Home NDC 58443-0517-4 Bullfrog
Product NDC 58443-0517
Requested package NDC 58443-0517-4
11-digit product format 584430517
Labeler code 58443
Product ID 58443-0517_d5cb6c15-3822-1c92-e053-2995a90a7203
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone,Octocrylene,Homosalate, Octinoxate, Octisalate
Dosage form SPRAY
Route TOPICAL
Labeler Prime Enterprises Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2021-12-03
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
Active strength 27 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2023-12-31
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58443-0517-4 BullfrogBroad Spectrum SPF 50 Sunscreen 138 mL in 1 BOTTLE, SPRAY SPRAY 138 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58443-0517 BULLFROG BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE,OCTOCRYLENE,HOMOSALATE, OCTINOXATE, OCTISALATE) SPRAY [PRIME ENTERPRISES INC.] 1 Legacy NDC, 1 package rows 20220118_d5cb6c15-3821-1c92-e053-2995a90a7203.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0517-4 58443051704 138 mL in 1 BOTTLE, SPRAY (58443-0517-4) 138 ml 2021-12-03 0000-00-00 No No Current