FDA.reportPublic FDA data

Sore Throat

Product NDC
11822-3109
11-digit product format
118223109
Labeler code
11822
Product ID
11822-3109_dce3a0d7-6a70-47ed-922e-be14dbf82416
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
SPRAY
Route
ORAL
Labeler
Rite Aid Corporation
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-08
Marketing end
2026-10-08
Substance
PHENOL
Active strength
1.4 g/100mL
NDC exclude flag
No
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 ThroatPHENOLRite Aid Corporation2858d1c1-f96f-42b7-886c-b8c14286e8ba2025-07-11WarningsExact 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. Ask a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor. When using this product, do not exceed recommended dose. Stop use and ask a dentist or doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, 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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii339NCG44TV
Rxcui198776

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3109-8Sore Throat177 mL in 1 BOTTLE, SPRAYSPRAY1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3109SORE THROAT (PHENOL) SPRAY [RITE AID CORPORATION]3Current NDC, Legacy NDC, 1 package rows20241113_2858d1c1-f96f-42b7-886c-b8c14286e8ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198776phenol 1.4 % Mucosal SprayPSN2858d1c1-f96f-42b7-886c-b8c14286e8ba4
198776phenol 14 MG/ML Mucosal SpraySCD2858d1c1-f96f-42b7-886c-b8c14286e8ba4
198776phenol 1.4 % Mucosal SpraySY2858d1c1-f96f-42b7-886c-b8c14286e8ba4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-3109-811822310908177 mL in 1 BOTTLE, SPRAY (11822-3109-8) 177 ml2021-10-082026-10-08NoNoCurrent