FDA.reportPublic FDA data

Chloraseptic Warming Sore Throat

Product NDC
67172-018
11-digit product format
671720018
Labeler code
67172
Product ID
67172-018_f5f9440a-90bd-40d6-b55d-3a5a80b46435
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
2012-09-01
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
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67172-018DDiscontinued by firm2026-09-14
excluded packagepackage67172-01867172-018-02DDiscontinued by firm2026-09-14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67172-018-02Chloraseptic Warming Sore Throat1 in 1 CARTONLOZENGE114
67172-018-02Chloraseptic 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
67172-018CHLORASEPTIC 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 1 of 42 · 825 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Opalescence Whitening Sensitivity ReliefPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.44e94663-895b-67da-e063-6394a90a5fe62026-09-09WarningsExact identifier
application number: M022
Opalescence Sensitivity Relief WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.b5176a84-76a3-4ad0-a2e2-4997a12da9a52026-09-09WarningsExact identifier
application number: M022
Opal by Opalescence SensitivityPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.5ffc0d14-0290-47bb-90e5-90a25a5acc282026-09-09WarningsExact identifier
application number: M022
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
application number: M022
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
application number: M022
Colgate Optic White Stain Fighter Sens ReliefSODIUM FLUORIDEColgate-Palmolive Company6ec2fff7-df44-4302-be2d-97946c6cd66a2026-09-08WarningsExact identifier
application number: M022
DRx Choice Sore Throat Menthol FlavorPHENOLRARITAN PHARMACEUTICALS INCe3269b12-5c05-45a6-81f2-65d9f016c3aa2026-09-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEAmerisourceBergen (Good Neighbor Pharmacy) 461220733015b-e81a-4a62-82ad-dacaf3f163cb2026-09-02WarningsExact identifier
application number: M022
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORTHEXYLRESORCINOLReckitt Benckiser LLC91cd2964-5d83-4e40-bc18-e3e5462f454a2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
application number: M022
LUDENS SUGAR FREE WILD CHERRY THROATPECTINPrestige Brands Holdings, Inc.274fc80c-e5b2-41c7-a119-287d6e8a22582026-08-28WarningsExact identifier
application number: M022
Medline Peroxi Fresh MouthwashHYDROGEN PEROXIDEMedline Industries, LPec7a9240-6c66-4471-b8b6-776e08a14fbc2026-08-27WarningsExact identifier
application number: M022
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
application number: M022
Ludens Watermelon Throat DropsPECTINPrestige Brands Holdings, Inc.adfb248a-96bb-4742-9df6-c47edccdd6712026-08-20WarningsExact 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
67172-018-02671720018021 BLISTER PACK in 1 CARTON (67172-018-02) / 18 LOZENGE in 1 BLISTER PACK1 blister pack2012-09-010000-00-00NoNoCurrent