FDA.reportPublic FDA data

Sore Throat

Product NDC
55319-376
11-digit product format
553190376
Labeler code
55319
Product ID
55319-376_29ffda8c-62ad-4d9a-8501-db72aac0f93b
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
SPRAY
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-30
Substance
PHENOL
Active strength
1.4 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Brand name suffix
Cherry
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
339NCG44TVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198776Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7806fac7-736e-44b0-baa2-42feb7237417Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-376-062023-02-11C16284748780-1f386c649-cf09-0266-e053-dadaa90a7c1aDrug Facts
55319-376-062023-01-30C16284748780-1f386c649-cf09-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-376-06Sore ThroatCherry177 mL in 1 BOTTLE, SPRAYSPRAY1775

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-376SORE THROAT CHERRY (PHENOL) SPRAY [FAMILY DOLLAR (FAMILY WELLNESS)]5Current NDC, Legacy NDC, 1 package rows20240328_7806fac7-736e-44b0-baa2-42feb7237417.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 11 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Kids Advanced Color ChangingSODIUM MONOFLUOROPHOSPHATEProcter & Gamble Manufactura, S de R.L. de C.V.fc86b98e-d556-4769-e053-6394a90afc6e2026-01-08WarningsExact identifier
application number: M022
Care One Maximum StrengthFLUORIDEAmerican Sales1b6618ea-6533-41d7-be2c-13bb9e108dc52026-01-08WarningsExact identifier
application number: M022
equate SensitivePOTASSIUM NITRATE, SODIUM FLUORIDEWal-Mart Stores Inc79899b59-3a16-6504-e053-2991aa0a895a2026-01-08WarningsExact identifier
application number: M022
Crest Kids Advanced Color ChangingSODIUM MONOFLUOROPHOSPHATEProcter & Gamble Manufactura, S de R.L. de C.V.451283d3-78b0-8361-e063-6294a90a1fd52026-01-08WarningsExact identifier
application number: M022
CVS Maximum StrengthBENZOCAINECVS Pharmacy8691d6b6-741e-47b2-8332-76742b34715f2026-01-08WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum GelBENZOCAINEPublix Super Markets INC16eb9d15-dba3-36e6-e063-6394a90ab8592026-01-08WarningsExact identifier
application number: M022
Toothache and Gum ReliefBENZOCAINE, MENTHOLCVS Pharmacy814ec7bf-f825-1095-e053-2a91aa0aee592026-01-08WarningsExact identifier
application number: M022
LemonGLYCERINSion Biotext Medical Ltddbd7ed86-1b92-4471-827a-89f3afa1b0dc2026-01-08WarningsExact identifier
application number: M022
Sootheez Organic Wild CherryPECTINBFY LLC47baa2a8-270c-fa07-e063-6394a90a97f62026-01-06WarningsExact identifier
application number: M022
Parodontax Gum Strengthen and ProtectCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC3bb378c8-14b2-aa13-e063-6294a90a4db32026-01-05WarningsExact identifier
application number: M022
MySweetSmile Toothpaste.MYSWEETSMILE TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd478baf87-9276-7288-e063-6294a90a9e8e2026-01-04WarningsExact identifier
application number: M022
MySweetSmile Mango Toothpaste.MYSWEETSMILE MANGO TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd478cbdeb-28e1-fa56-e063-6294a90af1242026-01-04WarningsExact identifier
application number: M022
Smile PaintSODIUM FLUORIDEJABBER JAW KIDS TOOTHPASTE LLCa7463b5c-53b2-4353-a5ea-800fbd7bd17d2026-01-02WarningsExact identifier
application number: M022
Dentek Canker CoverMENTHOLBershtel Enterprises2669183c-7a58-037e-e054-00144ff88e882025-12-31WarningsExact identifier
application number: M022
AutoBrush strawberrySODIUM FLUORIDELander Enterprises, LLC05929148-bffe-439f-a9d4-3170816c0fa22025-12-31WarningsExact identifier
application number: M022
AutoBrush WatermelonSODIUM FLUORIDELander Enterprises, LLC37a4e712-e3b5-42f6-971c-98dea4b8dd062025-12-31WarningsExact identifier
application number: M022
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLC6bcd35f5-18ea-4fc8-84cd-06db73f38a1e2025-12-31WarningsExact identifier
application number: M022
AutoBrush BubblegumSODIUM FLUORIDELander Enterprises, LLCe7bf7e31-650d-4a1c-9100-48722344b2012025-12-31WarningsExact identifier
application number: M022
Normal SaltSODIUM CHLORIDEGRAXCELL PHARMACEUTICAL, LLCf3f09817-8a38-4aa1-956b-69d9cf6950742025-12-25WarningsExact identifier
application number: M022
Sensitive Mint Tooth-pastePOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.1e5e8b24-8304-482c-ae80-73effcc345da2025-12-23WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198776phenol 1.4 % Mucosal SprayPSN7806fac7-736e-44b0-baa2-42feb72374175
198776phenol 14 MG/ML Mucosal SpraySCD7806fac7-736e-44b0-baa2-42feb72374175
198776phenol 1.4 % Mucosal SpraySY7806fac7-736e-44b0-baa2-42feb72374175

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-376-0655319037606177 mL in 1 BOTTLE, SPRAY (55319-376-06) 177 ml2014-06-300000-00-00NoNoCurrent