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 117 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Walgreens Flexible Pain Relieving Lidocaine LIDOCAINE, MENTHOL Walgreen Co. 6f070fa3-a61a-4523-a470-ab58bf9400a3 2024-11-27 Warnings Exact identifier application number: M017 Benadryl Original Strength Itch Stopping DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Kenvue Brands LLC 920c50cb-9bdd-4a36-bb3d-c2559db73327 2024-11-26 Warnings Exact identifier application number: M017 Universal ARTHRITIS and SPORT METHYL SALICYLATE, CAPSICUM Universal Distribution Center LLC 884907a8-c884-4cce-ac10-9d4848fdba3e 2024-11-22 Warnings Exact identifier application number: M017 Universal ARTHRITIS and SPORT METHYL SALICYLATE, CAPSICUM Universal Distribution Center LLC 7f067e95-e01c-4b9a-a02e-0af097beb18c 2024-11-22 Warnings Exact identifier application number: M017 Universal ARTHRITIS and SPORT METHYL SALICYLATE, CAPSICUM Universal Distribution Center LLC 9ece9b3a-0092-4c1c-a913-c2fefcd70541 2024-11-22 Warnings Exact identifier application number: M017 Sting Relief Pad BENZOCAINE, ISOPROPYL ALCOHOL Changzhou Maokang Medical Products Co., Ltd 1936c5f4-274b-8e49-e063-6394a90ac642 2024-11-21 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief Cream Platinum 4% Lidocaine LIDOCAINE 4% Telebrands Corp 2788189e-35bc-d48c-e063-6294a90ae6c2 2024-11-21 Warnings Exact identifier application number: M017 Family Wellness Ultra Strength Muscle Rub ULTRA STRENGTH MUSCLE RUB FAMILY DOLLAR (Family Wellness) 554c7d3c-09f4-4923-b4ca-d5de8f7e2c9a 2024-11-21 Warnings Exact identifier application number: M017 Family Wellness Anorectal Lidocaine ANORECTAL LIDOCAINE FAMILY DOLLAR (Family Wellness) ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d 2024-11-21 Warnings Exact identifier application number: M017 Family Wellness Hot and Cold Pain Relief HOT AND COLD PAIN RELIEF FAMILY DOLLAR (Family Wellness) b70e343b-18aa-4e45-ae8e-79d8c84ad205 2024-11-21 Warnings Exact identifier application number: M017 Signature Care Lidocaine Cream LIDOCAINE Better Living Brands LLC 5483729e-ef1a-47a2-b7cf-c19744f52073 2024-11-21 Warnings Exact identifier application number: M017 WINCO Hydrocortisone HYDROCORTISONE 1% WinCo Foods LLC 26a29de3-4b79-4a3a-93b6-a14c5e91a8c6 2024-11-21 Warnings Exact identifier application number: M017 Menthol and Zinc Oxide MENTHOL AND ZINC OXIDE Dynarex Corporation d0e43651-4215-465b-9ace-1bc23126b109 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Cold As Ice Pain Relief Gel-Patch MENTHOL Telebrands Corp 976a1bb2-b776-8199-e053-2995a90a1a1b 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief TROLAMINE SALICYLATE TELEBRANDS CORP d91a0fad-a38c-1580-e053-2a95a90ad268 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief - Platinum TROLAMINE SALICYLATE TELEBRANDS CORP d58da6c5-47a6-b8a8-e053-2995a90a7ce7 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Knee Bird Ultra Strength Pain Relief LIDOCAINE, MENTHOL TELEBRANDS CORP df5d3312-cbc5-5db9-e053-2995a90ab055 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Cold as Ice Gel MENTHOL Telebrands Corp a9e103f2-778f-e49b-e053-2a95a90aa8b7 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Knee Bird Ultra Strength Pain Relief LIDOCAINE, MENTHOL TELEBRANDS CORP d58e2c47-c0f4-625e-e053-2a95a90aa4d5 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Pain Relief TROLAMINE SALICYLATE Telebrands Corp 92a29553-a102-0a0e-e053-2a95a90ab24a 2024-11-20 Warnings Exact identifier application number: M017
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