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 83 of 84 · 1,670 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Resurfix PlusPETROLATUMTopiderm, Inc.f100f43d-6ace-4c3a-9c85-640c0ab2e3602019-11-19WarningsExact identifier
unii: 4T6H12BN9U
PetrolatumPETROLATUMGreenbrier International, Inc.91f24a0c-276f-4962-8da8-462b1f42040e2019-05-17WarningsExact identifier
unii: 4T6H12BN9U
Oatmeal Skin Relief Calming . 8ozDIMETHICONERejoice International Inc.8384dc52-ba36-da3d-e053-2a91aa0a4f402019-03-07WarningsExact identifier
unii: 92RU3N3Y1O
PetrolatumPETROLATUMGreenbrier International, Inc.b8832ee7-3e13-456b-b301-dad7473a032b2019-02-04WarningsExact identifier
unii: 4T6H12BN9U
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Gas ReliefSIMETHICONEAdvance Pharmaceutical Inc.531b9850-c93e-4a0c-bd1c-7da33d752d802018-12-17WarningsExact identifier
unii: 92RU3N3Y1O
SimethiconeSIMETHICONEAdvance Pharmaceutical Inc.e11928e8-b9db-43c5-972b-33b325090dfc2018-12-17WarningsExact identifier
unii: 92RU3N3Y1O
BALMEX MULTI-PURPOSEPETROLATUMRandob Labs,Ltd.83a9ba1a-b708-47e2-a4a3-ef847e1bb7922018-11-13WarningsExact identifier
unii: 4T6H12BN9U
VUSIONMICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUMMylan Pharmaceuticals Inc.b44b452d-3630-4cb5-8ed1-1f8edac4690c2018-08-15Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
VUSIONMICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUMMylan Pharmaceuticals Inc.b026bc7d-3a18-41e8-88c4-1e063cd2f42c2018-08-14Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Natures Choice Vitamins A and DA AND D OINTMENTUnipack, Inc.17861122-2231-4a54-b3d8-894153c708d72018-01-15WarningsExact identifier
unii: 4T6H12BN9U
Heartburn Plus Gas Relief Chewable Multi SymptomCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEWALGREEN CO.2c02e195-9c17-4ddc-80c2-52e51ae9eba02018-01-01WarningsExact identifier
unii: 92RU3N3Y1O
Vitamin A and DLANOLIN AND PETROLATUMFamily Dollar Services Inc4826b36d-3326-4f5c-8b22-c5ff79e550622017-11-08WarningsExact identifier
unii: 4T6H12BN9U
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
SimethiconeSIMETHICONERichmond Pharmaceuticals, Inc.f4be1c0d-01fc-4681-9068-905ed31845342017-10-30WarningsExact identifier
unii: 92RU3N3Y1O
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONECVSd97cd600-6fc4-4d39-9e41-344e446465062017-08-09WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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