NDC 68915-280-01 - Guardian Vaginal

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68915-280
Requested NDC: 68915-280-01
Package NDCs from labels: 68915-280-01, 68915-280-02
Manufacturer: Eastern Century Pharmaceuticals | Woodbine Products Company
Effective date: 2024-04-24
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Guardian Vaginal - Eastern Century Pharmaceuticals \| Woodbine Products Company	Eastern Century Pharmaceuticals \| Woodbine Products Company	2024-04-24	HUMAN OTC DRUG LABEL

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 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

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

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 3 of 175 · 3,494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Unscented NasalGuard Antiseptic Topical	BENZALKONIUM CHLORIDE	TRUTEK CORP.	eb036e11-a28c-fdc0-e053-2a95a90a9cdb	2026-09-02	Warnings	Exact identifier application number: M003 unii: F5UM2KM3W7
Harris Teeter	ISOPROPYL ALCOHOL	Harris Teeter, LLC	d2bb20bd-ec83-8d80-e053-2a95a90a2bba	2026-09-02	Warnings	Exact identifier application number: M003
School Health	ISOPROPYL ALCOHOL	School Health Corporation	db5d0b22-f2d7-23e5-e053-2a95a90aeb51	2026-09-02	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Topco Associates	2642298f-607e-fdca-e063-6394a90a69d9	2026-09-02	Warnings	Exact identifier application number: M003
HUSTLE BUTTER NUMBING	LIDOCAINE HCL, BENZALKONIUM CHLORIDE	H.B.D. DIST. INC.	5b4d0390-dac6-4a71-9fdc-5c31543e7c5a	2026-09-02	Warnings	Exact identifier application number: M003 unii: F5UM2KM3W7
NasalGuard Antiseptic Topical Cool Menthol	BENZALKONIUM CHLORIDE	TRUTEK CORP.	e9fd3ef8-78ff-6c9f-e053-2a95a90a21a8	2026-09-01	Warnings	Exact identifier application number: M003 unii: F5UM2KM3W7
Maximum Strength Betadine Clear	BENZALKONIUM CL AND PRAMOXINE HCL	Atlantis Consumer Healthcare, Inc.	31b94a76-1536-47c0-ab03-e487c2625c58	2026-08-31	Warnings	Exact identifier application number: M003 unii: F5UM2KM3W7
Swisher Advanced Antibacterial Foam Handsoap	BENZALKONIUM CHLORIDE	Ecolab Inc.	38bd6680-db95-424c-8e84-2e12c2388a73	2026-08-31	Warnings	Exact identifier unii: F5UM2KM3W7
Orajel 4X Medicated Toothache and Gum Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1c82b4-02b3-d456-e063-6294a90a16bb	2026-08-31	Warnings	Exact identifier unii: F5UM2KM3W7
Orajel 4X Medicated Toothache and Gum PM Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1cdaf4-3388-280c-e063-6294a90ac70f	2026-08-31	Warnings	Exact identifier unii: F5UM2KM3W7
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a28101f-ea8e-6071-e063-6294a90aad91	2026-08-31	Warnings	Exact identifier application number: M003 unii: F5UM2KM3W7
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a3e62ce-52dc-121b-e063-6294a90a898f	2026-08-31	Warnings	Exact identifier application number: M003 unii: F5UM2KM3W7
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a49db18-c270-6f46-e063-6294a90afb5d	2026-08-31	Warnings	Exact identifier application number: M003 unii: F5UM2KM3W7
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a4ac18e-8ba5-bef6-e063-6394a90a8811	2026-08-31	Warnings	Exact identifier application number: M003 unii: F5UM2KM3W7
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a4d11fa-3f65-b41f-e063-6394a90a30ae	2026-08-31	Warnings	Exact identifier application number: M003 unii: F5UM2KM3W7
Smart Care Hand Sanitizer,2pk -Gingerbread and Cherry Cobbler	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a52731b-5e8c-5ae6-e063-6394a90a8b04	2026-08-31	Warnings	Exact identifier application number: M003
70% Isopropyl Alcohol	ISOPROPYL ALCOHOL	UpLift Brands, LLC	8ae12375-3a95-475c-9600-17c51a9103f7	2026-08-31	Warnings, Adverse reactions	Exact identifier application number: M003
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggets	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	f875e065-7b3e-45dc-8a33-b893ab830695	2026-08-31	Warnings	Exact identifier application number: M003
hydrating mist hand sanitizer with silicone keychain holder - signature scent	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	30e11bf0-1a21-45b1-adf9-cf3845419a98	2026-08-31	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer(Oval Shape)with Beaded Wristlet - Cherry Blossom	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a4fb4b6-ba9e-5b82-e063-6294a90a4734	2026-08-30	Warnings	Exact identifier application number: M003

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.