FDA.reportPublic FDA data

Americaine

Product NDC
63736-375
11-digit product format
637360375
Labeler code
63736
Product ID
63736-375_41746b33-0ff3-4b02-8018-34e4fd54ef7b
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
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
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
BENZOCAINE5.6 g/28g

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
244557Internal RxNorm lookup
1426293Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d13c022f-2f91-40b4-bd66-0cfc0e147a5fAvailable on FDA.report

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 8 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hemorrhoid, Fissure, ProctalgiaSuppositoriesCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOLWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1d40d16a-ee52-463a-e063-6394a90a60772026-01-14WarningsExact identifier
application number: M015
Hemorrhoid, Fissure, Proctalgia Relief WashCARBON, PANTHENOL, SODIUM HYALURONATEWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1e20de39-45b0-54ec-e063-6294a90a04ed2026-01-14WarningsExact identifier
application number: M015
Hemorrhoid, Fissure, Proctalgia OintmentsCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL, GLYCERINWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1efe43d5-a29b-5cb2-e063-6394a90aca662026-01-14WarningsExact identifier
application number: M015
LONAZEMMENTHOL,PETROLATUMPEER PHARM LTD.91f7a741-4178-4639-9cd5-746a4b9a21bf2026-01-12WarningsExact identifier
application number: M015
Hemorrhoidal Hygiene padsWITCH HAZELAkron Pharma Inc.936a0cca-5049-4ddf-9581-75c2da6d9cfa2026-01-12WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD4805ba4e-45d3-bf0a-e063-6294a90a6eef2026-01-10WarningsExact identifier
application number: M015
THE SOLUTION 2.0LIDOCAINESCALP TECH INC0fa423b6-cc0f-b569-e063-6294a90a239e2026-01-09WarningsExact identifier
application number: M015
BLACK LABEL B NUMBLIDOCAINE HYDROCHLORIDESCALP TECH INC11fcf401-0891-04bc-e063-6294a90a8ad52026-01-09WarningsExact identifier
application number: M015
GOLD LABEL B NUMBLIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDESCALP TECH INC1211590a-13b5-2e75-e063-6394a90a0f862026-01-09WarningsExact identifier
application number: M015
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEUniversal Distribution Center LLC90844919-f16a-4390-9dca-b0405b5014452026-01-08WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD47dda425-86d8-441e-e063-6294a90a0f9a2026-01-08WarningsExact identifier
application number: M015
AER Traveler ToweletteAER TRAVELERBirchwood Laboratories LLC26556b9b-1c3a-6cf5-e063-6394a90ab26c2026-01-08WarningsExact identifier
application number: M015
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC49a93cfc-4ccd-4ef3-928f-901b9926f7942026-01-08WarningsExact identifier
application number: M015
PREPARATION H FOR WOMENWITCH HAZELHaleon US Holdings LLCa9099cf4-4e2e-4cf1-a52f-48f8e174cb152026-01-08WarningsExact identifier
application number: M015
LIPOCAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.849d6e28-a6b8-7f49-e053-2a91aa0a497d2026-01-08WarningsExact identifier
application number: M015
TOPICAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.15d33ff7-34ed-253d-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M015
Dr Wellskin Numbing Cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD47ebedc5-caf1-a774-e063-6394a90ae14d2026-01-08WarningsExact identifier
application number: M015
Dr. Care Numbing CreamLIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD47c94198-7718-bbc2-e063-6294a90a48f12026-01-07WarningsExact identifier
application number: M015
Healthwise Anorectal Pain ReliefLIDOCAINE 5%Veridian Healthcare19c24e1b-a31b-478b-a48b-c39bb4753ca72026-01-06WarningsExact identifier
application number: M015
Good Sense Hemorrhoidal Maximum Strength Pain ReliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUML. Perrigo Company1d6142b6-3746-46f1-99ec-4b19d26f056e2026-01-06WarningsExact 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 tube2009-07-100000-00-00NoNoCurrent