RevitaDERM Wound Care

Product NDC: 63347-120
11-digit product format: 633470120
Labeler code: 63347
Product ID: 63347-120_69b73949-a7e7-4e85-911e-ae688d658bbf
Type: HUMAN OTC DRUG
Nonproprietary name: BENZALKONIUM CHLORIDE
Dosage form: GEL
Route: TOPICAL
Labeler: Blaine Labs Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-05-24
Substance: BENZALKONIUM CHLORIDE
Active strength: 170 mg/89mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: RevitaDERM Wound Care
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	170 mg/89mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049228	Internal RxNorm lookup
1310820	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
9254dada-4e32-43a0-892b-c488d68e23e7	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63347-120-01	2022-02-18	C162847	48780-1	d6a99b39-8612-a426-e053-dadaa90af4c2	9254dada-4e32-43a0-892b-c488d68e23e7
63347-120-01	2022-01-28	C162847	48780-1	d6a99b39-8612-a426-e053-dadaa90af4c2	9254dada-4e32-43a0-892b-c488d68e23e7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63347-120-01	RevitaDERM Wound Care	89 mL in 1 TUBE	GEL	89		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63347-120-01	ML - Milliliter	63347-120	19e73614-c65a-4b43-818e-92123695d054	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]	1
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]	1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	59TL3WG5CO	REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]	1
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]	1
HYALURONIC ACID	INACTIVE INGREDIENT	S270N0TRQY	REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]	1
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)	INACTIVE INGREDIENT	ZR28QKN0WT	REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]	1
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63347-120	REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]	4	Current NDC, Legacy NDC, 1 package rows	20231222_9254dada-4e32-43a0-892b-c488d68e23e7.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 57 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Povidone Iodine Prep	POVIDONE IODINE	PHOENIX HEALTHCARE SOLUTIONS, LLC	c17603f2-3548-4225-b611-216c2763e51f	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions LLC	c601d9ea-25ab-cd1d-e053-2995a90ae252	2025-10-23	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	Cardinal Health	cc0a6e1e-ec95-cb48-e053-2a95a90ac0ce	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions, LLC	d07d103d-420b-5307-e053-2995a90a14f5	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Htl-Strefa, Inc.	d72ddf5a-72e7-c37d-e053-2995a90ad48b	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions LLC	c92524fd-8b91-592d-e053-2a95a90a88c6	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep	ISOPROPYL ALCOHOL	Cardinal Health	89852887-ae62-4277-b615-75663afb5436	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Henry Schein, Inc.	b9826baa-b976-14c6-e053-2995a90a7d09	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions LLC	c9261c7f-9f8f-6476-e053-2a95a90a0e93	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pad	ISOPROPYL ALCOHOL	Rugby Laboratories	ea28b27a-456e-4042-b769-f06072759933	2025-10-23	Warnings	Exact identifier application number: M003
School Health Sterile Alcohol Prep Pad	ISOPROPYL ALCOHOL	School Health Corporation	718640e1-826b-4b65-a021-3f82cd4c983a	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Henry Schein, Inc.	215fa8ac-c9b6-42b6-ae9d-a08d7ff0900f	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Cardinal Health	5459a0b4-65ca-455e-80b2-3fe1b24e0137	2025-10-23	Warnings	Exact identifier application number: M003
Hand Sanitizing Wipes	ETHYL ALCOHOL	Phoenix Healthcare Solutions LLC	c68d2d73-be78-8e1c-e053-2995a90a3a37	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep	ISOPROPYL ALCOHOL	PHOENIX HEALTHCARE SOLUTIONS, LLC	a7d77afc-588d-47d7-be2f-686ff3d75da2	2025-10-23	Warnings	Exact identifier application number: M003
Hand Sanitizing Wipes	ETHYL ALCOHOL	PHOENIX HEALTHCARE SOLUTIONS, LLC	ca9f8e68-cc15-42b4-81fd-e114e6a6d7df	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	PHOENIX HEALTHCARE SOLUTIONS, LLC	50b24287-4c91-43d2-9c2e-42d3c086b3b3	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep	ISOPROPYL ALCOHOL	PHOENIX HEALTHCARE SOLUTIONS, LLC	51b707c6-df09-441b-a3d1-3f0c1b0886cc	2025-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Prep Swabstick	POVIDONE IODINE	PHOENIX HEALTHCARE SOLUTIONS, LLC	8a0aba34-3f96-46b6-8521-f4388fb73edf	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	PHOENIX HEALTHCARE SOLUTIONS, LLC	9c34be37-b6e2-4c08-96a5-d9bb0e738f2d	2025-10-23	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
1049228	benzalkonium chloride 0.1 % Topical Gel	PSN	9254dada-4e32-43a0-892b-c488d68e23e7	4
1310820	RevitaDERM Wound Care 0.1 % Topical Gel	PSN	9254dada-4e32-43a0-892b-c488d68e23e7	4
1310820	benzalkonium chloride 0.001 MG/MG Topical Gel [RevitaDERM Wound Care]	SBD	9254dada-4e32-43a0-892b-c488d68e23e7	4
1049228	benzalkonium chloride 0.001 MG/MG Topical Gel	SCD	9254dada-4e32-43a0-892b-c488d68e23e7	4
1049228	benzalkonium chloride 0.1 % Topical Gel	SY	9254dada-4e32-43a0-892b-c488d68e23e7	4
1310820	RevitaDERM Wound Care 0.001 MG/MG Topical Gel	SY	9254dada-4e32-43a0-892b-c488d68e23e7	4
1310820	RevitaDERM Wound Care 0.1 % Topical Gel	SY	9254dada-4e32-43a0-892b-c488d68e23e7	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63347-120-01	63347012001	89 mL in 1 TUBE (63347-120-01)	89 ml	2012-05-24	0000-00-00	No	No	Current