FDA.reportPublic FDA data

PROCORT

Product NDC
50967-357
11-digit product format
509670357
Labeler code
50967
Product ID
50967-357_33de5899-7f16-c8d3-e063-6394a90a27b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
1.85% hydrocortisone acetate - 1.15% pramoxine hci cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Womens Choice Pharmaceuticals LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-06-30
Substance
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active strength
18.5; 11.5 mg/g; mg/g
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
PROCORT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE18.5 mg/g
PRAMOXINE HYDROCHLORIDE11.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X7931PO74, 88AYB867L5
Rxcui1114854, 1115730

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
50967-357-602025-04-29C16284748780-1ba0f9c33-32e5-a910-e053-dadaa90a0b85PROCORT (hydrocortisone acetate and pramoxine hydrochloride) cream
50967-357-602025-01-30C16284748780-1ba0f9c33-32e5-a910-e053-dadaa90a0b85PROCORT (hydrocortisone acetate and pramoxine hydrochloride) cream
50967-357-602021-06-30C16284748780-1ba0f9c33-32e5-a910-e053-dadaa90a0b85PROCORT (hydrocortisone acetate and pramoxine hydrochloride) cream
50967-357-602021-01-29C16284748780-1ba0f9c33-32e5-a910-e053-dadaa90a0b85PROCORT (hydrocortisone acetate and pramoxine hydrochloride) cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50967-357-60PROCORT1 in 1 TUBE, WITH APPLICATORCREAM16
50967-357-60PROCORT1 in 1 CARTONCREAM16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50967-357-60GM - Gram50967-3579c5fb4b4-e501-42da-a075-508c65944fd412013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74PROCORT (1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAM) CREAM [WOMENS CHOICE PHARMACEUTICALS LLC]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5PROCORT (1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAM) CREAM [WOMENS CHOICE PHARMACEUTICALS LLC]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJPROCORT (1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAM) CREAM [WOMENS CHOICE PHARMACEUTICALS LLC]1
PRAMOXINEACTIVE MOIETY068X84E056PROCORT (1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAM) CREAM [WOMENS CHOICE PHARMACEUTICALS LLC]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1PROCORT (1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAM) CREAM [WOMENS CHOICE PHARMACEUTICALS LLC]1
AMINOMETHYL PROPANEDIOLINACTIVE INGREDIENTCZ7BU4QZJZPROCORT (1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAM) CREAM [WOMENS CHOICE PHARMACEUTICALS LLC]1
BUTYL ESTER OF METHYL VINYL ETHER-MALEIC ANHYDRIDE COPOLYMER (125 KD)INACTIVE INGREDIENT389H2R62BDPROCORT (1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAM) CREAM [WOMENS CHOICE PHARMACEUTICALS LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TPROCORT (1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAM) CREAM [WOMENS CHOICE PHARMACEUTICALS LLC]1
POLOXAMER 124INACTIVE INGREDIENT1S66E28KXAPROCORT (1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAM) CREAM [WOMENS CHOICE PHARMACEUTICALS LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MPROCORT (1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAM) CREAM [WOMENS CHOICE PHARMACEUTICALS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPROCORT (1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAM) CREAM [WOMENS CHOICE PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPROCORT (1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAM) CREAM [WOMENS CHOICE PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50967-357PROCORT (1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAM) CREAM [WOMENS CHOICE PHARMACEUTICALS LLC]6Current NDC, Legacy NDC, 2 package rows20250430_9e899b72-a16e-4b55-93b5-ab5baec37d50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114854hydrocortisone acetate 1.85 % / pramoxine HCl 1.15 % Rectal CreamPSN9e899b72-a16e-4b55-93b5-ab5baec37d506
1115730ProCort 1.85 % / 1.15 % Rectal CreamPSN9e899b72-a16e-4b55-93b5-ab5baec37d506
1115730hydrocortisone acetate 18.5 MG/ML / pramoxine hydrochloride 11.5 MG/ML Rectal Cream [Procort 1.85/1.15]SBD9e899b72-a16e-4b55-93b5-ab5baec37d506
1114854hydrocortisone acetate 18.5 MG/ML / pramoxine hydrochloride 11.5 MG/ML Rectal CreamSCD9e899b72-a16e-4b55-93b5-ab5baec37d506
1115730Procort 1.85 % / 1.15 % (hydrocortisone acetate / pramoxine HCl) Rectal CreamSY9e899b72-a16e-4b55-93b5-ab5baec37d506

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50967-357-60509670357601 TUBE, WITH APPLICATOR in 1 CARTON (50967-357-60) / 1 TUBE, WITH APPLICATOR in 1 TUBE, WITH APPLICATOR / 60 g in 1 TUBE, WITH APPLICATOR2011-06-300000-00-00NoNoCurrent