Guardelle

Product NDC: 85754-000
11-digit product format: 857540000
Labeler code: 85754
Product ID: 85754-000_3a8774ed-4fdf-48b6-a54b-8db85492cb34
Type: HUMAN OTC DRUG
Nonproprietary name: BENZALKONIUM CHLORIDE
Dosage form: AEROSOL, FOAM
Route: TOPICAL
Labeler: Social Medical Supply LLC
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-10-16
Substance: BENZALKONIUM CHLORIDE
Active strength: .13 g/100mL
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: Guardelle
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	.13 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1020365	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
8793e3be-7409-4f71-9397-abbeacd27cf8	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
85754-000-02	Guardelle	52 mL in 1 BOTTLE, PUMP	AEROSOL, FOAM	52	1
85754-000-07	Guardelle	207 mL in 1 BOTTLE, PUMP	AEROSOL, FOAM	207	1
85754-000-18	Guardelle	500 mL in 1 BOTTLE, PUMP	AEROSOL, FOAM	500	1

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 25 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Smart Care Hand Sanitizer 3pk with Leather Case	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4f036ba3-3f21-d04b-e063-6294a90ad7d7	2026-04-09	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Pistachio Creme	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4eeedd3e-d4b4-9967-e063-6394a90abf33	2026-04-08	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer French Vanilla	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4eef33c2-695a-3a32-e063-6394a90a0a7b	2026-04-08	Warnings	Exact identifier application number: M003
Smart Care Licensed Hand Sanitizer Squishmallows Pink	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4eefc5bc-7dd4-e4c8-e063-6394a90a9a51	2026-04-08	Warnings	Exact identifier application number: M003
Verifine Alcohol Swabs	ALCOHOL SWABS	Promisemed Hangzhou Meditech Co.,LTD.	4ef56b6c-ad46-2d02-e063-6294a90ad407	2026-04-08	Warnings	Exact identifier application number: M003
Rubbing	ETHYL ALCOHOL	Perrigo Direct, Inc	ba2266d7-da25-495a-b035-97e149551c30	2026-04-08	Warnings, Adverse reactions	Exact identifier application number: M003
Smart Care Licensed Hand Sanitizer Squishmallows Purple	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4efeb523-0a73-2e48-e063-6394a90aac5e	2026-04-08	Warnings	Exact identifier application number: M003
Smart Care Licensed Hand Sanitizer Hot Wheels Red	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4efefd07-c1df-695a-e063-6294a90a51eb	2026-04-08	Warnings	Exact identifier application number: M003
Smart Care Licensed Hand Sanitizer Hot Wheels Purple	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4eff601c-7bcd-1ddd-e063-6294a90a8040	2026-04-08	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Ocean Breeze	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4effb28e-fa83-5a06-e063-6394a90aa2f5	2026-04-08	Warnings	Exact identifier application number: M003
70%	ISOPROPYL ALCOHOL	Perrigo Direct, Inc	f953a249-07ad-40a1-8aea-b2d419fd3d4d	2026-04-07	Warnings, Adverse reactions	Exact identifier application number: M003
50% Rubbing	ISOPROPYL ALCOHOL	Perrigo Direct, Inc	698bede7-4fc1-4e85-8ac4-d735f409cfae	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M003
Ethyl Rubbing Alcohol	ETHYL ALCOHOL	Amazon.com Services LLC	5369424a-ccbd-4dc6-af6b-7876484a9fe6	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M003
Caring Mill Triple Hand Sanitizer with Lavender	ETHYL ALCOHOL	FSA Store Inc. (Caring Mills)	4b0b5436-a1ce-cfa6-e063-6394a90a2efe	2026-04-04	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Passion Paradise	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4e850ea9-0999-12b4-e063-6394a90af406	2026-04-02	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Tropical Mango	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4e85630a-6d18-e6a4-e063-6394a90a1d12	2026-04-02	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Coco Cabana	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4e85923b-6b8c-f9a2-e063-6294a90a0d8e	2026-04-02	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Sea Breeze	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4e85e279-7751-8bd7-e063-6294a90a095b	2026-04-02	Warnings	Exact identifier application number: M003
Povidone Iodine 10%	POVIDONE IODINE	Farmacias De Similares TX LLC	4e6baed0-ea31-79e2-e063-6294a90a3bb1	2026-04-01	Warnings	Exact identifier application number: M003
FRESH LINES SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5005d615-d9c3-a46d-e063-6394a90af88a	2026-04-01	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1020365	benzalkonium chloride 0.13 % Topical Foam	PSN	8793e3be-7409-4f71-9397-abbeacd27cf8	1
1020365	benzalkonium chloride 1.3 MG/ML Topical Foam	SCD	8793e3be-7409-4f71-9397-abbeacd27cf8	1
1020365	benzalkonium chloride 0.13 % Topical Foam	SY	8793e3be-7409-4f71-9397-abbeacd27cf8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85754-000-02	85754000002	52 mL in 1 BOTTLE, PUMP (85754-000-02)	52 ml	2025-10-16	No	No	Current
85754-000-07	85754000007	207 mL in 1 BOTTLE, PUMP (85754-000-07)	207 ml	2025-10-16	No	No	Current
85754-000-18	85754000018	500 mL in 1 BOTTLE, PUMP (85754-000-18)	500 ml	2025-10-16	No	No	Current