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 46 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 Daily Deep Cleansing Acne Treatment SALICYLIC ACID L'Oreal USA Products Inc 74c49388-3314-47e8-80b1-19c09e6ea1f9 2024-07-14 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment SALICYLIC ACID COSMETIQUE ACTIVE PRODUCTION 873de079-8b8d-45cd-8c7c-4645818f5aaa 2024-07-14 Warnings Exact identifier application number: M006 Dr. Zenovia Clear Complexion SALICYLIC ACID Topiderm, Inc. 4ff9b26d-3cd9-4539-b389-edd2df24a466 2024-06-28 Warnings Exact identifier application number: M006 LEROSETT Botanical Acne Cleanser SALICYLIC ACID GUNILLA OF SWEDEN, INC. 8b31d155-c257-4452-9e22-0c69fa36173e 2024-06-27 Warnings Exact identifier application number: M006 SkinCeuticals Silymarin CF Acne Treatment Antioxidant SALICYLIC ACID Cosmetique Active Production fcc3c44b-3090-45b5-91e4-e591c92a08c8 2024-06-24 Warnings Exact identifier application number: M006 Peace Out Early Stage Acne Dot SALICYLIC ACID Peace Out LLC. 0632d458-d326-ade4-e063-6294a90af3ba 2024-06-20 Warnings Exact identifier application number: M006 Replenix BP Acne BENZOYL PEROXIDE Topiderm, Inc. f449e020-a4d8-4a1b-82eb-4dc59e99b8d4 2024-06-18 Warnings Exact identifier application number: M006 b pure Pressed Powder for Acne Prone Skin Fair SALICYLIC ACID Fourstar Group USA, Inc. ecf22bd1-4fc3-4455-ae01-13f97f53dc34 2024-06-17 Warnings Exact identifier application number: M006 b pure Pressed Powder for Acne Prone Skin Tan SALICYLIC ACID Fourstar Group USA, Inc. 1158f6c2-2b59-4ed3-8d28-73b6da885a5d 2024-06-17 Warnings Exact identifier application number: M006 Gly-Sal 10-2 SALICYLIC ACID Topiderm, Inc. 661cc58b-9360-4b96-b405-afdc2e378397 2024-06-13 Warnings Exact identifier application number: M006 BLAIR and JACK Anti-Bump Acne Treatment BENZOYL PEROXIDE Blair + Jack aa8df86a-639c-4416-aadf-4b58566ed9f1 2024-06-11 Warnings Exact identifier application number: M006 b pure Blemish Concealer for Acne Prone Skin Nude SALICYLIC ACID Fourstar Group USA, Inc. 76e91277-1fb4-490b-b351-39d626bc1fc2 2024-06-11 Warnings Exact identifier application number: M006 b pure Blemish Concealer for Acne Prone Skin Fair SALICYLIC ACID Fourstar Group USA, Inc. 764599e5-2ec3-4223-819e-36415fd915f7 2024-06-11 Warnings Exact identifier application number: M006 Dr. Zenovia Acne Cleanser BENZOYL PEROXIDE Topiderm, Inc. 00fb1ee5-6076-4980-8507-9e58a96e6a6b 2024-06-11 Warnings Exact identifier application number: M006 Dr. Zenovia Spot Treatment BENZOYL PEROXIDE Topiderm, Inc. dfdb3d8e-4d39-4ce4-851f-80b11972ca9e 2024-06-11 Warnings Exact identifier application number: M006 Rugby Benzoyl Peroxide Acne Medication BENZOYL PEROXIDE NuCare Pharmaceuticals,Inc. 69bd4f4c-017a-7422-e053-2991aa0aa655 2024-06-10 Warnings Exact identifier application number: M006 Thayers Natural Remedies Since 1847 Rapid Acne Treatment SULFUR L'Oreal USA Products Inc d7cc3c06-2f89-4c0b-b121-fdd53638b625 2024-06-07 Warnings Exact identifier application number: M006 Differin 10% BPO Acne Treatment BENZOYL PEROXIDE Galderma Laboratories, L.P. 05468eab-f239-42cb-9106-055a105f0fa5 2024-06-06 Warnings Exact identifier application number: M006 2.5 Acne Med BENZOYL PEROXIDE Face Reality, Inc. 58a7f677-996c-4951-8e5d-b5556244f800 2024-06-05 Warnings Exact identifier application number: M006 10 Acne Med BENZOYL PEROXIDE Face Reality, Inc. 91791905-086f-44cf-9c1a-e9f132c6c11b 2024-06-05 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