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 113 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Nighttime Sinus ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLTarget Corporation23f50b88-52c3-2029-e063-6394a90ac73e2025-06-14WarningsExact identifier
application number: M012
Cough Drops Dollar General Berries Flavor 25ctPECTINDollar General Corporationc53c19a9-5984-4b08-ae46-a53dc8bb7d742025-06-13WarningsExact identifier
application number: M012
Cough Drops Dollar General Strawberry Flavor 25ctPECTINDollar General Corporationd82034ca-b7fd-48c8-ab4a-8e1e564183242025-06-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLBelleview Biosciences1db57d86-39f0-f8ca-e063-6394a90a63972025-06-12WarningsExact identifier
application number: M012
TARGET Cold and Cough and Nighttime Value PackBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL,TARGET CORPORATIONce536313-7265-405c-88b7-f45e62781da52025-06-11WarningsExact identifier
application number: M012
Capron MaxDEXTROMETHORPHAN HBR AND PYRILAMINE MALEATECapital Pharmaceutical, LLC3756812b-f128-8946-e063-6294a90a59ba2025-06-11WarningsExact identifier
application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestionDEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES60311ca3-8544-417e-aa29-e9f65c6692ba2025-06-11WarningsExact identifier
application number: M012
Cold Max NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.e65d2815-6932-123c-e053-2a95a90a2cf92025-06-10WarningsExact identifier
application number: M012
Cold Head Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmerican Sales Company0cc66c6c-db26-4bb2-a97d-c4106210d70c2025-06-10WarningsExact identifier
application number: M012
Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL.N.K. International, Inc.75a9c736-bc7e-4b7f-84ea-9474a37508ec2025-06-10WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINKJD Pharma Private Limited8877bb8d-479f-4968-8033-5c269d449a462025-06-10WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEMorning Star OTCf4ff84b3-bb0c-4900-8ba4-6d1b903947822025-06-09WarningsExact identifier
application number: M012
Equate Kids Daytime Dex Cough GelsDEXTROMETHORPHANWalmart37269cd6-1528-9879-e063-6394a90a2b542025-06-09WarningsExact identifier
application number: M012
Nuvicare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDENUVICARE LLCbdc35570-c8df-4797-a13e-7f2479ec42b72025-06-09WarningsExact identifier
application number: M012
Nuvicare DayTime and NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATENUVICARE LLCf5764925-c586-40e4-8252-24d92389af012025-06-09WarningsExact identifier
application number: M012
Nuvicare NightTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATENUVICARE LLC2a29f0ed-d86b-4787-84e0-f7a8c5e7581f2025-06-09WarningsExact identifier
application number: M012
Nuvicare DayTime and NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATENUVICARE LLC7fa8e4ad-95cb-4905-90db-d53b3bc87c412025-06-09WarningsExact identifier
application number: M012
Vaporizing Steam LiquidMEDICATED COUGH SUPPRESSANTNeilMed Pharmaceuticals Inc.36cf6218-adb8-9d8b-e063-6394a90a49a02025-06-05WarningsExact identifier
application number: M012
Geri-Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp7e2fb43c-a7f1-4c1d-a700-7c6510999c032025-06-05WarningsExact identifier
application number: M012
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTINGCHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBRHaleon US Holdings LLCbecb4025-b63e-f2ea-9d11-d51fdf4e5c132025-06-04WarningsExact 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