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 9 of 49 · 967 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone CreamHYDROCORTISONE CREAMDirect_Rx364af43e-c1a9-3f03-e063-6294a90a14f52026-03-17Adverse reactionsExact identifier
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
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4cd62cba-075a-7448-e063-6394a90ab48d2026-03-12WarningsExact identifier
unii: WI4X0X7BPJ
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
unii: PDC6A3C0OX
HydrocortisoneHYDROCORTISONEStrides Pharma Science Limited90a46849-5b75-467b-9bc5-8f192d4d20d22026-03-11Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
FleetGLYCERINC.B. Fleet Company, Inc.31778652-e60e-4098-8e90-3e4f56b5800c2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd4c6094b7-c1ef-26a3-e063-6394a90af4cc2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: PDC6A3C0OX
HYDROCORTISONEHYDROCORTISONEDIRECT RX3d017594-3a00-40ba-b392-1699992fa1b12026-03-05Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone CreamHYDROCORTISONE CREAMDirect_Rx19b09776-165a-9579-e063-6294a90a9d392026-03-05Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Dry Eye Relief Sterile Lubricant Eye DropsGLYCERINSimilasan Corporation4c4cce1c-392e-354d-e063-6294a90a0ca32026-03-05WarningsExact identifier
unii: PDC6A3C0OX
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
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
unii: LKG8494WBH
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
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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