FDA.reportPublic FDA data

Fre

Product NDC
42421-600
Requested package NDC
42421-600-20
11-digit product format
424210600
Labeler code
42421
Product ID
42421-600_cff8f6fd-e1c0-29a4-e053-2a95a90ac09f
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form
CREAM
Route
TOPICAL
Labeler
Emilia Personal Care Inc
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-06-28
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
2 g/60mL; g/60mL; g/60mL; g/60mL
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42421-60042421-600-20DDiscontinued by firm2026-10-16

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 · 12 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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
42421-600-202023-06-17Fre Protect Me Defence Moisturizer
42421-600-602023-06-17Fre Protect Me Defence Moisturizer
42421-600-202023-01-30Fre Protect Me Defence Moisturizer
42421-600-602023-01-30Fre Protect Me Defence Moisturizer
42421-600-202020-05-18Fre Protect Me Defence Moisturizer
42421-600-602020-05-18Fre Protect Me Defence Moisturizer
42421-600-202020-01-31Fre Protect Me Defence Moisturizer
42421-600-602020-01-31Fre Protect Me Defence Moisturizer

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42421-600-204242106002020 mL in 1 TUBE (42421-600-20) 20 ml2018-08-130000-00-00NoNoCurrent