HurriCaine

Product NDC: 0283-0293
11-digit product format: 002830293
Labeler code: 0283
Product ID: 0283-0293_2b364db1-b3c2-9b01-e063-6294a90ac13b
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: 1993-02-15
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0283-0293	0283-0293-53	D	Discontinued by firm		2026-10-15

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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 Gel
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
e67b8def-c728-4952-9b35-874643cbe0f1	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	SPL version
0283-0293-31	HurriCaineTopical Anesthetic Gel	28.4 g in 1 BOTTLE, PLASTIC	GEL	28.4	25
0283-0293-43	HurriCaineTopical Anesthetic Gel	1 g in 1 PACKET	GEL	1	25
0283-0293-45	HurriCaineTopical Anesthetic Gel	0.5 g in 1 CUP, UNIT-DOSE	GEL	0.5	8
0283-0293-59	HurriCaineTopical Anesthetic Gel	60 in 1 BOX	GEL	60	8
0283-0293-45	HurriCaineTopical Anesthetic Gel	0.5 g in 1 CUP, UNIT-DOSE	GEL	0.5	5
0283-0293-53	HurriCaineTopical Anesthetic Gel	60 in 1 BOX	GEL	60	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0283-0293-31	GM - Gram	0283-0293	98d97e9b-95bd-43e2-b5cf-bf5d3dea2996	1	2012-07-24
0283-0293-45	EA - Each	0283-0293	db753360-afca-4d14-b286-665de8ff5c2b	1	2022-03-09
0283-0293-59	EA - Each	0283-0293	411efd25-85d0-4258-85c0-6ddd83774619	1	2022-03-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	5
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	5
Polyethylene Glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	5
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	5
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0283-0293	HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	25	Current NDC, Legacy NDC, 2 package rows	20250110_c113773b-dfb0-4797-ae0e-ecc06bfffd68.zip
0283-0293	HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	7	Current NDC, Legacy NDC, 2 package rows	20250110_106b6115-d043-4050-80c6-1d82456dea02.zip
0283-0293	HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20250110_e67b8def-c728-4952-9b35-874643cbe0f1.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	c113773b-dfb0-4797-ae0e-ecc06bfffd68	25
996288	HurriCaine 20 % Oral Gel	PSN	c113773b-dfb0-4797-ae0e-ecc06bfffd68	25
996288	benzocaine 0.2 MG/MG Oral Gel [Hurricaine]	SBD	c113773b-dfb0-4797-ae0e-ecc06bfffd68	25
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	c113773b-dfb0-4797-ae0e-ecc06bfffd68	25
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	c113773b-dfb0-4797-ae0e-ecc06bfffd68	25
996288	Hurricaine 0.2 MG/MG Oral Gel	SY	c113773b-dfb0-4797-ae0e-ecc06bfffd68	25
996288	Hurricaine 20 % Dental Gel	SY	c113773b-dfb0-4797-ae0e-ecc06bfffd68	25
238910	benzocaine 20 % Oral Gel	PSN	106b6115-d043-4050-80c6-1d82456dea02	8
996288	HurriCaine 20 % Oral Gel	PSN	106b6115-d043-4050-80c6-1d82456dea02	8
996288	benzocaine 0.2 MG/MG Oral Gel [Hurricaine]	SBD	106b6115-d043-4050-80c6-1d82456dea02	8
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	106b6115-d043-4050-80c6-1d82456dea02	8
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	106b6115-d043-4050-80c6-1d82456dea02	8
996288	Hurricaine 0.2 MG/MG Oral Gel	SY	106b6115-d043-4050-80c6-1d82456dea02	8
996288	Hurricaine 20 % Dental Gel	SY	106b6115-d043-4050-80c6-1d82456dea02	8
238910	benzocaine 20 % Oral Gel	PSN	e67b8def-c728-4952-9b35-874643cbe0f1	5
996288	HurriCaine 20 % Oral Gel	PSN	e67b8def-c728-4952-9b35-874643cbe0f1	5
996288	benzocaine 0.2 MG/MG Oral Gel [Hurricaine]	SBD	e67b8def-c728-4952-9b35-874643cbe0f1	5
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	e67b8def-c728-4952-9b35-874643cbe0f1	5
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	e67b8def-c728-4952-9b35-874643cbe0f1	5
996288	Hurricaine 0.2 MG/MG Oral Gel	SY	e67b8def-c728-4952-9b35-874643cbe0f1	5
996288	Hurricaine 20 % Dental Gel	SY	e67b8def-c728-4952-9b35-874643cbe0f1	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0283-0293-31	00283029331	28.4 g in 1 BOTTLE, PLASTIC (0283-0293-31)	28.4 g	1993-02-15	0000-00-00	No	No	Current
0283-0293-43	00283029343	1 g in 1 PACKET (0283-0293-43)	1 g	2020-01-28	0000-00-00	No	No	Current
0283-0293-45	00283029345	0.5 g in 1 CUP, UNIT-DOSE	0.5 g					Historical
0283-0293-53	00283029353	60 CUP, UNIT-DOSE in 1 BOX (0283-0293-53) > .5 g in 1 CUP, UNIT-DOSE (0283-0293-45)		2021-01-31	0000-00-00	No	No	Current
0283-0293-59	00283029359	60 CUP, UNIT-DOSE in 1 BOX (0283-0293-59) / .5 g in 1 CUP, UNIT-DOSE (0283-0293-45)		2021-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
WM Unit Dose Gel	Beutlich Pharmaceuticals, LLC \| Centrix Inc \| Dental Technologies Inc.	2025-11-06	HUMAN OTC DRUG LABEL	8
WM Gel 1oz and Packette	Beutlich Pharmaceuticals, LLC \| Dental Technologies Inc. \| Speciality Pharma Manufacturing	2025-01-08	HUMAN OTC DRUG LABEL	25
Drug Facts	Beutlich Pharmaceuticals, LLC \| Dental Technologies Inc.	2025-01-08	HUMAN OTC DRUG LABEL	5