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

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
Spot Defy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
70FD1KFU70Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
422938Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6f35f950-8d04-4181-a897-5679fde1e2d9Available on FDA.report

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

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 34 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALMAY CLEAR COMPLEXION MAKEUP FOUNDATION CaramelSALICYLIC ACIDALMAY2a982e0e-4720-797e-e063-6294a90a43c12024-12-31WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION MAKEUP FOUNDATION MochaSALICYLIC ACIDALMAY2a9807d1-cf87-7096-e063-6394a90afca32024-12-31WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION MAKEUP FOUNDATION Natural TanSALICYLIC ACIDALMAY2a981e22-d7d1-311b-e063-6294a90ab25f2024-12-31WarningsExact identifier
application number: M006
ALMAY CLEAR COMPLEXION CONCEALERSALICYLIC ACIDALMAYc3b57024-120e-390f-e053-2a95a90a6d352024-12-30WarningsExact identifier
application number: M006
Almay Clear Complexion Makeup BuffSALICYLIC ACIDAlmay2a83300a-15f0-365a-e063-6394a90a28d12024-12-30WarningsExact identifier
application number: M006
RETINOL CLEARINGSALICYLIC ACIDDermalogica, LLC.4c20d87c-f3cf-4a40-acec-b0a8bfb9b29c2024-12-30WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula BalmSALICYLIC ACIDL'Oreal USA Products Inc0c902cfa-d98a-42c3-967b-5a7c51a652492024-12-30WarningsExact identifier
application number: M006
Salicylic Acid CleanserEXFOLIATING AND CLARIFYING FACE WASHBentley Laboratories, LLCeb7fa2b5-3bdb-436c-8576-1eea29b8d1ff2024-12-27WarningsExact identifier
application number: M006
Acne Control Superclean Body Wash AHA BHA FormulaSALICYLIC ACIDBentley Laboratories, LLC16fd3343-d044-4f6b-af1a-30bc32ce20412024-12-27WarningsExact identifier
application number: M006
SkinCeuticals Blemish Plus Age Defense Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc5726d12c-708c-46e6-a584-9e5c7a544fc82024-12-27WarningsExact identifier
application number: M006
SkinCeuticals Clarifying Exfoliating CleanserSALICYLIC ACIDL'Oreal USA Products Inca0cc4ae7-c266-4321-92e6-a46d560a74b22024-12-27WarningsExact identifier
application number: M006
BRODA AcneSALICYLIC ACIDBentley Laboratories, LLCb7e1f105-8998-46a5-b1ae-85d21790b8162024-12-27WarningsExact identifier
application number: M006
Monat Be Clarified Acne-Clearing MoisturizerSALICYLIC ACIDCosmax Usa, Corporation2984d615-7ed1-46c3-e063-6294a90a1f8a2024-12-26WarningsExact identifier
application number: M006
Nativae Milia Acne SerumSALICYLIC ACIDCDE BRANDS LLCe04cf0a2-bda7-4e5b-9771-769995cf69252024-12-26WarningsExact identifier
application number: M006
Milani Erase Base Blemish Control PrimerSALICYLIC ACIDCosmax Usa, Corporation1b1f1948-2ad9-48d2-9871-6830b2442f432024-12-26WarningsExact identifier
application number: M006
Oxy Sensitive Skin Acne Cleansing PadsSALICYLIC ACID 0.5%The Mentholatum Company2a36b6c5-f518-66f0-e063-6394a90acd402024-12-26WarningsExact identifier
application number: M006
Oxy Deep Pore Acne Cleansing PadsSALICYLIC ACID 2%The Mentholatum Company2a385fac-399b-c111-e063-6394a90aefc32024-12-26WarningsExact identifier
application number: M006
Oxy 3-IN-1 Acne Cleansing PadsSALICYLIC ACID 2%The Mentholatum Company2a398c8d-09e6-513b-e063-6294a90ad8572024-12-26WarningsExact identifier
application number: M006
DEEP ACNESULFURDermalogica, LLC.d4e9d230-2ee4-4cc7-a7c9-a7dde50b6f402024-12-26WarningsExact identifier
application number: M006
SUNDAY RILEY SATURN SULFUR ACNE SPOT TREATMENT MASKSULFURSunday Riley Modern Skincare, LLC35364a71-b011-42f5-9941-4a2f8440808b2024-12-26WarningsExact identifier
application number: M006

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) 2024-09-01NoNoCurrent
49825-200-204982502002015 mL in 1 BOTTLE, GLASS15 mlHistorical