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 37 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSODYNE Rapid ReliefSTANNOUS FLUORIDEHaleon US Holdings LLCf9589e7c-c5ca-4465-8d37-47ad6c69249f2024-03-06WarningsExact identifier
application number: M022
SENSODYNE Repair and Protect Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLC34260c69-d829-46c0-b12a-5136ee073ba12024-03-06WarningsExact identifier
application number: M022
AQUAFRESH SENSITIVE MAXIMUM STRENGTHPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC76adbccb-0812-4407-a6fc-a57e6f144fbb2024-03-05WarningsExact identifier
application number: M022
SENSODYNE Advanced WhiteningPOTASSIUM NITRATEHaleon US Holdings LLCa06e2549-3c4e-4818-b53e-1dea6828219f2024-03-04WarningsExact identifier
application number: M022
Sensodyne Extra Whitening Cool MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCc977f2c4-e0f3-44d2-aa7a-845f0583af3e2024-03-04WarningsExact identifier
application number: M022
Sensodyne Natural whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC911ac7e4-2b92-43d5-af0b-b5f741b088fb2024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Healthy WhitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCaca38560-2fd7-47be-9e93-2abc3214e8562024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Gently SoothingPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC5403ab67-532c-4bdf-9b06-07b1866f37f12024-03-04WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Active Shield Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCe8684615-f544-4871-b935-0a0f93639d7d2024-03-04WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC3dfa6827-3aae-4f19-93f6-2ded2faf2ddd2024-03-04WarningsExact identifier
application number: M022
Made by Dentists Sensitive and Whitening Fresh MintPOTASSIUM NITRATE, SODIUM FLUORIDEMADE BY DENTISTS INC0d379c26-69ff-4666-9ad5-7618f0bd139f2024-02-27WarningsExact identifier
application number: M022
Polident ProPartialSTANNOUS FLUORIDEHaleon US Holdings LLC557eeb32-64f4-41e8-ada4-91bd39ae29202024-02-07WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Daily ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCedffce4d-108b-4ffd-9adf-e12cb42ffddd2024-01-24WarningsExact identifier
application number: M022
Peppermint TwistFLUORIDECaldwell Health LLC4b28cdd1-0dba-42f5-a9e8-06d9e75b23962024-01-17WarningsExact identifier
application number: M022
The Natural Dentist Groovy GrapeFLUORIDECaldwell Consumer Health LLC087abbed-1f58-4b45-a76b-a950fa81c18c2024-01-16WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINPharma Nobis, LLCe42fccc2-1b4f-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M022
Sunmark Benzoin Compound TinctureBENZOIN RESINStrategic Sourcing Services LLC0c96d810-83dc-47d3-9a75-63a79feaad0a2023-12-19WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINHumco Holding Group, Inc.b33b5896-673b-498c-8a58-76ece8552f7a2023-12-15WarningsExact identifier
application number: M022
Povidone IodinePOVIDONE IODINE ORAL RINSE 0.5%Humco Holding Group, Inc.b83dbdd1-ff63-caf8-e053-2a95a90a57642023-12-15WarningsExact identifier
application number: M022
Moon Whitening Gel AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c556a29-a697-3a66-e063-6394a90abfee2023-12-12WarningsExact 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