SLMD Spot Treatment

Product NDC: 59958-401
Requested package NDC: 59958-401-01
11-digit product format: 599580401
Labeler code: 59958
Product ID: 59958-401_c72ebc8b-dca0-101c-e053-2995a90afb76
Type: HUMAN OTC DRUG
Nonproprietary name: Benzoyl Peroxide
Dosage form: GEL
Route: TOPICAL
Labeler: Owen Biosciences, Inc.
Application: part333D
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2017-03-22
Marketing end: 0000-00-00
Substance: BENZOYL PEROXIDE
Active strength: 10 g/100g
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59958-401	59958-401-01	D	Discontinued by firm		2026-11-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59958-401	59958-401-01	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59958-401-01	2021-07-15	C162847	48780-1	ba0f9c33-328b-a910-e053-dadaa90a0b85	SLMD Moisturizer with SPF
59958-401-01	2021-01-29	C162847	48780-1	ba0f9c33-328b-a910-e053-dadaa90a0b85	SLMD Moisturizer with SPF

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59958-401	SLMD SPOT TREATMENT (BENZOYL PEROXIDE) GEL [OWEN BIOSCIENCES, INC.]	5	Legacy NDC	20250114_8d83ebaa-a292-402b-b239-bd603c52f396.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W9WZN9A0GM	BENZOYL PEROXIDE	94-36-0	BENZOYL PEROXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59958-401-01	59958040101	1 TUBE in 1 PACKAGE (59958-401-01) > 15 g in 1 TUBE	1 tube	2017-03-24	0000-00-00	No	No	Current