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 13 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	MY IMPORTS USA LLC	5599605b-28f0-a534-e063-6394a90a7213	2026-07-01	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pumpkin Cream	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	559987c0-7abd-13fc-e063-6294a90a9f27	2026-07-01	Warnings	Exact identifier application number: M003
MISTIFY STRAWBERRE HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5740a2ed-e77d-3f41-e063-6394a90aec03	2026-07-01	Warnings	Exact identifier application number: M003
MISTIFY VANILLA HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	574ba9b9-b44d-b014-e063-6394a90af768	2026-07-01	Warnings	Exact identifier application number: M003
MISTIFY COTTON CANDY HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	574bcf4f-ad36-5ede-e063-6294a90a0eab	2026-07-01	Warnings	Exact identifier application number: M003
MISTIFY COCONUT HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	57539bdd-641d-3c27-e063-6394a90af84a	2026-07-01	Warnings	Exact identifier application number: M003
Benzethonium chloride Plus Dyclonine hydrochloride	LIQUID BANDAGE	Hudson Health LLC	42789576-0ab4-1afb-e063-6294a90a1d27	2026-06-30	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing Spray, Sugared Plum	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	5572d336-f953-90ac-e063-6394a90a2d4d	2026-06-30	Warnings	Exact identifier application number: M003
McKesson Alcohol Prep Pad	ISOPROPYL ALCOHOL	McKesson Medical-Surgical	a8e759f3-91b1-44ae-960a-3a6cd4f746ce	2026-06-30	Warnings	Exact identifier application number: M003
Tinted Isopropyl Alcohol	ISOPROPYL ALCOHOL	Medical Chemical Corporation	f3c1c8a3-6b34-46cf-845e-c89db8f096f1	2026-06-30	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Medical Chemical Corporation	a04239d8-0fa9-4c00-aa81-d7a1242bc931	2026-06-30	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Autumn Berry Crumble	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	555da50d-f106-f27f-e063-6294a90a61f9	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Beach Sandalwood	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	55601f99-b1a7-ffb5-e063-6394a90a37d6	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Confetti Cupcake	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	556073a0-242b-dc26-e063-6394a90a9ccf	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pumpkin Cream	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	55709e6c-e2ec-9c16-e063-6394a90a269e	2026-06-29	Warnings	Exact identifier application number: M003
MedPride Alcohol Wipes	ISOPROPYL ALCOHOL	Shield Line LLC	ad2a29b2-0511-bbe4-e053-2a95a90ac0b1	2026-06-29	Warnings	Exact identifier application number: M003
Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Pharma Nobis, LLC	e42df0bf-cce7-3961-e053-2995a90a730a	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Berry Creme	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	556f24a7-2294-424f-e063-6394a90a0b68	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Gingerbread Cake	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	556fa2a3-38de-1393-e063-6294a90add6a	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Matcha Mist	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	556fcd84-0b0d-ed0b-e063-6394a90a45eb	2026-06-29	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