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 56 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAND SANITIZING LAVENDER	ALCOHOL	DR. BRONNER'S MAGIC SOAPS	8383605a-0bac-428c-b1cb-2f95ce9bd35e	2025-10-28	Warnings	Exact identifier application number: M003
ORGANIC HAND SANITIZER PEPPERMINT	ALCOHOL	DR. BRONNER'S MAGIC SOAPS	cad3a81e-88cb-4f44-a351-b086fd983795	2025-10-28	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Lavender Drift	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	421cfe98-7a20-c37c-e063-6294a90ad4b5	2025-10-27	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coastal Coconut	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	421ce33e-4639-e881-e063-6394a90a57ef	2025-10-27	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Watermelon Aloe	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	421d994c-bf62-2f40-e063-6294a90a6488	2025-10-27	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Peach Nectar	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	421d7326-d2fd-a845-e063-6394a90a39aa	2025-10-27	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sea Breeze	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	421d7bd9-c892-ec97-e063-6394a90a4b28	2025-10-27	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCake	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	421d7326-d300-a845-e063-6394a90a39aa	2025-10-27	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla Cloud	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	421d8811-7fb2-aef6-e063-6394a90a1cf8	2025-10-27	Warnings	Exact identifier application number: M003
American Red Cross 70% Isopropyl Alcohol	ISOPROPYL ALCOHOL(70%CONC.)	MY IMPORTS USA LLC	421d7bd9-c893-ec97-e063-6394a90a4b28	2025-10-27	Warnings	Exact identifier application number: M003
American Red Cross Antiseptic	BENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)	MY IMPORTS USA LLC	421dc192-97ed-0675-e063-6394a90aa156	2025-10-27	Warnings	Exact identifier application number: M003
American Red Cross First Aid	BENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)	MY IMPORTS USA LLC	421f3150-2027-c6aa-e063-6294a90ab6aa	2025-10-27	Warnings	Exact identifier application number: M003
American Red Cross First Aid	BENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	421b402e-233d-cebf-e063-6394a90aa421	2025-10-27	Warnings	Exact identifier application number: M003
Germ Attack Hand Sanitizer	ALCOHOL	Natural Essentials, Inc.	637dcb5f-8870-4613-a227-9fd612617061	2025-10-27	Warnings	Exact identifier application number: M003
SOURPATCH KIDS HAND SANITIZER SET WATERMELON	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	42143916-8d2e-dbbe-e063-6294a90a29c4	2025-10-26	Warnings	Exact identifier application number: M003
JOLLY RANCHER HAND SANITIZER SET CHERRY	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	42147184-18e6-f932-e063-6294a90a807e	2025-10-26	Warnings	Exact identifier application number: M003
JOLLY RANCHER HAND SANITIZER CHERRY	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	4214ba08-8d00-8de9-e063-6394a90a4c90	2025-10-26	Warnings	Exact identifier application number: M003
Sour Patch Kids Hand Sanitizer Watermelon	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	4214f0de-6b1d-dae7-e063-6294a90ade42	2025-10-26	Warnings	Exact identifier application number: M003
SOURPATCH KIDS HAND SANITIZER STRAWBERRY	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	4215130c-a298-02c7-e063-6394a90a74ff	2025-10-26	Warnings	Exact identifier application number: M003
SMARTIES ORANGE HAND SANTIZER SET ORANGE CREAMSICLE	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	421b1732-acdd-a6cc-e063-6394a90a5fb4	2025-10-26	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