FDA.reportPublic FDA data

NDC 42546-030-45 - 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
Requested NDC
42546-030-45
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
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-19Indexing - Billing Unit

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 75 of 84 · 1,661 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SystanePOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLAlcon Research Ltd14916d2c-a63d-491e-bd91-a61f300af38a2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane LubricantPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.15bc06ec-f3dc-3180-ca1a-106769a770ea2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane ULTRAPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.a5c1c194-3db5-4f18-9cd1-97f7f84c3cff2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.7eaa93ca-c843-4c89-921b-c76659410dce2023-12-14WarningsExact identifier
unii: 6DC9Q167V3
GenTeal Tears Gel DropsPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.84388a75-9d11-48ce-bf5a-88f0580d2d032023-12-14WarningsExact identifier
unii: 6DC9Q167V3
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.aa694e0d-7891-4870-8106-dd57f1e29fb42023-12-11WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.ed1b03f0-fabc-4c1c-8e6d-9f15c380300c2023-12-11WarningsExact identifier
unii: 92RU3N3Y1O
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin ProtectantGLYCERINL'Oreal USA Products Inc32eaaaab-41bd-4efe-a71d-92e3a702c1e52023-12-11WarningsExact identifier
unii: PDC6A3C0OX
Family Wellness HEMORRHOIDGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLFAMILY DOLLAR (Family Wellness)16ceb129-5c0a-428a-a867-cfbbb08bb62a2023-12-11WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5GLYCERINCosmetique Active Production01c8a0d5-bcd1-4639-be45-530a226401f02023-12-11WarningsExact identifier
unii: PDC6A3C0OX
AltalubeMINERAL OIL AND PETROLATUMAltaire Pharmaceuticals Inc.eb65004c-c3a7-4079-bd75-f2857d30c68a2023-12-09WarningsExact identifier
unii: 4T6H12BN9U
Mayinglong HemorrhoidalPETROLATUM, ZINC OXIDEMayinglong Pharmaceutical Group Co., Ltd.b14192ea-1bf7-da6a-e053-2a95a90a5b5e2023-12-08WarningsExact identifier
unii: 4T6H12BN9U
Hemorrhoidal Pain ReliefMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLWALGREENS03bc5c1a-d493-5082-e063-6394a90ae87b2023-12-05WarningsExact identifier
unii: 4T6H12BN9U
Welmedix HomeCare PRO Fragile Skin ProtectantPETROLATUMWelmedix LLC6e8d7151-c7fc-4b8f-9343-4a9f0f4e37cf2023-12-05WarningsExact identifier
unii: 4T6H12BN9U
Welmedix HomeCare PRO Extra Strength Rapid Rash ReliefPETROLATUM, ZINC OXIDEWelmedix LLC551e6cce-7adc-4e98-baff-2703b83d75262023-12-05WarningsExact identifier
unii: 4T6H12BN9U
Hemorrhoidal Pain Relief CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWALGREENS03bbe146-f185-bcfa-e063-6394a90a85bf2023-12-04WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
Mylanta Gas Minis Mint FlavorSIMETHICONEInfirst Healthcare Inc.5045b945-23ee-4c25-a32c-af3cd5045c732023-12-04WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Gas Minis Assorted Fruit FlavorSIMETHICONEInfirst Healthcare Inc.c6db9af2-d457-477d-baa9-470ddbba59052023-12-04WarningsExact identifier
unii: 92RU3N3Y1O
Infants Non-staining Gas reliefSIMETHICONEH E B99d94de2-9550-4d2d-99d4-1be0ef7b78802023-12-04WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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