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 37 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SENSODYNE Rapid Relief	STANNOUS FLUORIDE	Haleon US Holdings LLC	f9589e7c-c5ca-4465-8d37-47ad6c69249f	2024-03-06	Warnings	Exact identifier application number: M022
SENSODYNE Repair and Protect Extra Fresh	STANNOUS FLUORIDE	Haleon US Holdings LLC	34260c69-d829-46c0-b12a-5136ee073ba1	2024-03-06	Warnings	Exact identifier application number: M022
AQUAFRESH SENSITIVE MAXIMUM STRENGTH	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	76adbccb-0812-4407-a6fc-a57e6f144fbb	2024-03-05	Warnings	Exact identifier application number: M022
SENSODYNE Advanced Whitening	POTASSIUM NITRATE	Haleon US Holdings LLC	a06e2549-3c4e-4818-b53e-1dea6828219f	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Extra Whitening Cool Mint	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	c977f2c4-e0f3-44d2-aa7a-845f0583af3e	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Natural white	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	911ac7e4-2b92-43d5-af0b-b5f741b088fb	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Nourish Healthy White	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	aca38560-2fd7-47be-9e93-2abc3214e856	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Nourish Gently Soothing	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	5403ab67-532c-4bdf-9b06-07b1866f37f1	2024-03-04	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Active Shield Fresh Mint	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	e8684615-f544-4871-b935-0a0f93639d7d	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Gentle Whitening Fresh Mint	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	3dfa6827-3aae-4f19-93f6-2ded2faf2ddd	2024-03-04	Warnings	Exact identifier application number: M022
Made by Dentists Sensitive and Whitening Fresh Mint	POTASSIUM NITRATE, SODIUM FLUORIDE	MADE BY DENTISTS INC	0d379c26-69ff-4666-9ad5-7618f0bd139f	2024-02-27	Warnings	Exact identifier application number: M022
Polident ProPartial	STANNOUS FLUORIDE	Haleon US Holdings LLC	557eeb32-64f4-41e8-ada4-91bd39ae2920	2024-02-07	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Daily Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	edffce4d-108b-4ffd-9adf-e12cb42ffddd	2024-01-24	Warnings	Exact identifier application number: M022
Peppermint Twist	FLUORIDE	Caldwell Health LLC	4b28cdd1-0dba-42f5-a9e8-06d9e75b2396	2024-01-17	Warnings	Exact identifier application number: M022
The Natural Dentist Groovy Grape	FLUORIDE	Caldwell Consumer Health LLC	087abbed-1f58-4b45-a76b-a950fa81c18c	2024-01-16	Warnings	Exact identifier application number: M022
Benzoin Tincture	BENZOIN RESIN	Pharma Nobis, LLC	e42fccc2-1b4f-e7f3-e053-2a95a90aef39	2023-12-26	Warnings	Exact identifier application number: M022
Sunmark Benzoin Compound Tincture	BENZOIN RESIN	Strategic Sourcing Services LLC	0c96d810-83dc-47d3-9a75-63a79feaad0a	2023-12-19	Warnings	Exact identifier application number: M022
Benzoin Tincture	BENZOIN RESIN	Humco Holding Group, Inc.	b33b5896-673b-498c-8a58-76ece8552f7a	2023-12-15	Warnings	Exact identifier application number: M022
Povidone Iodine	POVIDONE IODINE ORAL RINSE 0.5%	Humco Holding Group, Inc.	b83dbdd1-ff63-caf8-e053-2a95a90a5764	2023-12-15	Warnings	Exact identifier application number: M022
Moon Whitening Gel Anticavity	SODIUM FLUORIDE	Moon Oral Care, LLC	0c556a29-a697-3a66-e063-6394a90abfee	2023-12-12	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