FDA.reportPublic FDA data

NDC 58443-0643 - Australian Gold SPF 15

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58443-0643
Package NDCs from labels
58443-0643-4
Manufacturer
Prime Enterprises, Inc.
Effective date
2023-10-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Australian Gold Instant Bronzer Spray Gel Sunscreen SPF 15Prime Enterprises, Inc.2023-10-31HUMAN OTC DRUG LABEL

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 232 of 266 · 5,317 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Redness ReliefGLYCERIN, NAPHAZOLINE HCIMeijer Distribution, Inc.9fea4e43-7525-bb66-e053-2a95a90acee92023-12-22WarningsExact identifier
unii: PDC6A3C0OX
Meijer Ultra Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.a0846e3e-687c-fd55-e053-2995a90a673e2023-12-22WarningsExact identifier
unii: 6DC9Q167V3
Meijer Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Meijer Distribution, Inc.9feaa5e2-6aca-96e8-e053-2a95a90a54bd2023-12-22WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
JLo Beauty That Big Screen Broad Spectrum SPF 30 MoisturizerHOMOSALATE, OCTISALATE, AND ZINC OXIDEAscendant Beauty LLCcba4e886-c4c6-4377-8f4c-250aef4b95fb2023-12-21WarningsExact identifier
unii: 4X49Y0596W
Walgreens Multi-Symptom Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEWalgreen Co.a03789ce-66bd-7b12-e053-2995a90af85a2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
Walgreens Lubricant Eye Drops Preservative FreeDEXTRAN 70, HYPROMELLOSEWalgreen Company9b383e41-e116-1c12-e053-2a95a90ab25f2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
Walgreens Eye Drops Maximum Redness Relief 15mLGLYCERIN, NAPHAZOLINE HCIWalgreen Company949d4a4d-b0f8-81f8-e053-2995a90a818d2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Lubricant Eye Drops High Performance 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94ee8310-1c19-dfd4-e053-2a95a90a83562023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Walgreens Redness Relief Eye Drops 15mLGLYCERIN, NAPHAZOLINE HCIWalgreen Company94a0d08a-a6db-1088-e053-2995a90ab4fd2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Lubricant Eye Drops Dry Eye 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94f6e1cd-073c-61ca-e053-2a95a90ae7252023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Target Eye Drops Maximum Redness Relief EyeGLYCERIN, NAPHAZOLINE HYDROCHLORIDETarget Corporation1b26cd3b-4a05-4623-b320-01f22b3106ff2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
Kroger High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKrogerd2aa8963-1922-02f3-e053-2a95a90a7d932023-12-20WarningsExact identifier
unii: 6DC9Q167V3
TopCare Health Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Topco Associates LLC9c617e34-fc66-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
Topcare Health Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTopco Assoc LLC9c6284f9-00bb-37b5-e053-2a95a90ae2ee2023-12-20WarningsExact identifier
unii: 6DC9Q167V3
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
Topcare Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDETopco Assoc LLC9c6193a6-d824-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
COOLA Full Spectrum 360 Refreshing Water Cream SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLCd12e30bd-88ee-4e34-ae63-c34766aed3a82023-12-20WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
COOLA Liplux Hydrating Oil SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC2d2ad94c-ea13-43c0-ab7f-acecf4d2309f2023-12-20WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
COOLA Classic Body Sunscreen SPF 70 - Peach BlossomAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC6efa0d9f-0ff3-4b2f-9587-9630261bcbd12023-12-20WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
COOLA CLASSIC FACE SUNSCREEN White Tea Broad Spectrum SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEBentley Laboratories, LLC4e0e426d-f037-428f-98f2-2d3e945bd0402023-12-19WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

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