FDA.reportPublic FDA data

Chloraseptic Sore Throat Citrus

Product NDC
67172-112
11-digit product format
671720112
Labeler code
67172
Product ID
67172-112_7013a023-7366-4c7a-b25b-c76942be98a5
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
2010-09-01
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
Chloraseptic Sore Throat Citrus
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
616480Internal RxNorm lookup
1101850Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d5d62f7a-8f92-4d42-a2fb-691f896f72fcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67172-112-31Chloraseptic Sore Throat Citrus177 mL in 1 BOTTLE, SPRAYSPRAY17711

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENOLACTIVE INGREDIENT339NCG44TVCHLORASEPTIC SORE THROAT CITRUS (PHENOL) SPRAY CHLORASEPTIC SORE THROAT CHERRY (PHENOL) SPRAY CHLORASEPTIC SORE THROAT MENTHOL (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
PHENOLACTIVE MOIETY339NCG44TVCHLORASEPTIC SORE THROAT CITRUS (PHENOL) SPRAY CHLORASEPTIC SORE THROAT CHERRY (PHENOL) SPRAY CHLORASEPTIC SORE THROAT MENTHOL (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCHLORASEPTIC SORE THROAT CITRUS (PHENOL) SPRAY CHLORASEPTIC SORE THROAT CHERRY (PHENOL) SPRAY CHLORASEPTIC SORE THROAT MENTHOL (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
D&C GREEN NO. 5INACTIVE INGREDIENT8J6RDU8L9XCHLORASEPTIC SORE THROAT CITRUS (PHENOL) SPRAY CHLORASEPTIC SORE THROAT CHERRY (PHENOL) SPRAY CHLORASEPTIC SORE THROAT MENTHOL (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORASEPTIC SORE THROAT CITRUS (PHENOL) SPRAY CHLORASEPTIC SORE THROAT CHERRY (PHENOL) SPRAY CHLORASEPTIC SORE THROAT MENTHOL (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCHLORASEPTIC SORE THROAT CITRUS (PHENOL) SPRAY CHLORASEPTIC SORE THROAT CHERRY (PHENOL) SPRAY CHLORASEPTIC SORE THROAT MENTHOL (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHLORASEPTIC SORE THROAT CITRUS (PHENOL) SPRAY CHLORASEPTIC SORE THROAT CHERRY (PHENOL) SPRAY CHLORASEPTIC SORE THROAT MENTHOL (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CHLORASEPTIC SORE THROAT CITRUS (PHENOL) SPRAY CHLORASEPTIC SORE THROAT CHERRY (PHENOL) SPRAY CHLORASEPTIC SORE THROAT MENTHOL (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHLORASEPTIC SORE THROAT CITRUS (PHENOL) SPRAY CHLORASEPTIC SORE THROAT CHERRY (PHENOL) SPRAY CHLORASEPTIC SORE THROAT MENTHOL (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHLORASEPTIC SORE THROAT CITRUS (PHENOL) SPRAY CHLORASEPTIC SORE THROAT CHERRY (PHENOL) SPRAY CHLORASEPTIC SORE THROAT MENTHOL (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCHLORASEPTIC SORE THROAT CITRUS (PHENOL) SPRAY CHLORASEPTIC SORE THROAT CHERRY (PHENOL) SPRAY CHLORASEPTIC SORE THROAT MENTHOL (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67172-112CHLORASEPTIC SORE THROAT CITRUS (PHENOL) SPRAY CHLORASEPTIC SORE THROAT CHERRY (PHENOL) SPRAY CHLORASEPTIC SORE THROAT MENTHOL (PHENOL) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]8Current NDC, Legacy NDC, 1 package rows20250117_d5d62f7a-8f92-4d42-a2fb-691f896f72fc.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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101850Chloraseptic 0.5 % Mucosal SprayPSNd5d62f7a-8f92-4d42-a2fb-691f896f72fc11
616480phenol 0.5 % Mucosal SprayPSNd5d62f7a-8f92-4d42-a2fb-691f896f72fc11
1101850phenol 5 MG/ML Mucosal Spray [Chloraseptic Spray]SBDd5d62f7a-8f92-4d42-a2fb-691f896f72fc11
616480phenol 5 MG/ML Mucosal SpraySCDd5d62f7a-8f92-4d42-a2fb-691f896f72fc11
1101850Chloraseptic 0.5 % Mucosal SpraySYd5d62f7a-8f92-4d42-a2fb-691f896f72fc11
1101850Chloraseptic Spray 5 MG/ML Mucosal SpraySYd5d62f7a-8f92-4d42-a2fb-691f896f72fc11
616480phenol 0.5 % Mucosal SpraySYd5d62f7a-8f92-4d42-a2fb-691f896f72fc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67172-112-3167172011231177 mL in 1 BOTTLE, SPRAY (67172-112-31) 177 ml2010-09-010000-00-00NoNoCurrent