FDA.reportPublic FDA data

Sore Throat Relief

Product NDC
67091-267
11-digit product format
670910267
Labeler code
67091
Product ID
67091-267_48a2c366-1513-45fb-9d22-888ce8b49aea
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
SPRAY
Route
ORAL
Labeler
WinCo Foods, LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-31
Marketing end
2028-02-28
Substance
PHENOL
Active strength
1.4 g/100mL
NDC exclude flag
No
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
Sore Throat Relief

Active Ingredients#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-267-17Sore Throat Relief177 mL in 1 BOTTLE, SPRAYSPRAY1776

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-267SORE THROAT RELIEF (PHENOL) SPRAY [WINCO FOODS, LLC]6Current NDC, Legacy NDC, 1 package rows20241122_0f4dae93-2e42-4815-be2f-ff4887a8fd5f.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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198776phenol 1.4 % Mucosal SprayPSN0f4dae93-2e42-4815-be2f-ff4887a8fd5f6
198776phenol 14 MG/ML Mucosal SpraySCD0f4dae93-2e42-4815-be2f-ff4887a8fd5f6
198776phenol 1.4 % Mucosal SpraySY0f4dae93-2e42-4815-be2f-ff4887a8fd5f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-267-1767091026717177 mL in 1 BOTTLE, SPRAY (67091-267-17) 177 ml2014-12-312028-02-28NoNoCurrent