Home NDC 82160-221-01 Photoblock
Product NDC 82160-221
Requested package NDC 82160-221-01
11-digit product format 821600221
Labeler code 82160
Product ID 82160-221_d393a99c-e3dc-3539-e053-2a95a90aed7a
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler Pella Pharmaceuticals Co. Ltd
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2010-06-17
Marketing end 0000-00-00
Substance AVOBENZONE; TITANIUM DIOXIDE
Active strength 4500 mg/150g; mg/150g
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record
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 · 15 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82160-221-01 Photoblock 150 g in 1 TUBE CREAM 150 221 82160-221-01 Photoblock 1 in 1 CARTON CREAM 1 221
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82160-221 PHOTOBLOCK (AVOBENZONE, TITANIUM DIOXIDE) CREAM [PELLA PHARMACEUTICALS CO. LTD] 221 Legacy NDC, 2 package rows 20211130_d1867c62-9af5-1abf-e053-2995a90a3c48.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82160-221-01 82160022101 1 TUBE in 1 CARTON (82160-221-01) > 150 g in 1 TUBE 1 tube 2010-06-17 0000-00-00 No No Current