FDA.reportPublic FDA data

Sore throat

Product NDC
55910-376
11-digit product format
559100376
Labeler code
55910
Product ID
55910-376_9ca7888c-aa54-47b6-a040-fe6d74566350
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
SPRAY
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-03-31
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 cherryPHENOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)de634cf1-ed39-4d8a-8855-006c69b7aee92023-10-10WarningsExact 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 that occurs with high fever, headache, nausea, and vomiting may be serious. Consult 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
Brand name suffix
cherry
Listing expiration
2026-12-31

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
55910-376-06Sore throatcherry177 mL in 1 BOTTLE, SPRAYSPRAY1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-376SORE THROAT CHERRY (PHENOL) SPRAY [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]4Current NDC, Legacy NDC, 1 package rows20231011_de634cf1-ed39-4d8a-8855-006c69b7aee9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198776phenol 1.4 % Mucosal SprayPSNde634cf1-ed39-4d8a-8855-006c69b7aee94
198776phenol 14 MG/ML Mucosal SpraySCDde634cf1-ed39-4d8a-8855-006c69b7aee94
198776phenol 1.4 % Mucosal SpraySYde634cf1-ed39-4d8a-8855-006c69b7aee94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-376-0655910037606177 mL in 1 BOTTLE, SPRAY (55910-376-06) 177 ml2018-03-310000-00-00NoNoCurrent