FDA.reportPublic FDA data

SunDrops 87

Product NDC
63621-387
Requested package NDC
63621-387-40
11-digit product format
636210387
Labeler code
63621
Product ID
63621-387_435389b8-9dde-0d17-e063-6294a90ab9b8
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
Sunburst Chemicals, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-08
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
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
SunDrops 87
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1 mg/mL

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
1233282Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
584ea129-aaf2-402f-b9f1-3fec2a23a21cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63621-387-14SunDrops 873785 mL in 1 BOTTLE, PLASTICSOAP37858
63621-387-40SunDrops 871000 mL in 1 BAGSOAP10008
63621-387-40SunDrops 874 in 1 BOXSOAP48
63621-387-50SunDrops 87500 mL in 1 BOTTLE, PUMPSOAP5008
63621-387-50SunDrops 876 in 1 BOXSOAP68
63621-387-65SunDrops 878 in 1 BOXSOAP88
63621-387-65SunDrops 871000 mL in 1 BAGSOAP10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63621-387SUNDROPS 87 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.]7Current NDC, Legacy NDC, 7 package rows20250117_584ea129-aaf2-402f-b9f1-3fec2a23a21c.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SunDrops 87BENZALKONIUM CHLORIDESunburst Chemicals, Inc.584ea129-aaf2-402f-b9f1-3fec2a23a21c2025-11-11WarningsExact identifier
ndc (package): 63621-387-40
ndc (product): 63621-387
ndc11 (package): 63621038740

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapPSN584ea129-aaf2-402f-b9f1-3fec2a23a21c8
1233282benzalkonium chloride 1 MG/ML Medicated Liquid SoapSCD584ea129-aaf2-402f-b9f1-3fec2a23a21c8
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapSY584ea129-aaf2-402f-b9f1-3fec2a23a21c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63621-387-40636210387404 BAG in 1 BOX (63621-387-40) / 1000 mL in 1 BAG4 bag2025-10-16NoNoCurrent