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
BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL
Active strength
6; 5; 10 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chloraseptic Total Sore Throat and Cough
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5, 9D2RTI9KYH, L7T10EIP3A
Rxcui1045532, 1045541

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

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