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 8 of 49 · 967 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
HydrocortisoneHYDROCORTISONEBryant Ranch Prepack9f64ed9d-64c8-48e9-ac54-1aa9b26a60602026-04-03Adverse reactionsExact identifier
unii: WI4X0X7BPJ
FifthPulse HydrocortisoneHYDROCORTISONEWeCare Products LLCf1fcb045-4a15-431b-9617-67eae9f87fbd2026-04-02WarningsExact identifier
unii: WI4X0X7BPJ
HydroxymHYDROCORTISONEOncora Pharma, LLCa161b69c-df9d-4827-ace8-f622aca9efc32026-04-02Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
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
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Moisture OysterGLYCERINMoisture Oyster Inc4e45317a-437f-4d88-e063-6294a90a98d02026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
unii: PDC6A3C0OX
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: PDC6A3C0OX
HydrocortisoneHYDROCORTISONEBryant Ranch Prepack5e95eb82-40cd-411b-9006-c27b65db4b3f2026-03-25Adverse reactionsExact identifier
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
unii: WI4X0X7BPJ
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: PDC6A3C0OX
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4e53d29c-ed3c-f481-e063-6294a90a31812026-03-25WarningsExact identifier
unii: WI4X0X7BPJ
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX
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

Reported adverse events (FAERS/openFDA)#

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