FDA.reportPublic FDA data

NDC 58443-0620 - Paulas Choice Anti-Redness

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
58443-0620
Package NDCs from labels
58443-0620-4
Manufacturer
Prime Enterprises, Inc.
Effective date
2023-04-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Soft Services Clearing Mist Medicated Breakout Tonic for bodyPrime Enterprises, Inc.2023-04-25HUMAN 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 79 of 81 · 1,614 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
fa2e5b1b-f3a1-11fe-e053-6394a90a4988fa2e549d-8f6d-d89b-e053-6294a90ad0562023-04-25WarningsExact identifier
spl id: fa2e5b1b-f3a1-11fe-e053-6394a90a4988
spl set id: fa2e549d-8f6d-d89b-e053-6294a90ad056
Acidum SalicylicumACIDUM SALICYLICUMHahnemann Laboratories, INC.f9cd7e8e-fa4d-03f2-e053-6294a90af8b62023-04-20Exact identifier
unii: O414PZ4LPZ
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Urea 39.5% with 2% Salicylic AcidUREA, SALICYLIC ACIDPureTek Corporationf7aa7b4f-3cb4-6113-e053-6394a90a41882023-03-24Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Gly-Sal 2-2 PadsSALICYLIC ACIDTopiderm, Inc.a92a9ffb-5c5b-43a4-b669-04667324920b2023-02-16WarningsExact identifier
unii: O414PZ4LPZ
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Thea SinensisTHEA SINENSISHahnemann Laboratories, INC.e98d5ff1-ec12-5ad7-e053-2a95a90ad6d02022-09-25Exact identifier
unii: W2ZU1RY8B0
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Aewajin HasuoShampooMENTHOL, SALICYLIC ACID, PANTHENOLMISOCOSd4950ac9-8c05-989a-e053-2995a90ac6b72022-01-02WarningsExact identifier
unii: O414PZ4LPZ
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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