FDA.reportPublic FDA data

Teatrical Pro-Aclarant Day

Product NDC
50066-071
Requested package NDC
50066-071-01
11-digit product format
500660071
Labeler code
50066
Product ID
50066-071_f3a39fbc-2894-4747-b4a1-32920e56ce6f
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octinoxate, and Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
Genomma Lab USA
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-04-22
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Active strength
30 mg/g; 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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50066-07150066-071-01IInactivated by FDA2026-10-16

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-071-012022-01-28C16284748780-1d6a99b39-be63-a426-e053-dadaa90af4c2Teatrical ® Pro-Aclarant Day Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-071-01Teatrical Pro-Aclarant Day1 in 1 CARTONCREAM11
50066-071-01Teatrical Pro-Aclarant Day48 g in 1 TUBECREAM481

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-071TEATRICAL PRO-ACLARANT DAY (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [GENOMMA LAB USA]1Legacy NDC, 2 package rows20200423_4f7a2e13-cd08-4b2f-b6ec-1305897f7b83.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50066-071-01500660071011 TUBE in 1 CARTON (50066-071-01) > 48 g in 1 TUBE1 tube2020-04-220000-00-00NoNoCurrent