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 59 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sting and Bite	BENZOCAINE	PHOENIX HEALTHCARE SOLUTIONS, LLC	82791832-1357-48ca-91d4-132899701261	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	PHOENIX HEALTHCARE SOLUTIONS, LLC	a225426a-c4d5-459c-bc11-2b521e08e510	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Swabs	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions LLC	1516d90b-4879-eb2f-e063-6294a90aa914	2025-10-23	Warnings	Exact identifier application number: M003
Povidone-Iodine Prep Pads Medium	POVIDONE-IODINE	Medline Industries, LP	28c05c5c-09d3-2c62-e054-00144ff8d46c	2025-10-23	Warnings	Exact identifier application number: M003
Koala Eco Hand Sanitizer	ETHYL ALCOHOL	Koala Eco Company USA Ltd	41d7d6e3-9961-770d-e063-6394a90a0d24	2025-10-23	Warnings	Exact identifier application number: M003
PROHEAL POVIDONE IODINE PREP PADS	POVIDONE-IODINE	Click Industries LLC	53733b6c-fa62-43e0-bfcc-3d23b5e1a95a	2025-10-23	Warnings	Exact identifier application number: M003
POVIDONE-IODINE	POVIDONE-IODINE	James Alexander Corporation	181a6363-2249-45f0-a28b-79f2c5ffad59	2025-10-23	Warnings	Exact identifier application number: M003
American Red Cross Antiseptic	BENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41bbf123-9ff9-5e8a-e063-6394a90af15f	2025-10-22	Warnings	Exact identifier application number: M003
CA-REZZ NORISC ANTIBACTERIAL SKIN CARE	BENZETHONIUM CHLORIDE	FNC MEDICAL CORPORATION	f93c55f9-b3e1-45f6-8e0d-09e60f5b822f	2025-10-22	Warnings	Exact identifier application number: M003
CA-REZZ - NORISC - INCONTINENT WASH	BENZETHONIUM CHLORIDE	FNC MEDICAL CORPORATION	ed26fa74-5ae8-4294-b61d-682d6ad4b32a	2025-10-22	Warnings	Exact identifier application number: M003
CA-REZZ - LONG TERM CARE - INCONTINENT CLEANSER	BENZETHONIUM CHLORIDE	FNC MEDICAL CORPORATION	d06b0489-86d3-4bf1-928f-fc524a71560e	2025-10-22	Warnings	Exact identifier application number: M003
Northside Hospital Maternity Backpack-BASE	ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	86458169-92eb-45a5-b3cc-6eccd8caa1e8	2025-10-22	Warnings	Exact identifier application number: M003
Northside Hospital Maternity Backpack BASE	SODIUM MONOFLUOROPHOSPATE	ALLIANCE FORMULATIONS	5d0e768f-086c-4b8c-b618-6dde70f302f9	2025-10-22	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sea Breeze	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41a5db85-05b8-ecd6-e063-6394a90ac387	2025-10-21	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCake	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41a62d9f-4d46-f8ca-e063-6294a90ae1ed	2025-10-21	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla Cloud	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41a69d10-f7bf-cf17-e063-6294a90a177d	2025-10-21	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Watermelon Aloe	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41a7735f-03b7-4fdc-e063-6394a90a100b	2025-10-21	Warnings	Exact identifier application number: M003
American Red Cross 70% Isopropyl Alcohol	ISOPROPYL ALCOHOL(70%CONC.)	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41b6ee3f-55f4-0502-e063-6394a90aa357	2025-10-21	Warnings	Exact identifier application number: M003
Smart Care Luxury Hand Sanitizer Tangy Terrane	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4192dbc6-5d9a-d42a-e063-6394a90aa2d8	2025-10-20	Warnings	Exact identifier application number: M003
Smart Care Luxury Hand Sanitizer Sweet and Still	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	41934870-d87e-1c51-e063-6294a90abd2d	2025-10-20	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