FDA.reportPublic FDA data

Chloraseptic Warming Sore Throat

Product NDC
67172-017
11-digit product format
671720017
Labeler code
67172
Product ID
67172-017_5b26d4aa-e6ce-ae37-e063-6394a90a5c1e
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LOZENGE
Route
ORAL
Labeler
Prestige Brands Holdings, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-01
Substance
BENZOCAINE
Active strength
15 mg/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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
BENZOCAINE15 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67172-017-02Chloraseptic Warming Sore Throat1 in 1 CARTONLOZENGE114
67172-017-02Chloraseptic Warming Sore Throat18 in 1 BLISTER PACKLOZENGE1814

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5CHLORASEPTIC WARMING SORE THROAT (BENZOCAINE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]3
BENZOCAINEACTIVE MOIETYU3RSY48JW5CHLORASEPTIC WARMING SORE THROAT (BENZOCAINE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]3
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NCHLORASEPTIC WARMING SORE THROAT (BENZOCAINE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]3
EPIGALLOCATECHIN GALLATEINACTIVE INGREDIENTBQM438CTELCHLORASEPTIC WARMING SORE THROAT (BENZOCAINE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORASEPTIC WARMING SORE THROAT (BENZOCAINE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]3
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MCHLORASEPTIC WARMING SORE THROAT (BENZOCAINE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHLORASEPTIC WARMING SORE THROAT (BENZOCAINE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]3
HONEYINACTIVE INGREDIENTY9H1V576FHCHLORASEPTIC WARMING SORE THROAT (BENZOCAINE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CHLORASEPTIC WARMING SORE THROAT (BENZOCAINE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHLORASEPTIC WARMING SORE THROAT (BENZOCAINE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHLORASEPTIC WARMING SORE THROAT (BENZOCAINE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RCHLORASEPTIC WARMING SORE THROAT (BENZOCAINE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67172-017CHLORASEPTIC WARMING SORE THROAT (BENZOCAINE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]13Current NDC, Legacy NDC, 2 package rows20241101_7c161a17-cf82-4de3-8348-888c040df0f9.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
199071benzocaine 15 MG Oral LozengePSN7c161a17-cf82-4de3-8348-888c040df0f914
1245378Chloraseptic Warming Sore Throat 15 MG Oral LozengePSN7c161a17-cf82-4de3-8348-888c040df0f914
1245378benzocaine 15 MG Oral Lozenge [Chloraseptic]SBD7c161a17-cf82-4de3-8348-888c040df0f914
199071benzocaine 15 MG Oral LozengeSCD7c161a17-cf82-4de3-8348-888c040df0f914
1245378Chloraseptic 15 MG Oral LozengeSY7c161a17-cf82-4de3-8348-888c040df0f914
1245378Chloraseptic Warming Sore Throat 15 MG Oral LozengeSY7c161a17-cf82-4de3-8348-888c040df0f914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67172-017-02671720017021 BLISTER PACK in 1 CARTON (67172-017-02) / 18 LOZENGE in 1 BLISTER PACK1 blister pack2012-01-010000-00-00NoNoCurrent