FDA.reportPublic FDA data

Americaine

Product NDC
63736-375
11-digit product format
637360375
Labeler code
63736
Product ID
63736-375_5dbb80f4-3570-183f-e063-6294a90a3b34
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Insight Pharmaceuticals LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-07-10
Marketing end
2028-03-31
Substance
BENZOCAINE
Active strength
5.6 g/28g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE5.6 g/28g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-375-01Americaine28 g in 1 TUBEOINTMENT286
63736-375-01Americaine1 in 1 BOXOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63736-375-01GM - Gram63736-375509a3589-ef43-4500-b39d-10830113663312022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5AMERICAINE (BENZOCAINE) OINTMENT [INSIGHT PHARMACEUTICALS]1
BenzocaineACTIVE MOIETYU3RSY48JW5AMERICAINE (BENZOCAINE) OINTMENT [INSIGHT PHARMACEUTICALS]1
Benzethonium ChlorideINACTIVE INGREDIENTPH41D05744AMERICAINE (BENZOCAINE) OINTMENT [INSIGHT PHARMACEUTICALS]1
Polyethylene glycol 300INACTIVE INGREDIENT5655G9Y8AQAMERICAINE (BENZOCAINE) OINTMENT [INSIGHT PHARMACEUTICALS]1
Polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PAMERICAINE (BENZOCAINE) OINTMENT [INSIGHT PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-375AMERICAINE (BENZOCAINE) OINTMENT [INSIGHT PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 2 package rows20241129_d13c022f-2f91-40b4-bd66-0cfc0e147a5f.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 11 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedlineMENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP006539c9-1982-d6de-e063-6294a90a1a5a2025-10-17WarningsExact identifier
application number: M015
Xesso Strawberry Rear Comfort Glide 4% LidocaineLIDOCAINEPremium Natural Cosmetics Incefba09fc-6dd7-0f73-e053-2995a90a628a2025-10-17WarningsExact identifier
application number: M015
medicated padsWITCH HAZELTARGET CORPORATIONacd0d99d-2a77-4227-bebb-c819f4a526662025-10-14WarningsExact identifier
application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.40b0e8d6-4686-960b-e063-6294a90a016e2025-10-09WarningsExact identifier
application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.40b452a3-76b7-2433-e063-6294a90ab6b42025-10-09WarningsExact identifier
application number: M015
EQUATE HEMORRHOID RELIEFLIDOCAIN 5%WALMART, INCd96e8152-e36e-22fc-e053-2995a90a8b2b2025-10-08WarningsExact identifier
application number: M015
Pramoxine Hydrochloride AnorectalPRAMOXINE HYDROCHLORIDEStratus Pharmaceuticals39a16b66-b0e9-412f-8773-8dec0a1227e02025-10-02WarningsExact identifier
application number: M015
Doctor Butlers Hemorrhoid and Fissure External Pain FormulaLIDOCAINE 5%Beyond Health, P.A.d92f22a7-c0b5-d8b8-e053-2a95a90a23762025-09-30WarningsExact identifier
application number: M015
RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream)LIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.3ffc57c7-5bf4-cba8-e063-6394a90a322f2025-09-29WarningsExact identifier
application number: M015
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF CREAMNeilmed Pharmaceuticals Inc.374dc1c0-4243-b272-e063-6394a90a5a6b2025-09-24WarningsExact identifier
application number: M015
Medi-First BurnLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation44bb5f25-1114-4bb1-8bcf-40402594abc42025-09-09WarningsExact identifier
application number: M015
Dr. Care Numbing Cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3e456af7-9726-d17e-e063-6394a90ab5602025-09-08WarningsExact identifier
application number: M015
Medi-first Ivy-Rid First AidBENZOCAINE AND BENZETHONIUM CHLORIDEUnifirst First Aid Corporation905c97ad-0bba-46b1-939c-f16fbdb028182025-09-08WarningsExact identifier
application number: M015
MediFirst BurnLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation9fa5b348-29c2-4cd0-a945-0486bd27f5e02025-09-08WarningsExact identifier
application number: M015
Medi-First BurnLIDOCAINE HCLUnifirst First Aid Corporationb3ebf104-cc51-0ef5-e053-2a95a90a25c92025-09-08WarningsExact identifier
application number: M015
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation4c2e2b91-d2f6-4e41-9a4c-ecabca9830e82025-09-08WarningsExact identifier
application number: M015
Pain ReliefANALGESIC MENTHOLUnifirst First Aid Corporation8162d22d-04c0-de07-e053-2991aa0a99752025-09-08WarningsExact identifier
application number: M015
Green Guard BurnLIDOCAINE HCLUnifirst First Aid Corporationb451e96f-fcba-6495-e053-2a95a90a2adf2025-09-08WarningsExact identifier
application number: M015
Lidochill(TM) GelLIDOCAINE HCL 4%, MENTHOL 1%PureTek Corporationd2a9aeb6-8a94-49e7-ab46-84403560b6c82025-09-08WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3e1892de-378b-d2d0-e063-6294a90ad7db2025-09-05WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1426293Americaine Hemorrhoidal 20 % Topical OintmentPSNd13c022f-2f91-40b4-bd66-0cfc0e147a5f6
244557benzocaine 20 % Topical OintmentPSNd13c022f-2f91-40b4-bd66-0cfc0e147a5f6
1426293benzocaine 0.2 MG/MG Topical Ointment [Americaine Hemorrhoidal]SBDd13c022f-2f91-40b4-bd66-0cfc0e147a5f6
244557benzocaine 0.2 MG/MG Topical OintmentSCDd13c022f-2f91-40b4-bd66-0cfc0e147a5f6
1426293Americaine Hemorrhoidal 0.2 MG/MG Topical OintmentSYd13c022f-2f91-40b4-bd66-0cfc0e147a5f6
1426293Americaine Hemorrhoidal 20 % Topical OintmentSYd13c022f-2f91-40b4-bd66-0cfc0e147a5f6
244557benzocaine 20 % Topical OintmentSYd13c022f-2f91-40b4-bd66-0cfc0e147a5f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-375-01637360375011 TUBE in 1 BOX (63736-375-01) / 28 g in 1 TUBE1 tube2009-07-102028-03-31NoNoCurrent