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
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chloraseptic Total Sore Throat and Cough, Sugar FreeMENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEPrestige Brands Holdings, Inc.34e4234c-ed61-4795-99fe-d281cdb0af882025-10-23WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: ∙ pale, gray, or blue colored skin (cyanosis) ∙ headache ∙ rapid heart rate ∙ shortness of breath ∙ dizziness or lightheadedness ∙ fatigue or lack of energy Allergy Alert : Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away. Sore Throat Warning : Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by a doctor. Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a health care professional before taking this product. for teething in children under 6 years of age Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, or emphysema a cough accompanied by excessive phlegm (mucus) When using this product do not exceed recommended dosage. Stop use and ask a dentist or doctor if: sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops cough persists for more than 1 week, tends to recur, or is accompanied by a high fever, rash, or persistent headache. These could be symptoms of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL6 mg/1
BENZOCAINE5 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A, U3RSY48JW5, 9D2RTI9KYH
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
67172-015-11Chloraseptic 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

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