FDA.reportPublic FDA data

Chloraseptic Total Sore Throat and Cough, Sugar Free

Product NDC
67172-015
11-digit product format
671720015
Labeler code
67172
Product ID
67172-015_247635af-52b5-423b-a45f-1cc9f10d59e4
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Benzocaine and Dextromethorphan Hydrobromide
Dosage form
LOZENGE
Route
ORAL
Labeler
Prestige Brands Holdings, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-08-01
Substance
MENTHOL; BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
10; 6; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Standardized Chemical Allergen [EPC], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 Total Sore Throat and Cough, Sugar Free
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL10 mg/1
BENZOCAINE6 mg/1
DEXTROMETHORPHAN HYDROBROMIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
U3RSY48JW5Internal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1045532Internal RxNorm lookup
1045541Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
34e4234c-ed61-4795-99fe-d281cdb0af88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67172-015-11Chloraseptic Total Sore Throat and Cough, Sugar Free1 in 1 CARTONLOZENGE16
67172-015-11Chloraseptic Total Sore Throat and Cough, Sugar Free15 in 1 BLISTER PACKLOZENGE156

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5CHLORASEPTIC SORE THROAT LIQUID CENTER (MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCHLORASEPTIC SORE THROAT LIQUID CENTER (MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ACHLORASEPTIC SORE THROAT LIQUID CENTER (MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5CHLORASEPTIC SORE THROAT LIQUID CENTER (MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCHLORASEPTIC SORE THROAT LIQUID CENTER (MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ACHLORASEPTIC SORE THROAT LIQUID CENTER (MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9CHLORASEPTIC SORE THROAT LIQUID CENTER (MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORASEPTIC SORE THROAT LIQUID CENTER (MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHLORASEPTIC SORE THROAT LIQUID CENTER (MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHLORASEPTIC SORE THROAT LIQUID CENTER (MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CHLORASEPTIC SORE THROAT LIQUID CENTER (MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHLORASEPTIC SORE THROAT LIQUID CENTER (MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCHLORASEPTIC SORE THROAT LIQUID CENTER (MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67172-015CHLORASEPTIC TOTAL SORE THROAT AND COUGH, SUGAR FREE (MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]5Current NDC, Legacy NDC, 2 package rows20241206_34e4234c-ed61-4795-99fe-d281cdb0af88.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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Gum Therapy Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCed6889b6-58db-41cf-e053-2a95a90a7de22024-11-11WarningsExact identifier
application number: M022
Listerine FreshBurst AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC62b5c3ee-01cc-4c4e-9f28-e7dafa7372d82024-11-11WarningsExact identifier
application number: M022
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLCdd3729c2-fd05-4db0-a542-487bb0f9001f2024-11-11WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC9e97e4f8-80c2-44e0-862c-0dfca392a4362024-11-11WarningsExact identifier
application number: M022
Orajel 2X Medicated GelORAL PAIN RELIEVERChurch & Dwight Co., Inc.262be295-4eaf-3136-e063-6294a90a7dcc2024-11-05WarningsExact identifier
application number: M022
BIOTENE Fresh Mint OriginalSODIUM FLUORIDEHaleon US Holdings LLC1101c17f-c848-4cd5-a7cd-679b59dbe1bf2024-11-05WarningsExact identifier
application number: M022
bioteneSODIUM MONOFLUOROPHOSPHATEHaleon US Holdings LLCa47a6502-efb2-4072-9562-cbe293531c2b2024-11-04WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser CherrySODIUM PERBORATE MONOHYDRATEVintage Brands Limiteda0e145c8-6b08-40be-ae4f-5678c4a78b1e2024-10-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33b-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33a-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043a3cb4-f560-0ffd-e063-6394a90a2ff62024-10-29WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser MintSODIUM PERBORATE MONOHYDRATEVintage Brands Limitedbe57ca56-834f-4170-a407-f193484d8b0a2024-10-29WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean MintSODIUM FLUORIDEHaleon US Holdings LLC817c0dad-d109-428e-adb5-3354604acc942024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC1f3d68f6-afd6-42e7-b3e5-210228c8e7de2024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals LLC0dd15227-6603-42ac-9a5f-f2dc49e0382a2024-10-28Warnings, Adverse reactionsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0605d5d6-82bd-415e-b5cb-e273f934a4a72024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLCf70fa3fc-cd65-4a80-9efd-129e98fd39982024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief MentholPHENOLChain Drug Consortiumaf661ef0-cdc3-4146-8ae5-59795aa496502024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief Cherry FlavorPHENOLChain Drug Consortiuma9cf9829-4b70-44fa-9719-240b65c067242024-10-28WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEPHARMACY VALUE ALLIANCE, LLC85ae80c1-2bc2-4c90-9559-63510d03e7392024-10-28WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045532benzocaine 6 MG / dextromethorphan HBr 5 MG / menthol 10 MG Oral LozengePSN34e4234c-ed61-4795-99fe-d281cdb0af886
1045541Chloraseptic Total Sore Throat + Cough 10 MG / 6 MG / 5 MG Oral LozengePSN34e4234c-ed61-4795-99fe-d281cdb0af886
1045541benzocaine 6 MG / dextromethorphan hydrobromide 5 MG / menthol 10 MG Oral Lozenge [Chloraseptic Sore Throat + Cough]SBD34e4234c-ed61-4795-99fe-d281cdb0af886
1045532benzocaine 6 MG / dextromethorphan hydrobromide 5 MG / menthol 10 MG Oral LozengeSCD34e4234c-ed61-4795-99fe-d281cdb0af886
1045541Chloraseptic Sore Throat + Cough (Benzocaine 6 MG / Dextromethorphan Hydrobromide 5 MG / Menthol 10 MG) Oral LozengeSY34e4234c-ed61-4795-99fe-d281cdb0af886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67172-015-11671720015111 BLISTER PACK in 1 CARTON (67172-015-11) / 15 LOZENGE in 1 BLISTER PACK1 blister pack2010-08-010000-00-00NoNoCurrent