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 7 of 49 · 967 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneHYDROCORTISONESportpharm LLCef9cf62a-5805-48bc-915e-c0e91a10837e2026-04-24Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONESportpharm LLC78f43570-b6fd-42eb-bb9e-580abf79bf0d2026-04-24Adverse reactionsExact identifier
unii: WI4X0X7BPJ
FixMySkin Healing Balm UnflavoredHYDROCORTISONELovely Skin, Inc.9ff8db07-ad6d-4865-a534-94bd8312957e2026-04-23WarningsExact identifier
unii: WI4X0X7BPJ
DCH Labs CortisoneHYDROCORTISONE 1%Derma Care Research Labs5025f53a-02e0-0f6a-e063-6394a90adbbf2026-04-23WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEBryant Ranch Prepackc3916e9f-f783-45a2-b38b-959b12c262522026-04-22Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone 1%HYDROCORTISONEPreferred Pharmaceuticals Inc.e0f46445-64c5-4f5d-90b0-3fa07ed7d1b42026-04-22WarningsExact identifier
unii: WI4X0X7BPJ
HydravexHYDRAVEXOncora Pharma, LLC1da8a263-354a-4ab1-90b4-cc2ecba7c2f62026-04-22Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact identifier
unii: PDC6A3C0OX
Alkindi SprinkleHYDROCORTISONEEton Pharmaceuticals, Inc.26c13a5f-7119-4c6a-bf10-fda4e07d76822026-04-21Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Anti-Itch Regular StrengthHYDROCORTISONECVS Pharmacy9fe7768b-9023-c9ee-e053-2a95a90a55b32026-04-17WarningsExact identifier
rxcui: 198707
unii: WI4X0X7BPJ
Hydrocortisone Cream 1%HYDROCORTISONE CREAM 1% WITH ALOEPublix Super Markets Inc.3c45a654-7fec-55b3-e063-6294a90a184b2026-04-13WarningsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%AMERISOURCE BERGEN4f5aea1c-ae51-4e1a-e063-6294a90a6aa12026-04-13WarningsExact identifier
unii: WI4X0X7BPJ
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: PDC6A3C0OX
blink boostGLYCERINBausch & Lomb Incorporatede765c224-1718-488f-99b2-976eb60c1d632026-04-13WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal Cream with LidocaineGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc4f1ef866-c4af-989b-e063-6294a90a148e2026-04-10WarningsExact identifier
unii: PDC6A3C0OX
WE FRESH Lubricating Eye DropsGLYCERINOculus Surgical, Inc.4f253b5d-001b-091e-e063-6394a90a9d392026-04-09WarningsExact identifier
unii: PDC6A3C0OX
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
unii: PDC6A3C0OX
DRMITSUI ECZEMA RELIEFHYDROCORTISONE 1% ECZEMA RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4eee7637-3a28-e0bd-e063-6294a90ae1a42026-04-08WarningsExact identifier
unii: WI4X0X7BPJ
Thera Plus HemorrhoidalGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMFourstar Group USA, Inc.5d63bf97-29d2-4c71-97c3-85f425e862072026-04-07WarningsExact identifier
unii: PDC6A3C0OX
HydrocortisoneHYDROCORTISONEBryant Ranch Prepack2352bb58-a624-4c5e-8966-f68817c304702026-04-03Adverse reactionsExact identifier
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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