Home NDC 58443-0051 Panama Jack
Product NDC 58443-0051
11-digit product format 584430051
Labeler code 58443
Product ID 58443-0051_9c5a6593-ae23-0825-e053-2995a90a58db
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, and Oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-01-25
Marketing end 0000-00-00
Substance OCTINOXATE; OXYBENZONE
Active strength 20 mg/mL; mg/mL
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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58443-0051-4 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58443-0051-4 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58443-0051-4 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58443-0051-4 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58443-0051-4 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58443-0051-4 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58443-0051-4 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58443-0051-4 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58443-0051-4 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58443-0051-4 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58443-0051-4 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58443-0051-4 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58443-0051-4 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58443-0051-4 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58443-0051-4 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 58443-0051-4 Panama JackSPF 8 177 mL in 1 BOTTLE LOTION 177 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 3-BUTYLPHTHALIDE INACTIVE INGREDIENT 822Q956KGM PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 C12-15 ALKYL BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 71DD5V995L PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 HIGH DENSITY POLYETHYLENE INACTIVE INGREDIENT UG00KM4WR7 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ISOPROPYLPHTHALIMIDE INACTIVE INGREDIENT 1J1MM83329 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 UBIDECARENONE INACTIVE INGREDIENT EJ27X76M46 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58443-0051 PANAMA JACK SPF 8 (OCTINOXATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 3 Legacy NDC, 1 package rows 20200118_7811ecfd-5618-47ea-9681-ad336c00590b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0051-4 58443005104 177 mL in 1 BOTTLE (58443-0051-4) 177 ml 2013-01-25 0000-00-00 No No Current