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 102 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Dermal Wound Cleanser	BENZETHONIUM CHLORIDE	Smith & Nephew Medical Ltd.	18704cd5-1ecf-4e8c-9897-7e45394e68c8	2024-07-15	Warnings	Exact identifier application number: M003
Novex Anti-Bacterial Hand Sanitizer Wipe	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	7832a0be-a8ce-4b56-a9bb-a375b97df287	2024-07-10	Warnings	Exact identifier application number: M003
Callington Anti-Bacterial Hand Sanitizer Wipe	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	00ca48ca-893d-4a3f-ad90-119522664e08	2024-07-10	Warnings	Exact identifier application number: M003
Assorted Licensed Hand Sanitizer Grape 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1c9095ad-ce19-3666-e063-6394a90ae22d	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUS	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccb78ed-36f9-a7d2-e063-6394a90a6477	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccb9671-1970-39f9-e063-6294a90ac079	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccbc68e-2b6b-768c-e063-6294a90a643b	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccbbc55-3f7d-76d1-e063-6294a90a5590	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	1cb701f7-61c8-e5f4-e063-6294a90a0c3c	2024-07-08	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