FDA.reportPublic FDA data

NDC 42546-033 - HPRplus - MB HydroGel

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
42546-033
Package NDCs from labels
42546-033-10, 42546-033-99
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 - MB HydroGel - PruGen, Inc.PruGen, Inc.2018-07-06PRESCRIPTION MEDICAL DEVICE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42546-033-10HPRplus - MB HydroGel1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42546-033HPRPLUS - MB HYDROGEL () KIT [PRUGEN, INC.]21 package rows20180706_9271209d-759f-4a80-ae8a-da0623f668fb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42546-033-10EA - Each42546-0330d9b6a7f-a14f-4188-8105-08cf02270cde12015-07-20

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 47 of 84 · 1,670 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GNP Regular Strength Gas ReliefDIMETHICONEATLANTIC BIOLOGICALS CORP.b31257ef-489b-4067-9cc6-8a593d9839582025-06-24WarningsExact identifier
unii: 92RU3N3Y1O
Walgreens Healing Balm Skin ProtectantPETROLATUMWalgreensbc585145-3588-446e-926f-e6baf43ca4ba2025-06-24WarningsExact identifier
unii: 4T6H12BN9U
Glycerin LaxativeGLYCERIN LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cc266a-196f-16ce-e063-6394a90a24af2025-06-20WarningsExact identifier
unii: PDC6A3C0OX
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Silicone Scar CreamDIMETHICONE, ASCORBIC ACID, TOCOPHEROL, PANTHENOL, ALLANTOINYunqi Cosmetics (Shenzhen) Co., Ltd37d02d8c-fbb5-5ba5-e063-6294a90a43ac2025-06-17WarningsExact identifier
unii: 92RU3N3Y1O
ProCure HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTwin Med LLC37a4cc43-0d53-f1bf-e063-6394a90a2dc92025-06-15WarningsExact identifier
unii: 4T6H12BN9U
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF OINTMENTNeilmed Pharmaceuticals Inc.374d89b6-9305-9adf-e063-6394a90adb322025-06-11WarningsExact identifier
unii: 4T6H12BN9U
Diabecin HRLIDOCAINE HCL, BENZALKONIUM CHLORIDEPureTek Corporation36c60fe2-5b7b-83dd-e063-6294a90ad4672025-06-10Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
EyeOne CleanerHYALURONIC ACID, TOCOPHERYL ACETATEIDO PHARM37311080-b269-5ba2-e063-6394a90a2c6c2025-06-10WarningsExact identifier
unii: 9E8X80D2L0
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLC4eb3c9ac-268a-5246-e054-00144ff88e882025-06-09WarningsExact identifier
unii: 4T6H12BN9U
Aluminum Hydroxide, Magnesium Hydroxide, and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEAmerican Health Packaging2faf291e-1d62-412a-a05e-e992cb7def6a2025-05-30WarningsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEATLANTIC BIOLOGICALS CORP376660a2-becb-48cf-a9f5-6a76a8b8ca702025-05-30WarningsExact identifier
unii: 92RU3N3Y1O
Code Red Eye Drops MicroGLYCERIN AND NAPHAZOLINE HYDROCHLORIDE4 Trees LLC2a15ea9a-ff67-446b-8b83-6517d25ff38a2025-05-29WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Gas-X Ultimate Strength SoftgelsSIMETHICONEHaleon US Holdings LLC24b777e5-f0b5-400d-8ca9-ae0c04b8503b2025-05-20WarningsExact identifier
unii: 92RU3N3Y1O
Biotrue Hydration BoostGLYCERINBausch & Lomb Incorporatede2621477-e6ee-4275-ba0a-939dca2550c42025-05-19WarningsExact identifier
unii: PDC6A3C0OX
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.3c4c3e7f-0ef9-4de0-b0bf-97fe7f6a527c2025-05-16WarningsExact identifier
unii: PDC6A3C0OX
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
GERI-LANTA ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEATLANTIC BIOLOGICALS CORP.043207dd-5e1c-4c78-b75a-7d341d71b1172025-05-12WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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