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 53 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Asepxia Charcoal Acne Bar SALICYLIC ACID Genomma Lab USA f727d947-fa91-47ae-8ea5-948afc9e5ba8 2023-11-06 Warnings Exact identifier application number: M006 Asepxia Oil-Free Acne Bar SALICYLIC ACID Genomma Lab USA 0b3a9224-f250-45e9-a1fe-a54940c6f93b 2023-11-06 Warnings Exact identifier application number: M006 Asepxia Softening Acne Bar SALICYLIC ACID Genomma Lab USA 9cf65052-b21a-42af-b45a-6a6db36fbb45 2023-11-06 Warnings Exact identifier application number: M006 Asepxia Scrub Acne Bar SALICYLIC ACID Genomma Lab USA 361a0b50-360e-4d9b-9780-16b02a2bee3c 2023-11-06 Warnings Exact identifier application number: M006 Dr. C. Tuna Acne Pore Purifying Toner SALICYLIC ACID Farmasi US LLC b8dcfaab-8c55-f23d-e053-2a95a90a8a01 2023-11-05 Warnings Exact identifier application number: M006 Dr. C. Tuna Acne Clear Complexion Cleanser SALICYLIC ACID Farmasi US LLC b8dd3370-fe03-f0f4-e053-2a95a90ab813 2023-11-05 Warnings Exact identifier application number: M006 Dr. C. Tuna Acne Blemish Control Serum SALICYLIC ACID Farmasi US LLC b8dd63d7-4ff2-60bc-e053-2a95a90ad16c 2023-11-05 Warnings Exact identifier application number: M006 Dr. C. Tuna Acne Clear Complexion Cleanser SALICYLIC ACID Farmasi US LLC de493e30-d10c-9def-e053-2995a90ae49a 2023-11-05 Warnings Exact identifier application number: M006 SERIOUS SKINCARE Continuously Clear Clearz It BENZOYL PEROXIDE Flageoli Limited af4c68ef-89a8-479a-a7b1-9b005193383e 2023-11-05 Warnings Exact identifier application number: M006 HUMANE ACNE WASH BENZOYL PEROXIDE Apprendista, LLC 1d25fb25-a3d2-4c6b-a975-be7b90b70265 2023-11-05 Warnings Exact identifier application number: M006 VIE NATURELLE ACNE BODY BENZOYL PEROXIDE TNT PRO SERIES 0278251d-bcf1-4177-8a57-163bd0f2df00 2023-11-05 Warnings Exact identifier application number: M006 enfuselle Acne Clarifying SALICYLIC ACID Shaklee Corporation dd429a9b-5c2d-4310-8506-6487b02e3880 2023-11-03 Warnings Exact identifier application number: M006 Peach and Lily Peaches Slices Acne Exfoliating toner SALICYLIC ACID Peach & Lily Inc. ba70ed1c-83cb-5eaa-e053-2a95a90a92cc 2023-10-28 Warnings Exact identifier application number: M006 Peach and Lily Peaches Slices Acne Clarifying Cleanser SALICYLIC ACID Peach & Lily, Inc. ba70f2b9-7a34-065c-e053-2a95a90a6eb2 2023-10-28 Warnings Exact identifier application number: M006 Peach and Lily Peaches Slices Acne Oil Acne Free Moisturizer SALICYLIC ACID Peach & Lily, Inc. ba70e7cf-af86-6a7f-e053-2995a90af962 2023-10-28 Warnings Exact identifier application number: M006 Modesa Acne Treatment BENZOYL PEROXIDE Zhejiang Jingwei Pharmaceutic Al Co., Ltd. dbfe8b9e-e343-4ed5-bd81-01b27b4aa912 2023-10-27 Warnings Exact identifier application number: M006 Acne Treatment BENZOYL PEROXIDE Vivier Pharma, Inc. b4844539-bdd2-42a6-b946-6028de4f3cf1 2023-10-27 Warnings Exact identifier application number: M006 Acne Treatment System BENZOYL PEROXIDE, SALICYLIC ACID Vivier Pharma, Inc. d39ee6a2-5d65-4198-82d9-deb83471f312 2023-10-27 Warnings Exact identifier application number: M006 Equate Beauty Quick Action Pads Salicylic Acid Acne Treatment SALICYLIC ACID Bath Concept Cosmetics (Dongguan) Co., Ltd c94e85a7-b799-b70d-e053-2a95a90aaee2 2023-10-26 Warnings Exact identifier application number: M006 ARTISTRY STUDiO Rose All Day Anti Acne Toner Pore Refresher SALICYLIC ACID Access Business Group LLC a9e26804-7989-41d2-8506-c4b65ca385b7 2023-10-21 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