OCTINOXATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE,ENSULIZOLE,TITANIUM DIOXIDE

Product NDC: 71801-541
Requested package NDC: 71801-541-01
11-digit product format: 718010541
Labeler code: 71801
Product ID: 71801-541_ba61353d-f750-704e-e053-2995a90abbf2
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE,ENSULIZOLE,TITANIUM DIOXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: PROKPIL SAS
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2017-09-01
Marketing end: 0000-00-00
Substance: OCTISALATE; OCTOCRYLENE; ENSULIZOLE; AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE
Active strength: 5 g/100g; g/100g; g/100g; g/100g; g/100g; 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	71801-541	71801-541-01	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 · 17 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2020-12-18 03:04 UTC · source 2020-12-17	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-07-29	5c4230af-280e-2b73-e053-2991aa0aa4a9
2021-03-02	5c4230af-280e-2b73-e053-2991aa0aa4a9
2020-09-27	5c4230af-280e-2b73-e053-2991aa0aa4a9
2020-09-25	5c4230af-280e-2b73-e053-2991aa0aa4a9
2020-07-22	5c4230af-280e-2b73-e053-2991aa0aa4a9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71801-541-01	OCTINOXATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE,ENSULIZOLE,TITANIUM DIOXIDE	30 g in 1 BOX	CREAM	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71801-541	OCTINOXATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE,ENSULIZOLE,TITANIUM DIOXIDE CREAM [PROKPIL SAS]	5	Legacy NDC, 1 package rows	20210303_5c4230af-280e-2b73-e053-2991aa0aa4a9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
9YQ9DI1W42	ENSULIZOLE	27503-81-7	ENSULIZOLE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
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
71801-541-01	71801054101	30 g in 1 BOX (71801-541-01)	30 g	2017-09-01	0000-00-00	No	No	Current