FDA.reportPublic FDA data

Giltuss Bucalsep

Manufacturer
Gil Pharmaceutical Corp | Dextrum Laboratories Inc.
Effective date
2025-10-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:38:33

Label at a glance#

ProductGiltuss Bucalsep
Active ingredientBENZOCAINE, MENTHOL, ZINC CHLORIDE
Label structure11 sections

Storage and handling

Other information Tamper evident: Do not use if safety seal is broken or missing Store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 30 mL)

Benzocaine, 6.5% (1950 mg)

Zinc Chloride, 0.12% (36 mg)

Menthol, 0.1% (30 mg)

OTC - PURPOSE SECTION

Purposes

Anesthetic

Astringent

Anesthetic

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • IN OR NEAR THE EYES.In the event of accidental contact with the eyes, flush immediately and continuously for 10 minutes. Seek immediate medical attention if pain or irritation persists
  • this product for more than 7 days unless directed by a doctor or a dentist

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you have

  • a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

OTC - WHEN USING SECTION

When using this product, do not exceed recommended dosage

OTC - STOP USE SECTION

Stop use and ask a doctor or dentist if

  • sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea, or vomiting
  • symptoms do not improve in 7 days
  • irritation, pain or redness persists or increases, or a rash appears on the skin

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 2 years of age and older:

  • Spray Giltuss Bucalsep several times to affected areas in the mouth or lips or as directed by a doctor or dentist
  • use as a gargle or mouthwash
  • gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out
  • use up to 4 times daily or as directed by a doctor or dentist
  • Children under 12 years of age:should be supervised in the use of this product

Children under 2 years of age:consult a dentist or doctor

STORAGE AND HANDLING SECTION

Other information

  • Tamper evident:Do not use if safety seal is broken or missing
  • Store at room temperature

OTC - QUESTIONS SECTION

Questions or Comments?

Call 1-800-848-9114, Mon. - Fri. 9:00 a.m. thru 5:00 p.m. EST. Call your doctor for medical advice in the event of side effects.

INACTIVE INGREDIENT SECTION

Inactive ingredients:Cetylpyridinium chloride, Spearmint Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sucralose

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR:

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

INDICATIONS & USAGE SECTION

Uses

  • for the temporary relief of occasional minor irritations, pain, sore mouth, sore throat, pain associated with canker sores, pain due to minor irritation or injury of the mouth and gums, pain due to dental procedures, pain due to minor irritations caused by dentures or orthodontic appliances, sore gums

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

Oral Spray

Giltuss BUCALSEP®

SORE THROAT AND ORAL INFECTIONS

ALCOHOL FREE. SUGAR FREE. DYE FREE

RELIEVES

  • SORE THROAT
  • THROAT INFECTION
  • CANKER SORES
  • OTHER ORAL PAINS AND INJURIES

SPEARMINT FLAVOR

1FL OZ (30 mL)

58552-135 Bucalsep58552-135 Bucalsep

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2170427benzocaine 6.5 % / menthol 0.1 % / zinc chloride 0.12 % Mucosal SprayPSN6
2170427benzocaine 65 MG/ML / menthol 1 MG/ML / zinc chloride 1.2 MG/ML Mucosal SpraySCD6
2170427benzocaine 6.5 % / menthol 0.1 % / zinc chloride 0.12 % Mucosal SpraySY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58552-135-012022-01-31C16284748780-1d6a99b39-9e6a-a426-e053-dadaa90af4c2Giltuss Bucalsep
58552-135-012022-01-31C16284748780-1d6a99b39-9e6a-a426-e053-dadaa90af4c2Giltuss Bucalsep
58552-135-012022-01-28C16284748780-1d6a99b39-9e6a-a426-e053-dadaa90af4c2Giltuss Bucalsep
58552-135-012022-01-28C16284748780-1d6a99b39-9e6a-a426-e053-dadaa90af4c2Giltuss 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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58552-13558552-135-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
SPEARMINTJ7I2T6IV1NIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
BENZOCAINEU3RSY48JW5ACTIB
MENTHOLL7T10EIP3AACTIB
ZINC CHLORIDE86Q357L16BACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-10-24full-release2026-06-01 00:29:53

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giltuss BucalsepBENZOCAINE, MENTHOL, ZINC CHLORIDEGil Pharmaceutical Corp85053391-8d71-ab4f-e053-2991aa0a7e082025-10-09WarningsExact identifier
ndc (package): 58552-135-01
ndc (product): 58552-135
ndc11 (package): 58552013501
spl id: 40b86bd0-283d-5043-e063-6394a90ada9c
spl set id: 85053391-8d71-ab4f-e053-2991aa0a7e08

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.