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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
828365Internal RxNorm lookup
828367Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cddc8d81-21b8-11e4-8c21-0800200c9a66Available on FDA.report

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROCTOFOAM NSPRAMOXINE HYDROCHLORIDEViatris Specialty LLCcddc8d81-21b8-11e4-8c21-0800200c9a662025-08-15WarningsExact identifier
application number: M346
ndc (product): 0037-6823

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