Home NDC 45334-327 Vanicream HC Anti-Itch
Product NDC 45334-327
11-digit product format 453340327
Labeler code 45334
Product ID 45334-327_4127509b-f9bd-2d67-e063-6394a90a291d
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Pharmaceutical Specialties, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-01-26
Marketing end 2026-11-25
Substance HYDROCORTISONE ACETATE
Active strength 1.12 g/100g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 Vanicream HC Anti-Itch Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE ACETATE 1.12 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3X7931PO74 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 45334-327-02 Vanicream HC Anti-Itch 1 in 1 CARTON CREAM 1 8 45334-327-02 Vanicream HC Anti-Itch 57 g in 1 TUBE CREAM 57 8 45334-327-04 Vanicream HC Anti-Itch 4 g in 1 TUBE CREAM 4 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45334-327 VANICREAM HC ANTI-ITCH (HYDROCORTISONE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 7 Current NDC, Legacy NDC, 3 package rows 20241013_28b06507-27a5-2cb1-e054-00144ff8d46c.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 156 · 3,115 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 45334-327-02 45334032702 1 TUBE in 1 CARTON (45334-327-02) / 57 g in 1 TUBE 1 tube 2016-01-26 2026-11-25 No No Current 45334-327-04 45334032704 4 g in 1 TUBE (45334-327-04) 4 g 2016-02-09 0000-00-00 No No Current