FDA.reportPublic FDA data

Sore Throat Relief

Product NDC
67091-267
11-digit product format
670910267
Labeler code
67091
Product ID
67091-267_315d7a68-4823-4169-aca1-25ec89a2fdd3
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
Substance
PHENOL
Active strength
1.4 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sore Throat ReliefPHENOLWinCo Foods, LLC0f4dae93-2e42-4815-be2f-ff4887a8fd5f2024-11-20WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days. When using this product, do not exceed recommended dose. Stop use and ask a dentist or doctor if sore throat is severe, or last for more than 2 days sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsen fever, headache, rash, swelling, nausea or vomiting develops If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If more than used for minor mouth or throat pain is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Sore Throat Relief
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii339NCG44TV
Rxcui198776

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

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 ml2014-12-310000-00-00NoNoCurrent