FDA.reportPublic FDA data

1438 DynaSoap

Product NDC
67777-319
11-digit product format
677770319
Labeler code
67777
Product ID
67777-319_509de84a-bd98-a1d7-e063-6294a90a5a9d
Type
HUMAN OTC DRUG
Nonproprietary name
Antibacterial Hand Soap
Dosage form
SOAP
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-01
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
1438 DynaSoap
Listing expiration
2027-12-31

Active Ingredients#

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

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
1046593Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab0d5f64-9168-2ea3-e053-2a95a90a321eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-319-011438 DynaSoap24 in 1 CASESOAP245
67777-319-021438 DynaSoap0.13 g in 1 BOTTLE, PUMPSOAP0.135

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-3191438 DYNASOAP (ANTIBACTERIAL HAND SOAP) SOAP [DYNAREX CORPORATION]4Current NDC, Legacy NDC, 2 package rows20241122_ab0d5f64-9168-2ea3-e053-2a95a90a321e.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 80 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Spicy CranberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b8e946-b52b-fa2e-e063-6294a90ae1a72025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Pine ForestALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b920b7-91b4-52df-e063-6394a90a745e2025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitize MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b95351-5115-7200-e063-6394a90a58402025-04-14WarningsExact identifier
application number: M003
Be Smart Get Prepared Alcohol Prep PadISOPROPYL ALCOHOLTotal Resources International, Inc6f2a4cb9-eea9-4894-b774-759f27b6f9a82025-04-14WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC9c85129b-29fa-4393-a9b4-b8ea1ba5be542025-04-14WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLTARGET Corporationf4ea4aa4-42c6-456b-9908-24f256d4a7692025-04-14WarningsExact identifier
application number: M003
Isopropyl alcohol WintergreenISOPROPYL ALCOHOLStrategic Sourcing Services LLC8dac7168-0140-470f-bf66-fd0aed519b382025-04-14WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC227b9292-0be7-47ef-ac8e-a9a8cc2fb4162025-04-14WarningsExact identifier
application number: M003
Be Smart Get Prepared Antiseptic WipeBENZALKONIUM CHLORIDETotal Resources International, Incf2151af3-d76a-490f-90ff-728c350fe1682025-04-11WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer 1.35oz - Whispering WoodsALCOHOLShenzhen Lantern Scicence Co.,Ltd.32676185-14e8-a56d-e063-6294a90adc7b2025-04-10WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer 1.35oz - Midnight MuskALCOHOLShenzhen Lantern Scicence Co.,Ltd.3267a5ff-03cb-86c9-e063-6394a90a678d2025-04-10WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer 1.35oz - Meadow MirageALCOHOLShenzhen Lantern Scicence Co.,Ltd.32681df8-0af0-d9c5-e063-6394a90a00f02025-04-10WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer 1.35oz - Botanic BlushALCOHOLShenzhen Lantern Scicence Co.,Ltd.32687109-0843-09e9-e063-6394a90a60272025-04-10WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer 1.35oz - Golden GroveALCOHOLShenzhen Lantern Scicence Co.,Ltd.3268b7e9-3de4-335b-e063-6394a90adfa02025-04-10WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer 1.35oz - Citrus SuedeALCOHOLShenzhen Lantern Scicence Co.,Ltd.3268f248-64da-7a22-e063-6294a90a6dd32025-04-10WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.32692c9c-11bb-d772-e063-6294a90a50d42025-04-10WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.32695a30-f9dd-11aa-e063-6294a90a78392025-04-10WarningsExact identifier
application number: M003
Walgreens 91% Isopropyl AlcoholISOPROPYL ALCOHOLWalgreens Co.21f204f9-a271-0062-e063-6294a90addcc2025-04-10WarningsExact identifier
application number: M003
UnguentinePHENOL, ZINC OXIDEOakhurst Company327038a1-b825-1199-e063-6394a90a7f5f2025-04-10WarningsExact identifier
application number: M003
Northside Hospital Grey Amenity KitSODIUM MONOFLUOROPHOSPATEASP Global, LLCa3cc89df-be1b-4d9a-8ba3-8578853254222025-04-09WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNab0d5f64-9168-2ea3-e053-2a95a90a321e5
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDab0d5f64-9168-2ea3-e053-2a95a90a321e5
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYab0d5f64-9168-2ea3-e053-2a95a90a321e5
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYab0d5f64-9168-2ea3-e053-2a95a90a321e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-319-016777703190124 BOTTLE, PUMP in 1 CASE (67777-319-01) / .13 g in 1 BOTTLE, PUMP (67777-319-02) 2020-08-010000-00-00NoNoCurrent
67777-319-02677770319020.13 g in 1 BOTTLE, PUMP0.13 gHistorical