FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-0569
11-digit product format
002830569
Labeler code
0283
Product ID
0283-0569_42f260d7-63f7-4356-e063-6394a90a4676
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
DENTAL; ORAL; PERIODONTAL
Labeler
Beutlich Pharmaceuticals, LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1969-05-15
Substance
BENZOCAINE
Active strength
200 mg/g
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0283-05690283-0569-02DDiscontinued by firm2026-10-15
excluded packagepackage0283-05690283-0569-72DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0283-05690283-0569-72DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0283-05690283-0569-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
HurriCaine
Brand name suffix
Topical Anesthetic Liquid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

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
308657Internal RxNorm lookup
808062Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fee9969d-ad1a-4f44-9741-a0a44c9e1128Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
0283-0569-02W/C Liquid
0283-0569-02W/C Liquid
0283-0569-17W/C Liquid
0283-0569-17W/C Liquid
0283-0569-31W/C Liquid
0283-0569-31W/C Liquid
0283-0569-72W/C Liquid
0283-0569-72W/C Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0283-0569-02HurriCaineTopical Anesthetic Liquid2 g in 1 APPLICATORLIQUID251
0283-0569-17HurriCaineTopical Anesthetic Liquid1 g in 1 PACKETLIQUID151
0283-0569-31HurriCaineTopical Anesthetic Liquid29.6 g in 1 BOTTLE, PLASTICLIQUID29.651
0283-0569-72HurriCaineTopical Anesthetic Liquid72 g in 1 APPLICATORLIQUID7251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0569-31ML - Milliliter0283-05691326f189-9c69-460f-a071-c36eae17939712012-07-24
0283-0569-72EA - Each0283-05690e9c6d99-ad67-4acf-8ed5-6b7b6f57967512016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5HURRICAINE TOPICAL ANESTHETIC LIQUID (BENZOCAINE) LIQUID [BEUTLICH PHARMACEUTICALS, LLC]6
BENZOCAINEACTIVE MOIETYU3RSY48JW5HURRICAINE TOPICAL ANESTHETIC LIQUID (BENZOCAINE) LIQUID [BEUTLICH PHARMACEUTICALS, LLC]6
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQHURRICAINE TOPICAL ANESTHETIC LIQUID (BENZOCAINE) LIQUID [BEUTLICH PHARMACEUTICALS, LLC]6
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYHURRICAINE TOPICAL ANESTHETIC LIQUID (BENZOCAINE) LIQUID [BEUTLICH PHARMACEUTICALS, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0569HURRICAINE TOPICAL ANESTHETIC LIQUID (BENZOCAINE) LIQUID [BEUTLICH PHARMACEUTICALS, LLC]50Current NDC, Legacy NDC, 4 package rows20240702_fee9969d-ad1a-4f44-9741-a0a44c9e1128.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 13 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
S.T.37HEXYLRESORCINOLNUMARK BRANDS, INC7d7acca2-aa8a-5272-e813-faab039cc7982025-12-15WarningsExact identifier
application number: M022
Esunix Oral Bacteriostatic GelCETYLPYRIDINIUM CHLORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f4ee467-8142-8cb7-e063-6394a90aa7f72025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999851ac-925c-7d1f-e053-2a95a90a240b2025-12-12WarningsExact identifier
application number: M022
Orajel 3X Medicated For Toothache and GumBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.99a2b061-0875-59a4-e053-2995a90ab3732025-12-12WarningsExact identifier
application number: M022
Orajel Antiseptic Rinse For All Mouth SoresHYDROGEN PEROXIDE AND MENTHOLChurch & Dwight Co., Inc.06188d36-0d60-6ae6-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M022
Orajel 3X Medicated For All Mouth SoresBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.99b589ac-9833-fb60-e053-2995a90a09352025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated For Toothache and Gum, CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999aa7b9-bf9e-9285-e053-2a95a90a345b2025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated PM For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999cff2b-c23e-5abe-e053-2a95a90a75692025-12-12WarningsExact identifier
application number: M022
Benzoin Compound TinctureBENZOIN RESINHumco Holding Group, Inc.a893a232-2ea8-4e0d-8cbf-7f5040b3be2e2025-12-11WarningsExact identifier
application number: M022
Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC456d45e8-bf6d-31c4-e063-6394a90a5c002025-12-10WarningsExact identifier
application number: M022
Oral pain reliefBENZOCAINEALAINA HEALTHCARE PRIVATE LIMITEDd98c1b2f-fe75-4d52-b082-1abb7628c59e2025-12-09WarningsExact identifier
application number: M022
HEB Sensitive Extra Whitening TwinSODIUM FLUORIDEHEB41d5ae3e-51c1-263b-e063-6394a90a33122025-12-08WarningsExact identifier
application number: M022
CankerMeltsBENZOCAINEQuest Products, LLC070dae82-14c2-66d2-e063-6394a90ab2592025-12-04WarningsExact identifier
application number: M022
Sore Throat ReadyInCasePHENOLP & L Development, LLC2fb3d17e-8ca3-4edb-8b82-4b484f42616e2025-12-03WarningsExact identifier
application number: M022
Listerine Cool Mint Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC44f2b66a-26ae-1044-e063-6394a90a9ab62025-12-02WarningsExact identifier
application number: M022
Sensodyne Fresh CleanSTANNOUS FLUORIDEHaleon US Holdings LLC2d433ac1-3ddf-a2f4-e063-6394a90a91f82025-12-01WarningsExact identifier
application number: M022
Walgreens SalineNASALWALGREEN COMPANY147e45c8-1e71-4c06-89f1-42e9f96833662025-12-01WarningsExact identifier
application number: M022
EELHOE Probiotic Bright White FreshGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.425cec0e-aa74-5341-e063-6294a90ac86b2025-11-27WarningsExact identifier
application number: M022
EELHOE 5 Days Tooth PowderGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.42f98b14-d1d5-4af8-e063-6294a90a8f672025-11-27WarningsExact identifier
application number: M022
JAYSUING Colour CorrectorGLYCERINShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.425d9c23-a692-3c62-e063-6294a90a94042025-11-27WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSNfee9969d-ad1a-4f44-9741-a0a44c9e112851
808062HurriCaine Oral Anesthetic 20 % Mucous Membrane Topical SolutionPSNfee9969d-ad1a-4f44-9741-a0a44c9e112851
808062benzocaine 200 MG/ML Mucous Membrane Topical Solution [Hurricaine]SBDfee9969d-ad1a-4f44-9741-a0a44c9e112851
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCDfee9969d-ad1a-4f44-9741-a0a44c9e112851
308657benzocaine 20 % Mucous Membrane Topical SolutionSYfee9969d-ad1a-4f44-9741-a0a44c9e112851
808062Hurricaine 20 % Mucous Membrane Topical SolutionSYfee9969d-ad1a-4f44-9741-a0a44c9e112851
808062Hurricaine 200 MG/ML Mucous Membrane Topical SolutionSYfee9969d-ad1a-4f44-9741-a0a44c9e112851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-0569-02002830569022 g in 1 APPLICATOR (0283-0569-02) 2 g1969-05-150000-00-00NoNoCurrent
0283-0569-17002830569171 g in 1 PACKET (0283-0569-17) 1 g2020-01-280000-00-00NoNoCurrent
0283-0569-310028305693129.6 g in 1 BOTTLE, PLASTIC (0283-0569-31) 29.6 g1969-05-150000-00-00NoNoCurrent
0283-0569-720028305697272 g in 1 APPLICATOR (0283-0569-72) 72 g1969-05-150000-00-00NoNoCurrent