FDA.reportPublic FDA data

PROCTOFOAM

Product NDC
0037-6823
11-digit product format
000376823
Labeler code
0037
Product ID
0037-6823_146e02e7-5477-4730-bdb1-be005dc57c4f
Type
HUMAN OTC DRUG
Nonproprietary name
pramoxine hydrochloride
Dosage form
AEROSOL, FOAM
Route
RECTAL
Labeler
Viatris Specialty LLC
Application
M346
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-08-18
Substance
PRAMOXINE HYDROCHLORIDE
Active strength
150 mg/15g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PROCTOFOAM
Brand name suffix
NS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE150 mg/15g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5
Rxcui828365, 828367

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0037-6823-152024-01-30C16284748780-11030e365-48bb-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0037-6823-15PROCTOFOAMNS1 in 1 CARTONAEROSOL, FOAM16
0037-6823-15PROCTOFOAMNS15 g in 1 CANISTERAEROSOL, FOAM156

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0037-6823-15GM - Gram0037-6823e55a2ac9-3b4e-40ad-8b56-94218dd0fce312014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5PROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]1
PRAMOXINEACTIVE MOIETY068X84E056PROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]1
ISOBUTANEINACTIVE INGREDIENTBXR49TP611PROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]1
LAURETH-23INACTIVE INGREDIENTN72LMW566GPROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RPROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IPROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]1
PROPANEINACTIVE INGREDIENTT75W9911L6PROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0037-6823PROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20240711_cddc8d81-21b8-11e4-8c21-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828365pramoxine HCl 1 % Rectal FoamPSNcddc8d81-21b8-11e4-8c21-0800200c9a666
828367proctofoam 1 % Rectal FoamPSNcddc8d81-21b8-11e4-8c21-0800200c9a666
828367pramoxine hydrochloride 10 MG/ML Rectal Foam [Proctofoam]SBDcddc8d81-21b8-11e4-8c21-0800200c9a666
828365pramoxine hydrochloride 10 MG/ML Rectal FoamSCDcddc8d81-21b8-11e4-8c21-0800200c9a666
828365pramoxine hydrochloride 1 % Rectal FoamSYcddc8d81-21b8-11e4-8c21-0800200c9a666
828367Proctofoam 1 % Rectal FoamSYcddc8d81-21b8-11e4-8c21-0800200c9a666
828367Proctofoam 10 MG/ML Rectal FoamSYcddc8d81-21b8-11e4-8c21-0800200c9a666

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0037-6823-15000376823151 CANISTER in 1 CARTON (0037-6823-15) / 15 g in 1 CANISTER1 canister2014-08-180000-00-00NoNoCurrent