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

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 1 of 42 · 821 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRO-SYS	ORAL WOUND CLEANSER	Forward Science Technologies LLC	c357c8f8-6fd6-c2f8-e053-2995a90a4023	2026-07-30	Warnings	Exact identifier application number: M022
Lornamead Natural White	FLUORIDE	Lornamead Products	9d7d08d7-8ca4-4b05-8b74-3bfa372b1608	2026-07-29	Warnings	Exact identifier application number: M022
Saline	NASAL	BEST CHOICE (VALU MERCHANDISERS COMPANY)	71485e82-bf54-4b8b-8dd2-2a0761534520	2026-07-17	Warnings	Exact identifier application number: M022
Good Neighbor Sore Throat Cherry Flavor	PHENOL	AMERISOURCE BERGEN	aa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f	2026-07-13	Warnings	Exact identifier application number: M022
ABC Sore Throat Menthol Flavor	PHENOL	AMERISOURCE BERGEN	9d9baf58-4790-4ff4-a462-5eb70c0e80c5	2026-07-13	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	P & L Development, LLC	350b5f64-d152-40cb-b22f-98541f0e1b0a	2026-07-09	Warnings	Exact identifier application number: M022
Quality Choice Natural White	FLUORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	561a75c2-a40c-ba7c-e063-6294a90aa119	2026-07-08	Warnings	Exact identifier application number: M022
SALINE NASAL	SODIUM CHLORIDE	ALAINA HEALTHCARE PRIVATE LIMITED	ed30a7f9-7132-42da-9bed-63a9b1c80ab2	2026-07-07	Warnings	Exact identifier application number: M022
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-07-06	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF	HEXYLRESORCINOL	Reckitt Benckiser LLC	4c150222-06ea-4fcf-967f-84e19846bd66	2026-07-03	Warnings	Exact identifier application number: M022
Dental system starter kit	US CONVENIENCE KIT (718907)	Dyson Technology Limited	5355b79b-711f-1a4a-e063-6394a90afc4b	2026-06-30	Warnings	Exact identifier application number: M022
Anticavity and sensitive peppermint	907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINT	Dyson Technology Limited	5332ab71-d994-39cf-e063-6294a90a0d98	2026-06-30	Warnings	Exact identifier application number: M022
NebuClear MD Saline	NEBUCLEAR MD SALINE	Blue Echo Care LLC	55820ff9-7b4b-2bce-e063-6394a90a8b43	2026-06-30	Warnings	Exact identifier application number: M022
NebuClear MD Saline	NEBUCLEAR MD SALINE	Blue Echo Care LLC	55806cb8-cf92-c4e5-e063-6394a90aaa2d	2026-06-30	Warnings	Exact identifier application number: M022
NebuClear MD Saline	NEBUCLEAR MD SALINE	Blue Echo Care LLC	5581d8e5-4105-e9da-e063-6394a90a316e	2026-06-30	Warnings	Exact identifier application number: M022
Corinz	CETYLPYRIDINIUM CHLORIDE	Sage Products, LLC	685b6023-89c4-417e-af2d-52e831855da1	2026-06-29	Warnings	Exact identifier application number: M022
Antiplaque solution	CETYLPYRIDINIUM CHLORIDE	Sage Products LLC	881d4d08-4b45-486a-93af-18c0e00a5b0e	2026-06-29	Warnings	Exact identifier application number: M022
GingiCaine gel, Cherry	GINGICAINE GEL, CHERRY FLAVOR	Gingi-Pak a Division of the Belport	6274d92e-c4e9-34fd-e053-2991aa0ae604	2026-06-29	Warnings	Exact identifier application number: M022
GingiCaine Gel, Mint Julep	GINGICAINE GEL, MINT JULEP FLABVOR	Gingi-Pak a Division of the Belport	6285fe10-08ba-8044-e053-2991aa0a8e8b	2026-06-29	Warnings	Exact identifier application number: M022
GingiCaine Gel, Pina Colada	GINGICAINE GEL, PINA COLADA FLAVOR	Gingi-Pak a Division of the Belport	6284e1fe-be33-69bf-e053-2991aa0a90ab	2026-06-29	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