Home NDC 67777-004 Hydrocortisone
Product NDC 67777-004
11-digit product format 677770004
Labeler code 67777
Product ID 67777-004_0fa32e68-a566-6d7e-e063-6394a90af08b
Type HUMAN OTC DRUG
Nonproprietary name Antipruritic (Anti-Itch)
Dosage form CREAM
Route TOPICAL
Labeler Dynarex Corporation
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-25
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
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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67777-004 HYDROCORTISONE (ANTIPRURITIC (ANTI-ITCH)) CREAM [DYNAREX CORPORATION] 6 Current NDC, Legacy NDC, 12 package rows 20240124_81dff9df-6f7e-49f0-e053-2a91aa0af7e7.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 16 of 31 · 615 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67777-004-01 67777000401 72 BOX in 1 CASE (67777-004-01) / 1 TUBE in 1 BOX (67777-004-02) / 28.4 g in 1 TUBE 72 box 2021-03-25 0000-00-00 No No Current 67777-004-02 67777000402 1 in 1 BOX Historical 67777-004-03 67777000403 0.9 g in 1 PACKET 0.9 g Historical 67777-004-04 67777000404 12 BOX in 1 CASE (67777-004-04) / 144 PACKET in 1 BOX (67777-004-03) / .9 g in 1 PACKET 12 box 2021-03-25 0000-00-00 No No Current 67777-004-05 67777000405 600 BOX in 1 CASE (67777-004-05) / 6 PACKET in 1 BOX (67777-004-06) / .9 g in 1 PACKET 600 box 2021-03-25 No No Current 67777-004-06 67777000406 6 in 1 BOX Historical 67777-004-07 67777000407 1800 BOX in 1 CASE (67777-004-07) / 25 PACKET in 1 BOX (67777-004-08) / .9 g in 1 PACKET 1800 box 2021-03-25 No No Current 67777-004-08 67777000408 25 in 1 BOX Historical