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 102 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	2216a551-9fbe-3721-e063-6294a90af13d	2024-09-14	Warnings	Exact identifier application number: M003
Danielle Creations Hand Sanitizer - Strawberry	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	7c4bab88-af65-48c2-8440-3ba7b139c013	2024-09-10	Warnings	Exact identifier application number: M003
Danielle Creations Hand Sanitizer - Apple	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	362d3233-79ac-41d8-9991-b5fc75c6cae9	2024-09-10	Warnings	Exact identifier application number: M003
Danielle Creations Hand Sanitizer - Peach	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	ad28fe19-2b81-40c2-8ffb-f9b09c79def8	2024-09-10	Warnings	Exact identifier application number: M003
Thompson Antiseptic	BENZALKONIUM CHLORIDE	Thompson	0c009ed0-23b8-e4b3-e063-6394a90a723d	2024-09-04	Warnings	Exact identifier application number: M003
Bravo Sierra - Antibacterial Body Wipes	BENZALKONIUM CHLORIDE WIPES	Underscore USA	20ed5566-9014-e35b-e063-6294a90a003a	2024-08-30	Warnings	Exact identifier application number: M003
BERRIS AND CREAMY SCENTED HAND SANITIZER	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	30fc7f33-238c-42a3-93a1-72b98d303d9a	2024-08-28	Warnings	Exact identifier application number: M003
MANGO SORBET SCENTED HAND SANITIZER	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	d44e43e1-717d-47a1-a152-45f12288cbd2	2024-08-28	Warnings	Exact identifier application number: M003
COCONUT VANILLA SCENTED HAND SANITIZER	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	574324ee-d98b-4939-889c-21ed04a4e46d	2024-08-28	Warnings	Exact identifier application number: M003
STRAWBERRY SHORTCAKE SCENTED HAND SANITIZER	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	997d0ff0-96b4-4b91-87fc-8f67d9b5013c	2024-08-28	Warnings	Exact identifier application number: M003
hand sanitizer 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	202dfeac-6e69-8667-e063-6294a90a26d2	2024-08-21	Warnings	Exact identifier application number: M003
antibacterial hand sanitizer gel 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	202e5c15-8749-0a76-e063-6294a90a2720	2024-08-21	Warnings	Exact identifier application number: M003
Be Smart Get Prepared Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS	Total Resources International, Inc	eacb5138-4af8-4550-b883-5603ad96ed7d	2024-08-16	Warnings	Exact identifier application number: M003
First Aid Only Povidone-Iodine Antiseptic	POVIDONE-IODINE	Acme United Corporation	e0052ac2-4f74-32a4-e053-2995a90a94c6	2024-08-13	Warnings	Exact identifier application number: M003
Keep Going Sting Relief Pad	BENZOCAINE AND ISOPROPYL ALCOHOL	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	36c11178-b70f-4355-8823-c2b72598dae5	2024-08-08	Warnings	Exact identifier application number: M003
Keep Going Non Sting Cleaning Wipe	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	6b7400d5-d4b8-4b68-b048-c1917cdf3ce3	2024-08-08	Warnings	Exact identifier application number: M003
Keep Going Alcohol Prep Pad	ISOPROPYL ALCOHOL	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	f67dd10c-746f-4c21-92f1-741f86218a69	2024-08-08	Warnings	Exact identifier application number: M003
Sugar Cookie Sanitizer 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1efc0e9e-b4eb-d2b0-e063-6394a90a7779	2024-08-06	Warnings	Exact identifier application number: M003
Lemon Lime Hand Sanitizer Spray. 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1efe7236-d7bd-2a1c-e063-6294a90a736e	2024-08-06	Warnings	Exact identifier application number: M003
Maokang Medical 10 Povidone Iodine	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	644e92c3-3043-4a76-9845-7e0482cf9f62	2024-07-19	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