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 5 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sensitivity Relief Fluoride Free	POTASSIUM NITRATE	Health and Natural Beauty USA Corp	c23b2a83-ebc3-4bcf-a216-7693944dcfa0	2026-05-22	Warnings	Exact identifier application number: M022
Sensitivity and Gum with Cavity Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Health and Natural Beauty USA Corp	137d6935-19a3-499d-957c-820156eec7a5	2026-05-22	Warnings	Exact identifier application number: M022
SEXYTEETH MINTY T00THPASTE	SEXYTEETH MINTY TOOTHPASTE	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	51d288c1-fe86-ffe1-e063-6394a90ab4c4	2026-05-14	Warnings	Exact identifier application number: M022
Cepacol Extra Strength Sore Throat cherry	BENZOCAINE AND MENTHOL	Reckitt Benckiser LLC	941e36dd-d8d0-4e5c-8585-10e8f06bf8f0	2026-05-12	Warnings	Exact identifier application number: M022
Cepacol Extra Strength Sore Throat honey lemon	BENZOCAINE AND MENTHOL	Reckitt Benckiser LLC	d771095b-7de3-48f3-a125-8bc76e7d1778	2026-05-12	Warnings	Exact identifier application number: M022
SEXYTEETH CHARCOAL T00THPASTE	SEXYTEETH CHARCOAL TOOTHPASTE	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	51ab8a9a-6c12-b13b-e063-6294a90ace2a	2026-05-12	Warnings	Exact identifier application number: M022
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity	FLUORIDE	WHOLE FOODS	25bc7ab1-116d-143a-e063-6394a90aa970	2026-05-04	Warnings	Exact identifier application number: M022
Gingicaine Gel Strawberry	GINGICAINE GEL STRAWBERRY FLAVOR	Gingi-Pak a Division of the Belport	2fd37612-a28b-3aa1-e054-00144ff8d46c	2026-05-01	Warnings	Exact identifier application number: M022
3ECARE Dual formula WhiteningToothpaste Refill	SODIUM FLUORIDE	Hangzhou Namei Zhikang Technology Co., Ltd.	501df1c7-4884-bb39-e063-6294a90aaf6a	2026-04-23	Warnings	Exact identifier application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain Reliever	MEDICATED TOOTH AND GUM PAIN RELIEVER	Kungpo Health Care & Herbal Center Inc	1f10a72f-0b49-41cb-92f9-b0160d7664de	2026-04-22	Warnings	Exact identifier application number: M022
EverSmile AlignerFresh Enamel Guard	SODIUM FLUORIDE	Everbrands, Inc.	7b3d0114-dac0-4370-8545-922ec018018e	2026-04-21	Warnings	Exact identifier application number: M022
PREOP	HYDROGEN PEROXIDE	Everbrands, Inc.	cc5cdd29-92c1-4ce0-997e-eb624b288b09	2026-04-20	Warnings	Exact identifier application number: M022
4x Medicated Toothache and Gum Cream	BENZOCAINE	CVS	a7576238-e7c8-7e86-e053-2995a90aaeb5	2026-04-20	Warnings	Exact identifier application number: M022
CVS Pharmacy Maximum Strength	BENZOCAINE	CVS Pharmacy	92747826-cf58-4406-b3b5-12f7c7077c2c	2026-04-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Family Dollar (FAMILY WELLNESS)	9f991292-bbaa-4f4e-b2cb-059d1a04849e	2026-04-20	Warnings	Exact identifier application number: M022
Osstem S Sensitivity relief tooth	POTASSIUM NITRATE, SODIUM FLUORIDE	Osstem Pharma Co., Ltd	4f8ab179-8f29-a7cf-e063-6294a90a0c22	2026-04-15	Warnings	Exact identifier application number: M022
Crest Pro-Health Gum DetoxifyWinter Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f6db58f-0b09-d155-e063-6394a90ae658	2026-04-14	Warnings	Exact identifier application number: M022
Lolleez Orange Mango	PECTIN	BFY LLC	4f6dec8b-078a-f321-e063-6294a90a248c	2026-04-14	Warnings	Exact identifier application number: M022
Crest Pro-Health Gum Restore Smooth Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f6e3b36-e565-7d27-e063-6294a90ae5ac	2026-04-14	Warnings	Exact identifier application number: M022
Crest Pro-Health Nightly Bacteria Shield	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f6ec1e0-c6b5-226f-e063-6294a90a8f14	2026-04-14	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