FDA.reportPublic FDA data

Chloraseptic Warming Sore Throat

Product NDC
67172-212
11-digit product format
671720212
Labeler code
67172
Product ID
67172-212_3af45e20-add4-44f4-ac68-9a723622f417
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
SPRAY
Route
ORAL
Labeler
Prestige Brands Holdings, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-07-01
Substance
PHENOL
Active strength
3.5 mg/.7mL
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
Chloraseptic Warming Sore Throat
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOL3.5 mg/.7mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a197fab2-70ce-4a6c-9add-29d7368a75c5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67172-212-31Chloraseptic Warming Sore Throat177 mL in 1 BOTTLESPRAY1779

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENOLACTIVE INGREDIENT339NCG44TVCHLORASEPTIC WARMING SORE THROAT (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
PHENOLACTIVE MOIETY339NCG44TVCHLORASEPTIC WARMING SORE THROAT (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHLORASEPTIC WARMING SORE THROAT (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CHLORASEPTIC WARMING SORE THROAT (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHLORASEPTIC WARMING SORE THROAT (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHLORASEPTIC WARMING SORE THROAT (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHLORASEPTIC WARMING SORE THROAT (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHLORASEPTIC WARMING SORE THROAT (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCHLORASEPTIC WARMING SORE THROAT (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67172-212CHLORASEPTIC WARMING SORE THROAT (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]9Current NDC, Legacy NDC, 1 package rows20241101_a197fab2-70ce-4a6c-9add-29d7368a75c5.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 30 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental72fd2232-cd5a-4e25-b139-522b589c44722025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC42521b29-67e4-4a16-848d-7e6ba4a7ece22025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals LLC723da3ae-3f1f-4962-920b-f2a30c8c32532025-01-08Warnings, Adverse reactionsExact identifier
application number: M022
V34 Colour CorrectorV34 COLOUR CORRECTORJiangxi Dentalbright Technology Co., Ltd2b2a0b47-7628-4b85-e063-6294a90a45a02025-01-07WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.bc2e7ac3-f9e4-49cc-9f0c-6fe94479314d2025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.fb38b10d-0faf-403c-9921-d4f6b0f6aa552025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.a9dc2245-c029-4453-bfc5-8fb899873c342025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.ba49a18d-8568-421b-a495-8fee863c97572025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.c9b584d9-7407-445a-b084-926250af9f8e2025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.4aa6eec8-394a-4ecb-8173-66561fd649132025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.25c99ae3-90f4-4a63-924d-f810b3ba6e602025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.84e8d5c8-2a35-4179-9a9c-9a4a52c2cae62025-01-03WarningsExact identifier
application number: M022
Prevention Oncology Mouth RinseGLYCERINPrevention Health Sciences, Inc.1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c2025-01-01WarningsExact identifier
application number: M022
Prevention Mouth Sore RinseHYDROGEN PEROXIDEPrevention Health Sciences, Inc.2eae61e4-1800-5fa6-e063-6394a90a95832025-01-01WarningsExact identifier
application number: M022
Antiseptic Lil Drug Store ProductsEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLLil' Drug Store Products, Incdca36a30-2c9f-4d0b-be88-b45c7046f5092024-12-31WarningsExact identifier
application number: M022
Sensodyne Clinical White Intensive CleanPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCf193ec40-032f-42c7-81f1-029ec89893742024-12-31WarningsExact identifier
application number: M022
TeethWhitening KitTEETHWHITENING KITJiangxi Dentalbright Technology Co., Ltd.29393313-217a-dc3a-e063-6294a90addb12024-12-20WarningsExact identifier
application number: M022
Breezers Cool BerryPECTINMondelez Global LLCb31d0078-21d7-4d18-a8d3-7c8d48d6d0042024-12-20WarningsExact identifier
application number: M022
Breezers Creamy StrawberryPECTINMondelez Global LLC777fd6db-f129-4489-8312-4b1aca94878e2024-12-20WarningsExact identifier
application number: M022
Halls Breezers Sugar Free Cool BerryPECTINMondelez Global LLCdd1b4b17-4f73-4052-9589-d5fd6bb059bb2024-12-20WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67172-212-3167172021231177 mL in 1 BOTTLE (67172-212-31) 177 ml2012-07-010000-00-00NoNoCurrent