FDA.reportPublic FDA data

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
IngredientStrength
BENZALKONIUM CHLORIDE170 mg/89mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049228Internal RxNorm lookup
1310820Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9254dada-4e32-43a0-892b-c488d68e23e7Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63347-120-012022-02-18C16284748780-1d6a99b39-8612-a426-e053-dadaa90af4c29254dada-4e32-43a0-892b-c488d68e23e7
63347-120-012022-01-28C16284748780-1d6a99b39-8612-a426-e053-dadaa90af4c29254dada-4e32-43a0-892b-c488d68e23e7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63347-120-01RevitaDERM Wound Care89 mL in 1 TUBEGEL894

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63347-120-01ML - Milliliter63347-12019e73614-c65a-4b43-818e-92123695d05412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YREVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XREVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COREVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXREVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]1
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQYREVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]1
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)INACTIVE INGREDIENTZR28QKN0WTREVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GREVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TREVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKREVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63347-120REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]4Current NDC, Legacy NDC, 1 package rows20231222_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 56 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Vanilla CloudETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d8811-7fb2-aef6-e063-6394a90a1cf82025-10-27WarningsExact identifier
application number: M003
American Red Cross 70% Isopropyl AlcoholISOPROPYL ALCOHOL(70%CONC.)MY IMPORTS USA LLC421d7bd9-c893-ec97-e063-6394a90a4b282025-10-27WarningsExact identifier
application number: M003
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)MY IMPORTS USA LLC421dc192-97ed-0675-e063-6394a90aa1562025-10-27WarningsExact identifier
application number: M003
American Red Cross First AidBENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)MY IMPORTS USA LLC421f3150-2027-c6aa-e063-6294a90ab6aa2025-10-27WarningsExact identifier
application number: M003
American Red Cross First AidBENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.421b402e-233d-cebf-e063-6394a90aa4212025-10-27WarningsExact identifier
application number: M003
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.637dcb5f-8870-4613-a227-9fd6126170612025-10-27WarningsExact identifier
application number: M003
SOURPATCH KIDS HAND SANITIZER SET WATERMELONALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42143916-8d2e-dbbe-e063-6294a90a29c42025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER SET CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42147184-18e6-f932-e063-6294a90a807e2025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4214ba08-8d00-8de9-e063-6394a90a4c902025-10-26WarningsExact identifier
application number: M003
Sour Patch Kids Hand Sanitizer WatermelonALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4214f0de-6b1d-dae7-e063-6294a90ade422025-10-26WarningsExact identifier
application number: M003
SOURPATCH KIDS HAND SANITIZER STRAWBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4215130c-a298-02c7-e063-6394a90a74ff2025-10-26WarningsExact identifier
application number: M003
SMARTIES ORANGE HAND SANTIZER SET ORANGE CREAMSICLEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd421b1732-acdd-a6cc-e063-6394a90a5fb42025-10-26WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Soft BerryETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421ce569-f2d3-c1e0-e063-6294a90a822f2025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER BLUE RASPBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d1f66d-45f6-bb9a-e063-6394a90a06aa2025-10-26WarningsExact identifier
application number: M003
Alcohol WipeISOPROPYL ALCOHOLCardinal Healthc95bfab6-bab4-79f3-e053-2995a90a80912025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC3a6e97d7-7eea-f7ca-e063-6394a90a4ecd2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC3a6cabf7-9310-cba5-e063-6394a90a3f912025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC39529f87-ed4e-52b8-e063-6394a90af8792025-10-23WarningsExact identifier
application number: M003
CareTouchETHYL ALCOHOLPhoenix Healthcare Solutions LLCf0b55f6c-4afd-2154-e053-2995a90afcfa2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCe8cdf841-cf56-26cc-e053-2995a90aab512025-10-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049228benzalkonium chloride 0.1 % Topical GelPSN9254dada-4e32-43a0-892b-c488d68e23e74
1310820RevitaDERM Wound Care 0.1 % Topical GelPSN9254dada-4e32-43a0-892b-c488d68e23e74
1310820benzalkonium chloride 0.001 MG/MG Topical Gel [RevitaDERM Wound Care]SBD9254dada-4e32-43a0-892b-c488d68e23e74
1049228benzalkonium chloride 0.001 MG/MG Topical GelSCD9254dada-4e32-43a0-892b-c488d68e23e74
1049228benzalkonium chloride 0.1 % Topical GelSY9254dada-4e32-43a0-892b-c488d68e23e74
1310820RevitaDERM Wound Care 0.001 MG/MG Topical GelSY9254dada-4e32-43a0-892b-c488d68e23e74
1310820RevitaDERM Wound Care 0.1 % Topical GelSY9254dada-4e32-43a0-892b-c488d68e23e74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63347-120-016334701200189 mL in 1 TUBE (63347-120-01) 89 ml2012-05-240000-00-00NoNoCurrent