FDA.reportPublic FDA data

NDC 42546-033-99 - 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
Requested NDC
42546-033-99
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 49 of 84 · 1,661 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VaselineBABY HEALING JELLYConopco Inc. d/b/a Unileverbca3176f-86fe-5969-e053-2995a90a24192025-03-31WarningsExact identifier
unii: 4T6H12BN9U
MQ Pain Relieving PatchPAIN RELIEVING PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0978ff22-c357-e266-e063-6394a90a98a42025-03-24WarningsExact identifier
unii: 9E8X80D2L0
Gold Bond Diabetics Medicated Dry Skin Relief Foot CreamDIMETHICONE, WHITE PETROLATUMChattem, Inc.b951d1cb-b81e-4d7f-9a67-8405daa896672025-03-19WarningsExact identifier
unii: 92RU3N3Y1O
TopCare Max Gas Antacid plus Anti-Gas ChewsSIMETHICONETopCo309e8215-84b0-dd84-e063-6394a90ac4422025-03-18WarningsExact identifier
unii: 92RU3N3Y1O
TopCare Cherry Berry Lime Antacid HBGCALCIUM CARBONATETopCo30a01bf6-28c8-87ae-e063-6394a90a6fb52025-03-18WarningsExact identifier
unii: 92RU3N3Y1O
Gas-X Extra Strength SoftgelsSIMETHICONEHaleon US Holdings LLCfa4a3b07-591b-4445-aa67-b17ba1e67d5c2025-03-14WarningsExact identifier
unii: 92RU3N3Y1O
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Winco Medicated Lip BalmPETROLATUMWincoc81cd9f7-f23a-4873-8542-1926497d39ce2025-03-07WarningsExact identifier
unii: 4T6H12BN9U
AD Skin ProtectantAD SKIN PROTECTANTWellSpring Pharmaceutical Corporationd26f1312-2e1b-4106-bc48-a336d4e034ad2025-03-07WarningsExact identifier
unii: 4T6H12BN9U
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
Equate SPF 15 Lip BalmAVOBENZONE, OCTINOXATE, PETROLATUMWalmarte41e15cf-3284-426e-9e81-d60c39fb29962025-03-05WarningsExact identifier
unii: 4T6H12BN9U
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: 6DC9Q167V3
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
Clear Eyes Maximum Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINPrestige Brands Holdings, Inc.c3b0e344-68dd-4c35-bf46-744e612a5b152025-02-28WarningsExact identifier
unii: PDC6A3C0OX
Infants Non staining Gas reliefSIMETHICONERetail Business Services, LLC.1501bee6-4734-4836-8573-54af919d42212025-02-27WarningsExact identifier
unii: 92RU3N3Y1O
Anti-Diarrheal/Anti-GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEDiscount Drug Mart, Inc2e0b3aec-f436-c0fb-e063-6394a90abb512025-02-27WarningsExact identifier
unii: 92RU3N3Y1O
Gas-X Extra StrengthSIMETHICONEHaleon US Holdings LLCf553374b-c20e-4c92-a8c0-cef0aeda8d1c2025-02-26WarningsExact identifier
unii: 92RU3N3Y1O
SHINE pH CLEANSINGSODIUM HYALURONATECH BIO CO., LTD.2f15d85d-0e80-2040-e063-6294a90a54b22025-02-26WarningsExact identifier
unii: YSE9PPT4TH
SHINE pH MOISTURESODIUM HYALURONATECH BIO CO., LTD.2f15d0e6-d9e0-3928-e063-6294a90af66f2025-02-26WarningsExact identifier
unii: YSE9PPT4TH
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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