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 52 of 84 · 1,661 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Geri-Gentle petrolatumWHITE PETROLATUMGeri-gentle corporation0adfbb9e-173c-925a-e063-6394a90aeb5d2025-01-25WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalPAIN RELIEFNeilMed Pharmaceuticals Inc.038a2cf5-1b72-227b-e063-6394a90a84ad2025-01-24WarningsExact identifier
unii: 4T6H12BN9U
Royal Creamy Petroleum Jelly Cocoa ButterPETROLATUM JELLYMission Series Inc. dba Prestige Beauty Careaca24d5e-42ee-1606-e053-2a95a90ab4e62025-01-23WarningsExact identifier
unii: 4T6H12BN9U
Royal Creamy Petroleum JellyPETROLATUM JELLYMission Series Inc. dba Prestige Beauty Carea903becc-443d-284b-e053-2a95a90a6c752025-01-23WarningsExact identifier
unii: 4T6H12BN9U
Pharmacys Prescription Petroleum JellyPETROLATUMAmerican Consumer Products Corpc4d29ecb-bb00-cb0b-e053-2995a90a37ef2025-01-23WarningsExact identifier
unii: 4T6H12BN9U
Baby XtraCare OatmealDIMETHICONERejoice International0049462b-ff31-440f-9244-b61153625bca2025-01-23WarningsExact identifier
unii: 92RU3N3Y1O
Repair and ProtectPETROLATUMBlistex Inc.a51e1b67-e2c7-4b67-95db-07f5f3bdc0682025-01-23WarningsExact identifier
unii: 4T6H12BN9U
OASIS Tears Lubricant EyeGLYCERINOASIS Medical, Inc.00071697-4ac6-4962-8eee-388b8b52bd402025-01-22WarningsExact identifier
unii: PDC6A3C0OX
OASIS Tears Plus Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.ea931c0f-c61e-4771-84f1-0274b1c3e28e2025-01-22WarningsExact identifier
unii: PDC6A3C0OX
HEB Gas Relief Extra Strength PeppermintSIMETHICONEH E B52f6db66-ce4c-40dc-b483-6ba83977cd8b2025-01-20WarningsExact identifier
unii: 92RU3N3Y1O
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
Glycerin LaxativeGLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEFNeilMed Pharmaceuticals Inc.03b4be69-6488-76be-e063-6394a90a7edf2025-01-17WarningsExact identifier
unii: PDC6A3C0OX
Aluminum Hydroxide, Magnesium Hydroxide and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEEverpharm LLC2bda74cb-e77d-46bb-e063-6394a90af5802025-01-16WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone 125 mgSIMETHICONEReliable 1 Laboratires LLC330aed4b-7109-09b8-e054-00144ff8d46c2025-01-15WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone 80 mgSIMETHICONEReliable 1 Laboratories LLC32fb242b-7051-072c-e054-00144ff88e882025-01-15WarningsExact identifier
unii: 92RU3N3Y1O
Beautyturess Collagen Moisturizing Firming 14-Piece SetBEAUTYTURESS COLLAGEN MOISTURIZING FIRMING 14-PIECE SETGuangdong Bisutang Biotechnology Co., Ltd.2bc94a8a-effb-8319-e063-6394a90a535d2025-01-15WarningsExact identifier
unii: PDC6A3C0OX
Skin Barista 2in1 White Body PerfectionDIMETHICONEPioom Cosmetic Co.,ltd2d7fc20c-31a7-195b-e054-00144ff88e882025-01-15WarningsExact identifier
unii: 92RU3N3Y1O
Hammertech Vitamin A and DWHITE PETROLATUMHAMMER TECH LLCffe96aa1-db6b-33e4-e053-6394a90a7e4e2025-01-14WarningsExact identifier
unii: 4T6H12BN9U
CalmoseptineANORECTAL OINTMENTCalmoseptine Inc.ff9539ed-d9ae-401d-adbc-df8f1d7514312025-01-13WarningsExact identifier
unii: 4T6H12BN9U
SIMETHICONESIMETHICONEAphena Pharma Solutions - Tennessee, LLC5df94be7-0bc9-4be1-9982-8193e3a3c8ef2025-01-10WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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