NDC 0091-0690 - proctofoam HC

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
0091-0690
Package NDCs from labels
0091-0690-10
Manufacturer
Schwarz Pharma
Effective date
2008-09-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
proctofoam HC - Schwarz PharmaSchwarz Pharma2008-09-26Human prescription drug label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0091-0690-10proctofoam HC10 g in 1 CONTAINERAEROSOL, FOAM101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0091-0690PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [SCHWARZ PHARMA]11 package rows20081211_B4C6A2B1-427F-4499-AE6C-1886ADE59E37.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
hydrocortisone acetateACTIVE INGREDIENT3X7931PO74PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [SCHWARZ PHARMA]1
pramoxine hydrochlorideACTIVE INGREDIENT88AYB867L5PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [SCHWARZ PHARMA]1
hydrocortisoneACTIVE MOIETYWI4X0X7BPJPROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [SCHWARZ PHARMA]1
pramoxineACTIVE MOIETY068X84E056PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [SCHWARZ PHARMA]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNPROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [SCHWARZ PHARMA]1
emulsifying waxINACTIVE INGREDIENTPROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [SCHWARZ PHARMA]1
isobutaneINACTIVE INGREDIENTBXR49TP611PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [SCHWARZ PHARMA]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TPROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [SCHWARZ PHARMA]1
polyoxyethylene-10-stearyl etherINACTIVE INGREDIENTPROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [SCHWARZ PHARMA]1
propaneINACTIVE INGREDIENTT75W9911L6PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [SCHWARZ PHARMA]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [SCHWARZ PHARMA]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHPROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [SCHWARZ PHARMA]1
trolamineINACTIVE INGREDIENT9O3K93S3TKPROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [SCHWARZ PHARMA]1
waterINACTIVE INGREDIENT059QF0KO0RPROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [SCHWARZ PHARMA]1

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 1 of 1 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROCTOFOAM HCPRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATEViatris Specialty LLC3831e931-ec0a-11e3-ac10-0800200c9a662025-04-15Warnings, Adverse reactionsExact identifier
rxcui: 828364
rxcui: 828362
4EB1B252-BC06-E2DC-C564-73F583497BBBB4C6A2B1-427F-4499-AE6C-1886ADE59E372008-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 4EB1B252-BC06-E2DC-C564-73F583497BBB
spl set id: B4C6A2B1-427F-4499-AE6C-1886ADE59E37

Reported adverse events (FAERS/openFDA)#

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