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 98 of 278 · 5,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrate 1BERBERISAQUI,BETAVULGARIS,BOLDO,CARDUUSMARIANUS,CHELIDONIUMMAJUS,ELEUTHEROCOCCUS SENTICOSUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,TARAXACUMOFFICINALE,XANTHOXYLUMFRAXINEUM,ULMUSFULVA,GLYCYRRHIZAGLABRA,GETTYSBURGAQUA,WILDBADAQUA,CARLSBADAQUA,ATP,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA,HYDROGENNatural Creations, Inc189bc53c-5d75-48df-a74e-cfff2d08d3a92025-12-16WarningsExact identifier
unii: 451W47IQ8X
Hydrate 2BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUANatural Creations, Inc1122605f-715e-4f12-9d9d-a20442f9cd452025-12-16WarningsExact identifier
unii: 451W47IQ8X
Gas ReliefSIMETHICONE CAPSULES USP, 125 MGDr. Reddy's Laboratories Inc.b3069d83-5654-8469-302a-0f76c30e39762025-12-15WarningsExact identifier
unii: 92RU3N3Y1O
HealthWise Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare7ba0ac53-c78c-4a70-a977-a082f731919e2025-12-15WarningsExact identifier
unii: 92RU3N3Y1O
Aquaphor Lip Protectant and SunscreenPETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBeiersdorf Inca43c2802-9cf1-477e-9f93-e11cf40b480d2025-12-15WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Migraine Headache TherapyATROPA BELLADONNA - BRYONIA ALBA ROOT - BLACK COHOSH - ARABICA COFFEE BEAN - NITROGLYCERIN - IRIS VERSICOLOR ROOT - SODIUM CHLORIDE -TRP Company317d3f42-783e-02b7-e054-00144ff88e882025-12-15WarningsExact identifier
unii: 451W47IQ8X
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
Mucus and Sinus Mucus and Sinus Symptom ReliefBRYONIA ALBA, HYDRASTIS CANADENSIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA PRATENSIS, SILICEA, STANNUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM GLUCONICUMTRP Company2a42c4a3-9486-9b29-e063-6294a90a7c702025-12-15WarningsExact identifier
unii: 451W47IQ8X
Natural Relief Cold and Flu Plus ZincALLIUM CEPA, ARSENICUM ALBUM, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, NATRUM MURIATICUM, NUX VOMICA, SILICEA, SULPHUR, ZINCUM GLUCONICUMTRP Company2a352cf2-48fb-4862-e063-6294a90a2eeb2025-12-15WarningsExact identifier
unii: 451W47IQ8X
Natural Relief Cough and Congestion Cough and Congestion Symptom ReliefANTIMONIUM TARTARICUM, COCCUS CACTI, CUPRUM METALLICUM, DROSERA ROTUNDIFOLIA, ECHINACEA ANGUSTIFOLIA, KALI CARBONICUM, MEPHITIS MEPHITICA, NATRUM MURIATICUM, RUMEX CRISPUS, ZINCUM GLUCONICUMTRP Company2a430f41-bd33-32af-e063-6394a90ae8012025-12-15WarningsExact identifier
unii: 451W47IQ8X
COOLA BARE REPUBLIC CLEARSCREEN SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCbcbab676-fbe2-f0cc-e053-2a95a90ad4d22025-12-15WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
COOLA BARE REPUBLIC CLEARSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf14cf2b8-b110-1210-e053-2995a90a01022025-12-15WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
COOLA BARE REPUBLIC CLEARSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf1504311-4865-5499-e053-2995a90acdcd2025-12-15WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
COOLA BARE REPUBLIC CLEARSCREEN SUNSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf14d70f1-440b-900d-e053-2995a90a30a02025-12-15WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
REVERSE Brightening Defense FluidAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATERodan & Fieldsdc230e1e-bfb8-4d7c-bad5-bff77d78220e2025-12-15WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
COOLA CLASSIC SUNSCREEN FRAGRANCE FREEAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCcfc21b1a-4a26-1573-e053-2995a90a2d502025-12-14WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Kopari Sunglaze Sheer Body Mist Sunscreen SPF42AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKopari Beauty7c96b799-e24d-473f-8f0a-3fad83d5ed482025-12-14WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
ElixirLidoFast Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEELIXIR HEALTHCARE USA, LLC.45de9dfa-6c89-1eae-e063-6294a90a4dac2025-12-13WarningsExact identifier
unii: PDC6A3C0OX
ULTRA STRENGTH Gas Relief SoftgelsSIMETHICONETopco Associates LLC42c449cc-a450-1796-e063-6294a90a762a2025-12-13WarningsExact identifier
unii: 92RU3N3Y1O
Sinu-RiteGLYCYRRHIZA, KALI BIC, NAT MUR, PULSATILLA, SAMBUCUSSILVER STAR BRANDSb79e177c-6bd7-2f9a-e053-2a95a90abedb2025-12-12WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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