NDC 0283-0871-01 - HurriCaine Topical Anesthetic

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0283-0871
Requested NDC
0283-0871-01
Package NDCs from labels
0283-0871-01, 0283-0871-75, 0283-0871-12, 0283-0871-45, 0283-0871-59, 0283-0871-31
Manufacturer
Beutlich Pharmaceuticals, LLC | Dental Technologies, Inc.
Effective date
2025-08-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HurriCaine Gel W/C TubesBeutlich Pharmaceuticals, LLC | Dental Technologies, Inc.2025-08-12HUMAN OTC DRUG LABEL
HurriCaine Unit Dose Gel and Swab - CherryBeutlich Pharmaceuticals, LLC | Centrix Inc | Dental Technologies, Inc.2025-01-08HUMAN OTC DRUG LABEL
HurriCaine Gel - Cherry 1ozBeutlich Pharmaceuticals, LLC | Speciality Pharma Manufacturing, LLC | Dental Technologies Inc.2024-10-28HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0283-0871-592023-02-01C16284748780-1f386c649-f23d-0266-e053-dadaa90a7c1aHurriCaine Unit Dose Gel and Swab - Cherry

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0283-0871-31HurriCaineTopical Anesthetic1 in 1 BOXGEL127
0283-0871-31HurriCaineTopical Anesthetic28.4 g in 1 BOTTLE, PLASTICGEL28.427
0283-0871-45HurriCaineTopical Anesthetic0.5 g in 1 CUP, UNIT-DOSEGEL0.526
0283-0871-59HurriCaineTopical Anesthetic60 in 1 BOXGEL6026
0283-0871-01HurriCaineTopical Anesthetic5.25 g in 1 TUBEGEL5.2525
0283-0871-12HurriCaineTopical Anesthetic12 in 1 CELLO PACKGEL1225
0283-0871-75HurriCaineTopical Anesthetic1 in 1 BOXGEL125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0871HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]27Current NDC, Legacy NDC, 2 package rows20241030_1f3d68f6-afd6-42e7-b3e5-210228c8e7de.zip
0283-0871HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]26Current NDC, Legacy NDC, 2 package rows20250110_e628bd9f-99e5-4c71-ba8a-caa6c337de54.zip
0283-0871HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]24Current NDC, Legacy NDC, 3 package rows20250110_113cdb83-0fdd-40f2-8ee6-b771dca99713.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0871-12GM - Gram0283-08716691d8d3-e365-4b3c-ac65-03bdf46d01f612012-07-24
0283-0871-31GM - Gram0283-087113270ff7-44c9-4115-bc6e-688a24f23ac512012-07-24
0283-0871-45EA - Each0283-08717e35be3f-eaad-4633-ae1f-b5241f28592012022-03-09
0283-0871-59EA - Each0283-08714ee3acb3-dc3a-4da0-8528-b4c60fc376b512022-03-09
0283-0871-75GM - Gram0283-08712f16edc3-01b9-467d-b7e6-941c9305aff412012-07-24

DailyMed Socrata Ingredients#

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 33 of 61 · 1,208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Kesin Pharma Corporation3729a1d2-4c98-dfdf-e063-6394a90a5a872025-06-12WarningsExact identifier
unii: G2M7P15E5P
Dermoplast Post PartumBENZOCAINEAdvantice Health, LLC374dced3-6527-b458-e063-6394a90a911e2025-06-11WarningsExact identifier
unii: U3RSY48JW5
CLEARLAXPOLYETHYLENE GLYCOL 3350STRATEGIC SOURCING SERVICES LLC041157b8-476c-e7d2-e063-6394a90ac3a02025-06-11WarningsExact identifier
unii: G2M7P15E5P
Red Cross ToothacheEUGENOLThe Mentholatum Company3537e599-65d9-48d6-8a46-d42312f71e842025-06-11WarningsExact identifier
application number: M022
QUALITY CHOICE Sore ThroatPHENOLCHAIN DRUG MARKETING ASSOCIATIONc95ee086-f384-475d-ad0c-75518cb9d2fe2025-06-10WarningsExact identifier
application number: M022
Everlight Survival Sting Relief PadBENZOCAINEYiwu Ori-Power Medtech Co.,Ltd.364c9882-339e-fe22-e063-6294a90a37f42025-06-04WarningsExact identifier
unii: U3RSY48JW5
LIGHTS Sting Relief Prep PadBENZOCAINELights Medical Manufacture Co., Ltd.4f4d7758-be62-4304-8871-087a90497fa52025-06-04WarningsExact identifier
unii: U3RSY48JW5
Onral Oral Pain Reliever MouthwashBENZOCAINESyka Pharma Inc.5dd8d933-6f32-4eaf-8eca-9365d7de55a22025-06-03WarningsExact identifier
application number: M022
unii: U3RSY48JW5
Orajel Rescue Relief PenORAL PAIN RELIEVERChurch & Dwight Co., Inc.2d68eec5-ae8a-9cdf-e063-6294a90a97992025-06-01WarningsExact identifier
application number: M022
unii: U3RSY48JW5
First Aid Only Antiseptic First AidBENZALKONIUM CHLORIDEAcme United Corporation35d06b38-55dd-e306-e063-6394a90aaf262025-05-23WarningsExact identifier
unii: U3RSY48JW5
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC9e1f7462-a052-4db4-bc59-cce437b695d02025-05-20WarningsExact identifier
application number: M022
unii: U3RSY48JW5
Saline 1.5 FL OZSALINEALAINA HEALTHCARE PRIVATE LIMITEDf1bdbb25-6943-4828-9ae0-7d9783c18b5f2025-05-19WarningsExact identifier
application number: M022
Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries BlueberryFLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRYWORLD DENTISTS ASSOCIATION AMERICA LIMITED3573f149-2af9-4c86-e063-6294a90a7b3f2025-05-18WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDESafeway, Inc.8fe2f1df-3264-455d-b62c-953dce171c022025-05-16WarningsExact identifier
application number: M022
Parodontax Active Gum Health Daily Mouthwash Breath FreshenerCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC32b632bf-058d-447b-a7fb-a9dd05c1e2b82025-05-08WarningsExact identifier
application number: M022
Parodontax Active Gum Health Clear MintCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC444f931d-5e38-4cda-97ba-98aa0b5fe4f62025-05-08WarningsExact identifier
application number: M022
Climax Shield DelayBENZOCAINEPRODUCT MAX GROUP INC9c720cdc-f753-47ce-95ff-3b26e461a0ab2025-05-05WarningsExact identifier
unii: U3RSY48JW5
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Camber Consumer Care Incb321a7f5-f80b-4a51-9fd9-2c21fc1cae9b2025-04-23WarningsExact identifier
unii: G2M7P15E5P
Listerine Clinical Solutions Gum Health Icy MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC06e1122b-1100-43c0-e063-6394a90a2e782025-04-22WarningsExact identifier
application number: M022
good neighbor pharmacy clearlaxPOLYETHYLENE GLYCOL 3350Amerisource Bergene0b419b6-6ce0-4aaa-948f-dee5b2ec20822025-04-17WarningsExact identifier
unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.