FDA.reportPublic FDA data

SunDrops 75

Product NDC
63621-356
Requested package NDC
63621-356-25
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581658Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b0623424-939e-4b49-aa99-c1ef22cf0f2dAvailable on FDA.report

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

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 75ALCOHOLSunburst Chemicals, Inc.b0623424-939e-4b49-aa99-c1ef22cf0f2d2025-11-11WarningsExact identifier
ndc (package): 63621-356-25
ndc (product): 63621-356
ndc11 (package): 63621035625

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63621-356-256362103562512 BOTTLE, PUMP in 1 BOX (63621-356-25) / 236.6 mL in 1 BOTTLE, PUMP2009-10-140000-00-00NoNoCurrent