ANAL-ESE

Product NDC
83608-107
11-digit product format
836080107
Labeler code
83608
Product ID
83608-107_434a76c7-1c49-2308-e063-6294a90a964b
Type
HUMAN OTC DRUG
Nonproprietary name
Desensitizer
Dosage form
CREAM
Route
TOPICAL
Labeler
Novelties by Nasswalk, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-07
Substance
BENZOCAINE
Active strength
7.5 g/100mL
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
ANAL-ESE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE7.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03b89eed-b433-a263-e063-6294a90a675bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83608-107-05ANAL-ESE0.5 mL in 1 TUBECREAM0.53
83608-107-05ANAL-ESE1 in 1 CARTONCREAM13
83608-107-15ANAL-ESE1.5 mL in 1 TUBECREAM1.53
83608-107-15ANAL-ESE1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83608-107ANAL-ESE (DESENSITIZER) CREAM [NOVELTIES BY NASSWALK, INC.]2Current NDC, 4 package rows20241123_03b89eed-b433-a263-e063-6294a90a675b.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 148 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INTIMALE Benzocaine Delay GelBENZOCAINESKINS SEXUAL HEALTH LIMITEDb845bfd5-ab73-495f-97ef-e959bc6311d92023-11-06WarningsExact identifier
application number: M017
RAPID PAIN-RELIEF TOPICALLIDOCAINE HYDROCHLORIDE, MENTHOLNORDIC HEALTHY LIVING INC.a06d6aca-9aa2-4bbe-bf77-4c85f1dd78702023-11-06WarningsExact identifier
application number: M017
PURE PERSONAL All Natural Pain Relief CreamMENTHOLPURE PERSONAL CARE, LLC8f3fb1d0-d238-4b4c-9816-7e335258d71d2023-11-06WarningsExact identifier
application number: M017
DIRT Pain Relieving GelMENTHOLPURIVITAE, LLC89c80a8f-227d-4ec0-9327-683892e73b6a2023-11-06WarningsExact identifier
application number: M017
DIRT Pain Relieving GelMENTHOLPURIVITAE, LLCe43e2cbd-d114-4b11-8baf-7a775881cd972023-11-06WarningsExact identifier
application number: M017
Celadrin Joint and Muscle Pain RelievingMENTHOLFactors Group of Nutritional Products6396e4b6-2130-433b-bdb3-97c76dbe685c2023-11-06WarningsExact identifier
application number: M017
Atomic BalmMETHYL SALICYLATE, CAPSAICINThe Hygenic Company, LLCd10028f3-ae6a-7b01-e053-2995a90a5a842023-11-05WarningsExact identifier
application number: M017
HEMPCIN Advanced Topical Pain Relief CreamMENTHOLPedicis Research, LLC97f5e300-b780-4694-a681-60d5e0cfad652023-11-05WarningsExact identifier
application number: M017
Point Relief cold Spot Pain Relieving roll-onMENTHOLFabrication Enterprises3f1db0ad-aaa8-4e14-9349-45057e0fb4a62023-11-05WarningsExact identifier
application number: M017
LidoStatLIDOCAINE HCLClinical Therapeutic Solutions1825885b-9141-4515-bb69-a1c4a39fb10d2023-11-05WarningsExact identifier
application number: M017
Point Relief Cold Spot Pain RelievingMENTHOLFabrication Enterprises391af69f-74aa-48cf-bc96-75e5c4e0e4452023-11-05WarningsExact identifier
application number: M017
FEEL GOOD LABS NATURAL PAINMENTHOLThe Feel Good Lab778b62a1-ebd3-4a30-8f76-6d6773b698c52023-11-05WarningsExact identifier
application number: M017
FEEL GOOD LABS SPORT RECOVERYMENTHOLThe Feel Good Lab103c5e33-42fb-41ac-957e-bb46d85e204c2023-11-05WarningsExact identifier
application number: M017
INSTA RELIEF DMLIDOCAINE HYDROCHLORIDE, MENTHOLDM LAB CORP6ef66fb9-9f49-409d-9503-175c7555ee9e2023-11-05WarningsExact identifier
application number: M017
DR. MIKES Ponos Pain Relief Cream Roll-OnHISTAMINE DIHYDROCHLORIDE, MENTHOLDr. Mike's Vitamins, LLCfcc45464-f1fe-4244-95a7-9b4288b0ce452023-11-05WarningsExact identifier
application number: M017
AcuPlus Pain ReliefMENTHOLInnovations for Wellness, LLC7f222a4f-85a8-4f3d-aa97-5c695d4da37f2023-11-05WarningsExact identifier
application number: M017
Ana Cool Rapid Soothing Cooling FormulaHYDROCORTISONEAna-Cool, LLC64b80cc2-e2d8-4535-aaf8-c031f4159cd12023-11-05WarningsExact identifier
application number: M017
FEEL GOOD LABS SPORT RECOVERYMENTHOLTHE FEEL GOOD LAB, LLC19b08cbf-5f43-4f07-8f4d-8cddb1492ab82023-11-05WarningsExact identifier
application number: M017
PlayMakar Roll On Cool Pain ReliefMENTHOLPlayMakar Inc.a12c16e7-561f-45a7-93c6-34d693ffdc7c2023-11-05WarningsExact identifier
application number: M017
AcuPlus Advanced Therapy for Pain and RecoveryMENTHOLINNOVATIONS FOR WELLNESS, LLC840cfd15-4ea1-49bf-8c4f-86c12461d8602023-11-05WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83608-107-05836080107051 TUBE in 1 CARTON (83608-107-05) / .5 mL in 1 TUBE1 tube2023-08-07NoNoCurrent
83608-107-15836080107151 TUBE in 1 CARTON (83608-107-15) / 1.5 mL in 1 TUBE1 tube2023-08-07NoNoCurrent