FDA.reportPublic FDA data

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
2027-12-31
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE11.4 g/57g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
211315Internal RxNorm lookup
360349Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4fd14452-0285-40c4-b835-36935c2056b2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-378-02Americaine57 g in 1 CANAEROSOL, SPRAY578

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5AMERICAINE (BENZOCAINE) AEROSOL, SPRAY [INSIGHT PHARMACEUTICALS]3
BenzocaineACTIVE MOIETYU3RSY48JW5AMERICAINE (BENZOCAINE) AEROSOL, SPRAY [INSIGHT PHARMACEUTICALS]3
IsobutaneINACTIVE INGREDIENTBXR49TP611AMERICAINE (BENZOCAINE) AEROSOL, SPRAY [INSIGHT PHARMACEUTICALS]3
Polyethylene Glycol 300INACTIVE INGREDIENT5655G9Y8AQAMERICAINE (BENZOCAINE) AEROSOL, SPRAY [INSIGHT PHARMACEUTICALS]3
PropaneINACTIVE INGREDIENTT75W9911L6AMERICAINE (BENZOCAINE) AEROSOL, SPRAY [INSIGHT PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-378AMERICAINE (BENZOCAINE) AEROSOL, SPRAY [INSIGHT PHARMACEUTICALS LLC]7Current NDC, Legacy NDC, 1 package rows20241208_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 102 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
K19 RELIEFMENTHOLK19 LLCe2e1ca96-1ae8-4c99-b8de-ce26754292f92025-01-15WarningsExact identifier
application number: M017
AnecreamLIDOCAINE 4%Focus Health Group2d7706e2-7363-4047-96cb-85b718277e8c2025-01-15WarningsExact identifier
application number: M017
BoroleumCAMPHOR, MENTHOL, WHITE PETROLATUMReliable 1 Laboratories846568af-0fdd-a80e-e053-2a91aa0a9c9e2025-01-15WarningsExact identifier
application number: M017
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEAdvanced Rx of Tennessee, LLC27d5997b-1cc2-41c2-e063-6394a90ac74a2025-01-15WarningsExact identifier
application number: M017
Pain Relief Patch 4% LidocaineLIDOCAINEReliable 1 Laboratories LLC2b624763-c310-63d9-e063-6394a90a19282025-01-15WarningsExact identifier
application number: M017
Cannarelief 1000mgMENTHOLCarolina Cannabis Creations LLC01e2ae1a-c969-6dd2-e063-6394a90a9d9e2025-01-15WarningsExact identifier
application number: M017
Healing Hand Cream 2000mgMENTHOLCarolina Cannabis Creations LLC01f8795b-9f95-c793-e063-6394a90a83302025-01-15WarningsExact identifier
application number: M017
CBD Clinic Deep-Rub Pain Relief - Level 5CAMPHOR, MENTHOLABACUS HEALTH PRODUCTS, INC.31e2e5cd-d33e-f058-e063-6394a90af7d22025-01-14WarningsExact identifier
application number: M017
Meijer Odor Free Analgesic Pain Relieving Topical AnalgesicLIDOCAINE HYDROCHLORIDEMeijer Distribution, Inc6288efea-f636-4eea-bb9f-78aa2f9af54a2025-01-14WarningsExact identifier
application number: M017
IKONIK TONIKLIDOCAINE HYDROCHLORIDEIKONIK CARE, LLC122fdfe8-b5fa-46d1-9fd9-3df9887ed3202025-01-14WarningsExact identifier
application number: M017
elp essential MANTECA DE UBREMETHYL SALICYLATE, CAMPHORMiramar Cosmetics, Inc DBA Miramar Labc3964dfe-17fe-4d89-a4c4-cf500f9822592025-01-13WarningsExact identifier
application number: M017
MethyltenMETHYL SALICYLATE 10%Puretek Corporation28f4093f-803f-0e70-e063-6294a90a98a42025-01-13WarningsExact identifier
application number: M017
Refill Bundle 7 Large OfficeBENZALKONIUM CHLORIDECMC Group, Inc.6620a8f3-098d-d045-e053-2a91aa0a0d942025-01-13WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Zanming Trading Co., Ltd.2ba1de83-494a-6c54-e063-6294a90a9b2d2025-01-13WarningsExact identifier
application number: M017
Arthritis HotMENTHOL AND METHYL SALICYLATEChattem, Inc.cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd2025-01-13WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b40dda-53ad-0458-e063-6394a90aa8352025-01-11WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b47eb7-6b43-d9e2-e063-6294a90a9a382025-01-11WarningsExact identifier
application number: M017
Re-Lieved 4% Lidocaine Fabric TapeLIDOCAINE 4% FABRIC TAPETransfer Technologye9a894b0-54f2-707e-e053-2a95a90a0f0d2025-01-11WarningsExact identifier
application number: M017
Re-Lieved 3 in 1 PatchMENTHOL, CAMPHOR, METHYL SALICYLATE PATCHTransfer Technologye9ab9a03-b9e3-7317-e053-2995a90a99502025-01-11WarningsExact identifier
application number: M017
ASTRAPHARM CHILLI BRANDCAPSAICINDersan Pharmaceutical Co., Ltdb4c2d4fd-7d5d-4156-ac27-e72ebc9671ec2025-01-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
211315Americaine 20 % Topical SprayPSN4fd14452-0285-40c4-b835-36935c2056b28
360349benzocaine 20 % Topical SprayPSN4fd14452-0285-40c4-b835-36935c2056b28
211315benzocaine 200 MG/ML Topical Spray [Americaine]SBD4fd14452-0285-40c4-b835-36935c2056b28
360349benzocaine 200 MG/ML Topical SpraySCD4fd14452-0285-40c4-b835-36935c2056b28
211315Americaine 20 % Topical SpraySY4fd14452-0285-40c4-b835-36935c2056b28
211315Americaine 200 MG/ML Topical SpraySY4fd14452-0285-40c4-b835-36935c2056b28
360349benzocaine 20 % Topical SpraySY4fd14452-0285-40c4-b835-36935c2056b28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-378-026373603780257 g in 1 CAN (63736-378-02) 57 g2009-07-140000-00-00NoNoCurrent