FDA.reportPublic FDA data

Sore Throat

Product NDC
49348-991
11-digit product format
493480991
Labeler code
49348
Product ID
49348-991_a456cda4-cd0f-4e24-a359-bbd01d0351b8
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
SPRAY
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-09-30
Marketing end
2025-08-29
Substance
PHENOL
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49348-991DDiscontinued by firm2026-10-12
excluded packagepackage49348-99149348-991-36DDiscontinued by firm2026-10-12

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct49348-991DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49348-99149348-991-36DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
49348-991-36ML - Milliliter49348-991050079cd-4148-4ced-8a13-2f1e5869bef512014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENOLACTIVE INGREDIENT339NCG44TVSORE THROAT CHERRY (PHENOL) SPRAY [MCKESSON (SUNMARK)]1
PHENOLACTIVE MOIETY339NCG44TVSORE THROAT CHERRY (PHENOL) SPRAY [MCKESSON (SUNMARK)]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSORE THROAT CHERRY (PHENOL) SPRAY [MCKESSON (SUNMARK)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASORE THROAT CHERRY (PHENOL) SPRAY [MCKESSON (SUNMARK)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSORE THROAT CHERRY (PHENOL) SPRAY [MCKESSON (SUNMARK)]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSORE THROAT CHERRY (PHENOL) SPRAY [MCKESSON (SUNMARK)]1
WATERINACTIVE INGREDIENT059QF0KO0RSORE THROAT CHERRY (PHENOL) SPRAY [MCKESSON (SUNMARK)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-991SORE THROAT CHERRY (PHENOL) SPRAY [STRATEGIC SOURCING SERVICES LLC]8Legacy NDC20240529_c004b55b-79c6-44e8-acce-fcc019786005.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-991-3649348099136177 mL in 1 BOTTLE, SPRAY (49348-991-36) 177 ml2014-09-300000-00-00NoNoCurrent