FDA.reportPublic FDA data

Giltuss Bucalsep

Product NDC
58552-135
11-digit product format
585520135
Labeler code
58552
Product ID
58552-135_40b86bd0-283d-5043-e063-6394a90ada9c
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine, Menthol, Zinc chloride
Dosage form
SPRAY
Route
ORAL; TOPICAL
Labeler
Gil Pharmaceutical Corp
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-26
Substance
BENZOCAINE; MENTHOL; ZINC CHLORIDE
Active strength
6.5; .1; .12 g/100mL; g/100mL; g/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
BENZOCAINE6.5 g/100mL
MENTHOL.1 g/100mL
ZINC CHLORIDE.12 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
L7T10EIP3AInternal UNII lookup
86Q357L16BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2170427Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
85053391-8d71-ab4f-e053-2991aa0a7e08Available 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-01-31Giltuss Bucalsep
2022-01-31Giltuss Bucalsep
2022-01-28Giltuss Bucalsep
2022-01-28Giltuss Bucalsep

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-135-01Giltuss Bucalsep1 in 1 CARTONSPRAY16
58552-135-01Giltuss Bucalsep30 mL in 1 BOTTLE, SPRAYSPRAY306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-135-01ML - Milliliter58552-135b8573309-6625-4360-b020-5ace6b97acd212019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58552-135GILTUSS BUCALSEP (BENZOCAINE, MENTHOL, ZINC CHLORIDE) SPRAY [GIL PHARMACEUTICAL CORP]5Current NDC, Legacy NDC, 2 package rows20241027_85053391-8d71-ab4f-e053-2991aa0a7e08.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 33 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOL RELIEF LEMON FROST ORAL ANESTHETICMENTHOLRicola Ag908f5ce5-94a4-4c35-ae7a-b308ea37fa082024-12-05WarningsExact identifier
application number: M022
ORGANIC PEPPERMINT HERB THROAT DROPSMENTHOLRicola Aga6657ecf-e74a-4912-a68c-73abc456f9e22024-12-05WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola Ag67373cf1-e8c3-4db2-98e1-c88d25a762092024-12-05WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola Ag586b2a46-2673-4f27-a62a-2d48a9b520ab2024-12-05WarningsExact identifier
application number: M022
BERRY MEDLEY THROAT DROPSMENTHOLRicola Aga2bdd035-4678-4cff-b24f-8e2f06acad962024-12-05WarningsExact identifier
application number: M022
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
application number: M022
Orajel Antiseptic Alcohol-Free Mouth Sore RinseHYDROGEN PEROXIDE, MENTHOLChurch & Dwight Co., Inc.99d47d6a-fa2e-d5ee-e053-2995a90aa11d2024-11-27WarningsExact identifier
application number: M022
Orajel 2x Gum Pain Alcohol-FreeMENTHOL AND HYDROGEN PEROXIDEChurch & Dwight Co., Inc.adf37010-922c-4441-93d6-1e1a95025e902024-11-27WarningsExact identifier
application number: M022
Maximum Strength Cold Sore TreatmentCAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUMMeijer Distribution Inc9220772c-b3b7-4855-e053-2a95a90a94f62024-11-27WarningsExact identifier
application number: M022
Peroxyl Mouth Sore Mild MintHYDROGEN PEROXIDEColgate Oral Pharmaceuticals Inc.b1e1b7c9-dea7-4d64-b6a8-5343f41763592024-11-25WarningsExact identifier
application number: M022
NICE SORE THROAT SpearmintPHENOLLeosons Overseas Corp5fc68f04-ec15-11c0-e053-2a91aa0a19522024-11-20WarningsExact identifier
application number: M022
TANAC Oral Pain RelieverBENZOCAINELeosons Overseas Corp81cc61fa-31a7-2214-e053-2a91aa0ae46a2024-11-15WarningsExact identifier
application number: M022
NICE SORE THROAT Honey LemonPHENOLLeosons Overseas Corp601aea98-e6ab-de6f-e053-2a91aa0a824a2024-11-15WarningsExact identifier
application number: M022
NICE SORE THROAT CherryPHENOLLeosons Overseas Corp5f21694c-d1c9-0e64-e053-2a91aa0a0ff02024-11-15WarningsExact identifier
application number: M022
Sore ThroatPHENOLSafeway, Inc.f1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d2024-11-14WarningsExact identifier
application number: M022
Sore Throat Relief CherryPHENOLBest Choice (Valu Merchandisers Company)c0a47d59-3e15-453d-97a7-d626e86508622024-11-14WarningsExact identifier
application number: M022
Listerine Gum Therapy Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCed6889b6-58db-41cf-e053-2a95a90a7de22024-11-11WarningsExact identifier
application number: M022
Listerine FreshBurst AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC62b5c3ee-01cc-4c4e-9f28-e7dafa7372d82024-11-11WarningsExact identifier
application number: M022
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLCdd3729c2-fd05-4db0-a542-487bb0f9001f2024-11-11WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC9e97e4f8-80c2-44e0-862c-0dfca392a4362024-11-11WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2170427benzocaine 6.5 % / menthol 0.1 % / zinc chloride 0.12 % Mucosal SprayPSN85053391-8d71-ab4f-e053-2991aa0a7e086
2170427benzocaine 65 MG/ML / menthol 1 MG/ML / zinc chloride 1.2 MG/ML Mucosal SpraySCD85053391-8d71-ab4f-e053-2991aa0a7e086
2170427benzocaine 6.5 % / menthol 0.1 % / zinc chloride 0.12 % Mucosal SpraySY85053391-8d71-ab4f-e053-2991aa0a7e086

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58552-135-01585520135011 BOTTLE, SPRAY in 1 CARTON (58552-135-01) / 30 mL in 1 BOTTLE, SPRAY2018-07-260000-00-00NoNoCurrent