FDA.reportPublic FDA data

DERMADIVE ULTRACARE - TETRAID

Product NDC
78663-102
11-digit product format
786630102
Labeler code
78663
Product ID
78663-102_2b47af26-00c4-5628-e063-6294a90ad70b
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Releaf Technologies LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-07
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100mL
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
DERMADIVE ULTRACARE - TETRAID
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046442Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
025c0b33-73ca-334b-e063-6394a90ad668Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78663-102-34DERMADIVE ULTRACARE - TETRAID100 mL in 1 TUBELOTION1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78663-102DERMADIVE ULTRACARE - TETRAID (BENZALKONIUM CHLORIDE) LOTION [RELEAF TECHNOLOGIES LLC]3Current NDC, 1 package rows20250112_025c0b33-73ca-334b-e063-6394a90ad668.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 25 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer 3pk with Leather CaseALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f036ba3-3f21-d04b-e063-6294a90ad7d72026-04-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Pistachio CremeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eeedd3e-d4b4-9967-e063-6394a90abf332026-04-08WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer French VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eef33c2-695a-3a32-e063-6394a90a0a7b2026-04-08WarningsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Squishmallows PinkALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eefc5bc-7dd4-e4c8-e063-6394a90a9a512026-04-08WarningsExact identifier
application number: M003
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4ef56b6c-ad46-2d02-e063-6294a90ad4072026-04-08WarningsExact identifier
application number: M003
RubbingETHYL ALCOHOLPerrigo Direct, Incba2266d7-da25-495a-b035-97e149551c302026-04-08Warnings, Adverse reactionsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Squishmallows PurpleALCOHOLShenzhen Lantern Scicence Co.,Ltd.4efeb523-0a73-2e48-e063-6394a90aac5e2026-04-08WarningsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Hot Wheels RedALCOHOLShenzhen Lantern Scicence Co.,Ltd.4efefd07-c1df-695a-e063-6294a90a51eb2026-04-08WarningsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Hot Wheels PurpleALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eff601c-7bcd-1ddd-e063-6294a90a80402026-04-08WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Ocean BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4effb28e-fa83-5a06-e063-6394a90aa2f52026-04-08WarningsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLPerrigo Direct, Incf953a249-07ad-40a1-8aea-b2d419fd3d4d2026-04-07Warnings, Adverse reactionsExact identifier
application number: M003
50% RubbingISOPROPYL ALCOHOLPerrigo Direct, Inc698bede7-4fc1-4e85-8ac4-d735f409cfae2026-04-06Warnings, Adverse reactionsExact identifier
application number: M003
Ethyl Rubbing AlcoholETHYL ALCOHOLAmazon.com Services LLC5369424a-ccbd-4dc6-af6b-7876484a9fe62026-04-06Warnings, Adverse reactionsExact identifier
application number: M003
Caring Mill Triple Hand Sanitizer with LavenderETHYL ALCOHOLFSA Store Inc. (Caring Mills)4b0b5436-a1ce-cfa6-e063-6394a90a2efe2026-04-04WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Passion ParadiseALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e850ea9-0999-12b4-e063-6394a90af4062026-04-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Tropical MangoALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85630a-6d18-e6a4-e063-6394a90a1d122026-04-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Coco CabanaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85923b-6b8c-f9a2-e063-6294a90a0d8e2026-04-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Sea BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85e279-7751-8bd7-e063-6294a90a095b2026-04-02WarningsExact identifier
application number: M003
Povidone Iodine 10%POVIDONE IODINEFarmacias De Similares TX LLC4e6baed0-ea31-79e2-e063-6294a90a3bb12026-04-01WarningsExact identifier
application number: M003
FRESH LINES SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5005d615-d9c3-a46d-e063-6394a90af88a2026-04-01WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046442benzalkonium chloride 0.13 % Topical LotionPSN025c0b33-73ca-334b-e063-6394a90ad6683
1046442benzalkonium chloride 1.3 MG/ML Topical LotionSCD025c0b33-73ca-334b-e063-6394a90ad6683
1046442benzalkonium chloride 0.13 % Topical LotionSY025c0b33-73ca-334b-e063-6394a90ad6683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78663-102-3478663010234100 mL in 1 TUBE (78663-102-34) 100 ml2023-08-07NoNoCurrent