FDA.reportPublic FDA data

NDC 68071-3968-01 - Procto-Med HC

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68071-3968
Requested NDC
68071-3968-01
Package NDCs from labels
68071-3968-1, 68071-3968-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2026-03-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Procto-Med HC TM 2.5% (Hydrocortisone Cream USP, 2.5%) Rx onlyNuCare Pharmaceuticals,Inc.2026-03-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3968-1Procto-Med HC28 g in 1 TUBECREAM282
68071-3968-1Procto-Med HC1 in 1 CARTONCREAM12

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 5 of 38 · 745 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneHYDROCORTISONEMylan Pharmaceuticals Inc.bc751403-94f2-4f9d-b533-cf6186a40ceb2026-05-25Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC858053a0-d888-4bb9-b94e-503bcf3864cb2026-05-21WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEBryant Ranch Prepack04758c46-0ca4-4852-acdc-1f8553ce2e6e2026-05-21Adverse reactionsExact identifier
unii: WI4X0X7BPJ
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Scalpicin Anti-Itch Maximum StrengthHYDROCORTISONEReckitt Benckiser LLC7b1a29fa-b266-43e6-a87b-aa3c96ab40412026-05-13WarningsExact identifier
unii: WI4X0X7BPJ
DERMFREE Anti-itch CreamHYDROCORTISONE1% ANTI-ITCH CREAMJiangxi Zhongletang Pharmaceuticals Co.,Ltd.519c319a-9c43-0e63-e063-6394a90ab8692026-05-13WarningsExact identifier
unii: WI4X0X7BPJ
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
HydrocortisoneHYDROCORTISONEPreferred Pharmaceuticals Inc.02ab1006-c7c8-42c9-bda8-62c9d71425212026-05-11Adverse reactionsExact identifier
rxcui: 310891
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEPreferred Pharmaceuticals, Inc.058bb2ff-ff51-4a3b-ba47-cb02272d06312026-05-11Adverse reactionsExact identifier
application number: ANDA085025
rxcui: 310891
unii: WI4X0X7BPJ
hydrocortisoneHYDROCORTISONEPreferred Pharmaceuticals Inc.12cd35e3-e707-4551-b778-bf615c1a8d322026-05-11WarningsExact identifier
unii: WI4X0X7BPJ
HYDROCORTISONEHYDROCORTISONEPreferred Pharmaceuticals Inc.0bbb8a63-ae1d-41d7-b201-d1b171b31f462026-05-11Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEPreferred Pharmaceuticals, Inc.026728d4-846b-4bd4-9183-ae6c4a7141382026-05-11Adverse reactionsExact identifier
rxcui: 310891
unii: WI4X0X7BPJ
Harris Teeter HydrocortisoneHYDROCORTISONEHARRIS TEETER LLC4e8199f8-96ec-5342-e063-6294a90afb2d2026-05-07WarningsExact identifier
unii: WI4X0X7BPJ
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: 2KR89I4H1Y
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Inc.5114cdba-96a1-c399-e063-6294a90aac122026-05-06WarningsExact identifier
unii: WI4X0X7BPJ
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd2dc7f76f-f9ad-46ba-8b41-952e1c15f0522026-04-29WarningsExact identifier
unii: WI4X0X7BPJ
anti itchHYDROCORTISONEHyVee Ince1db3641-2e83-4fec-8394-98d0d876ce0d2026-04-29WarningsExact identifier
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.