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 89 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerALCOHOLCMC Group Inc.dcca50e6-0935-401d-a23e-be4d1231dde92025-01-13WarningsExact identifier
application number: M003
Refill 2BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.45dde3f0-546c-4ec5-beb0-c3d0432f49832025-01-13WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.e5cb395f-5037-4b0e-9c9d-2d78b5b01b252025-01-13WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLCMC Group Inc.6f4a4538-7522-4bcf-b3cf-8dea60438a4d2025-01-13WarningsExact identifier
application number: M003
Refill 6ALCOHOL, WATERCMC Group, Inc.7849ae59-5484-4b86-a0b9-ec9b93d9afe02025-01-13WarningsExact identifier
application number: M003
EVR Povidone lodine WipePOVIDONE LODINEChangzhou Maokang Medical Products Co., Ltd.2b57e301-74e0-e1db-e063-6294a90a6c182025-01-10WarningsExact identifier
application number: M003
EVR Sting Relief WipeBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.2b584d09-916c-00f8-e063-6294a90adbcf2025-01-10WarningsExact identifier
application number: M003
Alcohol Prep Pad-LargeISOPROPYL ALCOHOLGlobal Biomedical Technologies, LLC93d00515-e93f-48a3-b66b-7d933e734e542025-01-10WarningsExact identifier
application number: M003
DERMADIVE ULTRACARE - TETRAIDBENZALKONIUM CHLORIDEReleaf Technologies LLC025c0b33-73ca-334b-e063-6394a90ad6682025-01-09WarningsExact identifier
application number: M003
Drs. pharmacy triple antibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLCbb730976-0045-c0ae-e053-2a95a90af34e2025-01-09WarningsExact identifier
application number: M003
Drs. Antibiotic BacitracinBACITRACINOL PHARMA TECH, LLCc26493c4-0bc1-5fdc-e053-2995a90a81e62025-01-09WarningsExact identifier
application number: M003
Drs. Pharmacy Triple Antibiotic PlusBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACYd037bfb8-0d8c-4eda-e053-2995a90ae1f22025-01-09WarningsExact identifier
application number: M003
BACTINE MAXBACTINE MAX WOUND WASHWellSpring Pharmaceutical Corporation39b26c28-93e0-41a9-8018-f73525ebc0152025-01-08WarningsExact identifier
application number: M003
sterilePOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0658a0c8-f5ec-b380-e063-6394a90afff52025-01-08WarningsExact identifier
application number: M003
Betadine Surgical ScrubPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1ad39e11-ea1e-44a4-8224-93f8135436c22025-01-06WarningsExact identifier
application number: M003
First Aid AntisepticBENZALKONIUM CHLORIDEWater-Jel Technologies2b3cb958-c0c4-47fd-8338-7c7821135f2b2025-01-06WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLWater-Jel Technologies54e62104-8076-41db-afe5-6dc5c3563acc2025-01-06WarningsExact identifier
application number: M003
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.41891599-420e-48d2-8e31-d28a2209e3832025-01-06WarningsExact identifier
application number: M003
Signature Care Alcohol Prep PadISOPROPYL ALCOHOLBetter Living Brands LLCadc87331-1aa1-3457-e053-2a95a90a7eb12025-01-03WarningsExact identifier
application number: M003
Alcohol Extra-ThickISOPROPYL ALCOHOLMeijer Distribution Inc0b02643d-ea14-4877-ae9c-f0749d1b2d102025-01-03WarningsExact 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