Home NDC 33358-901 Avalin External Analgesic Patch
Product NDC 33358-901
11-digit product format 333580901
Labeler code 33358
Product ID 33358-901_72035ad0-7153-4429-839c-5c04d5742fd1
Type HUMAN OTC DRUG
Nonproprietary name LIDOCAINE, MENTHOL
Dosage form PATCH
Route TOPICAL
Labeler RxChange Co.
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2015-01-29
Marketing end 0000-00-00
Substance LIDOCAINE; MENTHOL
Active strength 40 mg/g; mg/g
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33358-901-15 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33358-901-15 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33358-901-15 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33358-901-15 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 33358-901-15 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 33358-901-15 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 33358-901-15 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 33358-901-15 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 33358-901-15 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 33358-901-15 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 33358-901-15 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 33358-901-15 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 33358-901-15 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 33358-901-15 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 33358-901-15 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 33358-901-15 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 33358-901-15 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 33358-901-15 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 33358-901-15 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 33358-901-15 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 33358-901-15 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 33358-901-15 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33358-901-15 Avalin External Analgesic Patch 15 in 1 CARTON PATCH 15 1 33358-901-15 Avalin External Analgesic Patch 100 g in 1 PATCH PATCH 100 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LIDOCAINE ACTIVE INGREDIENT 98PI200987 AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 MENTHOL ACTIVE INGREDIENT L7T10EIP3A AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 LIDOCAINE ACTIVE MOIETY 98PI200987 AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 2-ETHYLHEXYL ACRYLATE INACTIVE INGREDIENT HR49R9S6XG AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 ACRYLIC ACID INACTIVE INGREDIENT J94PBK7X8S AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 ALUMINUM HYDROXIDE INACTIVE INGREDIENT 5QB0T2IUN0 AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 METHYL ACRYLATE INACTIVE INGREDIENT WC487PR91H AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 NONOXYNOL-30 INACTIVE INGREDIENT JJX07DG188 AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 SORBITAN SESQUIOLEATE INACTIVE INGREDIENT 0W8RRI5W5A AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 TARTARIC ACID INACTIVE INGREDIENT W4888I119H AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33358-901 AVALIN EXTERNAL ANALGESIC PATCH (LIDOCAINE, MENTHOL) PATCH [RXCHANGE CO.] 1 Legacy NDC, 2 package rows 20150131_dc00f4b2-f407-4f89-8db7-1c67d610b64b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 33358-901-15 33358090115 15 in 1 CARTON Historical