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 51 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dceced03-eeb8-fced-e053-2995a90afd5c	2025-12-06	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dced643b-96fb-193f-e053-2a95a90a16aa	2025-12-06	Warnings	Exact identifier application number: M003
Betadine Foam Cleanser	BENZALKONIUM CHLORIDE	Atlantis Consumer Healthcare, Inc.	3be9fa6e-3ae8-496b-876b-f81f1cd98af4	2025-12-05	Warnings	Exact identifier application number: M003
2XL Mega Rolls Sanitizing Wipes	BENZALKONIUM CHLORIDE	2xl Corporation	9da541ab-6836-4149-a86d-3b2f2e586628	2025-12-05	Warnings	Exact identifier application number: M003
Hand Wipes	BENZALKONIUM CHLORIDE	Advanced Ultrasound Solutions Inc.	2c2abaa8-c152-470b-a4d9-5056815a1987	2025-12-05	Warnings	Exact identifier application number: M003
Benzalkonium Chloride	SANITIZING HAND WIPES	ALO NEW YORK LLC	d3d95355-3af7-43e3-e053-2a95a90a0fa4	2025-12-05	Warnings	Exact identifier application number: M003
Giant Eagle Antibacterial Hand Wipes	BENZALKONIUM CHLORIDE	Giant Eagle	e20e9a93-03c3-77f8-e053-2995a90ae59f	2025-12-05	Warnings	Exact identifier application number: M003
Antibacterial Wipes	BENZALKONIUM CHLORIDE	ERC Acquisition, Inc	dc6c39af-447c-481a-98b5-33b8f09b83bc	2025-12-05	Warnings	Exact identifier application number: M003
Sanitex Antibacterial Hand Wipes Fresh Scent	BENZALKONIUM CHLORIDE	Precare Corp	48907146-ca66-46e1-928b-a8f968a6bff8	2025-12-05	Warnings	Exact identifier application number: M003
Benzalkonium Chloride	ANTIBACTERIAL HAND WIPES	Quest USA Corp	d9ab219d-07e3-2019-e053-2a95a90a1668	2025-12-05	Warnings	Exact identifier application number: M003
Benzalkonium Chloride	DUAL ACTION ANTIBACTERIAL WIPES	Avro Enterprises LLC	cf42e470-19c8-2e11-e053-2995a90ae90d	2025-12-05	Warnings	Exact identifier application number: M003
Benzalkonium Chloride	DUAL ACTION ANTIMICROBIAL WIPES	Avro Enterprises LLC	cf4680f4-24b2-1242-e053-2a95a90a9374	2025-12-05	Warnings	Exact identifier application number: M003
Benzalkonium Chloride	ANTIBACTERIAL HAND WIPES	Target Corporation	f6037707-c6bb-11a0-e053-2995a90acce8	2025-12-05	Warnings	Exact identifier application number: M003
Sanitizing Wipes	BENZALKONIUM CHLORIDE	Zogics, LLC	2cd916ee-dc6d-49e4-a9b5-06ad4b2b054d	2025-12-05	Warnings	Exact identifier application number: M003
GELLE-N-DETOX - LAVENDER AND ROSEMARY MASSAGE	BENZALKONIUM CHLORIDE	CHEMCO CORPORATION	f28c2c1e-7d0a-45b9-e053-2995a90a4710	2025-12-05	Warnings	Exact identifier application number: M003
GELLE-N-DETOX ICE MINT AND EUCALYPTUS MASSAGE	BENZALKONIUM CHLORIDE	CHEMCO CORPORATION	f2a107aa-5ad3-7bad-e053-2a95a90a1d97	2025-12-05	Warnings	Exact identifier application number: M003
PROHEAL POVIDONE IODINE SWABSTICK	POVIDONE-IODINE	Click Industries LLC	974e1205-01ab-4599-9229-cdf5225d268a	2025-12-03	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Jasmine Gardenia	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	45082749-6f53-c595-e063-6294a90ac3e9	2025-12-03	Warnings	Exact identifier application number: M003
ALCOHOL PREP PAD	70% ISOPROPY ALCOHOL SWAB	PurCel Labs LLC	450c39fd-d172-492e-e063-6294a90aa396	2025-12-03	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Dynarex Corporation	450e56f0-b8ae-072a-e063-6394a90a2d4b	2025-12-03	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