PATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT

Product NDC: 72204-002
Requested package NDC: 72204-002-01
11-digit product format: 722040002
Labeler code: 72204
Product ID: 72204-002_dabb83f5-14e0-7f18-e053-2995a90afb88
Type: HUMAN OTC DRUG
Nonproprietary name: SALICYLIC ACID
Dosage form: KIT
Labeler: Iontera, Inc
Application: part333D
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-06-03
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
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	72204-002	72204-002-01	I	Inactivated by FDA		2026-10-12

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 · 2 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72204-002	72204-002-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72204-002	72204-002-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
72204-002-01	2025-07-29	C162847	48780-1	3b156c62-2e60-fb37-e063-e6dba90a4e07	PATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT KIT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72204-002-01	PATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT	1 in 1 BOX	KIT	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72204-002	PATCHOLOGY BREAKOUT BOX 3-IN-1 ACNE TREATMENT (SALICYLIC ACID) KIT [IONTERA, INC]	4	Legacy NDC, 1 package rows	20241208_8a6c911b-5714-0884-e053-2a95a90a5d3c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O414PZ4LPZ	SALICYLIC ACID	69-72-7	SALICYLIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1994404	salicylic acid 0.5 % Medicated Patch	PSN	8a6c911b-5714-0884-e053-2a95a90a5d3c	4
1994404	salicylic acid 0.005 MG/MG Medicated Patch	SCD	8a6c911b-5714-0884-e053-2a95a90a5d3c	4
1994404	salicylic acid 0.5 % Medicated Patch	SY	8a6c911b-5714-0884-e053-2a95a90a5d3c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72204-002-01	72204000201	1 KIT in 1 BOX (72204-002-01) * 3 STRIP in 1 PACKET * 24 PATCH in 1 PACKET * 24 PATCH in 1 PACKET > .5 g in 1 PATCH	1 kit	2019-06-03	0000-00-00	No	No	Current