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 16 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalmoseptineANORECTAL OINTMENTCalmoseptine Inc.ff9539ed-d9ae-401d-adbc-df8f1d7514312025-01-13WarningsExact identifier
application number: M015
DibucaineDIBUCAINEAkron Pharma Inc.60469e43-ab6f-46d3-a1df-00e58275f5652025-01-12WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIChain Drug Marketing Association Inc.2b490a08-149d-76ab-e063-6394a90a084f2025-01-09WarningsExact identifier
application number: M015
Drs. pharmacy HEMORRHOIDAL COOLINGPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACYd6f6b482-d85d-001c-e053-2995a90ad98c2025-01-09WarningsExact identifier
application number: M015
Hemorrhoidal Cream with AloeGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMChain Drug Marketing Association2b33c710-ac17-20f9-e063-6294a90ad29c2025-01-08WarningsExact identifier
application number: M015
THE SOLUTIONLIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDESCALP TECH INCdf51623c-e0b6-8e86-e053-2995a90a59b22025-01-08WarningsExact identifier
application number: M015
frida mom Perineal Cooling Pad LinersWITCH HAZELFridababy, LLCa461ff3d-e115-4f15-a545-bacb502ff6cd2024-12-30WarningsExact identifier
application number: M015
frida mom Postpartum Recovery EssentialsWITCH HAZELFridababy, LLC2d26c6f2-5d31-4c07-9f40-2fbfcfbf12342024-12-30WarningsExact identifier
application number: M015
frida mom Perineal HealingWITCH HAZELFridababy, LLC6a58e2a8-c4d5-4078-b5f4-28504de1f0202024-12-30WarningsExact identifier
application number: M015
frida mom Labor and Delivery Plus Postpartum RecoveryWITCH HAZELFridababy, LLC4b5fc312-4c8c-4396-a70c-b1ed129038c72024-12-30WarningsExact identifier
application number: M015
Tucks Triple Relief HemorrhoidalWHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEBlistex Inc.bf892e90-2d9b-4fa0-8ee4-8a2736be6c302024-12-24WarningsExact identifier
application number: M015
BLISS GVS HEMORRHOIDALPHENYLEPHRINE HCLBliss GVS Pharma Limitedfceea303-2ea0-10e9-e053-6294a90a54922024-12-21WarningsExact identifier
application number: M015
DibucaineDIBUCAINE 1%Geri-Care Pharmaceuticals, Corpafe88610-5cac-960e-e053-2a95a90a7ba42024-12-20WarningsExact identifier
application number: M015
Hemorroidal Cooling gelPHENYLEPHRINE, WITCH HAZELPharmacy Value Alliance, LLC7276aab8-0297-2a55-e053-2a91aa0a8d212024-12-20WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIPharmacy Value Alliance, LLC3803a61b-308a-14a9-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M015
Bliss GVS HemorrhoidalHARD FAT, PHENYLEPHRINE HCLBliss GVS Pharma Limited88c49f6c-2a48-2dae-e053-2a95a90af20a2024-12-19WarningsExact identifier
application number: M015
Rectal Care Cream RevivolLIDOCAINE 5%Derma Care Research Labsa1c75161-f84a-e996-e053-2a95a90ac0c52024-12-19WarningsExact identifier
application number: M015
DCH Numbing ReliefLIDOCAINE 5%Derma Care Research Labs, LLCffd70a31-7d0c-d2d0-e053-6394a90a86742024-12-19WarningsExact identifier
application number: M015
DCH HemorrhoidalGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0050701f-4393-3f01-e063-6394a90a4e0e2024-12-19WarningsExact identifier
application number: M015
Moshe Numbing HemorrhoidalLIDOCAINE 5%Derma Care Research Labsfbd5b488-1921-e9b7-e053-6294a90aba702024-12-19WarningsExact 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