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
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
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 63 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
After Bite OutdoorDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands22b891a9-6386-dee1-e063-6394a90a5c2f2025-11-14WarningsExact identifier
application number: M017
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
application number: M017
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger3f881349-fcdd-e276-e063-6394a90ae49e2025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED434cb8b2-a996-5360-e063-6394a90ada032025-11-13WarningsExact identifier
application number: M017
Rapid ReliefCOLD RELIEF PATCH 5% MENTHOLRAPID AID VIET NAM COMPANY LIMITED4360e3ec-7a4b-b28e-e063-6294a90a0bd62025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MGRAPID AID VIET NAM COMPANY LIMITED4360e3be-0ec4-cd57-e063-6394a90aca632025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED43616ad7-58bb-e5ad-e063-6394a90a192b2025-11-13WarningsExact identifier
application number: M017
4x Medicated Severe Toothache and Gum GelBENZALKONIUM CHLORIDEMeijer97ce7890-5093-1763-e053-2a95a90afae72025-11-13WarningsExact identifier
application number: M017
Pain RelieverCAMPHOR, MENTHOLKool 'N Fit Inc.2253f6bd-5707-b993-e063-6394a90aa74a2025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED4360e0d1-46cd-ab4b-e063-6394a90a55e12025-11-12WarningsExact identifier
application number: M017
CVS Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECVS8723e097-296f-784a-e053-2991aa0a552e2025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.154d8821-3e76-b0e2-e063-6294a90ae0772025-11-12WarningsExact identifier
application number: M017
Good neighbor Pharmacy Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEAMERISOURCEBERGEN DRUG CORPORATION87395273-380c-7cef-e053-2991aa0a54c62025-11-12WarningsExact identifier
application number: M017
Quality Choice Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEChain Drug Marketing Association8735b298-83f3-0b5d-e053-2a91aa0a82922025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.1550e794-b3c0-4769-e063-6294a90a8c2d2025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.154fd46e-f00d-1772-e063-6394a90aba7d2025-11-12WarningsExact identifier
application number: M017
Best Choice Itch StoppingDIPHENHYDRAMINE HCLValu Merchandisers884cfd64-2cd1-8c12-e053-2995a90a89252025-11-12WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HCLCVS8839149d-e6d5-57cc-e053-2995a90a98322025-11-12WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HCLChain Drug Marketing Association884c9b47-d511-1d17-e053-2995a90a42eb2025-11-12WarningsExact 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