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 23 of 84 · 1,670 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lanolin, PetrolatumLANOLIN, PETROLATUMRite Aid Corporation1b6d7cdf-e7bc-4fd4-939c-5eb0eaa1744d2026-01-30Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Pure petroleumWHITE PETROLATUMRite Aid Corporationf67be4cc-9983-4758-93c8-383919ec07ca2026-01-30Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMRite Aid Corporation0d535736-ba61-42eb-9112-c154295372a22026-01-30Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
unii: PDC6A3C0OX
UNIVERSAL BABY FRESH SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCec67a1ee-ad71-54f2-e053-2995a90a76902026-01-29WarningsExact identifier
unii: 4T6H12BN9U
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
unii: PDC6A3C0OX
PetroleumWHITE PETROLATUM7-Select7e93df71-74bd-4d95-9a64-54756c7b234a2026-01-29Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
TheraCare Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare49132a75-4a16-cede-e063-6294a90a62172026-01-29WarningsExact identifier
unii: 4T6H12BN9U
unii: 92RU3N3Y1O
TheraCare A and DLANOLIN, PETROLATUMVeridian Healthcare1303aa33-2111-b36c-e063-6294a90af1312026-01-29WarningsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMAldi, Inc94fea2f2-fea8-4923-afc6-36068bc2fef52026-01-29Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
DAILY MOISTURIZINGDIMETHICONE LOTIONAldi, Inc4ad18f4a-e148-4bf5-a04b-4168fa48eeb22026-01-29Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
UNIVERSAL LAVENDER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC066b1313-aed8-9436-e063-6294a90a2b112026-01-29WarningsExact identifier
unii: 4T6H12BN9U
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
careone hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmerican Sales Company46794d2e-8fe6-490d-9cfa-ba9b6c209ad62026-01-29WarningsExact identifier
unii: 4T6H12BN9U
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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