HurriCaine

Product NDC: 0283-0220
11-digit product format: 002830220
Labeler code: 0283
Product ID: 0283-0220_2b36463d-2787-74ec-e063-6294a90a0154
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: 2023-08-31
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0283-0220		D	Discontinued by firm		2026-10-23
excluded package	package	0283-0220	0283-0220-34	D	Discontinued by firm		2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0283-0220-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0283-0220-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0283-0220-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0283-0220-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0283-0220-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0283-0220-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0283-0220-34	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0283-0220-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0283-0220-34	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0283-0220-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0283-0220-34	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0283-0220-34	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
043c336f-60e3-dc23-e063-6294a90a4b13	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0283-0220-27	HurriCaineTopical Anesthetic	42.52 g in 1 TUBE	GEL	42.52		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0283-0220-34	GM - Gram	0283-0220	63fb746b-ef08-43f3-b5b2-67291024d573	1	2022-03-09
0283-0220-43	GM - Gram	0283-0220	2d7aa6ec-d155-4fda-beb7-66deb9adf2ac	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0283-0220	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	2	Current NDC, Legacy NDC, 1 package rows	20250110_043c336f-60e3-dc23-e063-6294a90a4b13.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 25 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	d923fa75-f556-45e3-9f52-39a62e89984b	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	cd3ede8c-2c77-4d81-8dff-8198025a2156	2025-01-09	Warnings	Exact identifier application number: M022
KAYLAAN	ZERO WASTE REFILL FOR TOOTHPASTE	Kaylaan LLC	cb7f5f9b-4192-15e6-e053-2995a90a6457	2025-01-09	Warnings	Exact identifier application number: M022
KAYLAAN	ZERO WASTE REFILL FOR TOOTHPASTE	Kaylaan LLC	2b494372-de59-e462-e063-6294a90a08da	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	a225d515-430d-4e34-846c-0bfec3e74109	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	372f99c9-4ad3-4631-b8c8-2a34c47343cc	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	e554b5b2-cf91-464a-a930-3e1087f12c8d	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	98da331c-76c2-49fe-b687-6bfba4ae2e75	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	d2195efa-597d-4ba9-a9b0-8df0d8f49311	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	fba82d55-94db-4432-b532-603fe57202be	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	9ed0fe31-e5f2-4d6d-8686-1286c6659847	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	d5f42c30-343c-4e1d-950c-89bbd361fd27	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	7dce407f-bbe4-4a27-97ff-be33fd447461	2025-01-09	Warnings	Exact identifier application number: M022
KAYLAAN	ZERO WASTE REFILL FOR TOOTHPASTE	Kaylaan LLC	cb7f28f3-a908-47a9-e053-2995a90a6cbd	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	921bdb76-f6d3-4e0a-a0ac-277dcc4e8d28	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	a80cfd29-8314-4639-a811-afd5fdb630b0	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	69271b7a-18c0-4445-8164-cb1620fb5475	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	40bd7406-7ee6-47fe-8481-0a4c8cefce65	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	43194fe1-87a1-4ffa-ad73-a1dcec91fd63	2025-01-09	Warnings	Exact identifier application number: M022
iSmile Topical Anesthetic	BENZOCAINE	iSmile Dental Products, Inc.	b0b3ab27-704a-44b8-8473-d21ac3359ba1	2025-01-09	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	043c336f-60e3-dc23-e063-6294a90a4b13	2
996288	HurriCaine 20 % Oral Gel	PSN	043c336f-60e3-dc23-e063-6294a90a4b13	2
996288	benzocaine 0.2 MG/MG Oral Gel [Hurricaine]	SBD	043c336f-60e3-dc23-e063-6294a90a4b13	2
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	043c336f-60e3-dc23-e063-6294a90a4b13	2
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	043c336f-60e3-dc23-e063-6294a90a4b13	2
996288	Hurricaine 0.2 MG/MG Oral Gel	SY	043c336f-60e3-dc23-e063-6294a90a4b13	2
996288	Hurricaine 20 % Dental Gel	SY	043c336f-60e3-dc23-e063-6294a90a4b13	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0283-0220-27	00283022027	42.52 g in 1 TUBE (0283-0220-27)	42.52 g	2023-08-31		No	No	Current
0283-0220-34	00283022034	4 SYRINGE, PLASTIC in 1 BOX (0283-0220-34) > 1.5 g in 1 SYRINGE, PLASTIC (0283-0220-43)		2021-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HurriCaine Gel Watermelon 1.5oz tube	Beutlich Pharmaceuticals, LLC \| Dental Technologies, Inc.	2025-01-08	HUMAN OTC DRUG LABEL	2
HurriCaine Gel LV Syringe - Watermelon	Beutlich Pharmaceuticals, LLC \| Dental Technologies, Inc.	2023-12-01	HUMAN OTC DRUG LABEL	4