FDA.reportPublic FDA data

Sore Throat

Product NDC
50804-377
Requested package NDC
50804-377-06
11-digit product format
508040377
Labeler code
50804
Product ID
50804-377_7a81e62f-0d01-4d9a-8a3e-9a42f3276b28
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
SPRAY
Route
ORAL
Labeler
Good Sense (Geiss, Destin & Dunn, Inc.)
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-09-30
Marketing end
0000-00-00
Substance
PHENOL
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50804-37750804-377-06DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-377-06ML - Milliliter50804-3778b89b8c7-8e96-41ab-a40a-e23218fd5cca12017-10-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENOLACTIVE INGREDIENT339NCG44TVSORE THROAT (PHENOL) SPRAY [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
PHENOLACTIVE MOIETY339NCG44TVSORE THROAT (PHENOL) SPRAY [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
D&C GREEN NO. 5INACTIVE INGREDIENT8J6RDU8L9XSORE THROAT (PHENOL) SPRAY [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSORE THROAT (PHENOL) SPRAY [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SSORE THROAT (PHENOL) SPRAY [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSORE THROAT (PHENOL) SPRAY [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3ASORE THROAT (PHENOL) SPRAY [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSORE THROAT (PHENOL) SPRAY [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
WATERINACTIVE INGREDIENT059QF0KO0RSORE THROAT (PHENOL) SPRAY [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-377SORE THROAT (PHENOL) SPRAY [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]6Legacy NDC20241025_60379ea1-b37b-4a54-bafe-e4fad18b0bd9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50804-377-0650804037706177 mL in 1 BOTTLE, SPRAY (50804-377-06) 177 ml2014-09-300000-00-00NoNoCurrent