HurriCaine

Product NDC: 0283-1016
11-digit product format: 002831016
Labeler code: 0283
Product ID: 0283-1016_259039d7-ae05-7abc-e063-6294a90af1fd
Type: HUMAN OTC DRUG
Nonproprietary name: BENZOCAINE
Dosage form: GEL
Route: DENTAL; ORAL; PERIODONTAL
Labeler: Beutlich Pharmaceuticals, LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-10-15
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

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
Ingredient	Strength
BENZOCAINE	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238910	Internal RxNorm lookup
996288	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
0605d5d6-82bd-415e-b5cb-e273f934a4a7	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0283-1016-00	HurriCaineTopical Anesthetic	28.4 g in 1 BOTTLE, PLASTIC	GEL	28.4	45
0283-1016-31	HurriCaineTopical Anesthetic	1 in 1 BOX	GEL	1	45
0283-1016-43	HurriCaineTopical Anesthetic	1 g in 1 PACKET	GEL	1	45
0283-1016-45	HurriCaineTopical Anesthetic	0.5 g in 1 CUP, UNIT-DOSE	GEL	0.5	6
0283-1016-59	HurriCaineTopical Anesthetic	60 in 1 BOX	GEL	60	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0283-1016-31	GM - Gram	0283-1016	63b9ec1c-583b-4b8e-bdc3-b8b655959561	1	2018-05-09
0283-1016-45	EA - Each	0283-1016	8385d8b9-ec94-4266-84a9-7b44ed56fa24	1	2022-03-09
0283-1016-59	EA - Each	0283-1016	8952eeef-e587-474c-98cf-a7386719c335	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0283-1016	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	45	Current NDC, Legacy NDC, 3 package rows	20250110_42521b29-67e4-4a16-848d-7e6ba4a7ece2.zip
0283-1016	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241030_0605d5d6-82bd-415e-b5cb-e273f934a4a7.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 30 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Patterson Dental Topical Anesthetic	BENZOCAINE	Patterson Dental	72fd2232-cd5a-4e25-b139-522b589c4472	2025-01-08	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	42521b29-67e4-4a16-848d-7e6ba4a7ece2	2025-01-08	Warnings	Exact identifier application number: M022 ndc (product): 0283-1016
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals LLC	723da3ae-3f1f-4962-920b-f2a30c8c3253	2025-01-08	Warnings, Adverse reactions	Exact identifier application number: M022
V34 Colour Corrector	V34 COLOUR CORRECTOR	Jiangxi Dentalbright Technology Co., Ltd	2b2a0b47-7628-4b85-e063-6294a90a45a0	2025-01-07	Warnings	Exact identifier application number: M022
Benzo-Jel	BENZOCAINE	Henry Schein Inc.	bc2e7ac3-f9e4-49cc-9f0c-6fe94479314d	2025-01-03	Warnings	Exact identifier application number: M022
Benzo-Jel	BENZOCAINE	Henry Schein Inc.	fb38b10d-0faf-403c-9921-d4f6b0f6aa55	2025-01-03	Warnings	Exact identifier application number: M022
Benzo-Jel	BENZOCAINE	Henry Schein Inc.	a9dc2245-c029-4453-bfc5-8fb899873c34	2025-01-03	Warnings	Exact identifier application number: M022
Benzo-Jel	BENZOCAINE	Henry Schein Inc.	ba49a18d-8568-421b-a495-8fee863c9757	2025-01-03	Warnings	Exact identifier application number: M022
Benzo-Jel	BENZOCAINE	Henry Schein Inc.	c9b584d9-7407-445a-b084-926250af9f8e	2025-01-03	Warnings	Exact identifier application number: M022
Benzo-Jel	BENZOCAINE	Henry Schein Inc.	4aa6eec8-394a-4ecb-8173-66561fd64913	2025-01-03	Warnings	Exact identifier application number: M022
Benzo-Jel	BENZOCAINE	Henry Schein Inc.	25c99ae3-90f4-4a63-924d-f810b3ba6e60	2025-01-03	Warnings	Exact identifier application number: M022
Benzo-Jel	BENZOCAINE	Henry Schein Inc.	84e8d5c8-2a35-4179-9a9c-9a4a52c2cae6	2025-01-03	Warnings	Exact identifier application number: M022
Prevention Oncology Mouth Rinse	GLYCERIN	Prevention Health Sciences, Inc.	1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c	2025-01-01	Warnings	Exact identifier application number: M022
Prevention Mouth Sore Rinse	HYDROGEN PEROXIDE	Prevention Health Sciences, Inc.	2eae61e4-1800-5fa6-e063-6394a90a9583	2025-01-01	Warnings	Exact identifier application number: M022
Antiseptic Lil Drug Store Products	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Lil' Drug Store Products, Inc	dca36a30-2c9f-4d0b-be88-b45c7046f509	2024-12-31	Warnings	Exact identifier application number: M022
Sensodyne Clinical White Intensive Clean	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	f193ec40-032f-42c7-81f1-029ec8989374	2024-12-31	Warnings	Exact identifier application number: M022
TeethWhitening Kit	TEETHWHITENING KIT	Jiangxi Dentalbright Technology Co., Ltd.	29393313-217a-dc3a-e063-6294a90addb1	2024-12-20	Warnings	Exact identifier application number: M022
Breezers Cool Berry	PECTIN	Mondelez Global LLC	b31d0078-21d7-4d18-a8d3-7c8d48d6d004	2024-12-20	Warnings	Exact identifier application number: M022
Breezers Creamy Strawberry	PECTIN	Mondelez Global LLC	777fd6db-f129-4489-8312-4b1aca94878e	2024-12-20	Warnings	Exact identifier application number: M022
Halls Breezers Sugar Free Cool Berry	PECTIN	Mondelez Global LLC	dd1b4b17-4f73-4052-9589-d5fd6bb059bb	2024-12-20	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238910	benzocaine 20 % Oral Gel	PSN	42521b29-67e4-4a16-848d-7e6ba4a7ece2	45
996288	HurriCaine 20 % Oral Gel	PSN	42521b29-67e4-4a16-848d-7e6ba4a7ece2	45
996288	benzocaine 0.2 MG/MG Oral Gel [Hurricaine]	SBD	42521b29-67e4-4a16-848d-7e6ba4a7ece2	45
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	42521b29-67e4-4a16-848d-7e6ba4a7ece2	45
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	42521b29-67e4-4a16-848d-7e6ba4a7ece2	45
996288	Hurricaine 0.2 MG/MG Oral Gel	SY	42521b29-67e4-4a16-848d-7e6ba4a7ece2	45
996288	Hurricaine 20 % Dental Gel	SY	42521b29-67e4-4a16-848d-7e6ba4a7ece2	45
238910	benzocaine 20 % Oral Gel	PSN	0605d5d6-82bd-415e-b5cb-e273f934a4a7	6
996288	HurriCaine 20 % Oral Gel	PSN	0605d5d6-82bd-415e-b5cb-e273f934a4a7	6
996288	benzocaine 0.2 MG/MG Oral Gel [Hurricaine]	SBD	0605d5d6-82bd-415e-b5cb-e273f934a4a7	6
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	0605d5d6-82bd-415e-b5cb-e273f934a4a7	6
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	0605d5d6-82bd-415e-b5cb-e273f934a4a7	6
996288	Hurricaine 0.2 MG/MG Oral Gel	SY	0605d5d6-82bd-415e-b5cb-e273f934a4a7	6
996288	Hurricaine 20 % Dental Gel	SY	0605d5d6-82bd-415e-b5cb-e273f934a4a7	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0283-1016-00	00283101600	28.4 g in 1 BOTTLE, PLASTIC	28.4 g					Historical
0283-1016-31	00283101631	1 BOTTLE, PLASTIC in 1 BOX (0283-1016-31) / 28.4 g in 1 BOTTLE, PLASTIC (0283-1016-00)		2016-10-15	0000-00-00	No	No	Current
0283-1016-43	00283101643	1 g in 1 PACKET (0283-1016-43)	1 g	2020-01-28	0000-00-00	No	No	Current
0283-1016-45	00283101645	0.5 g in 1 CUP, UNIT-DOSE	0.5 g					Historical
0283-1016-59	00283101659	60 CUP, UNIT-DOSE in 1 BOX (0283-1016-59) / .5 g in 1 CUP, UNIT-DOSE (0283-1016-45)		2021-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SB Gel	Beutlich Pharmaceuticals, LLC \| Dental Technologies \| Speciality Pharma Manufacturing	2025-01-08	HUMAN OTC DRUG LABEL	45
SB Unit Dose Gel	Beutlich Pharmaceuticals, LLC \| Centrix Inc. \| Dental Technologies	2024-10-28	HUMAN OTC DRUG LABEL	6