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 8 of 38 · 745 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llcf4d4a56b-b4b7-9a07-e053-2a95a90ad8532026-03-04WarningsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llc9987165c-1a0f-dd57-e053-2a95a90ae7352026-03-04WarningsExact identifier
unii: WI4X0X7BPJ
HYDROCORTISONEHYDROCORTISONE 1%PHARMACY CHOICE INC4cdfe8b6-c332-7bf8-e063-6394a90abaec2026-03-03WarningsExact identifier
unii: WI4X0X7BPJ
CortenemaHYDROCORTISONEANI Pharmaceuticals, Inc.a307448a-ccc4-41a8-977a-11f28f0bded92026-03-02Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Procto-Med HCHYDROCORTISONENuCare Pharmaceuticals,Inc.4b972547-5bd4-155d-e063-6394a90a03ee2026-03-02Adverse reactionsExact identifier
application number: ANDA085025
ndc (package): 68071-3968-1
ndc (product): 68071-3968
ndc11 (package): 68071396801
rxcui: 310891
rxcui: 1790684
spl id: 4c0f749a-cfc1-b9fb-e063-6294a90a48dd
spl set id: 4b972547-5bd4-155d-e063-6394a90a03ee
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEANI Pharmaceuticals, Inc.40654d12-56e4-4489-be49-19c60ad918ad2026-03-02Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEPD-Rx Pharmaceuticals, Inc.931ed426-89a1-4877-a4a5-cb963d51e7172026-02-25Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEA-S Medication Solutions1185a82b-e731-456a-8fc1-d9f0fc1ab0bc2026-02-24Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEA-S Medication Solutionsa3fbdae4-d1dc-42de-939f-f9a7aab60e492026-02-24Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONESportpharm LLC9578b39e-3df7-4d75-abd7-f1d5524545e52026-02-23WarningsExact identifier
unii: WI4X0X7BPJ
Alocane Anti-ItchHYDROCORTISONE 1%Quest Products, LLC45252043-d41a-3cdd-e063-6394a90aa9e52026-02-18WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEA-S Medication Solutionsbb959c6f-7c9a-43c5-a45b-2ad9a87baa882026-02-18Adverse reactionsExact identifier
application number: ANDA085025
rxcui: 310891
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEMedrock Pharmacy LLC43e00e17-1a48-43db-9589-834568917bbf2026-02-17WarningsExact identifier
unii: WI4X0X7BPJ
Natureplex Hydrocortisone HydroHYDROCORTISONENatureplex, LLC2fc6a148-34bb-4289-8588-32c1bb011b982026-02-13WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONE CREAM 1%Aldermed Inc.4a7f2c0e-5cf3-29cb-e063-6394a90a5d8d2026-02-10WarningsExact identifier
unii: WI4X0X7BPJ
Aquanil HCHYDROCORTISONEPerson and Covey4a698246-05a6-d01f-e063-6294a90a34012026-02-09WarningsExact identifier
unii: WI4X0X7BPJ
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
hydrocortisoneHYDROCORTISONESportpharm LLCee64ad1e-78db-4553-a3cf-b539b770fa262026-02-06WarningsExact identifier
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONEA-S Medication Solutions498f34db-89e8-49cc-8543-87da3f4344ec2026-02-04Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HYDROCORTISONEHYDROCORTISONECVS PHARMACY, INC8b8cdb26-8e8f-4e95-9d83-d685c90afe012026-02-02WarningsExact identifier
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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