FDA.reportPublic FDA data

Proctocort

Product NDC
65649-511
11-digit product format
656490511
Labeler code
65649
Product ID
65649-511_22516e69-93a6-2892-e063-6394a90ae27b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCORTISONE ACETATE
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Salix Pharmaceuticals, Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2004-06-01
Substance
HYDROCORTISONE ACETATE
Active strength
30 mg/1
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
Proctocort
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3X7931PO74Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1291085Internal RxNorm lookup
1291092Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a2e1222a-ab91-4382-a210-7dfdd6de1407Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65649-511-12Proctocort12 in 1 BOXSUPPOSITORY124
65649-511-24Proctocort24 in 1 BOXSUPPOSITORY244

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65649-511-12EA - Each65649-5113bb75bb7-0c8b-4e71-83a8-da9edbae349f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74PROCTOCORT (HYDROCORTISONE ACETATE) SUPPOSITORY [SALIX PHARMACEUTICALS, INC]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJPROCTOCORT (HYDROCORTISONE ACETATE) SUPPOSITORY [SALIX PHARMACEUTICALS, INC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UPROCTOCORT (HYDROCORTISONE ACETATE) SUPPOSITORY [SALIX PHARMACEUTICALS, INC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROCTOCORT (HYDROCORTISONE ACETATE) SUPPOSITORY [SALIX PHARMACEUTICALS, INC]1
HYDROGENATED PALM OILINACTIVE INGREDIENT257THB963HPROCTOCORT (HYDROCORTISONE ACETATE) SUPPOSITORY [SALIX PHARMACEUTICALS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65649-511PROCTOCORT (HYDROCORTISONE ACETATE) SUPPOSITORY [SALIX PHARMACEUTICALS, INC]4Current NDC, Legacy NDC, 2 package rows20240919_a2e1222a-ab91-4382-a210-7dfdd6de1407.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
ProctocortHYDROCORTISONE ACETATESalix Pharmaceuticals, Inca2e1222a-ab91-4382-a210-7dfdd6de14072024-09-17Adverse reactionsExact identifier
ndc (product): 65649-511

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1291085hydrocortisone acetate 30 MG Rectal SuppositoryPSNa2e1222a-ab91-4382-a210-7dfdd6de14074
1291092PROCTOCORT 30 MG Rectal SuppositoryPSNa2e1222a-ab91-4382-a210-7dfdd6de14074
1291092hydrocortisone acetate 30 MG Rectal Suppository [Proctocort]SBDa2e1222a-ab91-4382-a210-7dfdd6de14074
1291085hydrocortisone acetate 30 MG Rectal SuppositorySCDa2e1222a-ab91-4382-a210-7dfdd6de14074
1291092Proctocort 30 MG Rectal SuppositorySYa2e1222a-ab91-4382-a210-7dfdd6de14074

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65649-511-126564905111212 SUPPOSITORY in 1 BOX (65649-511-12) 12 suppository2004-06-010000-00-00NoNoCurrent
65649-511-246564905112424 SUPPOSITORY in 1 BOX (65649-511-24) 24 suppository2004-06-010000-00-00NoNoCurrent