Home NDC 58228-2045 Hydrocortisone 1%
Product NDC 58228-2045
11-digit product format 582282045
Labeler code 58228
Product ID 58228-2045_46013b99-8359-912c-e063-6294a90a1050
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone 1%
Dosage form CREAM
Route TOPICAL
Labeler ProStat First Aid LLC
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-10
Substance HYDROCORTISONE
Active strength 1 g/100g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hydrocortisone 1%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106258 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58228-2045-1 Hydrocortisone 1% 0.9 g in 1 PACKET CREAM 0.9 3 58228-2045-1 Hydrocortisone 1% 25 in 1 BOX CREAM 25 3 58228-2045-2 Hydrocortisone 1% 1800 in 1 CASE CREAM 1800 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58228-2045 HYDROCORTISONE 1% CREAM [PROSTAT FIRST AID LLC] 2 Current NDC, 3 package rows 20241127_f707bda4-074a-6406-e053-6394a90a7ae1.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 28 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XtraCare Anti-Dandruff Conditioner Coconut and Shea Butter PYRITHIONE ZINC Rejoice International Inc. e69319c8-c49c-415b-a7ea-ec6e77fa625c 2024-02-28 Warnings Exact identifier application number: M032 XtraCare Anti-Dandruff Conditioner mint and eucalyptus PYRITHIONE ZINC Rejoice International Inc. 08330f44-45e2-47cb-bd2e-cef15ba61aee 2024-02-28 Warnings Exact identifier application number: M032 XtraCare Anti-Dandruff Hair Cleanse Coconut and Shea Butter PYRITHIONE ZINC Rejoice International Inc. 7d9bf611-db24-4915-9b13-b7b36f47711f 2024-02-28 Warnings Exact identifier application number: M032 XtraCare Anti-Dandruff Hair Cleanse mint and eucalyptus PYRITHIONE ZINC Rejoice International Inc. b05742fe-692f-45a3-9de0-5f3f08642d78 2024-02-28 Warnings Exact identifier application number: M032 XtraCare Dandruff Hair Wash SALICYLIC ACID Rejoice International 1902e6bb-e829-4b1a-b85a-1394913c77ca 2024-02-28 Warnings Exact identifier application number: M032 amazon basics maximum strength dandruff Anti-dandruff SELENIUM SULFIDE AMAZON.COM SERVICES LLC 194e4c51-ff7b-4def-a71d-efa5dfca3efd 2024-02-26 Warnings Exact identifier application number: M032 Doo Gro Braids Twists Locs Dandruff Control Moisturizing SALICYLIC ACID J. Strickland and Co. 116f4f0d-66c7-49dd-e063-6394a90ab2b5 2024-02-15 Warnings Exact identifier application number: M032 amazon basics therapeutic tar anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR AMAZON.COM SERVICES LLC ada1be0c-53a7-443c-bc3c-f7a26b5f96a9 2024-02-05 Warnings Exact identifier application number: M032 Equate Dry Scalp 2 in 1 Dandruff Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. 6440fdd9-daa8-4f15-bdee-33724993bd7b 2024-02-01 Warnings Exact identifier application number: M032 Equate Everyday Clean Dandruff Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. 4c84a67a-1f43-4f40-a172-271de7e76785 2024-01-29 Warnings Exact identifier application number: M032 Equate Everyday Clean 2 in 1 Dandruff Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. c85095f2-5dbd-4822-a83a-dc3641c4a330 2024-01-29 Warnings Exact identifier application number: M032 Hydrocortisone ANTIPRURITIC (ANTI-ITCH) Dynarex Corporation 81dff9df-6f7e-49f0-e053-2a91aa0af7e7 2024-01-23 Warnings Exact identifier application number: M032 Walgreens Original T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Walgreen Company 42cc63ab-6f79-4544-8529-7b8c36021b18 2024-01-22 Warnings Exact identifier application number: M032 True plus Real Therapeutic T plus Plus Original Strength Tar Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Garcoa, Inc. 1f4c23d5-ca00-4387-abc7-59d9ef471977 2024-01-22 Warnings Exact identifier application number: M032 Walgreens Extra Strength T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Walgreen Company 7f681386-976c-40f4-8b18-97413989ab78 2024-01-22 Warnings Exact identifier application number: M032 Prosoria Medicated SELENIUM SULFIDE Nuvothera, Inc. 44eaaeb0-1400-4697-85d0-e8c2282c1cba 2024-01-11 Warnings Exact identifier application number: M032 Prosoria Scalp SALICYLIC ACID Nuvothera, Inc. 52a98715-3e57-4b86-b91e-0ce433dc22bd 2024-01-10 Warnings Exact identifier application number: M032 Prosoria Psoriasis Treatment SALICYLIC ACID Nuvothera, Inc. f94f4481-c58e-4555-9863-cbaa2c4cdd07 2024-01-10 Warnings Exact identifier application number: M032 Equate Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Wal-Mart Stores, Inc. 408d57e4-a707-4826-a04c-99517dc9b5af 2024-01-04 Warnings Exact identifier application number: M032 Equate Extra Strength Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Wal-Mart Stores, Inc. 986ac1ab-c7c3-40df-b41b-6f26cce22a43 2024-01-04 Warnings Exact identifier application number: M032
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58228-2045-1 58228204501 0.9 g in 1 PACKET 0.9 g Historical 58228-2045-2 58228204502 1800 BOX in 1 CASE (58228-2045-2) / 25 PACKET in 1 BOX (58228-2045-1) / .9 g in 1 PACKET 1800 box 2023-04-10 No No Current