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 244 of 266 · 5,317 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e82a4f4-c7da-09cb-e053-2a91aa0abf5b2023-11-01WarningsExact identifier
unii: 92RU3N3Y1O
INFANTS GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corp5e08709c-846a-7f13-e053-2991aa0a09a62023-11-01WarningsExact identifier
unii: 92RU3N3Y1O
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEWAL-MART STORES, INC.7cc2ad32-fdff-0772-e053-2a91aa0aad9e2023-11-01WarningsExact identifier
unii: 92RU3N3Y1O
MAXIMUM STRENGTH ANTACID CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWAL-MART STORES, INC.7cc2771e-abd7-4120-e053-2a91aa0a8af02023-11-01WarningsExact identifier
unii: 92RU3N3Y1O
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEProficient Rx LPb7711b50-c14a-44d6-b647-1f31284f87ea2023-11-01WarningsExact identifier
unii: 92RU3N3Y1O
09056903-7f8d-530f-e063-6294a90a9d5709054ee0-d31c-37d6-e063-6294a90aae232023-10-31WarningsExact identifier
spl id: 09056903-7f8d-530f-e063-6294a90a9d57
spl set id: 09054ee0-d31c-37d6-e063-6294a90aae23
Mineffect nasal mistCALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM,Kadesh Incoporation Co,Ltd3a29bf95-a8a3-4517-aedf-0cd4a91b349c2023-10-31WarningsExact identifier
unii: 451W47IQ8X
MAXIMUM STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e811783-cbf6-d0e3-e053-2991aa0ae69f2023-10-31WarningsExact identifier
unii: 92RU3N3Y1O
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS5f880b43-2977-7a2d-e053-2991aa0a024d2023-10-31WarningsExact identifier
unii: 92RU3N3Y1O
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYd5661964-9d2c-7a3d-e053-2995a90a86ef2023-10-31WarningsExact identifier
unii: 92RU3N3Y1O
MAXIMUM STRENGTH ANTACID AND ANTIGAS CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e94cb90-b616-dcfe-e053-2a91aa0ada722023-10-31WarningsExact identifier
unii: 92RU3N3Y1O
InsomniaAQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISLiddell Laboratories, Inc.18c15f17-1a16-4595-9d23-20353363cd722023-10-31WarningsExact identifier
unii: 451W47IQ8X
LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INCecc942c7-5495-43b1-9ffa-d38be78911522023-10-30WarningsExact identifier
unii: 4X49Y0596W
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe5e5777c-2f67-14ed-e053-2a95a90a58a52023-10-30WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
CoreTex Sun X SPF 30 NewAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Products Inc08fb4748-d22d-35af-e063-6394a90a08272023-10-30WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
LIVE TINTED Hueguard Invisible Sunscreen Stick Broad Spectrum SPF 50 Water Resistant 80 MinsHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELive Tinted, Inc.8e4d7c84-5acb-4857-860d-bf6837e4901e2023-10-28WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15 dry skinAVOBENZONE, OCTISALATE, AND OCTOCRYLENEESTEE LAUDER INCd1ca8372-28a0-41e1-b92a-913fc09f71562023-10-27WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Vivier Sheer SPF 45ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATEVivier Pharma, Inc.c057138a-1111-4e7c-b94d-2ccd6bc3963c2023-10-27WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W
360 by QUR Spanish lime lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb3347-7498-3d7a-e053-2995a90a4b122023-10-26WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
360 by QUR Vanilla lace lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb4c53-adaa-3a8a-e053-2a95a90ae93a2023-10-26WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

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