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 1 of 56 · 1,102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defense Acne Care 2% Salicylic AcidSALICYLIC ACID 2%Defense Soap LLC98fcc243-d789-181d-e053-2995a90a9b5d2026-09-09WarningsExact identifier
application number: M006
Jack Black Bump FixSALICYLIC ACIDJack Black, L.L.C.e8f51678-2675-405c-8462-351ec260051a2026-09-08WarningsExact identifier
application number: M006
Abib Acne foam cleanser Heartleaf foamSALICYLIC ACIDFourcompany Co., Ltd.5aa353ad-0ca5-77c1-e063-6394a90a62542026-09-04WarningsExact identifier
application number: M006
Dr.Leo Acne Buster Salicylic Acid DryingSALICYLIC ACIDDoctor Leo USA Inc5792fa71-eb6b-3c70-e063-6394a90abde82026-09-03WarningsExact identifier
application number: M006
Blackhead Clearing ScrugSALICYLIC ACIDWalmart Inc.6989591a-a78b-4971-baf2-51ebfaf9c7e72026-09-02Warnings, Adverse reactionsExact identifier
application number: M006
Beisitian FACIAL BUMP REFINING ESSENCESALICYLIC ACID 2% FACIAL BUMP REFINING ESSENCEWenzhou Yuyuan Pharmaceutical Co., Ltd.5a6784cd-93d3-aecc-e063-6294a90af0212026-09-01WarningsExact identifier
application number: M006
Folliculitis Treatment CreamBENZOYL PEROXIDEGuangzhou Hechuang Commercial Service Co.,Ltd.5a93f753-eb7d-ad11-e063-6294a90a67782026-09-01WarningsExact identifier
application number: M006
INVISIBLE ACNE PATCHESSALICYLIC ACID 0.5%Global America Group LLC1527e15f-472f-4e05-adb6-c2e561f503cf2026-08-31WarningsExact identifier
application number: M006
The Acne Spot TreatmentSALICYLIC ACID SPOTSpotless, Inc.4a1a3716-9eaf-6be4-e063-6294a90a31c32026-08-30WarningsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Your Military Exchanges57f06989-3ffa-4cd3-bde5-9d3cc639ac4d2026-08-28Warnings, Adverse reactionsExact identifier
application number: M006
Proactivplus Pore Clearing TreatmentSALICYLIC ACIDAlchemee, LLC334efe89-3775-5ddb-e063-6294a90ae3a82026-08-27WarningsExact identifier
application number: M006
GENTLE ACNE CLEANSERSALICYLIC ACIDDrmtlgy, LLC2abed972-3fae-4ef0-abb6-1883457e98be2026-08-26WarningsExact identifier
application number: M006
RAVN Mens Back AcneSALICYLIC ACIDNorth Forge Brands LLC4a512df2-4ad7-495c-868a-1f4d0a8863912026-08-26WarningsExact identifier
application number: M006
Salicylic Acid Body WashSALICYLIC ACIDGuangdong Danlan International Biotechnology Co., Ltd59d671e7-7bbc-a963-e063-6394a90a776f2026-08-24WarningsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDWalmart Inc.5a76498e-a6f6-4e04-a2c7-245be947b0062026-08-21Warnings, Adverse reactionsExact identifier
application number: M006
Acne Treatment CreamBENZOYL PEROXIDECVS Healthaef82711-e3c3-439d-adda-542933ff44202026-08-19WarningsExact identifier
application number: M006
Tula Skincare Acne Heroes Acne Clearing KitSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5967255f-b511-9c7f-e063-6294a90a3e632026-08-19WarningsExact identifier
application number: M006
BYT BANGYTONG MILIA REMOVERSALICYLIC ACID 2% MILIA REMOVERShenzhen Jindali Technology Co., Ltd596a2471-d07c-14a5-e063-6394a90a4fcc2026-08-19WarningsExact identifier
application number: M006
RFA Clear and Calm Balancing SerumSALICYLIC ACIDTopiderm, Inc.f63f2c89-3567-4b08-be51-3fdfc5e0b1ba2026-08-14WarningsExact identifier
application number: M006
WART REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD58e901b8-66e0-d2d6-e063-6394a90ae6012026-08-13WarningsExact 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