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 55 of 84 · 1,670 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vitamin A and DPETROLATUMTrifecta Pharmaceuticals USA LLCf1ea9640-4a6d-1c76-e053-2a95a90ad3b12024-12-31WarningsExact identifier
unii: 4T6H12BN9U
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
unii: 6DC9Q167V3
A and D Diaper Rash and Skin ProtectantLANOLIN AND PETROLATUMNatureplex LLCfcaf27c9-3634-4fb7-a311-2e093f0552782024-12-31WarningsExact identifier
unii: 4T6H12BN9U
ELIZABETH ARDEN EIGHT HR PROTECTANT CLEARLIP PROTECTANTREVLON CONSUMER PRODUCTS CORPf3a6fe29-7af7-bfb1-e053-2a95a90a01012024-12-30WarningsExact identifier
unii: 4T6H12BN9U
Maximum Strength Gas Relief SoftgelSIMETHICONECVS PHARMACY, INCde059bd9-40de-432d-9370-5d1e53bd89ac2024-12-30WarningsExact identifier
unii: 92RU3N3Y1O
Personal Cleansing with DimethiconeDIMETHICONECardinal Health 200, Inc3f9a1a90-ab12-4911-b8c2-df200b0dde5b2024-12-27WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONETopco Associates, LLCc90d68a0-22e1-4a37-8487-16ecdc431ede2024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
Regular Strength Antacid MintALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC59c16c09-c23d-4a37-8460-d6c00a268ed52024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone Certified PlusSIMETHICONEAdvance Pharmaceutical Inc.d087743f-b82f-2a5c-e053-2995a90abb202024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
GNP Regular Strength Gas ReliefDIMETHICONEAmerisource Bergen7b63b265-e4f2-4103-935c-22d2d89cc5e82024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
Maximum Strength Antacid Cherry liquidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC31d2e77d-5eda-4f47-917c-3390d6c782af2024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
Maximum Strength Antacid MintALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC50ceff1e-b6df-40f8-89f3-667cc8f9e7502024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
Infants Gas reliefSIMETHICONETopco Associates, LLCfd6a2537-8db2-492d-b045-6404df2fb9c32024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEH E Bf294cf44-fb21-4b2e-8b7c-efd41416c6b22024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
Tucks Triple Relief HemorrhoidalWHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEBlistex Inc.bf892e90-2d9b-4fa0-8ee4-8a2736be6c302024-12-24WarningsExact identifier
unii: PDC6A3C0OX
EIGHT HOUR LIP PROTECTANT SPF 15PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONEREVLON2a0ac6aa-0315-d79e-e063-6294a90a9c532024-12-24WarningsExact identifier
unii: 4T6H12BN9U
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.4e15f6ca-a40c-485f-be3f-07c2ed7cb4982024-12-23WarningsExact identifier
unii: PDC6A3C0OX
CUREFINIPETROLATUM, COD LIVER OILMiramar Cosmetics, Inc DBA Miramar Labfc9211db-71aa-44d8-a00b-65f1482d39812024-12-23WarningsExact identifier
unii: 4T6H12BN9U
OASIS Tears Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.d9d71b1d-82a6-42e7-9ef2-2d041daef9362024-12-23WarningsExact identifier
unii: PDC6A3C0OX
LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin ProtectantDIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDELOreal USA Products Ince8539a43-db85-451c-bce8-2c488f3dc40d2024-12-23WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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