FDA.reportPublic FDA data

Giltuss Bucalsep

Product NDC
65852-015
11-digit product format
658520015
Labeler code
65852
Product ID
65852-015_3fa233dc-156d-1e95-e063-6294a90a8bbd
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine, Menthol, Zinc chloride
Dosage form
SPRAY
Route
ORAL; TOPICAL
Labeler
Dextrum Laboratories Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-26
Substance
ZINC CATION; BENZOCAINE; MENTHOL
Active strength
.12; 6.5; .1 mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Giltuss Bucalsep
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC CATION.12 mg/100mL
BENZOCAINE6.5 mg/100mL
MENTHOL.1 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
13S1S8SF37Internal UNII lookup
U3RSY48JW5Internal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3fa233dc-156c-1e95-e063-6294a90a8bbdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65852-015-01Giltuss Bucalsep1 in 1 CARTONSPRAY11
65852-015-01Giltuss Bucalsep30 mL in 1 BOTTLE, PLASTICSPRAY301

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 30 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental72fd2232-cd5a-4e25-b139-522b589c44722025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC42521b29-67e4-4a16-848d-7e6ba4a7ece22025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals LLC723da3ae-3f1f-4962-920b-f2a30c8c32532025-01-08Warnings, Adverse reactionsExact identifier
application number: M022
V34 Colour CorrectorV34 COLOUR CORRECTORJiangxi Dentalbright Technology Co., Ltd2b2a0b47-7628-4b85-e063-6294a90a45a02025-01-07WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.bc2e7ac3-f9e4-49cc-9f0c-6fe94479314d2025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.fb38b10d-0faf-403c-9921-d4f6b0f6aa552025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.a9dc2245-c029-4453-bfc5-8fb899873c342025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.ba49a18d-8568-421b-a495-8fee863c97572025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.c9b584d9-7407-445a-b084-926250af9f8e2025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.4aa6eec8-394a-4ecb-8173-66561fd649132025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.25c99ae3-90f4-4a63-924d-f810b3ba6e602025-01-03WarningsExact identifier
application number: M022
Benzo-JelBENZOCAINEHenry Schein Inc.84e8d5c8-2a35-4179-9a9c-9a4a52c2cae62025-01-03WarningsExact identifier
application number: M022
Prevention Oncology Mouth RinseGLYCERINPrevention Health Sciences, Inc.1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c2025-01-01WarningsExact identifier
application number: M022
Prevention Mouth Sore RinseHYDROGEN PEROXIDEPrevention Health Sciences, Inc.2eae61e4-1800-5fa6-e063-6394a90a95832025-01-01WarningsExact identifier
application number: M022
Antiseptic Lil Drug Store ProductsEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLLil' Drug Store Products, Incdca36a30-2c9f-4d0b-be88-b45c7046f5092024-12-31WarningsExact identifier
application number: M022
Sensodyne Clinical White Intensive CleanPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCf193ec40-032f-42c7-81f1-029ec89893742024-12-31WarningsExact identifier
application number: M022
TeethWhitening KitTEETHWHITENING KITJiangxi Dentalbright Technology Co., Ltd.29393313-217a-dc3a-e063-6294a90addb12024-12-20WarningsExact identifier
application number: M022
Breezers Cool BerryPECTINMondelez Global LLCb31d0078-21d7-4d18-a8d3-7c8d48d6d0042024-12-20WarningsExact identifier
application number: M022
Breezers Creamy StrawberryPECTINMondelez Global LLC777fd6db-f129-4489-8312-4b1aca94878e2024-12-20WarningsExact identifier
application number: M022
Halls Breezers Sugar Free Cool BerryPECTINMondelez Global LLCdd1b4b17-4f73-4052-9589-d5fd6bb059bb2024-12-20WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65852-015-01658520015011 BOTTLE, PLASTIC in 1 CARTON (65852-015-01) / 30 mL in 1 BOTTLE, PLASTIC2018-07-26NoNoCurrent