FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-0610
11-digit product format
002830610
Labeler code
0283
Product ID
0283-0610_4628591f-110c-f93c-e063-6394a90ab42c
Type
HUMAN OTC DRUG
Nonproprietary name
Topical Anesthetic
Dosage form
SPRAY
Route
DENTAL; PERIODONTAL
Labeler
Beutlich Pharmaceuticals LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-06-15
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

Additional Listing Data#

Finished product
Yes
Brand name base
HurriCaine
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
255fba91-6357-4414-ad23-a18694ef886bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0283-0610-11HurriCaine2 in 1 BOXSPRAY229
0283-0610-26HurriCaine25 in 1 BOXSPRAY2529
0283-0610-43HurriCaine0.492 g in 1 APPLICATORSPRAY0.49229

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0610-11EA - Each0283-0610a0d290b2-6028-4065-83b2-182dbdb9548812013-02-13
0283-0610-26EA - Each0283-0610d76b6641-8bc7-4240-84eb-904f4aa9031912013-02-13
0283-0610-43EA - Each0283-0610449fbf46-3d69-4d5d-9500-e9bb98bbace712024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5HURRICAINE (TOPICAL ANESTHETIC) SPRAY [BEUTLICH PHARMACEUTICALS LLC]9
BENZOCAINEACTIVE MOIETYU3RSY48JW5HURRICAINE (TOPICAL ANESTHETIC) SPRAY [BEUTLICH PHARMACEUTICALS LLC]9
CHERRYINACTIVE INGREDIENTBUC5I9595WHURRICAINE (TOPICAL ANESTHETIC) SPRAY [BEUTLICH PHARMACEUTICALS LLC]9
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQHURRICAINE (TOPICAL ANESTHETIC) SPRAY [BEUTLICH PHARMACEUTICALS LLC]9
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYHURRICAINE (TOPICAL ANESTHETIC) SPRAY [BEUTLICH PHARMACEUTICALS LLC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0610HURRICAINE (TOPICAL ANESTHETIC) SPRAY [BEUTLICH PHARMACEUTICALS LLC]27Current NDC, Legacy NDC, 3 package rows20240208_255fba91-6357-4414-ad23-a18694ef886b.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 1 of 42 · 825 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Opalescence Whitening Sensitivity ReliefPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.44e94663-895b-67da-e063-6394a90a5fe62026-09-09WarningsExact identifier
application number: M022
Opalescence Sensitivity Relief WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.b5176a84-76a3-4ad0-a2e2-4997a12da9a52026-09-09WarningsExact identifier
application number: M022
Opal by Opalescence SensitivityPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.5ffc0d14-0290-47bb-90e5-90a25a5acc282026-09-09WarningsExact identifier
application number: M022
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
application number: M022
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
application number: M022
Colgate Optic White Stain Fighter Sens ReliefSODIUM FLUORIDEColgate-Palmolive Company6ec2fff7-df44-4302-be2d-97946c6cd66a2026-09-08WarningsExact identifier
application number: M022
DRx Choice Sore Throat Menthol FlavorPHENOLRARITAN PHARMACEUTICALS INCe3269b12-5c05-45a6-81f2-65d9f016c3aa2026-09-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEAmerisourceBergen (Good Neighbor Pharmacy) 461220733015b-e81a-4a62-82ad-dacaf3f163cb2026-09-02WarningsExact identifier
application number: M022
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORTHEXYLRESORCINOLReckitt Benckiser LLC91cd2964-5d83-4e40-bc18-e3e5462f454a2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
application number: M022
LUDENS SUGAR FREE WILD CHERRY THROATPECTINPrestige Brands Holdings, Inc.274fc80c-e5b2-41c7-a119-287d6e8a22582026-08-28WarningsExact identifier
application number: M022
Medline Peroxi Fresh MouthwashHYDROGEN PEROXIDEMedline Industries, LPec7a9240-6c66-4471-b8b6-776e08a14fbc2026-08-27WarningsExact identifier
application number: M022
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
application number: M022
Ludens Watermelon Throat DropsPECTINPrestige Brands Holdings, Inc.adfb248a-96bb-4742-9df6-c47edccdd6712026-08-20WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
360348benzocaine 20 % Mucosal SprayPSN255fba91-6357-4414-ad23-a18694ef886b29
808357HurriCaine 20 % Mucosal SprayPSN255fba91-6357-4414-ad23-a18694ef886b29
808357benzocaine 200 MG/ML Mucosal Spray [Hurricaine]SBD255fba91-6357-4414-ad23-a18694ef886b29
360348benzocaine 200 MG/ML Mucosal SpraySCD255fba91-6357-4414-ad23-a18694ef886b29
360348benzocaine 20 % Mucosal SpraySY255fba91-6357-4414-ad23-a18694ef886b29
808357Hurricaine 20 % Mucosal SpraySY255fba91-6357-4414-ad23-a18694ef886b29
808357Hurricaine 200 MG/ML Mucosal SpraySY255fba91-6357-4414-ad23-a18694ef886b29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-0610-11002830610112 APPLICATOR in 1 BOX (0283-0610-11) / .492 g in 1 APPLICATOR (0283-0610-43) 2 applicator2016-04-010000-00-00NoNoCurrent
0283-0610-260028306102625 APPLICATOR in 1 BOX (0283-0610-26) / .492 g in 1 APPLICATOR (0283-0610-43) 25 applicator2016-04-010000-00-00NoNoCurrent
0283-0610-43002830610430.492 g in 1 APPLICATOR0.492 gHistorical