FDA.reportPublic FDA data

NDC 42546-030 - HPRplus cream

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
42546-030
Package NDCs from labels
42546-030-10, 42546-030-45
Manufacturer
PruGen, Inc.
Effective date
2018-07-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HPRplus creamPruGen, Inc.2018-07-06PRESCRIPTION MEDICAL DEVICE LABEL
HPRplus - MB HydroGel - PruGen, Inc.PruGen, Inc.2018-07-06PRESCRIPTION MEDICAL DEVICE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42546-030-10HPRplus cream1 in 1 BOX12
42546-030-10HPRplus cream100 g in 1 TUBE1002
42546-030-45HPRplus cream450 g in 1 JAR4502
42546-030-45HPRplus cream1 in 1 BOX12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42546-030HPRPLUS - MB HYDROGEL () KIT [PRUGEN, INC.]2Unmatched20180706_9271209d-759f-4a80-ae8a-da0623f668fb.zip
42546-030HPRPLUS CREAM () [PRUGEN, INC.]24 package rows20180706_4648ec77-be12-4369-a68b-4ba54aa6abfb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42546-030-10GM - Gram42546-030eb9e7871-5aa6-481d-8810-48e362e42df912013-02-19
42546-030-45GM - Gram42546-03075d6f311-4a92-48fb-8e7c-80bfe29cedb212013-02-19

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 84 of 84 · 1,670 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIND BICHON CLEANSING MASKGLYCERINPioom Cosmetic Co.,ltd50b7db48-7b55-6df4-e054-00144ff88e882017-05-30WarningsExact identifier
unii: PDC6A3C0OX
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
CVS Health Original SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMCVS6d58a18c-62ba-4cee-b3cc-51db746ba50e2016-09-14WarningsExact identifier
unii: 4T6H12BN9U
CVS Health Cherry SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMCVS84a621fe-890e-4c88-9f26-f013c32b52b72016-09-14WarningsExact identifier
unii: 4T6H12BN9U
CVS Health Cherry SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMCVSbfbf0241-51a6-4d9d-bee1-741d1645037d2016-09-14WarningsExact identifier
unii: 4T6H12BN9U
CVS Health Original SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMCVSe49680bd-bd61-40cf-abc8-51a1c88087262016-09-14WarningsExact identifier
unii: 4T6H12BN9U
ARGAN AIR WATER BANG ESSENCEDIMETHICONEPioom Cosmetic Co.,ltd34e79668-0710-5753-e054-00144ff88e882016-06-08WarningsExact identifier
unii: 92RU3N3Y1O
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONESafewayd36b56a4-06f0-47ff-8add-4c327d60be222016-01-21WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONESafeway14a9fb00-707a-4b55-a060-82ad53a806e32016-01-08WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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