FDA.reportPublic FDA data

Sore Throat Logenzes

Product NDC
0904-6255
11-digit product format
009046255
Labeler code
0904
Product ID
0904-6255_4b972e11-08d1-5afd-e063-6294a90a97f1
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine and Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-12-28
Substance
BENZOCAINE; MENTHOL
Active strength
15; 3.6 mg/1; 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0904-6255-49fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0904-6255-4986f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0904-6255-49bd6a592717d7…303034d00443…

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
Sore Throat Logenzes
Brand name suffix
Sore Throat
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE15 mg/1
MENTHOL3.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
824574Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
11416620-4892-44ba-9780-db27efff6743Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0904-6255-492023-11-09C16284748780-1d6a99b39-9f14-a426-e053-dadaa90af4c2Cēpacol ® SORE THROAT
0904-6255-492022-01-28C16284748780-1d6a99b39-9f14-a426-e053-dadaa90af4c2Cēpacol ® SORE THROAT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6255-49Sore Throat LogenzesSore Throat18 in 1 BLISTER PACKLOZENGE185
0904-6255-49Sore Throat LogenzesSore Throat18 in 1 CARTONLOZENGE185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6255-49EA - Each0904-6255a2eb59a3-971e-4b7e-9167-67437d05552812013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5SORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ASORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5SORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]1
MENTHOLACTIVE MOIETYL7T10EIP3ASORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]1
ALLYL SUCROSEINACTIVE INGREDIENTVI3D59RW0USORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]1
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NSORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]1
HYDROGENATED SOYBEAN OILINACTIVE INGREDIENTA2M91M918CSORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RSORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6255SORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20231110_11416620-4892-44ba-9780-db27efff6743.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 114 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HCL STRAWBERRY FLAVORDIPHENHYDRAMINE HCLInnovida Pharmaeutique Corporation7eb709a5-c587-4f1d-bc2d-576d07a3a3bf2025-06-04WarningsExact identifier
application number: M012
Children Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLTARGET CORPORATION69d33f77-06e1-48fa-a516-892fdf11bb1c2025-06-03WarningsExact identifier
application number: M012
oxymetazoline hydrochlorideOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fd058e2b-5445-e416-e053-6394a90a611b2025-06-03WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.36b1a7e0-c8b9-0890-e063-6394a90ab13a2025-06-03WarningsExact identifier
application number: M012
COLD, FLU and SORE THROAT RELIEFACETAMINOPHEN 650 MG, DEXTROMETHORPHAN HBR 20 MG, GUAIFENESIN 400 MG, PHENYLEPHRINE HCL 10 MGBETTER LIVING BRANDS, LLC202d60a8-83da-5afc-e063-6394a90ad7792025-05-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLTARGET CORPORATIONf935341f-1e33-d78e-e053-6294a90a348e2025-05-30WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLAARNA USA INC.365bb414-8425-a900-e063-6394a90aa8872025-05-30WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEP & L Development, LLC8559be55-8b00-4353-8e26-b5dff2ada8062025-05-30WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWalmart Inc.35da8429-1f83-9e81-e063-6294a90a35152025-05-23WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORP9dfef3dc-dbc8-659a-e053-2995a90a8c3b2025-05-21WarningsExact identifier
application number: M012
Adult TussinGUAIFENESINCamber Consumer Care896d2540-279a-4405-b176-acbff56303e52025-05-20WarningsExact identifier
application number: M012
Nuvicare NightTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATENUVICARE LLC37a88914-6234-4191-86f5-103c396c52af2025-05-20WarningsExact identifier
application number: M012
Nuvicare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDENUVICARE LLC1ea15426-4f3d-4a97-a590-6bd73bc6cbcd2025-05-19WarningsExact identifier
application number: M012
Quality Choice NasalOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION3833e781-f6ee-4c6d-8756-d8ea2293a1f22025-05-19WarningsExact identifier
application number: M012
Quality Choice Nasal Mist Severe CongestionOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONd45e99e5-ce66-4458-8d23-63a5dc7ae5092025-05-19WarningsExact identifier
application number: M012
Quality Choicel Nasal Mist Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION460f0cc1-6a85-4d79-af87-a94fd151769e2025-05-19WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC812a093f-cf83-4f7a-927a-1b5695be7f902025-05-19WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINSDA Laboratories, Inc.1fd16b06-0c3e-4a30-ae6a-7b1632189c202025-05-16WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLAkron Pharma Inc.79a6b8c7-0e81-4a46-a854-31f4490427092025-05-16WarningsExact identifier
application number: M012
Tussin DM Sugar freeDEXTROMETHORPHAN HBR AND GUAIFENESINAARNA USA, Inc.3a521b65-fb35-4cc3-b826-88513afda0f92025-05-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
824574benzocaine 15 MG / menthol 3.6 MG Oral LozengePSN11416620-4892-44ba-9780-db27efff67435
824574benzocaine 15 MG / menthol 3.6 MG Oral LozengeSCD11416620-4892-44ba-9780-db27efff67435
824574benzocaine 15 MG / menthol 3.6 MG Oral LozengePSN71a80e13-bda3-40fb-b4e7-45e9985e707c2
824574benzocaine 15 MG / menthol 3.6 MG Oral LozengeSCD71a80e13-bda3-40fb-b4e7-45e9985e707c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6255-490090462554918 BLISTER PACK in 1 CARTON (0904-6255-49) / 18 LOZENGE in 1 BLISTER PACK18 blister pack2012-12-280000-00-00NoNoCurrent