Impact Fix Pure Essence Foundation

Product NDC: 42361-135
Requested package NDC: 42361-135-01
11-digit product format: 423610135
Labeler code: 42361
Product ID: 42361-135_b614985b-1c2c-e3e5-e053-2a95a90a2cb0
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate, Titanium Dioxide
Dosage form: CREAM
Route: TOPICAL
Labeler: DongSung Pharm Co., Ltd.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2017-12-21
Marketing end: 0000-00-00
Substance: OCTINOXATE; TITANIUM DIOXIDE
Active strength: 20 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2021-12-31
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	42361-135	42361-135-01	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42361-135-01	42361013501	1 BOTTLE in 1 CARTON (42361-135-01) > 40 g in 1 BOTTLE	1 bottle	2017-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
42361-135 Drug Facts	DongSung Pharm Co., Ltd. \| Dong Sung World Wide USA, Inc. \| Omar Sharif Cosmetic Co., Ltd.	2020-12-09	HUMAN OTC DRUG LABEL	10

Impact Fix Pure Essence Foundation

NDC auxiliary status#

Observed NDC auxiliary status history#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#