FDA.reportPublic FDA data

HEB Sore Throat

Product NDC
37808-805
11-digit product format
378080805
Labeler code
37808
Product ID
37808-805_e9021076-d9a6-4eff-aa68-9ff8209dceee
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
SPRAY
Route
ORAL
Labeler
HEB
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-14
Substance
PHENOL
Active strength
1.4 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
HEB Sore Throat
Brand name suffix
Menthol Flavor
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOL1.4 g/100mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-805-06HEB Sore ThroatMenthol Flavor177 mL in 1 BOTTLE, SPRAYSPRAY1777

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-805HEB SORE THROAT MENTHOL FLAVOR (PHENOL) SPRAY [HEB]6Current NDC, Legacy NDC, 1 package rows20240915_94fce8d0-2337-4938-94c7-79d5635a4df6.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 25 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.0192ccf9-1715-4e23-a6bf-8bd838cd8b0d2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.edcb8451-6fa7-4bc2-95f6-2a0806f7f3da2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.576660ed-203a-4842-9d39-c5be10daf9762025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.1796b3ec-833a-4cf1-ba50-bc4da827f84f2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.d923fa75-f556-45e3-9f52-39a62e89984b2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.cd3ede8c-2c77-4d81-8dff-8198025a21562025-01-09WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCcb7f5f9b-4192-15e6-e053-2995a90a64572025-01-09WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLC2b494372-de59-e462-e063-6294a90a08da2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Citya225d515-430d-4e34-846c-0bfec3e741092025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City372f99c9-4ad3-4631-b8c8-2a34c47343cc2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Citye554b5b2-cf91-464a-a930-3e1087f12c8d2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City98da331c-76c2-49fe-b687-6bfba4ae2e752025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Cityd2195efa-597d-4ba9-a9b0-8df0d8f493112025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Cityfba82d55-94db-4432-b532-603fe57202be2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City9ed0fe31-e5f2-4d6d-8686-1286c66598472025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Cityd5f42c30-343c-4e1d-950c-89bbd361fd272025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City7dce407f-bbe4-4a27-97ff-be33fd4474612025-01-09WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCcb7f28f3-a908-47a9-e053-2995a90a6cbd2025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.921bdb76-f6d3-4e0a-a0ac-277dcc4e8d282025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.a80cfd29-8314-4639-a811-afd5fdb630b02025-01-09WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198776phenol 1.4 % Mucosal SprayPSN94fce8d0-2337-4938-94c7-79d5635a4df67
198776phenol 14 MG/ML Mucosal SpraySCD94fce8d0-2337-4938-94c7-79d5635a4df67
198776phenol 1.4 % Mucosal SpraySY94fce8d0-2337-4938-94c7-79d5635a4df67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-805-0637808080506177 mL in 1 BOTTLE, SPRAY (37808-805-06) 177 ml2019-05-140000-00-00NoNoCurrent