number: M
Health One Deep Relieving GelDEEP RELIEVING GELONE2ZEE LIMITED LIABILITY COMPANY41d837f1-09e4-4ce3-8c1a-725c2147c7de2025-12-03WarningsExact identifier
application number: M
Hand SanitizerANTISEPTIC GELHART Health87fcd27f-e4bf-4ae9-ad2e-b9b11ac554cc2025-12-02WarningsExact identifier
application number: M
AB 3000BENZALKONIUM CHLORIDEChemco892c8911-9f1a-4c0c-9106-6d9a90d577a92025-11-06WarningsExact identifier
application number: M
Strike Bac Antibacterial HandBENZALKONIUM CHLORIDEGenlabs Corporation4014aa67-8016-40c5-88ec-daec9dba4f452025-11-06WarningsExact identifier
application number: M
Metro Antimicrobial HandBENZALKONIUM CHLORIDEMaintexa84d83dd-2445-4d0f-b763-2c69e8248cf92025-11-06WarningsExact identifier
application number: M
Butler Clean HandsBENZALKONIUM CHLORIDEMaintex3fd526a8-d197-4a12-b51b-165e706720a72025-11-06WarningsExact identifier
application number: M
First Street Dishwashing Concentrate and Antibacterial HandBENZALKONIUM CHLORIDEAmerifoods Trading Companyfc81ef1a-db55-411e-8b25-7dd59dd38eda2025-11-06WarningsExact identifier
application number: M
Champion Ultra CleanBENZALKONIUM CHLORIDEMaintex47426f67-af14-4b42-8ada-11b3648269492025-11-06WarningsExact identifier
application number: M
Premium Protection Antibacterial HandBENZALKONIUM CHLORIDEMaintex53bd6860-dde3-4525-ba1b-50f69be09abc2025-11-06WarningsExact identifier
application number: M
Hy-G-ClenzBENZALKONIUM CHLORIDEMicronova Manufacturing, Inc.ce96634e-1ce8-4244-b317-8e1da249de832025-11-06WarningsExact 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