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 109 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RevitaDERM Wound Care	BENZALKONIUM CHLORIDE	Blaine Labs Inc.	9254dada-4e32-43a0-892b-c488d68e23e7	2023-12-21	Warnings	Exact identifier application number: M003
NUMSTAT Antiseptic and Pain Relieving Prep Pad	ALCOHOL, MENTHOL, AND BENZOCAINE PREP PAD	Spectra Medical Devices, LLC	07d20040-9dd9-0aba-e063-6294a90ab7cf	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Iodides	ALCOHOL	Strategic Sourcing Services LLC	8d9f2112-c678-4559-b567-9d6d287c5fa3	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Strategic Sourcing Services LLC	72eeb3e6-c0a1-4b18-87f1-8db06f9bd111	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Strategic Sourcing Services LLC	cbe02fa1-c167-4b77-8f63-817362090e19	2023-12-20	Warnings	Exact identifier application number: M003
Health Mart Isopropyl Alcohol 91 Percent	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	fbd2aa69-b1c7-4a28-9642-a436ae09faaf	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Povidone Iodine	POVIDONE IODINE 10%	Chain Drug Market Association	9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Chain Drug Market Association	55c970ed-13a9-4ea2-a8cb-aaf14d3a214d	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Iodides Tincture	ETHYL ALCOHOL	Chain Drug Market Association	71aedfd5-e81f-4b69-b163-527ff1ce30b1	2023-12-20	Warnings	Exact identifier application number: M003
Quality Choice Merthiolate	BENZALKONIUM CHLORIDE	Chain Drug Market Association	5b7303b9-b8c4-4e7c-876f-70ed76443055	2023-12-20	Warnings	Exact identifier application number: M003
Premier Value Povidone Iodine	POVIDONE IODINE 10%	Chain Drug Consortium	5cc9d782-5f7e-27d9-e053-2991aa0a2428	2023-12-20	Warnings	Exact identifier application number: M003
Harris Teeter Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Harris Teeter, LLC	5c88d7cb-2917-54e9-e053-2991aa0a0bd9	2023-12-20	Warnings	Exact identifier application number: M003
CVS Iodine	IODINE, SODIUM IODIDE AND ALCOHOL	CVS Pharmacy	b11db4e5-6a6d-4d4a-b980-600692b54176	2023-12-20	Warnings	Exact identifier application number: M003
CVS Povidone-Iodine	POVIDONE IODINE	CVS Pharmacy	402d571f-e1e8-43fd-9e7b-05aab1837905	2023-12-20	Warnings	Exact identifier application number: M003
Sanitizing wipes with aloe Grapefruit Grove	ALCOHOL	The Honest Company	faa3690b-ce0d-43d4-9e5c-f2ce77daabe7	2023-12-19	Warnings	Exact identifier application number: M003
Sanitizing Wipes Fragrance Free	ALCOHOL	The Honest Company	0ce3e7ee-aa50-16bc-e063-6294a90a527d	2023-12-19	Warnings	Exact identifier application number: M003
sunmark Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	46da2750-37d1-4ed1-baf3-1fd426617567	2023-12-19	Warnings	Exact identifier application number: M003
Sunmark Iodine	IODINE, SODIUM IODIDE, ALCOHOL	Strategic Sourcing Services LLC	e8dae2d6-58b1-4c4e-a4c1-371db055b7ae	2023-12-19	Warnings	Exact identifier application number: M003
Sunmark Isopropyl Alcohol 70 Percent With Wintergreen Oil	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	515dd733-1b44-4df0-928f-a3b202b5f9c2	2023-12-19	Warnings	Exact identifier application number: M003
Sunmark Isopropyl Alcohol 91 Percent	ISOPROPYL ALCOHOL	Strategic Sourcing Services LLC	92afb1ce-6a9e-456e-b3ee-e8a8d93ebc5e	2023-12-19	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