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 32 of 61 · 1,208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLCac398ff0-0010-4e13-8b89-dc986fd7f9742025-08-08WarningsExact identifier
application number: M022
clearlaxPOLYETHYLENE GLYCOL 3350Meijer, Inc.8cca18a8-94f6-43f6-bdb7-2d44a6cdf1512025-08-08WarningsExact identifier
unii: G2M7P15E5P
QUALITY CHOICE SALINEPLUS SOOTHING ALOEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)4ae4e88a-aaa5-4195-bedc-622fd5cd93942025-07-30WarningsExact identifier
application number: M022
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: B697894SGQ
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: B697894SGQ
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: B697894SGQ
Chigg AwayBENZOCAINEPierson Laboratories, Inc.8372e7c1-f145-4bc5-85ab-cf831abe70ce2025-07-24WarningsExact identifier
unii: U3RSY48JW5
Chigg AwayBENZOCAINEPharma Nobis, LLCe42fa1c6-d804-630f-e053-2995a90add6b2025-07-24WarningsExact identifier
unii: U3RSY48JW5
GAVILAXPOLYETHYLENE GLYCOL 3350ATLANTIC BIOLOGICALS CORP.c9688f06-b6db-4afb-b8ff-ef5fb8bf99462025-07-22WarningsExact identifier
unii: G2M7P15E5P
Aseptil RojoPHENOLMenper Distributors, Inc.62c96dc1-4698-43c1-8e6d-f4062dc5eea22025-07-22WarningsExact identifier
application number: M022
AnestenkaBENZOCAINEMenper Distributors, Inc00a3f1bc-ddfe-47c6-8221-f48f915135032025-07-22WarningsExact identifier
application number: M022
unii: U3RSY48JW5
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
application number: M022
SprinJene Natural Sensitivity and GumPOTASSIUM NITRATEHealth and Natural Beauty USA Corp3cb23e36-0e8c-4172-b4ae-859b58a2739f2025-07-07WarningsExact identifier
application number: M022
Normal SaltSODIUM CHLORIDETwin Med LLCdc82ff0f-8600-373a-e053-2995a90a75052025-07-03WarningsExact identifier
application number: M022
Sensodyne Pronamel Kids Berry TwistSODIUM FLUORIDEHaleon US Holdings LLC69c07c36-b5e0-420b-ab29-7d10913863222025-07-03WarningsExact identifier
application number: M022
DenTek Instant Pain Relief Maximum StrengthBENZOCAINEDenTek Oral Care, Inc.ae92b76e-815a-4b4c-8128-bd045098caa52025-06-30WarningsExact identifier
application number: M022
unii: U3RSY48JW5
Sensodyne Clinical White Stain ProtectorPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC99037e59-53d6-492c-8fce-67641fc8efdd2025-06-25WarningsExact identifier
application number: M022
Meret Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.385def83-38fe-df7f-e063-6394a90abbf02025-06-24WarningsExact identifier
unii: U3RSY48JW5
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Morning Star OTCdcd4164c-aa1e-4f07-ab2c-b439275629db2025-06-16WarningsExact identifier
unii: B697894SGQ
Iolite-SBENZOCAINEDharma Research, Inc.b3b68914-2adc-4f07-9521-0b18756be5222025-06-14WarningsExact identifier
application number: M022
unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

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