FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-0610
11-digit product format
002830610
Labeler code
0283
Product ID
0283-0610_5c90e595-a2ce-1246-e063-6294a90a0d5c
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
2027-12-31
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

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 19 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Caref5252b4f-5e14-509e-e053-2995a90a6db82025-09-18WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3f199947-bf25-914b-e063-6394a90a8a6f2025-09-18WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3f199947-bf28-914b-e063-6394a90a8a6f2025-09-18WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3f19a1a7-c234-8d26-e063-6394a90ad7e92025-09-18WarningsExact identifier
application number: M022
McKesson Orasol GelBENZOCAINE 20%McKesson Medical-Surgicalcc8724f4-c482-5e7d-e053-2a95a90a608f2025-09-09WarningsExact identifier
application number: M022
MGC Health Drops Sugar Free Lemon MintMENTHOLMedical Group Care LLC3d70bca7-e830-e693-e063-6294a90a73f92025-08-28WarningsExact identifier
application number: M022
Exchange Select Drops Sugar Free Lemon MintMENTHOLArmy & Air Force Exchange Service3d70450f-04ea-1885-e063-6294a90a05bd2025-08-28WarningsExact identifier
application number: M022
Ki No SinCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa2bad-5b8b-8aac-e063-6394a90a9f492025-08-27WarningsExact identifier
application number: M022
R CosCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa767a-1344-5ed9-e063-6394a90a5fe62025-08-27WarningsExact identifier
application number: M022
Na Mi CalCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.20cfbcd1-eb13-933c-e063-6294a90a7e592025-08-27WarningsExact identifier
application number: M022
Ki No SinCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.20cf8f80-c638-4d94-e063-6294a90a54002025-08-27WarningsExact identifier
application number: M022
Charm Tex FLUORIDESODIUM MONOFLUOROPHOSPHATEYangzhou Hongshengding Chemical Co.,Ltd.63a69664-8611-4d69-b871-8d1d5b553e5c2025-08-18WarningsExact identifier
application number: M022
QUALITY CHOICE SALINESODIUM CHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f51491d8-12ad-4b1b-a171-c621bfdcc3412025-08-12WarningsExact identifier
application number: M022
MGC Health Drops Sugar Free Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.b9227966-847c-40c3-87f2-8bea3954ec842025-08-12WarningsExact identifier
application number: M022
Exchange Select Drops Sugar Free Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.5f4b1960-43ac-4c74-9410-210c48bd8a1b2025-08-12WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC113cdb83-0fdd-40f2-8ee6-b771dca997132025-08-12WarningsExact identifier
application number: M022
CVS Pharmacy Maximum StrengthBENZOCAINECVS Pharmacy13bf31c1-78e3-459f-9249-b0b6e2c17a132025-08-12WarningsExact identifier
application number: M022
Rexall Maximum StrengthBENZOCAINERexall8f6e2780-cfb7-4bef-9b7d-13cb80d8923e2025-08-12WarningsExact identifier
application number: M022
Walgreens Maximum StrengthBENZOCAINEWalgreens8f24309d-d393-455a-a9a5-a55344adf36b2025-08-12WarningsExact identifier
application number: M022
Oral Anesthetic LiquidBENZOCAINEMeijer, Inc.0321c480-e150-421d-e063-6294a90ad6872025-08-12WarningsExact 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