FDA.reportPublic FDA data

SunDrops 75

Product NDC
63621-356
11-digit product format
636210356
Labeler code
63621
Product ID
63621-356_435330fc-c021-151b-e063-6394a90a229b
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Sunburst Chemicals, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-10-14
Substance
ALCOHOL
Active strength
.6 mL/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SunDrops 75
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL.6 mL/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581658

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63621-356-14SunDrops 753785 mL in 1 BOTTLE, PLASTICGEL378510
63621-356-20SunDrops 751000 mL in 1 BAGGEL100010
63621-356-20SunDrops 758 in 1 BOXGEL810
63621-356-25SunDrops 7512 in 1 BOXGEL1210
63621-356-25SunDrops 75236.6 mL in 1 BOTTLE, PUMPGEL236.610
63621-356-30SunDrops 756 in 1 BOXGEL610
63621-356-30SunDrops 751000 mL in 1 BAGGEL100010
63621-356-40SunDrops 751000 mL in 1 BAGGEL100010
63621-356-40SunDrops 754 in 1 BOXGEL410
63621-356-50SunDrops 75473.2 mL in 1 BOTTLE, PUMPGEL473.210

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90MSUNDROPS 75 (ALCOHOL) GEL [SUNBURST CHEMICALS, INC.]1
AlcoholACTIVE MOIETY3K9958V90MSUNDROPS 75 (ALCOHOL) GEL [SUNBURST CHEMICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63621-356SUNDROPS 75 (ALCOHOL) GEL [SUNBURST CHEMICALS, INC.]9Current NDC, Legacy NDC, 10 package rows20240322_b0623424-939e-4b49-aa99-c1ef22cf0f2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581658ethanol 60 % Topical GelPSNb0623424-939e-4b49-aa99-c1ef22cf0f2d10
581658ethanol 0.6 ML/ML Topical GelSCDb0623424-939e-4b49-aa99-c1ef22cf0f2d10
581658ethanol 60 % Topical GelSYb0623424-939e-4b49-aa99-c1ef22cf0f2d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63621-356-14636210356143785 mL in 1 BOTTLE, PLASTIC (63621-356-14) 3785 ml2020-05-070000-00-00NoNoCurrent
63621-356-20636210356208 BAG in 1 BOX (63621-356-20) / 1000 mL in 1 BAG8 bag2009-10-140000-00-00NoNoCurrent
63621-356-256362103562512 BOTTLE, PUMP in 1 BOX (63621-356-25) / 236.6 mL in 1 BOTTLE, PUMP2009-10-140000-00-00NoNoCurrent
63621-356-30636210356306 BAG in 1 BOX (63621-356-30) > 1000 mL in 1 BAG6 bag2016-07-200000-00-00NoNoCurrent
63621-356-40636210356404 BAG in 1 BOX (63621-356-40) / 1000 mL in 1 BAG4 bag2025-10-16NoNoHistorical
63621-356-5063621035650473.2 mL in 1 BOTTLE, PUMP (63621-356-50) 473.2 ml2020-06-290000-00-00NoNoCurrent