FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-0914
11-digit product format
002830914
Labeler code
0283
Product ID
0283-0914_2c3f1dd1-5b11-f3aa-e063-6394a90a8114
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
SPRAY
Route
DENTAL; ORAL; PERIODONTAL
Labeler
Beutlich Pharmaceuticals, LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-09-01
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

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
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
360348Internal RxNorm lookup
808357Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
159d412c-6d1a-45d4-88c0-8c93960f946eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0283-0914-02HurriCaineTopical Anesthetic59.7 g in 1 CANSPRAY59.738
0283-0914-60HurriCaineTopical Anesthetic1 in 1 BOXSPRAY138

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0914-02GM - Gram0283-0914be77cda6-741a-49b4-817c-2c9e63e4bd9a12016-02-04
0283-0914-60GM - Gram0283-0914800f2e04-3c84-4e06-a6dc-3d151ade940812023-03-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) SPRAY [BEUTLICH PHARMACEUTICALS, LLC]8
BENZOCAINEACTIVE MOIETYU3RSY48JW5HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) SPRAY [BEUTLICH PHARMACEUTICALS, LLC]8
MINTINACTIVE INGREDIENTFV98Z8GITPHURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) SPRAY [BEUTLICH PHARMACEUTICALS, LLC]8
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQHURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) SPRAY [BEUTLICH PHARMACEUTICALS, LLC]8
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) SPRAY [BEUTLICH PHARMACEUTICALS, LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0914HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) SPRAY [BEUTLICH PHARMACEUTICALS, LLC]38Current NDC, Legacy NDC, 2 package rows20250123_159d412c-6d1a-45d4-88c0-8c93960f946e.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 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Walgreen SalineNASALWALGREENS CO.ee264d8b-0bb2-472a-907c-6a6291f154cd2025-11-26WarningsExact identifier
application number: M022
Walgreens Sore Throat Cherry FlavorPHENOLWALGREEN COMPANYfe092017-1f3e-41f1-b718-e24de53cf2762025-11-26WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
360348benzocaine 20 % Mucosal SprayPSN159d412c-6d1a-45d4-88c0-8c93960f946e38
808357HurriCaine 20 % Mucosal SprayPSN159d412c-6d1a-45d4-88c0-8c93960f946e38
808357benzocaine 200 MG/ML Mucosal Spray [Hurricaine]SBD159d412c-6d1a-45d4-88c0-8c93960f946e38
360348benzocaine 200 MG/ML Mucosal SpraySCD159d412c-6d1a-45d4-88c0-8c93960f946e38
360348benzocaine 20 % Mucosal SpraySY159d412c-6d1a-45d4-88c0-8c93960f946e38
808357Hurricaine 20 % Mucosal SpraySY159d412c-6d1a-45d4-88c0-8c93960f946e38
808357Hurricaine 200 MG/ML Mucosal SpraySY159d412c-6d1a-45d4-88c0-8c93960f946e38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-0914-020028309140259.7 g in 1 CAN (0283-0914-02) 59.7 g2014-09-010000-00-00NoNoCurrent
0283-0914-60002830914601 CAN in 1 BOX (0283-0914-60) / 59.7 g in 1 CAN (0283-0914-02) 1 can2014-09-01NoNoCurrent