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 27 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr. Groot Anti-dandruff Scalp Care SALICYLIC ACID TAI GUK PHARM. CO., LTD 1e572a86-9115-4597-e063-6394a90a484e 2024-05-31 Warnings Exact identifier application number: M032 Dr. Groot Anti-dandruff Scalp Care 2 in 1 SALICYLIC ACID TAI GUK PHARM. CO., LTD 1e572a97-1a38-8360-e063-6394a90a47a3 2024-05-31 Warnings Exact identifier application number: M032 Dr. Groot Anti-dandruff Scalp Care SALICYLIC ACID LG H&H CO., LTD. 1e584724-7059-38ab-e063-6394a90aceb7 2024-05-31 Warnings Exact identifier application number: M032 Dr. Groot Anti-dandruff Scalp Care 2 in 1 SALICYLIC ACID LG H&H CO., LTD. 1e584724-705a-38ab-e063-6394a90aceb7 2024-05-31 Warnings Exact identifier application number: M032 Thera-Gel COAL TAR Major Pharmaceuticals 1c18fde9-d39b-4339-8f62-3f352d450291 2024-05-28 Warnings Exact identifier application number: M032 upandup Anti-dandruff with Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SALICYLIC ACID TARGET CORPORATION 482332f8-0db4-4ec7-81e9-c4efbba16a26 2024-05-20 Warnings Exact identifier application number: M032 True Plus Real Therapeutic T PLUS EXTRA STRENGTH COAL TAR TAR DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Garcoa, Inc. 20116e1e-56f1-4018-99ef-758de7fc2464 2024-05-10 Warnings Exact identifier application number: M032 up and up Moisturizing Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SELENIUM SULFIDE TARGET CORPORATION e315b2d8-304d-4807-9594-9286e9b642ef 2024-05-10 Warnings Exact identifier application number: M032 amazon basics therapeutic tar gel anti-dandruff Extra Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR AMAZON.COM SERVICES LLC 0464b4ff-1be1-4d84-b7fd-b771ebc1e16c 2024-05-09 Warnings Exact identifier application number: M032 Walgreens Clinical Strength Medicated Dandruff Anti-dandruff, Anti-seborrheic dermatitis SELENIUM SULFIDE Walgreen Company cc83427d-49e6-4a20-9d03-9ec8ce27e487 2024-05-09 Warnings Exact identifier application number: M032 meijer MEDICATED selenium sulfide Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SELENIUM SULFIDE Meijer Distribution, Inc c8dee061-3362-400f-aa59-93ec0b8125ba 2024-05-01 Warnings Exact identifier application number: M032 Walgreens Dandruff With Menthol/Selenium Sulfide Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SELENIUM SULFIDE Walgreen Company 70c7b400-a295-4b99-8673-e6a38343d76f 2024-05-01 Warnings Exact identifier application number: M032 up and up Medicated Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SELENIUM SULFIDE TARGET CORPORATION a516282f-ed6b-4e94-b269-ea34f700dd69 2024-04-25 Warnings Exact identifier application number: M032 Walgreens Tplus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SALICYLIC ACID Walgreen Company 339d390e-0b09-4c42-af1f-9465daa9f7c9 2024-04-22 Warnings Exact identifier application number: M032 Walgreens Everyday Clean Dandruff Anti-Dandruff PYRITHIONE ZINC Walgreen Company 930d92a9-d0bc-42e1-873e-5c27e93a39b5 2024-04-22 Warnings Exact identifier application number: M032 Rugby Anti-Dandruff SELENIUM SULFIDE Rugby Laboratories f8942f2b-32fb-4a2d-b0cf-0f2d1c6974c2 2024-03-14 Warnings Exact identifier application number: M032 Leader Medicated Dandruff Anti-Seborrheic Dermatitis, Anti-Dandruff SELENIUM SULFIDE Cardinal Health, 110 dba LEADER 3f64a2ef-a415-49b0-bf14-eb4da66d511f 2024-03-13 Warnings Exact identifier application number: M032 Leader Therapeutic Dandruff Anti-Dandruff, anti-seborrheic dematitis and anti-psoriasis SALICYLIC ACID Cardinal Health, 110 dba LEADER 509434a9-50c4-4337-8e5b-17bdc667d23b 2024-03-13 Warnings Exact identifier application number: M032 meijer therapeutic t plus plus tar gel dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Meijer Distribution, Inc f7cce683-6e1f-4214-a38b-37eb046b7f4d 2024-03-05 Warnings Exact identifier application number: M032 Sebex Antidandruff, anti-seborrheic dermatitis, anti-psoriasis SALICYLIC ACID, SULFUR Rugby Laboratories aec81d61-1d28-490f-9654-f66bd4a30ffa 2024-03-01 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