Home NDC 58418-001-08 SS-TMPFL
Product NDC 58418-001
Requested package NDC 58418-001-08
11-digit product format 584180001
Labeler code 58418
Product ID 58418-001_a05e42d9-4842-6b2a-e053-2995a90a7b12
Type HUMAN OTC DRUG
Nonproprietary name BS Spf30 spray - DL
Dosage form SPRAY
Route TOPICAL
Labeler Tropical Enterprises International, Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2018-10-01
Marketing end 0000-00-00
Substance OCTOCRYLENE; AVOBENZONE
Active strength 2 g/30mL; g/30mL
NDC exclude flag No
Listing certified through 2021-12-31
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 · 18 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…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
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 58418-001-01 SS-TMPFL 30 mL in 1 BOTTLE, DISPENSING SPRAY 30 3 58418-001-02 SS-TMPFL 60 mL in 1 BOTTLE, DISPENSING SPRAY 60 3 58418-001-04 SS-TMPFL 120 mL in 1 BOTTLE, DISPENSING SPRAY 120 3 58418-001-08 SS-TMPFL 240 mL in 1 BOTTLE, DISPENSING SPRAY 240 3 58418-001-10 SS-TMPFL 10 mL in 1 BOTTLE, SPRAY SPRAY 10 3 58418-001-12 SS-TMPFL 360 mL in 1 BOTTLE, PUMP SPRAY 360 3 58418-001-16 SS-TMPFL 480 mL in 1 BOTTLE, PUMP SPRAY 480 3 58418-001-25 SS-TMPFL 960000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK SPRAY 960000 3 58418-001-28 SS-TMPFL 3840 mL in 1 BOTTLE, PUMP SPRAY 3840 3 58418-001-32 SS-TMPFL 1228800 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK SPRAY 1228800 3 58418-001-64 SS-TMPFL 1920 mL in 1 BOTTLE, PUMP SPRAY 1920 3 58418-001-70 SS-TMPFL 211200 mL in 1 DRUM SPRAY 211200 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58418-001 SS-TMPFL (BS SPF30 SPRAY - DL) SPRAY [TROPICAL ENTERPRISES INTERNATIONAL, INC.] 3 Legacy NDC, 12 package rows 20200716_70ac6e5f-2fca-733a-e053-2a91aa0aaf5b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58418-001-08 58418000108 240 mL in 1 BOTTLE, DISPENSING (58418-001-08) 240 ml 2018-10-01 0000-00-00 No No Current