Home NDC 54473-336 HemAway
Product NDC 54473-336
11-digit product format 544730336
Labeler code 54473
Product ID 54473-336_315a0b74-9363-a429-e063-6394a90adc0d
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine
Dosage form CREAM
Route TOPICAL
Labeler Melaleuca, Inc.
Application M015
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-08-04
Substance LIDOCAINE
Active strength 1.5 g/30g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 14 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 2025-04-01 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 54473-336-01 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 54473-336-01 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 54473-336-01 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 54473-336-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 54473-336-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 54473-336-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 54473-336-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 HemAway
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 1.5 g/30g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1366789 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54473-336-02 HemAway 1 in 1 BOX CREAM 1 3 54473-336-31 HemAway 30 g in 1 TUBE CREAM 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-336 HEMAWAY (LIDOCAINE) CREAM [MELALEUCA, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20250409_cf842adf-fcd7-2c8c-e053-2995a90adea6.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 4 of 22 · 438 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HEMORRHOIDAL MINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE CVS PHARMACY, INC 93482a9b-145b-42d4-96db-599c281a39f1 2026-06-10 Warnings Exact identifier application number: M015 Oudetas Lidocaine Cream LIDOCAINE CREAM Guangzhou Jingliang Cosmetics Co., Ltd. 53f11395-f460-943f-e063-6294a90affef 2026-06-10 Warnings Exact identifier application number: M015 Terramed Just Think Comfort Hemorrhoidal Wipes LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE Rida LLC f6ad00e7-c7b8-40b8-80c2-6e6bf85098b3 2026-06-08 Warnings Exact identifier application number: M015 Witch Hazel WITCH HAZEL CVS Pharmacy, Inc. 50f920da-b41a-480d-b3a0-df940caaee2d 2026-06-08 Warnings, Adverse reactions Exact identifier application number: M015 Adellina Lidocaine Numbing Cream Topical Anorectal Cream LIDOCAINE Guangdong Aimu Biological Technology Co., Ltd 5356cf53-935d-a02f-e063-6394a90a6e5a 2026-06-05 Warnings Exact identifier application number: M015 Hemorrhoidal GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM HyVee Inc b867f691-7a13-4659-b664-06aa36899310 2026-06-03 Warnings Exact identifier application number: M015 Healcome Lidocaine Numbing Cream LIDOCAINE YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD 9b4eac02-1b1f-4630-92b4-b1d8c21abab5 2026-05-29 Warnings Exact identifier application number: M015 Terramed Just Think Comfort Armor Antifungal Body Wash Lavender and chamomile TOLNAFTATE Rida LLC 5517c43f-03b2-499a-a217-d9cba3fb9fd2 2026-05-27 Warnings Exact identifier application number: M015 Terramed Just Think Comfort Armor Antifungal Body Wash Citrus TOLNAFTATE Rida LLC b4c5da66-5928-4352-ab90-fd46039e7955 2026-05-27 Warnings Exact identifier application number: M015 Terramed Just Think Comfort GynoCare BV Guard Intimate Wipes PRAMOXINE HYDROCHLORIDE Rida LLC bb29f156-37b8-400e-802b-3e2671cb7dc8 2026-05-27 Warnings Exact identifier application number: M015 myDerm MEDICAL NEW Soothing Hemorrhoidal WITCH HAZEL PENYLEPHRINE LIDOCAINE Inspec Solutions 2ff42501-7730-42de-99dd-6fc53bbdf25f 2026-05-27 Warnings Exact identifier application number: M015 Terramed Just Think Comfort Armor Antifungal Body Wash Icy Cool Menthol TOLNAFTATE Rida LLC 8b15cb3b-f7cb-4a80-94b2-eeeafc9794e8 2026-05-27 Warnings Exact identifier application number: M015 Lidocaine Roll-on LIDOCAINE YYBA Corp 52d060df-2095-dd68-e063-6394a90a7740 2026-05-27 Warnings Exact identifier application number: M015 PUVIDA NUMBING Cream Anorectal (Hemorrhoidal) Cream LIDOCAINE 5% NUMBING CREAM ANORECTAL (HEMORRHOIDAL) CREAM Jiangxi Yudexi Pharmaceutical Co., LTD 52a25b97-7721-6410-e063-6394a90a228f 2026-05-25 Warnings Exact identifier application number: M015 Arlun LIDOCAINE Cream LIDOCAINE CREAM Guangzhou Jingliang Cosmetics Co., Ltd. 5241c26b-6c91-65a5-e063-6394a90a2477 2026-05-20 Warnings Exact identifier application number: M015 tuiwaro LIDOCAINE Cream LIDOCAINE CREAM Guangzhou Jingliang Cosmetics Co., Ltd. 5223b7fe-6aba-c77b-e063-6394a90ad27b 2026-05-18 Warnings Exact identifier application number: M015 HEMORRHOIDAL WITH LIDOCAINE GLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUM CVS PHARMACY, INC 4d870c68-9e72-464e-b0b8-900d0d661e43 2026-05-14 Warnings Exact identifier application number: M015 Oxify LIDOCAINE 5% Weeks & Leo Compnay, INC. 51cd58f7-c1c9-f4e2-e063-6294a90ad970 2026-05-14 Warnings Exact identifier application number: M015 Lidocaine anorectal cream LIDOCAINE 5% EveryMarket Inc 1604daec-812f-4684-ba98-fbcda07a7461 2026-05-12 Warnings Exact identifier application number: M015 PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES WITCH HAZEL Haleon US Holdings LLC 485437a8-b2e9-4acf-a20e-edb1f08a9cae 2026-05-11 Warnings Exact identifier application number: M015
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 54473-336-01 54473033601 1 TUBE in 1 BOX (54473-336-01) > 30 g in 1 TUBE (54473-336-30) 1 tube 2020-08-04 0000-00-00 No No Current 54473-336-02 54473033602 1 TUBE in 1 BOX (54473-336-02) / 30 g in 1 TUBE (54473-336-31) 1 tube 2020-08-04 No No Current 54473-336-31 54473033631 30 g in 1 TUBE 30 g Historical