Home NDC 49825-200 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 Ingredient Strength SULFUR 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 70FD1KFU70 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 422938 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49825-200-10 Spot Defy 1 in 1 CARTON LOTION 1 3 49825-200-20 Spot Defy 15 mL in 1 BOTTLE, GLASS LOTION 15 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49825-200 SPOT DEFY (SULFUR) LOTION [BIOELEMENTS] 2 Current NDC, 2 package rows 20240901_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 50 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vichy Laboratoires Normaderm SOS Acne Rescue Spot Corrector SULFUR L'Oreal USA Products Inc 4907bc52-62e3-4256-b4ca-bcde896a4aab 2023-12-27 Warnings Exact identifier application number: M006 Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Pads SALICYLIC ACID L'Oreal USA Products Inc bc0d1691-c13d-4c15-8c44-ecee30cb0ae2 2023-12-27 Warnings Exact identifier application number: M006 Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Cleanser SALICYLIC ACID L'Oreal USA Products Inc 935a58f0-d9a3-4423-9a5f-65fd19fad3db 2023-12-27 Warnings Exact identifier application number: M006 All Acne Treatment SALICYLIC ACID Blaine Labs Inc. ee85939e-64fc-4b18-af5b-6ebd7e14e572 2023-12-21 Warnings Exact identifier application number: M006 In the Clear Acne Serum SALICYLIC ACID The Honest Company, Inc dc9e0545-43af-3d27-e053-2a95a90a5249 2023-12-19 Warnings Exact identifier application number: M006 Spot Stopper Acne Spot Treatment SALICYLIC ACID The Honest Company, Inc dc7afebd-e212-b9ff-e053-2a95a90a15a5 2023-12-19 Warnings Exact identifier application number: M006 Get Clarity Foaming Acne Cleanser SULFUR The Honest Company, Inc dd948b1b-d71c-1a89-e053-2a95a90a8719 2023-12-19 Warnings Exact identifier application number: M006 Acne Med 10% BENZOYL PEROXIDE Face Reality, LLC 45ad7429-ccd0-28f6-e054-00144ff88e88 2023-12-15 Warnings Exact identifier application number: M006 Acne Face and Body BENZOYL PEROXIDE Face Reality, Inc. 454983d2-4b00-6268-e054-00144ff8d46c 2023-12-15 Warnings Exact identifier application number: M006 Acne Med 5% BENZOYL PEROXIDE Face Reality, LLC 454983d2-4b11-6268-e054-00144ff8d46c 2023-12-15 Warnings Exact identifier application number: M006 Acne Face and Body Wash BENZOYL PEROXIDE Face Reality Skin Care, LLC 454983d2-4aec-6268-e054-00144ff8d46c 2023-12-15 Warnings Exact identifier application number: M006 Acne Med 2.5% BENZOYL PEROXIDE Face Reality, LLC 454983d2-4b0f-6268-e054-00144ff8d46c 2023-12-15 Warnings Exact identifier application number: M006 Nighttime Control BENZOYL PEROXIDE Circadia by Dr Pugliese, Inc. fb4cc832-4cfd-4e29-a78e-ab848681a224 2023-12-15 Warnings Exact identifier application number: M006 La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment SALICYLIC ACID L'Oreal USA Products Inc 5056320e-e472-44ed-9afd-759ba55f0fd7 2023-12-13 Warnings Exact identifier application number: M006 La Roche Posay Laboratoire Dermatologique Effaclar AntiAcne Pore Refining Acne Treatment SALICYLIC ACID COSMETIQUE ACTIVE PRODUCTION 418d480c-4131-4262-bb56-d5b10bbf7dcb 2023-12-13 Warnings Exact identifier application number: M006 Acne Advanced Clarifying Masque SALICYLIC ACID Eminence Organic Skin Care Ltd. 7916a299-fc90-4eb7-882f-4caa39e2c7aa 2023-12-12 Warnings Exact identifier application number: M006 Serious Skincare Continuously Clear Acne Medication For Problematic skin Dry Lo Pro All- Over Treatment SALICYLIC ACID Flageoli Limited eb57517c-cf9e-4272-9c00-380385f916e0 2023-12-12 Warnings Exact identifier application number: M006 111MedCo 6% Sulfur Skin Cleansing Bar SULFUR 111MedCo LLC 7a2d647f-f10f-4637-b28b-319fed93677b 2023-12-12 Warnings Exact identifier application number: M006 111MedCo 2% Salicylic Acid Cleansing Bar SALICYLIC ACID 111MedCo LLC 6ba7dd8f-b59f-4dfb-b55e-c7fe65a54d8a 2023-12-12 Warnings Exact identifier application number: M006 111 Medco Benzoyl Peroxide BENZOYL PEROXIDE 111 Medco 8590214e-e5a7-8934-e053-2a91aa0a248b 2023-12-12 Warnings Exact identifier application number: M006
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 49825-200-10 49825020010 1 BOTTLE, GLASS in 1 CARTON (49825-200-10) / 15 mL in 1 BOTTLE, GLASS (49825-200-20) 2024-09-01 No No Current 49825-200-20 49825020020 15 mL in 1 BOTTLE, GLASS 15 ml Historical