DEBROX

Product NDC: 71205-136
Requested package NDC: 71205-136-15
11-digit product format: 712050136
Labeler code: 71205
Product ID: 71205-136_61b565d3-ad7d-4ab6-931a-099f2392c9ab
Type: HUMAN OTC DRUG
Nonproprietary name: Carbamide Peroxide
Dosage form: LIQUID
Route: AURICULAR (OTIC)
Labeler: Proficient Rx LP
Application: part344
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-06-01
Marketing end: 0000-00-00
Substance: CARBAMIDE PEROXIDE
Active strength: 65 mg/mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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	71205-136	71205-136-15	D	Discontinued by firm		2026-10-16

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	71205-136	71205-136-15	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-136	71205-136-15	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-136-15	ML - Milliliter	71205-136	22b1afce-c303-4c6c-8ffb-4d5b15d4cf89	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-136	DEBROX (CARBAMIDE PEROXIDE) LIQUID [PROFICIENT RX LP]	4	Legacy NDC	20240201_e1dacadf-cfb4-4a06-9858-dd6fba2975f8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
31PZ2VAU81	CARBAMIDE PEROXIDE	124-43-6	CARBAMIDE PEROXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-136-15	71205013615	1 BOTTLE, DROPPER in 1 CARTON (71205-136-15) > 15 mL in 1 BOTTLE, DROPPER	2018-10-01	0000-00-00	No	No	Current