FDA.reportPublic FDA data

NDC 0363-0639-01 - Regular Strength Hydrocortisone Cream

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
0363-0639
Requested NDC
0363-0639-01
Package NDCs from labels
0363-0639-01, 0363-0639-03
Manufacturer
Walgreens | Unipack, Inc.
Effective date
2020-10-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Regular Strength Hydrocortisone Cream - Walgreens | Unipack, Inc.Walgreens | Unipack, Inc.2020-10-29HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0639-032022-01-28C16284748780-1d6a99b39-e56f-a426-e053-dadaa90af4c2f872781e-6571-4295-8ab6-1455f0b823df

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0639-01Regular Strength Hydrocortisone Cream56 g in 1 TUBECREAM569
0363-0639-03Regular Strength Hydrocortisone Cream1 in 1 CARTONCREAM19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0639REGULAR STRENGTH HYDROCORTISONE CREAM (HYDROCORTISONE CREAM) CREAM [WALGREENS]9Legacy NDC, 2 package rows20201031_f872781e-6571-4295-8ab6-1455f0b823df.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 2 of 49 · 967 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
unii: WI4X0X7BPJ
HydralynHYDRALYNOncora Pharma, LLC835f0335-0215-4955-9099-b601604916952026-08-12Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HYDROCORTISONEHYDROCORTISONEAmazon.com Services LLCf40b4223-e81f-4cd0-bc9b-d3d33ce8cce52026-08-12WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONESolco Healthcare LLC04f112e5-ec88-46c8-b675-8b4e38a86ab42026-08-11Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone with AloeHYDROCORTISONETARGET Corporation4a140b9a-0e3c-4b50-b9c0-9e72616bb7d52026-08-11WarningsExact identifier
unii: WI4X0X7BPJ
Instant Cooling Itch ReliefHYDROCORTISONECVS Pharmacy46545d04-5958-d136-e063-6394a90a34622026-08-07WarningsExact identifier
unii: WI4X0X7BPJ
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic SuspensionNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTICPreferred Pharmaceuticals, Inc.5f17fae0-c6ea-452e-b84f-066caf2a95fc2026-08-04Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEPreferred Pharmaceuticals, Inc.f8dc2b6f-daf3-4a3a-b31f-b97e2f152eae2026-08-04Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEPreferred Pharmaceuticals Inc.e7c7d23c-25f0-41ea-a563-59f46882d9fc2026-08-04Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack484fe5e4-a058-49c0-a382-c8fc3e20c3b22026-08-04WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEREMEDYREPACK INC.f0e66726-946b-4f63-b457-2851dc69e6b42026-08-03Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Cortizone 10 Itch Relief Massaging RollerballHYDROCORTISONEChattem, Inc.1e27682c-f856-41f1-9935-37540960a4c72026-07-31WarningsExact identifier
unii: WI4X0X7BPJ
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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