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 107 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hand sanitizer 8oz with aloe vera	ETHYL ALCOHOL 70%V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	0fbd6962-59e6-7230-e063-6394a90afd8e	2024-01-24	Warnings	Exact identifier application number: M003
Cold Sore Treatment, 24-7 Life by 7-Eleven	BENZALKONIUM CHLORIDE	Lil' Drug Store Products, Inc.	0f4fb868-1462-f88e-e063-6394a90a69e4	2024-01-19	Warnings	Exact identifier application number: M003
Medi-First Burn with Lidocaine	BENZALKONIUM CHLORIDE, LIDOCAINE	Unifirst First Aid Corporation	bd46efc8-0b36-0931-e053-2a95a90adb6f	2024-01-17	Warnings	Exact identifier application number: M003
Green Guard Antiseptic	BENZALKONIUM CHLORIDE	Unifirst First Aid Corporation	bc914c36-e0f0-18c5-e053-2a95a90a894e	2024-01-17	Warnings	Exact identifier application number: M003
Medi-First Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	bca2b641-7fbc-5462-e053-2995a90ae2b4	2024-01-17	Warnings	Exact identifier application number: M003
Medi-First Isopropyl Alcohol 70%	ISOPROPYL ALCOHOL	Unifirst First Aid Corporation	dbeac2f5-b897-5e71-e053-2995a90a7549	2024-01-17	Warnings	Exact identifier application number: M003
Green Guard Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	bca4545e-d477-270a-e053-2995a90a0ed6	2024-01-17	Warnings	Exact identifier application number: M003
MyMedic Calendula Gel	CALENDULA OFFICINALIS FLOWER	Nantong Health & Beyond Hygienic Products Inc.	0f0aa235-ac35-ac91-e063-6394a90a73fc	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Oral Pain Relief Gel	BENZOCAINE	Nantong Health & Beyond Hygienic Products Inc.	0f0b6157-ec18-13ef-e063-6294a90a2e0c	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Super Sanitizer	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	0f0c535d-8ff3-4799-e063-6394a90a7063	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	0f0d1ba7-fe9c-8e0b-e063-6394a90a3081	2024-01-16	Warnings	Exact identifier application number: M003
White Petrolatum	WHITE PETROLATUM	Nantong Health & Beyond Hygienic Products Inc.	0f0d6ff0-ff30-aaf8-e063-6394a90a2716	2024-01-16	Warnings	Exact identifier application number: M003
Thompson Hand Sanitizer	ETHYL ALCOHOL	Thompson	deada606-8a82-9eeb-e053-2a95a90a9e6d	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Arnica Gel	ARNICA MONTANA	Nantong Health & Beyond Hygienic Products Inc.	0ef8760d-27c0-7ece-e063-6294a90a6873	2024-01-15	Warnings	Exact identifier application number: M003
American Safety First Aid Antispetic	HYDROGEN PEROXIDE	Orazen Inc	ea2fbdfe-1932-9fb4-e053-2a95a90a3563	2024-01-15	Warnings	Exact identifier application number: M003
First Aid Antispetic	BENZALKONIUM CHLORIDE	Orazen Inc	ea2debcb-892c-339f-e053-2a95a90a4b18	2024-01-15	Warnings	Exact identifier application number: M003
Ever Ready First Aid	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Ever Ready First Aid	e53f3bf5-25c0-2b86-e053-2a95a90a010f	2024-01-15	Warnings	Exact identifier application number: M003
FIRST SHIELD First Aid Antiseptic	BENZALKONIUM CHLORIDE	Ever Ready First Aid	e013ef0a-ef3d-7af5-e053-2a95a90a54d3	2024-01-15	Warnings	Exact identifier application number: M003
Latalia Hand Sanitizer 80 Alcohol Antiseptic	ALCOHOL	INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD	ae55fab3-3177-383e-e053-2995a90a17a0	2024-01-10	Warnings	Exact identifier application number: M003
Latalia Sanitizing Wipe	ALCOHOL	INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD	ae564635-898e-fbf6-e053-2995a90a8119	2024-01-10	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