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

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 Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5, L7T10EIP3A, 86Q357L16B
Rxcui2170427

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

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

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