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 7 of 38 · 745 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KhindiviHYDROCORTISONEEton Pharmaceuticals, Inc.1ef80500-8386-40ee-b608-516cd687b3762026-04-01Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONERedmont Pharmaceuticals, LLCfb2f9fa2-5feb-4398-a21b-15a3137ac3bd2026-03-31Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEBryant Ranch Prepack5e95eb82-40cd-411b-9006-c27b65db4b3f2026-03-25Adverse reactionsExact identifier
rxcui: 310891
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEBryant Ranch Prepack7f262fa3-4d2a-43f2-a4a7-f49f6034cf502026-03-25Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEBryant Ranch Prepack3d17e73a-15f5-4881-baf2-47a0149585fd2026-03-25Adverse reactionsExact identifier
rxcui: 310891
unii: WI4X0X7BPJ
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4e53d29c-ed3c-f481-e063-6294a90a31812026-03-25WarningsExact identifier
unii: WI4X0X7BPJ
Barmicil Anti-itchHYDROCORTISONEOPMX LLC850084c3-1dd4-eb8d-e053-2a91aa0a130b2026-03-24WarningsExact identifier
unii: WI4X0X7BPJ
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack99726aa3-3b45-4175-8471-279419af54572026-03-18WarningsExact identifier
unii: WI4X0X7BPJ
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Hydrocortisone CreamHYDROCORTISONE CREAMDirect_Rx364af43e-c1a9-3f03-e063-6294a90a14f52026-03-17Adverse reactionsExact identifier
rxcui: 310891
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEMericon Industries8f351b04-8f6d-4353-9100-13a8a80d656a2026-03-17WarningsExact identifier
unii: WI4X0X7BPJ
Crane Safety HydrocortisoneHYDROCORTISONECrane Safety LLC96d9527d-9bf7-ce82-e053-2995a90aff0c2026-03-16WarningsExact identifier
unii: WI4X0X7BPJ
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4cd62cba-075a-7448-e063-6394a90ab48d2026-03-12WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEStrides Pharma Science Limited90a46849-5b75-467b-9bc5-8f192d4d20d22026-03-11Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
HYDROCORTISONEHYDROCORTISONEDIRECT RX3d017594-3a00-40ba-b392-1699992fa1b12026-03-05Adverse reactionsExact identifier
rxcui: 310891
unii: WI4X0X7BPJ
Hydrocortisone CreamHYDROCORTISONE CREAMDirect_Rx19b09776-165a-9579-e063-6294a90a9d392026-03-05Adverse reactionsExact identifier
application number: ANDA085025
rxcui: 310891
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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