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 21 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries BlueberryFLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRYWORLD DENTISTS ASSOCIATION AMERICA LIMITED3573f149-2af9-4c86-e063-6294a90a7b3f2025-05-18WarningsExact identifier
application number: M022
Bubble Gum Flavor For Kids 25g 50gBUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50GWORLD DENTISTS ASSOCIATION AMERICA LIMITED354c1eda-ec5b-a8c7-e063-6294a90a871d2025-05-16WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDESafeway, Inc.8fe2f1df-3264-455d-b62c-953dce171c022025-05-16WarningsExact identifier
application number: M022
Parodontax Active Gum Health Daily Mouthwash Breath FreshenerCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC32b632bf-058d-447b-a7fb-a9dd05c1e2b82025-05-08WarningsExact identifier
application number: M022
Parodontax Active Gum Health Clear MintCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC444f931d-5e38-4cda-97ba-98aa0b5fe4f62025-05-08WarningsExact identifier
application number: M022
Listerine Clinical Solutions Gum Health Icy MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC06e1122b-1100-43c0-e063-6394a90a2e782025-04-22WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEStrategic Sourcing Services LLC5260258a-bb1e-43d6-bce1-70a38778a64a2025-04-14WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDETARGET Corporation93d0bb3a-51d3-44c8-8fb7-bdb82adfbb652025-04-14WarningsExact identifier
application number: M022
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCee467ec4-bd5e-644a-e053-2a95a90ac2732025-04-10WarningsExact identifier
application number: M022
MouthwashMENTHOL, METHYL SALICYLATE, THYMOLOrazen Inc873c43df-1d46-359b-e053-2a91aa0a43192025-04-07WarningsExact identifier
application number: M022
Sensodyne Complete Protection Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLCe3cc3146-8aed-4f6b-a252-e379418c2b8d2025-03-26WarningsExact identifier
application number: M022
Listerine Freshburst AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCee1e1df9-74c6-d24b-e053-2a95a90a43d32025-03-04WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCedb9e374-4dba-5823-e053-2a95a90a3da52025-03-03WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEGood Sense (Geiss, Destin & Dunn, Inc.)cfe9be26-e4a4-413c-a602-2f5948e3bb7a2025-03-03WarningsExact identifier
application number: M022
LISTERINE Original AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC78e2e172-09a4-4bf1-9871-d099c49087be2025-02-28WarningsExact identifier
application number: M022
WHITE GLO CHARCOAL SENSITIVEPOTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCa5edb7fd-c637-5447-e053-2995a90a5a6f2025-02-26WarningsExact identifier
application number: M022
Glorysmile Toothpaste.GLORYSMILE TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd2ef48156-904d-e42a-e063-6394a90a3cd02025-02-25WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEWalgreensc4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa2025-02-21WarningsExact identifier
application number: M022
Sheffield Pain ReliefBENZOCAINESheffield Pharmaceuticals LLCe21abfdd-373d-42af-9535-fe1571382a652025-02-19WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEWhole Foods Marketa2bb142e-8cbe-481e-bf4f-810ca6d145912025-02-12WarningsExact 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