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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6f35f950-8d04-4181-a897-5679fde1e2d9	Available on FDA.report

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 54 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Artistry Studio Done With Zit Acne Treatment Clearing Gel	SALICYLIC ACID	Access Business Group LLC	7a9bb4a0-c463-44e8-90a3-12bd58829f9d	2023-10-21	Warnings	Exact identifier application number: M006
PERSISTENT BODY ACNE WASH 8.5OZ	SALICYLIC ACID	China Ningbo Shangge Cosmetics Technology Corp.	074079cd-866d-0af0-e063-6394a90a7214	2023-10-09	Warnings	Exact identifier application number: M006
Skin Laundry. Clean Slate Exfoliating 2 Salicylic Acid Treatment Gel Cleanser Cleanse Exfoliate	SALICYLIC ACID	Skin Laundry Holdings, Inc.	07100fe5-3884-0948-e063-6294a90a6ec7	2023-10-06	Warnings	Exact identifier application number: M006
NAS PORE REFINING SCRUB	SALICYLIC ACID	BURT'S BEES, INC.	bc2c6b1e-999c-91a7-e053-2a95a90a9d1a	2023-10-05	Warnings	Exact identifier application number: M006
NAS Targeted Spot Treatment	SALICYLIC ACID	Burt's Bees	bc193e1f-c2bd-6415-e053-2995a90ae6eb	2023-10-05	Warnings	Exact identifier application number: M006
ACNE AND LINE CORRECTING SERUM	SALICYLIC ACID	CLINIQUE LABORATORIES LLC	b03bdef4-a099-4543-8673-85466bd64961	2023-10-05	Warnings	Exact identifier application number: M006
SPOT ACNE TREATMENT 0.75OZ	BENZOYL PEROXIDE	Rejoice International Corp.	06de40a2-45bf-bf4b-e063-6294a90a586c	2023-10-04	Warnings	Exact identifier application number: M006
PERSISTENT BODY ACNE WASH 8.5OZ	SALICYLIC ACID	Rejoice International Corp.	06df07f7-e4c5-ccef-e063-6394a90a9f3c	2023-10-04	Warnings	Exact identifier application number: M006
SPOT ACNE TREATMENT 0.75OZ	BENZOYL PEROXIDE	China Ningbo Shangge Cosmetics Technology Corp.	06e07266-6483-e7ef-e063-6294a90a9395	2023-10-04	Warnings	Exact identifier application number: M006
Acne Control	CREAM	Walgreen	fc60cccb-405b-e49e-e053-6394a90a5a12	2023-09-11	Warnings	Exact identifier application number: M006
AnubisMed	AZELAIC ACID, SALICYLIC ACID	ANUBIS COSMETICS SL	ebf3153d-30f5-54e4-e053-2995a90a74b1	2023-09-05	Warnings	Exact identifier application number: M006
AnubisMed	GLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACID	ANUBIS COSMETICS SL	eca95dde-cb57-2ab6-e053-2995a90af84f	2023-09-05	Warnings	Exact identifier application number: M006
Anubis Barcelona	PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOIN	ANUBIS COSMETICS SL	eb9244ea-6102-3cbe-e053-2a95a90ab8f6	2023-09-01	Warnings	Exact identifier application number: M006
Anubis Barcelona Regul Oil	PROPYLENE GLYCOL, PANTHENOL, THIAMINE HCL	ANUBIS COSMETICS SL	eb8e5beb-4452-58c2-e053-2a95a90a66e0	2023-09-01	Warnings	Exact identifier application number: M006
Anubis Barcelona Regul Oil	CETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SE	ANUBIS COSMETICS SL	eb68c3ab-7835-1a1c-e053-2995a90a0d66	2023-09-01	Warnings	Exact identifier application number: M006
Anubis Barcelona Regul OIl	PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACT	ANUBIS COSMETICS SL	eb905bd0-c600-b8b2-e053-2995a90ad259	2023-09-01	Warnings	Exact identifier application number: M006
Anubis Barcelona Regul Oil	PROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACT	ANUBIS COSMETICS SL	eb7c418b-8bee-26a3-e053-2a95a90a4e96	2023-09-01	Warnings	Exact identifier application number: M006
ACNE CLEANSING	SALICYLIC ACID	CLINIQUE LABORATORIES LLC	7bae5802-cf51-4b41-9d7c-d72f1eb4c4af	2023-08-30	Warnings	Exact identifier application number: M006
Gly-Sal 2-2 Pads	SALICYLIC ACID	Topiderm, Inc.	a92a9ffb-5c5b-43a4-b669-04667324920b	2023-02-16	Warnings	Exact identifier application number: M006
Derma E Acne Clarifying Mask	SULFUR	derma e	55df8fb4-abc3-43fe-b89b-6e7d638b27a6	2023-02-14	Warnings	Exact identifier application number: M006

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
70FD1KFU70	SULFUR	7704-34-9	SULFUR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
422938	sulfur 5 % Topical Lotion	PSN	6f35f950-8d04-4181-a897-5679fde1e2d9	3
422938	sulfur 50 MG/ML Topical Lotion	SCD	6f35f950-8d04-4181-a897-5679fde1e2d9	3
422938	sulfur 5 % Topical Lotion	SY	6f35f950-8d04-4181-a897-5679fde1e2d9	3

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