Renew Periprotect

Product NDC: 61924-435
Requested package NDC: 61924-435-04
11-digit product format: 619240435
Labeler code: 61924
Product ID: 61924-435_d58c7e3a-05d3-c446-e053-2a95a90a5495
Type: HUMAN OTC DRUG
Nonproprietary name: Skin Protectant
Dosage form: OINTMENT
Route: TOPICAL
Labeler: DermaRite Industries, LLC
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2016-10-18
Marketing end: 0000-00-00
Substance: DIMETHICONE; ZINC OXIDE
Active strength: 1 g/100g; g/100g
Pharmacologic classes: Skin Barrier Activity [PE]
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	61924-435	61924-435-04	I	Inactivated by FDA		2026-10-05

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 · 7 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61924-435-04	2024-12-06	C162847	48780-1	1030e365-4e27-111a-e063-dadaa90a10e2	Renew Periprotect
61924-435-04	2024-01-30	C162847	48780-1	1030e365-4e27-111a-e063-dadaa90a10e2	Renew Periprotect

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61924-435-04	Renew Periprotect	114 g in 1 TUBE	OINTMENT	114		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61924-435	RENEW PERIPROTECT (SKIN PROTECTANT) OINTMENT [DERMARITE INDUSTRIES, LLC]	4	Legacy NDC, 1 package rows	20241208_5bd49bb0-03a7-562c-e053-2a91aa0a19d8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61924-435-04	61924043504	114 g in 1 TUBE (61924-435-04)	114 g	2016-10-18	0000-00-00	No	No	Current