Home NDC 63736-378 Americaine
Product NDC 63736-378
11-digit product format 637360378
Labeler code 63736
Product ID 63736-378_d727db6e-b2c9-4bf6-96c5-751713baaf6a
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Insight Pharmaceuticals LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2009-07-14
Substance BENZOCAINE
Active strength 11.4 g/57g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [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 Americaine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 11.4 g/57g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 211315 Internal RxNorm lookup 360349 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63736-378-02 Americaine 57 g in 1 CAN AEROSOL, SPRAY 57 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63736-378 AMERICAINE (BENZOCAINE) AEROSOL, SPRAY [INSIGHT PHARMACEUTICALS LLC] 7 Current NDC, Legacy NDC, 1 package rows 20241208_4fd14452-0285-40c4-b835-36935c2056b2.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 93 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join WaxRx EarAcheRx Pain Relieving Drops 4% LIDOCAINE HCL DOCTOR EASY MEDICAL PRODUCTS, LLC 34156655-8706-f0a4-e063-6294a90acc90 2025-05-01 Warnings Exact identifier application number: M017 foster and thrive anti itch cream DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Strategic Sourcing Services LLC bb08293d-5db8-4cc8-9fe3-bd02061dbeb9 2025-04-30 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch LIDOCAINE Solis Pharmaceuticals Inc. 3061d301-2104-b1b2-e063-6394a90a9b6e 2025-04-29 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch LIDOCAINE InterMed Laboratories Private Limited 33ed754e-8852-d5b2-e063-6394a90a7cf2 2025-04-29 Warnings Exact identifier application number: M017 Cold Hot Medicated Patch 5% Menthol MENTHOL InterMed Laboratories Private Limited 33ee6e48-243e-4ded-e063-6394a90a987d 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 32b96689-8e9b-4c2e-e063-6294a90a7d1c 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 3304e362-dcda-3f5e-e063-6294a90a7015 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 2f2f753d-c791-e863-e063-6394a90aec5d 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 3162c96a-061d-2971-e063-6394a90a9b74 2025-04-29 Warnings Exact identifier application number: M017 Ivarest Poison Ivy Removal and Itch Relief PRAMOXINE HYDROCHLORIDE Blistex Inc. dedbf5d9-0f86-4f32-8321-da86c9838c0a 2025-04-29 Warnings Exact identifier application number: M017 HealthWise 2X Medicated Pain Relief Cream Roll-on MENTHOL Veridian Healthcare 33dae8a8-4197-f276-e063-6294a90aea83 2025-04-28 Warnings Exact identifier application number: M017 HealthWise Roll-on Menthol Pain Relief Gel MENTHOL Veridian Healthcare 33dbb939-9397-7e70-e063-6294a90ac8f4 2025-04-28 Warnings Exact identifier application number: M017 Stopain Extra Strength Gel MENTHOL Troy Manufacturing, Inc. fa1a98bc-c233-410d-a20e-71111c897372 2025-04-28 Warnings Exact identifier application number: M017 Lidocaine Patch 4% LIDOCAINE 4% Medcore LLC b961906c-fe66-466b-af2c-072781fa098b 2025-04-28 Warnings Exact identifier application number: M017 Walgreens Lidocaine Knee and Elbow LIDOCAINE Walgreen Co. a3fb4c78-1493-4ba4-ae83-502dd825ed67 2025-04-25 Warnings Exact identifier application number: M017 Walgreens Lidocaine Back LIDOCAINE Walgreen Co. e6bfd342-c0db-46b9-b5e6-5acbd860adf1 2025-04-25 Warnings Exact identifier application number: M017 Electrum Numb Foam LIDOCAINE HCI RENU LABORATORIES, LLC c8472932-28b7-9189-e053-2a95a90a44df 2025-04-25 Warnings Exact identifier application number: M017 Benadryl Extra Strength Itch Stopping DIPHENHYDRAMINE HYDROCHLORIDE Kenvue Brands LLC 66a2fd60-1757-45cc-a195-ecb9241dca2a 2025-04-24 Warnings Exact identifier application number: M017 Jakwork Numbing Cream NUMBING CREAM Guangzhou Zanming Trading Co., Ltd. 3385cddb-609f-62e8-e063-6294a90add81 2025-04-24 Warnings Exact identifier application number: M017 PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED LIDOCAINE, MENTHOL Compass Health Brands Corp. 2bd8aae0-2606-c7f2-e063-6294a90a9a20 2025-04-22 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 63736-378-02 63736037802 57 g in 1 CAN (63736-378-02) 57 g 2009-07-14 0000-00-00 No No Current