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 5 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitivity Relief Fluoride FreePOTASSIUM NITRATEHealth and Natural Beauty USA Corpc23b2a83-ebc3-4bcf-a216-7693944dcfa02026-05-22WarningsExact identifier
application number: M022
Sensitivity and Gum with Cavity ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHealth and Natural Beauty USA Corp137d6935-19a3-499d-957c-820156eec7a52026-05-22WarningsExact identifier
application number: M022
SEXYTEETH MINTY T00THPASTESEXYTEETH MINTY TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51d288c1-fe86-ffe1-e063-6394a90ab4c42026-05-14WarningsExact identifier
application number: M022
Cepacol Extra Strength Sore Throat cherryBENZOCAINE AND MENTHOLReckitt Benckiser LLC941e36dd-d8d0-4e5c-8585-10e8f06bf8f02026-05-12WarningsExact identifier
application number: M022
Cepacol Extra Strength Sore Throat honey lemonBENZOCAINE AND MENTHOLReckitt Benckiser LLCd771095b-7de3-48f3-a125-8bc76e7d17782026-05-12WarningsExact identifier
application number: M022
SEXYTEETH CHARCOAL T00THPASTESEXYTEETH CHARCOAL TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51ab8a9a-6c12-b13b-e063-6294a90ace2a2026-05-12WarningsExact identifier
application number: M022
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash AnticavityFLUORIDEWHOLE FOODS25bc7ab1-116d-143a-e063-6394a90aa9702026-05-04WarningsExact identifier
application number: M022
Gingicaine Gel StrawberryGINGICAINE GEL STRAWBERRY FLAVORGingi-Pak a Division of the Belport2fd37612-a28b-3aa1-e054-00144ff8d46c2026-05-01WarningsExact identifier
application number: M022
3ECARE Dual formula WhiteningToothpaste RefillSODIUM FLUORIDEHangzhou Namei Zhikang Technology Co., Ltd.501df1c7-4884-bb39-e063-6294a90aaf6a2026-04-23WarningsExact identifier
application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Inc1f10a72f-0b49-41cb-92f9-b0160d7664de2026-04-22WarningsExact identifier
application number: M022
EverSmile AlignerFresh Enamel GuardSODIUM FLUORIDEEverbrands, Inc.7b3d0114-dac0-4370-8545-922ec018018e2026-04-21WarningsExact identifier
application number: M022
PREOPHYDROGEN PEROXIDEEverbrands, Inc.cc5cdd29-92c1-4ce0-997e-eb624b288b092026-04-20WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum CreamBENZOCAINECVSa7576238-e7c8-7e86-e053-2995a90aaeb52026-04-20WarningsExact identifier
application number: M022
CVS Pharmacy Maximum StrengthBENZOCAINECVS Pharmacy92747826-cf58-4406-b3b5-12f7c7077c2c2026-04-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)9f991292-bbaa-4f4e-b2cb-059d1a04849e2026-04-20WarningsExact identifier
application number: M022
Osstem S Sensitivity relief toothPOTASSIUM NITRATE, SODIUM FLUORIDEOsstem Pharma Co., Ltd4f8ab179-8f29-a7cf-e063-6294a90a0c222026-04-15WarningsExact identifier
application number: M022
Crest Pro-Health Gum DetoxifyWinter MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6db58f-0b09-d155-e063-6394a90ae6582026-04-14WarningsExact identifier
application number: M022
Lolleez Orange MangoPECTINBFY LLC4f6dec8b-078a-f321-e063-6294a90a248c2026-04-14WarningsExact identifier
application number: M022
Crest Pro-Health Gum Restore Smooth MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6e3b36-e565-7d27-e063-6294a90ae5ac2026-04-14WarningsExact identifier
application number: M022
Crest Pro-Health Nightly Bacteria ShieldCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6ec1e0-c6b5-226f-e063-6294a90a8f142026-04-14WarningsExact 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