FDA.reportPublic FDA data

SunDrops 77

Product NDC
63621-354
11-digit product format
636210354
Labeler code
63621
Product ID
63621-354_43535ccc-3e06-c1e0-e063-6294a90a3acb
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
2008-05-05
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63621-35463621-354-70DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 77
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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc0ba65c-5307-4251-a60b-cde84ad56ad8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63621-354-40SunDrops 771000 mL in 1 BAGSOAP10009
63621-354-40SunDrops 774 in 1 BOXSOAP49
63621-354-70SunDrops 77500 mL in 1 BOTTLE, PUMPSOAP5009
63621-354-70SunDrops 776 in 1 BOXSOAP69
63621-354-85SunDrops 778 in 1 BOXSOAP89
63621-354-85SunDrops 771000 mL in 1 BAGSOAP10009

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W7SUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.]2
BenzalkoniumACTIVE MOIETY7N6JUD5X6YSUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.]2
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBPSUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.]2
DIHYDROXYETHYL COCAMINE OXIDEINACTIVE INGREDIENT8AR51R3BL5SUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.]2
GLYCERETH-17 COCOATEINACTIVE INGREDIENT3057VPT0KCSUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.]2
LAURTRIMONIUM CHLORIDEINACTIVE INGREDIENTA81MSI0FICSUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RSUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63621-354SUNDROPS 77 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.]8Current NDC, Legacy NDC, 6 package rows20241017_fc0ba65c-5307-4251-a60b-cde84ad56ad8.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 77BENZALKONIUM CHLORIDESunburst Chemicals, Inc.fc0ba65c-5307-4251-a60b-cde84ad56ad82025-11-11WarningsExact identifier
ndc (product): 63621-354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63621-354-40636210354404 BAG in 1 BOX (63621-354-40) / 1000 mL in 1 BAG4 bag2025-10-16NoNoCurrent
63621-354-70636210354706 BOTTLE, PUMP in 1 BOX (63621-354-70) > 500 mL in 1 BOTTLE, PUMP2008-05-080000-00-00NoNoCurrent
63621-354-85636210354858 BAG in 1 BOX (63621-354-85) / 1000 mL in 1 BAG8 bag2012-09-280000-00-00NoNoCurrent