Spot Defy

Product NDC
49825-200
11-digit product format
498250200
Labeler code
49825
Product ID
49825-200_462acf75-cc59-2738-e063-6294a90a47de
Type
HUMAN OTC DRUG
Nonproprietary name
Sulfur
Dosage form
LOTION
Route
TOPICAL
Labeler
Bioelements, Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-01
Substance
SULFUR
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Spot Defy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii70FD1KFU70
Rxcui422938

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49825-200-10Spot Defy1 in 1 CARTONLOTION13
49825-200-20Spot Defy15 mL in 1 BOTTLE, GLASSLOTION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49825-200SPOT DEFY (SULFUR) LOTION [BIOELEMENTS]2Current NDC, 2 package rows20240901_6f35f950-8d04-4181-a897-5679fde1e2d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
422938sulfur 5 % Topical LotionPSN6f35f950-8d04-4181-a897-5679fde1e2d93
422938sulfur 50 MG/ML Topical LotionSCD6f35f950-8d04-4181-a897-5679fde1e2d93
422938sulfur 5 % Topical LotionSY6f35f950-8d04-4181-a897-5679fde1e2d93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49825-200-10498250200101 BOTTLE, GLASS in 1 CARTON (49825-200-10) / 15 mL in 1 BOTTLE, GLASS (49825-200-20) 2024-09-01NoNoHistorical
49825-200-204982502002015 mL in 1 BOTTLE, GLASS15 mlHistorical