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#

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 39 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIGHTS Insect Sting Relief PadBENZOCAINELights Medical Manufacture Co., Ltd.ccb4185c-1a67-4775-9392-16bc0f7df3cc2026-01-21WarningsExact identifier
application number: M017
Equate Pain Relieving Cream LidocaineLIDOCAINEWal-Mart Stores Inc52b91508-22aa-4c4b-94f4-977f14a01dad2026-01-20WarningsExact identifier
application number: M017
Easment advanced absorption creamCAPSAICIN 0.1%Easment LLC48de3ced-f67f-7c86-e063-6294a90a340c2026-01-20WarningsExact identifier
application number: M017
Black Cobra Tattoo NumbingSpray 4% LidocaineLIDOCAINEFoshan Sugar Max Cosmetics CO.,Ltd3605fcbf-63c8-87b5-e063-6294a90a9c3e2026-01-19WarningsExact identifier
application number: M017
Black Cobra Tattoo Numbing Cream 4% LidocaineLIDOCAINEFoshan Sugar Max Cosmetics CO.,Ltd3605961a-d596-9c4a-e063-6394a90a99dc2026-01-19WarningsExact identifier
application number: M017
Bakers Best Arthritis Pain ReliefHISTAMINE DIHYDROCHLORIDEBaker's Best Health Products, LLC869735f9-335e-4a5e-adfc-91167ae943c52026-01-19WarningsExact identifier
application number: M017
SIMPLY VITAL PAIN RELIEF HEMPMENTHOLALPHA PLANTS INCc14f4c06-cfe5-497e-9f9e-b2ba442e61bb2026-01-19WarningsExact identifier
application number: M017
AsperFlexMENTHOL AND METHYL SALICYLATEAkron Pharma Inc.117de175-976d-44f3-85ed-3d127fbe3a7c2026-01-19WarningsExact identifier
application number: M017
Equate Pain Relieving Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATEWal-Mart Stores Inc5ed1d7b3-925e-4a18-8e15-636f5b442ad72026-01-19WarningsExact identifier
application number: M017
Equate Medicated Pain Relieving Patch, Large 6-CountCAMPHOR, MENTHOL, METHYL SALICYLATEWalmart Stores Inc2c25cd7a-7e7b-5add-e063-6294a90a9e9b2026-01-19WarningsExact identifier
application number: M017
Equate Hydrocortione1% HYDROCORTISONEWalmart Inc.85b7f620-cc95-4333-b124-bbcc8fd5f7eb2026-01-19WarningsExact identifier
application number: M017
GuruNanda Pain ReliefMENTHOLGURUNANDA, LLC3f1d146e-0d18-7f2f-e063-6394a90ab8162026-01-19WarningsExact identifier
application number: M017
Aspercreme with LidocaineLIDOCAINEChattem, Inc.7ad8efa9-7031-4cd0-be1d-6dee63091fd12026-01-19WarningsExact identifier
application number: M017
Best Choice Targeted Warming Capsaicin Heat PatchCAPSAICINValu Merchandisers Company24ca40b7-e17b-42a3-bcc8-6861b9a5934a2026-01-18WarningsExact identifier
application number: M017
TOPCARE PAIN RELIEF PATCHESLIDOCAINETOPCO ASSOCIATES, LLCfa2f7768-e779-4409-aad3-6c33ce2e6b362026-01-18WarningsExact identifier
application number: M017
Neuropathy Pain Relief CreamMENTHOL CREAMOwell Naturals Brand, LLC48979093-2992-5fd8-e063-6394a90a815d2026-01-17WarningsExact identifier
application number: M017
CVS Lidocaine Pain Relief CreamLIDOCAINE HYDROCHLORIDECVS Pharmacy45c4f946-13b9-7a0a-e063-6394a90a73532026-01-16WarningsExact identifier
application number: M017
TopCare Pain Relieving CreamLIDOCAINE HCL 4%Topco Associates, LLC4885a7e6-a127-450a-e063-6294a90a4f912026-01-16WarningsExact identifier
application number: M017
CalmaraCALMARADynarex Corporation487393e9-6619-6033-e063-6294a90a68b22026-01-16WarningsExact identifier
application number: M017
Maximum Strength HydrocortisoneHYDROCORTISONE OINTMENTWalgreens7088092c-3a5f-4fcc-84cc-931d238f75012026-01-15WarningsExact 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