FDA.reportPublic FDA data

Chloraseptic Total Sore Throat and Cough

Product NDC
67172-016
11-digit product format
671720016
Labeler code
67172
Product ID
67172-016_297845ee-691e-434a-8958-a4f5df9635e0
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
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
6b1a50d0-be54-4fcb-b5e2-b47abf3555c0Available 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
67172-016-11Chloraseptic Total Sore Throat and Cough15 in 1 BLISTER PACKLOZENGE156
67172-016-11Chloraseptic Total Sore Throat and Cough1 in 1 CARTONLOZENGE16

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
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NCHLORASEPTIC 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
SUCROSEINACTIVE INGREDIENTC151H8M554CHLORASEPTIC 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
67172-016CHLORASEPTIC TOTAL SORE THROAT AND COUGH (MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]5Current NDC, Legacy NDC, 2 package rows20241206_6b1a50d0-be54-4fcb-b5e2-b47abf3555c0.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045532benzocaine 6 MG / dextromethorphan HBr 5 MG / menthol 10 MG Oral LozengePSN6b1a50d0-be54-4fcb-b5e2-b47abf3555c06
1045541Chloraseptic Total Sore Throat + Cough 10 MG / 6 MG / 5 MG Oral LozengePSN6b1a50d0-be54-4fcb-b5e2-b47abf3555c06
1045541benzocaine 6 MG / dextromethorphan hydrobromide 5 MG / menthol 10 MG Oral Lozenge [Chloraseptic Sore Throat + Cough]SBD6b1a50d0-be54-4fcb-b5e2-b47abf3555c06
1045532benzocaine 6 MG / dextromethorphan hydrobromide 5 MG / menthol 10 MG Oral LozengeSCD6b1a50d0-be54-4fcb-b5e2-b47abf3555c06
1045541Chloraseptic Sore Throat + Cough (Benzocaine 6 MG / Dextromethorphan Hydrobromide 5 MG / Menthol 10 MG) Oral LozengeSY6b1a50d0-be54-4fcb-b5e2-b47abf3555c06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67172-016-11671720016111 BLISTER PACK in 1 CARTON (67172-016-11) / 15 LOZENGE in 1 BLISTER PACK1 blister pack2010-08-010000-00-00NoNoCurrent