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 113 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5726f-d314-50d9-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08ad-5092-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c7f9a00-6600-4b0d-af11-fa776b22e6782023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c9f2c8b-6ed6-4e54-a151-5be4acb290e42023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd878bfaa7-d553-40db-8311-19010930abd92023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc1273e40-5c09-435b-adf3-e352fdd01e9e2023-10-23WarningsExact identifier
application number: M003
POVIDONE IODINE SCRUB SWABSTICK 3sPOVIDONE-IODINEJianerkang Medical Co., Ltd65783da9-acca-41c7-860b-1de108edc5832023-10-23WarningsExact identifier
application number: M003
Obstetrical ToweletteBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd8db4eb14-85b6-4c8e-9623-39a43b3827a12023-10-23WarningsExact identifier
application number: M003
POVIDONE IODINE PREP PAD SterilePOVIDONE-IODINEJianerkang Medical Co., Ltdac3aa401-a124-4eb7-9598-119be0f24ddd2023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc13af96e-f76a-4577-8d57-811ccc6527382023-10-23WarningsExact identifier
application number: M003
Povidone-Iodine Prep PadPOVIDONE-IODINECardinal Health 200, Inc.06c8a6f6-2fc8-4292-a3b5-6311a918a5212023-10-23WarningsExact identifier
application number: M003
Antiseptic BZK ToweletteBENZALKONIUM CHLORIDECardinal Health 200, Inc.8dd79ffe-f742-438c-9814-612f900ad6a92023-10-23WarningsExact identifier
application number: M003
Povidone Iodine Topical Solution PaintPOVIDONE IODINE 10%Jianerkang Medical Co., Ltdf231a572-a99d-4146-afa3-e73ea1cee0272023-10-22WarningsExact identifier
application number: M003
Povidone Iodine Topical Solution PaintPOVIDONE IODINE 10%Jianerkang Medical Co., Ltd42778607-6170-4a5e-94d0-5e6cd064eec62023-10-22WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd76048b01-28f3-4e43-9da9-974b2b511a102023-10-22WarningsExact identifier
application number: M003
GENUINE FIRST AID Antiseptic Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.d25f02f1-268c-44d8-9a55-c6efcbe8eed12023-10-19WarningsExact identifier
application number: M003
Brompton and Langley Moisturizing Hand Sanitizer Lavnder VanillaALCOHOLGanzhou Olivee Cosmetic Co., Ltd.90bd3436-a8bc-4c19-a300-d59236a8de272023-10-19WarningsExact identifier
application number: M003
Up and Up 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLTarget Corporationbecc8fe3-eaf5-4429-b462-a87dd09c4db82023-10-17WarningsExact identifier
application number: M003
Henry Schein Povidone-Iodine SwabsticksPOVIDONE-IODINEHenry Schein, Inc.766ad4df-2100-4f26-bd8b-5c5a0918698e2023-10-13WarningsExact identifier
application number: M003
GoodSense Alcohol SwabsISOPROPYL ALCOHOLGeiss, Destin and Dunn968bab9f-5b74-270b-e053-2995a90a0df42023-10-13WarningsExact 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