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 14 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pistachio Glow	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	5570310b-c587-13aa-e063-6394a90a6c06	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Sea Salt Air	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	55726238-3b6b-55a2-e063-6394a90a570a	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Apple Splash	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	555d7248-8cc8-fe70-e063-6294a90a69a4	2026-06-28	Warnings	Exact identifier application number: M003
COCONUT ANTIBACTERIAL HAND SANITIZER	ALCOHOL	ENCHANTE ACCESSORIES INC.	270dcb5d-113b-4278-b61e-a8808846c895	2026-06-27	Warnings	Exact identifier application number: M003
ORANGE CITRUS ANTIBACTERIAL HAND SANITIZER	ALCOHOL	ENCHANTE ACCESSORIES INC.	86b77b42-53a1-4f9f-a607-18b1ddc04c44	2026-06-27	Warnings	Exact identifier application number: M003
Lights Alcohol Wipes	ISOPROPYL ALCOHOL	Lights Medical Manufacture Co., Ltd.	f9601021-4c52-4b48-96c1-b25fe8fef8b1	2026-06-26	Warnings	Exact identifier application number: M003
WILD CHERRY HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	552e958f-414d-9917-e063-6294a90aa977	2026-06-26	Warnings	Exact identifier application number: M003
VANILLA HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	552ebc73-6e43-3527-e063-6394a90af58a	2026-06-26	Warnings	Exact identifier application number: M003
Lights Medium Alcohol	ISOPROPYL ALCOHOL	Lights Medical Manufacture Co., Ltd.	873e0c9d-e0aa-44bb-a1f4-447458479023	2026-06-25	Warnings	Exact identifier application number: M003
MOUTAIN DEW HAND SANITIZING WIPES	HAND SANITIZING WIPES	Zhejiang Bright Care Co., Ltd	54fbbdde-ef7b-0a8b-e063-6294a90ad9e4	2026-06-24	Warnings	Exact identifier application number: M003
BAJA BLAST HAND SANITIZING WIPES	HAND SANITIZING WIPES	Zhejiang Bright Care Co., Ltd	54fc7e91-53f7-70b4-e063-6294a90ac085	2026-06-24	Warnings	Exact identifier application number: M003
MISTIFY SEA SALT CARAMEL HAND SANITIZING WIPES	HAND SANITIZING WIPES	Zhejiang Bright Care Co., Ltd	54fce390-6b53-f9f7-e063-6294a90aa44f	2026-06-24	Warnings	Exact identifier application number: M003
MISTIFY CHERRY CRUSH HAND SANITIZING WIPES	HAND SANITIZING WIPES	Zhejiang Bright Care Co., Ltd	54fd0c49-bf20-c2e3-e063-6294a90a5640	2026-06-24	Warnings	Exact identifier application number: M003
MISTIFY VANILLA CUPCAKE HAND SANITIZING WIPES	HAND SANITIZING WIPES	Zhejiang Bright Care Co., Ltd	54fd0885-0d8c-614d-e063-6394a90acef9	2026-06-24	Warnings	Exact identifier application number: M003
CVS Povidone Iodine	POVIDONE IODINE	CVS Pharmacy Inc	a8d754f4-a696-d0d9-e053-2a95a90a4aff	2026-06-24	Warnings	Exact identifier application number: M003
MISTIFY SWEET STRAWBERRY HAND SANITIZING WIPES	HAND SANITIZING WIPES	Zhejiang Bright Care Co., Ltd	55042fdb-ce19-2396-e063-6394a90a9986	2026-06-24	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizers 2pk Apple and Marshmallow	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	54e6b242-6f50-0e3e-e063-6294a90a5269	2026-06-23	Warnings	Exact identifier application number: M003
Meijer Hand Sanitizer Silicone Holiday Gift Set 3pk	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	54e6ecb7-5cd5-fc13-e063-6294a90a038c	2026-06-23	Warnings	Exact identifier application number: M003
Swab Applicator Brushes Iodine (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w)	IODINE, ISOPROPYL ALCOHOL	XINXIANG XINDA TECHNOLOGY CO.,LTD	54e83df5-bbeb-d068-e063-6394a90ad513	2026-06-23	Warnings	Exact identifier application number: M003
VANILL HAND SANITIZING WIPES	HAND SANITIZING WIPES	Zhejiang Bright Care Co., Ltd	54e9d23b-45e5-5e53-e063-6394a90a6066	2026-06-23	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
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