Guardian

Product NDC: 68915-280
11-digit product format: 689150280
Labeler code: 68915
Product ID: 68915-280_16e363c4-5db3-ef40-e063-6394a90a6941
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: DOUCHE
Route: VAGINAL
Labeler: Eastern Century Pharmaceuticals
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-05-23
Substance: BENZALKONIUM CHLORIDE
Active strength: 1 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68915-280-02	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68915-280-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68915-280-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68915-280-02	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68915-280-02	`8dfbde2a14a4…`	`c9ff85d89658…`

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: Guardian
Brand name suffix: Vaginal
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	1 mg/mL

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
1111013	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
1605ba44-02b7-4c72-9fec-89a5aa962b44	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68915-280-02	2024-04-24	C162847	48780-1	ba0f9c33-1e5c-a910-e053-dadaa90a0b85	Eastern Century - Guardian Gel Vaginal Douche
68915-280-02	2021-01-29	C162847	48780-1	ba0f9c33-1e5c-a910-e053-dadaa90a0b85	Eastern Century - Guardian Gel Vaginal Douche

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68915-280-01	GuardianVaginal	5.5 mL in 1 BOTTLE	DOUCHE	5.5		11
68915-280-02	GuardianVaginal	1 in 1 BOX	DOUCHE	1		11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	GUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]	8
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	GUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]	8
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	GUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]	8
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	GUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]	8
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	GUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]	8
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	GUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68915-280	GUARDIAN VAGINAL (BENZALKONIUM CHLORIDE) DOUCHE [EASTERN CENTURY PHARMACEUTICALS]	11	Current NDC, Legacy NDC, 2 package rows	20240426_1605ba44-02b7-4c72-9fec-89a5aa962b44.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 32 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Universal Rubbing Alcohol	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	183efdc2-cf3e-4f06-b292-0cfd097418b3	2026-02-23	Warnings	Exact identifier application number: M003
Konix Povidone Iodine Topical Antiseptic	POVIDONE-IODINE	TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS	0cc6b001-4982-40ee-a476-151f86c14a8e	2026-02-19	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Save-A-Lot Food Stores Ltd	e279b23d-6779-4f04-a93c-1c2a49559639	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M003
First Aid Antiseptic	POVIDONE-IODINE	Meijer, Inc.	193292da-390b-4430-91b1-1d159ac50507	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Meijer, Inc.	4989f1cd-4555-405a-a5f8-8714d472983c	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M003
First Aid Antiseptic	POVIDONE-IODINE	Target Corporation	78693ec1-d725-408c-bb95-2261faad84ac	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M003
Travel Wipes Fresh Citrus Scent	ALCOHOL	SINGULAR ENTERPRISES LLC	ea77be5e-7c69-4787-b39a-4753b002dbbd	2026-02-18	Warnings	Exact identifier application number: M003
Travel Wipes Unscented	ISOPROPYL ALCOHOL	SINGULAR ENTERPRISES LLC	dd046146-fda7-438c-98ca-96ea1dd0ae0b	2026-02-18	Warnings	Exact identifier application number: M003
Benzalkonium chloride	FIRST AID ANTISEPTIC FOAM	Target Corporation	4599eb25-2877-fc62-e063-6294a90a5d18	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M003
Konix Povidone Iodine Topical Antiseptic	POVIDONE-IODINE	TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS	8a9848b0-19df-455a-9984-5ea2e5ce1b9f	2026-02-17	Warnings	Exact identifier application number: M003
Wintergreen 91 - Iron Lab	ETHYL ALCOHOL	Iron Lab SA de CV	323a0717-0d61-c911-e063-6394a90a4854	2026-02-17	Warnings	Exact identifier application number: M003
Ethyl Rubbing Alcohol	ALCOHOL	Iron Lab SA de CV	323b2f5d-34b9-8f5b-e063-6394a90a59d5	2026-02-17	Warnings	Exact identifier application number: M003
50 Ethyl Rubbing Alcohol	ALCOHOL	Iron Lab SA de CV	323b7ff8-91ce-c7a4-e063-6394a90a69fc	2026-02-17	Warnings	Exact identifier application number: M003
70 Alcohol Hand Sanitizer	ALCOHOL	Iron Lab SA de CV	323c06d5-c984-39b8-e063-6294a90a0d3f	2026-02-17	Warnings	Exact identifier application number: M003
50 Wintergreen Alcohol	ALCOHOL	Iron Lab SA de CV	323baeb1-e3ee-ec70-e063-6294a90a30f0	2026-02-17	Warnings	Exact identifier application number: M003
70 Rubbing Ethyl Alcohol	ALCOHOL	Iron Lab SA de CV	323be8b4-4588-e2a6-e063-6394a90ab68b	2026-02-17	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	United Natural Foods, Inc. dba UNFI	8a44aa29-58d6-4971-b572-4579f03ed227	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M003
INSTACLEAN HAND SANITIZING	ALCOHOL	SHIELD LINE LLC	6d606fae-d95e-cffc-e053-2991aa0a988b	2026-02-17	Warnings	Exact identifier application number: M003
Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	087ac43c-1076-d1e2-e063-6294a90a5859	2026-02-16	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Valu Merchandisers Company	a631c976-cb9b-4099-8630-2a10c14bd3bd	2026-02-16	Warnings, Adverse reactions	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
1111013	benzalkonium chloride 0.1 % Vaginal Gel	PSN	1605ba44-02b7-4c72-9fec-89a5aa962b44	11
1111013	benzalkonium chloride 0.001 MG/MG Vaginal Gel	SCD	1605ba44-02b7-4c72-9fec-89a5aa962b44	11
1111013	benzalkonium chloride 0.1 % Vaginal Gel	SY	1605ba44-02b7-4c72-9fec-89a5aa962b44	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68915-280-01	68915028001	5.5 mL in 1 BOTTLE	5.5 ml				Historical
68915-280-02	68915028002	1 BOTTLE in 1 BOX (68915-280-02) / 5.5 mL in 1 BOTTLE (68915-280-01)	1 bottle	2011-05-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eastern Century - Guardian Gel Vaginal Douche	Eastern Century Pharmaceuticals \| Woodbine Products Company	2024-04-24	HUMAN OTC DRUG LABEL	11