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
Ingredient	Strength
BENZOCAINE	6.5 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
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup
86Q357L16B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
85053391-8d71-ab4f-e053-2991aa0a7e08	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58552-135-01	Giltuss Bucalsep	1 in 1 CARTON	SPRAY	1		6
58552-135-01	Giltuss Bucalsep	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58552-135-01	ML - Milliliter	58552-135	b8573309-6625-4360-b020-5ace6b97acd2	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58552-135	GILTUSS BUCALSEP (BENZOCAINE, MENTHOL, ZINC CHLORIDE) SPRAY [GIL PHARMACEUTICAL CORP]	5	Current NDC, Legacy NDC, 2 package rows	20241027_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 1 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrogen Peroxide 3 Percent ReadyInCase	HYDROGEN PEROXIDE	P & L Development, LLC	b0866db5-3b0d-4478-9b3b-1f077d2f5393	2026-08-06	Warnings	Exact identifier application number: M022
Ollie Fresh Mint	SODIUM FLUORIDE, POTASSIUM NITRATE	Brio Product Group LLC.	ebeec44f-3c22-43f2-9256-6ece6025c105	2026-08-06	Warnings	Exact identifier application number: M022
PRO-SYS	ORAL WOUND CLEANSER	Forward Science Technologies LLC	c357c8f8-6fd6-c2f8-e053-2995a90a4023	2026-07-30	Warnings	Exact identifier application number: M022
Lornamead Natural White	FLUORIDE	Lornamead Products	9d7d08d7-8ca4-4b05-8b74-3bfa372b1608	2026-07-29	Warnings	Exact identifier application number: M022
Made by Dentists Enamel 10 Fluoride Anticavity	POTASSIUM NITRATE, SODIUM FLUORIDE	Made By Dentists Inc	3c62eab1-0cb6-4bdf-bfd4-c5afe734d036	2026-07-24	Warnings	Exact identifier application number: M022
Saline	NASAL	BEST CHOICE (VALU MERCHANDISERS COMPANY)	71485e82-bf54-4b8b-8dd2-2a0761534520	2026-07-17	Warnings	Exact identifier application number: M022
Good Neighbor Sore Throat Cherry Flavor	PHENOL	AMERISOURCE BERGEN	aa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f	2026-07-13	Warnings	Exact identifier application number: M022
ABC Sore Throat Menthol Flavor	PHENOL	AMERISOURCE BERGEN	9d9baf58-4790-4ff4-a462-5eb70c0e80c5	2026-07-13	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	P & L Development, LLC	350b5f64-d152-40cb-b22f-98541f0e1b0a	2026-07-09	Warnings	Exact identifier application number: M022
Quality Choice Natural White	FLUORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	561a75c2-a40c-ba7c-e063-6294a90aa119	2026-07-08	Warnings	Exact identifier application number: M022
SALINE NASAL	SODIUM CHLORIDE	ALAINA HEALTHCARE PRIVATE LIMITED	ed30a7f9-7132-42da-9bed-63a9b1c80ab2	2026-07-07	Warnings	Exact identifier application number: M022
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-07-06	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF	HEXYLRESORCINOL	Reckitt Benckiser LLC	4c150222-06ea-4fcf-967f-84e19846bd66	2026-07-03	Warnings	Exact identifier application number: M022
Dental system starter kit	US CONVENIENCE KIT (718907)	Dyson Technology Limited	5355b79b-711f-1a4a-e063-6394a90afc4b	2026-06-30	Warnings	Exact identifier application number: M022
Anticavity and sensitive peppermint	907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINT	Dyson Technology Limited	5332ab71-d994-39cf-e063-6294a90a0d98	2026-06-30	Warnings	Exact identifier application number: M022
NebuClear MD Saline	NEBUCLEAR MD SALINE	Blue Echo Care LLC	55820ff9-7b4b-2bce-e063-6394a90a8b43	2026-06-30	Warnings	Exact identifier application number: M022
NebuClear MD Saline	NEBUCLEAR MD SALINE	Blue Echo Care LLC	55806cb8-cf92-c4e5-e063-6394a90aaa2d	2026-06-30	Warnings	Exact identifier application number: M022
NebuClear MD Saline	NEBUCLEAR MD SALINE	Blue Echo Care LLC	5581d8e5-4105-e9da-e063-6394a90a316e	2026-06-30	Warnings	Exact identifier application number: M022
Corinz	CETYLPYRIDINIUM CHLORIDE	Sage Products, LLC	685b6023-89c4-417e-af2d-52e831855da1	2026-06-29	Warnings	Exact identifier application number: M022
Antiplaque solution	CETYLPYRIDINIUM CHLORIDE	Sage Products LLC	881d4d08-4b45-486a-93af-18c0e00a5b0e	2026-06-29	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE
86Q357L16B	ZINC CHLORIDE	7646-85-7	ZINC CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2170427	benzocaine 6.5 % / menthol 0.1 % / zinc chloride 0.12 % Mucosal Spray	PSN	85053391-8d71-ab4f-e053-2991aa0a7e08	6
2170427	benzocaine 65 MG/ML / menthol 1 MG/ML / zinc chloride 1.2 MG/ML Mucosal Spray	SCD	85053391-8d71-ab4f-e053-2991aa0a7e08	6
2170427	benzocaine 6.5 % / menthol 0.1 % / zinc chloride 0.12 % Mucosal Spray	SY	85053391-8d71-ab4f-e053-2991aa0a7e08	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
58552-135-01	58552013501	1 BOTTLE, SPRAY in 1 CARTON (58552-135-01) / 30 mL in 1 BOTTLE, SPRAY	2018-07-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Giltuss Bucalsep	Gil Pharmaceutical Corp \| Dextrum Laboratories Inc.	2025-10-09	HUMAN OTC DRUG LABEL	6