FDA.reportPublic FDA data

PROCTOFOAM

Product NDC
0037-6822
11-digit product format
000376822
Labeler code
0037
Product ID
0037-6822_d63033a1-dca0-44f9-a6f3-210e38c2691e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pramoxine hydrochloride hydrocortisone acetate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Viatris Specialty LLC
Application
ANDA086195
Marketing category
ANDA
Marketing start
2014-08-15
Substance
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active strength
100; 100 mg/10g; mg/10g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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
HC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE100 mg/10g
PRAMOXINE HYDROCHLORIDE100 mg/10g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X7931PO74, 88AYB867L5
Rxcui828362, 828364

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0037-6822-102024-01-30C16284748780-11030e365-2f12-111a-e063-dadaa90a10e23831e931-ec0a-11e3-ac10-0800200c9a66

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0037-6822-10PROCTOFOAMHC1 in 1 CARTONAEROSOL, FOAM110
0037-6822-10PROCTOFOAMHC10 g in 1 CANISTERAEROSOL, FOAM1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0037-6822-10GM - Gram0037-6822d07a3823-26ee-42fe-afb1-431cef27eb3712014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74PROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5PROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJPROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2
PRAMOXINEACTIVE MOIETY068X84E056PROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2
ISOBUTANEINACTIVE INGREDIENTBXR49TP611PROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2
LAURETH-23INACTIVE INGREDIENTN72LMW566GPROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RPROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IPROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2
PROPANEINACTIVE INGREDIENTT75W9911L6PROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RPROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0037-6822PROCTOFOAM HC (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE) AEROSOL, FOAM [MEDA PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 2 package rows20250331_3831e931-ec0a-11e3-ac10-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828362hydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal FoamPSN3831e931-ec0a-11e3-ac10-0800200c9a6610
828364proctofoam-HC 1 % / 1 % Rectal FoamPSN3831e931-ec0a-11e3-ac10-0800200c9a6610
828364hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Foam [Proctofoam-HC]SBD3831e931-ec0a-11e3-ac10-0800200c9a6610
828362hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal FoamSCD3831e931-ec0a-11e3-ac10-0800200c9a6610
828362hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal FoamSY3831e931-ec0a-11e3-ac10-0800200c9a6610
828364Proctofoam-HC (hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % ) Rectal FoamSY3831e931-ec0a-11e3-ac10-0800200c9a6610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0037-6822-10000376822101 CANISTER in 1 CARTON (0037-6822-10) / 10 g in 1 CANISTER1 canister2014-08-150000-00-00NoNoCurrent