HurriCaine

Product NDC: 0283-0871
11-digit product format: 002830871
Labeler code: 0283
Product ID: 0283-0871_258ffae7-a428-8dae-e063-6294a90adcc0
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: 1971-08-15
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
1f3d68f6-afd6-42e7-b3e5-210228c8e7de	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0283-0871-59	2023-02-01	C162847	48780-1	f386c649-f23d-0266-e053-dadaa90a7c1a	HurriCaine Unit Dose Gel and Swab - Cherry

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0283-0871-31	HurriCaineTopical Anesthetic	1 in 1 BOX	GEL	1	27
0283-0871-31	HurriCaineTopical Anesthetic	28.4 g in 1 BOTTLE, PLASTIC	GEL	28.4	27
0283-0871-45	HurriCaineTopical Anesthetic	0.5 g in 1 CUP, UNIT-DOSE	GEL	0.5	26
0283-0871-59	HurriCaineTopical Anesthetic	60 in 1 BOX	GEL	60	26
0283-0871-01	HurriCaineTopical Anesthetic	5.25 g in 1 TUBE	GEL	5.25	25
0283-0871-12	HurriCaineTopical Anesthetic	12 in 1 CELLO PACK	GEL	12	25
0283-0871-75	HurriCaineTopical Anesthetic	1 in 1 BOX	GEL	1	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0283-0871-12	GM - Gram	0283-0871	6691d8d3-e365-4b3c-ac65-03bdf46d01f6	1	2012-07-24
0283-0871-31	GM - Gram	0283-0871	13270ff7-44c9-4115-bc6e-688a24f23ac5	1	2012-07-24
0283-0871-45	EA - Each	0283-0871	7e35be3f-eaad-4633-ae1f-b5241f285920	1	2022-03-09
0283-0871-59	EA - Each	0283-0871	4ee3acb3-dc3a-4da0-8528-b4c60fc376b5	1	2022-03-09
0283-0871-75	GM - Gram	0283-0871	2f16edc3-01b9-467d-b7e6-941c9305aff4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	8
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	8
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	8
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	8
Polyethylene Glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	8
POLYETHYLENE GLYCOL 3500	INACTIVE INGREDIENT	FVS1AZD90Y	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	8
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	8
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	8
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	8
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0283-0871	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	27	Current NDC, Legacy NDC, 2 package rows	20241030_1f3d68f6-afd6-42e7-b3e5-210228c8e7de.zip
0283-0871	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	26	Current NDC, Legacy NDC, 2 package rows	20250110_e628bd9f-99e5-4c71-ba8a-caa6c337de54.zip
0283-0871	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	24	Current NDC, Legacy NDC, 3 package rows	20250110_113cdb83-0fdd-40f2-8ee6-b771dca99713.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 36 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	872365ca-0c6b-550a-e053-2a91aa0ab25a	2024-06-14	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Spearmint	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	7ac6c649-758f-4128-9920-466c0967b86a	2024-05-21	Warnings	Exact identifier application number: M022
Sensodyne	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	9e8e7b9f-3ccd-4935-b886-93f3a5045b67	2024-05-15	Warnings	Exact identifier application number: M022
Sensodyne Extra Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	1ed4a62b-f1d3-4740-8150-b94e02398740	2024-05-15	Warnings	Exact identifier application number: M022
Attitude Adult Fluoride-free - Sensitive - Spearmint	POTASSIUM NITRATE	9055-7588 Qubec Inc. DBA Attitude	46d5c908-f0e3-444c-9d96-461feef39137	2024-05-14	Warnings	Exact identifier application number: M022
sensodyne	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	16225f06-1d40-416a-aaec-7890e398fe4b	2024-05-13	Warnings	Exact identifier application number: M022
Sore Throat Cherry	PHENOL	QUALITY CHOICE (Chain Drug Marketing Association)	9162ae27-ddbb-4336-9655-487995919de4	2024-05-01	Warnings	Exact identifier application number: M022
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE AND POTASSIUM NITRATE	9055-7588 Quebec Inc. DBA Attitude	42b79ec5-f37f-4dc9-9631-c8b1c153fe88	2024-04-26	Warnings	Exact identifier application number: M022
Quality Choice Oral Pain Relief	BENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%	Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)	162702b4-4bf7-8868-e063-6294a90a5921	2024-04-15	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	9991de96-99a1-42f0-9ddd-e530ca9ceab1	2024-04-11	Warnings	Exact identifier application number: M022
Aquafresh Extreme Clean Pure Breath Action	SODIUM FLUORIDE	Haleon US Holdings LLC	462eb309-deca-4464-b13a-7ae314e53ede	2024-04-08	Warnings	Exact identifier application number: M022
Sore Throat Cherry	PHENOL	Family Dollar (FAMILY WELLNESS)	7806fac7-736e-44b0-baa2-42feb7237417	2024-03-27	Warnings	Exact identifier application number: M022
Sucrets	DYCLONINE HCL, MENTHOL, AND PECTIN	Insight Pharmaceuticals LLC	2a2839ea-11d3-4390-930d-0da912a9c6f5	2024-03-20	Warnings	Exact identifier application number: M022
Sucrets Sore Throat Wild Cherry	DYCLONINE HYDROCHLORIDE	Insight Pharmaceuticals LLC	da4967c7-ee18-42e7-8c97-8919f3bb1b7d	2024-03-20	Warnings	Exact identifier application number: M022
NATEAN Clean plus Sensitivity Relief	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	cea6f992-8a44-4eb8-baea-97b7b181b227	2024-03-19	Warnings	Exact identifier application number: M022
NATEAN Clean and Whiten	SODIUM FLUORIDE	Haleon US Holdings LLC	71b95962-2693-49f5-94d2-f2a035b5e0c8	2024-03-19	Warnings	Exact identifier application number: M022
SENSODYNE Sensitivity and Gum Mint	STANNOUS FLUORIDE	Haleon US Holdings LLC	ed093acd-255c-40ff-a010-d276f5844453	2024-03-07	Warnings	Exact identifier application number: M022
SENSODYNE Sensitivity Gum and Enamel Mint	STANNOUS FLUORIDE	Haleon US Holdings LLC	d4e9e5cf-d058-4c3f-ab5e-0b5a20a012e2	2024-03-07	Warnings	Exact identifier application number: M022
Sensodyne True white	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	671f8f45-389c-4375-be43-f5500ee21a0e	2024-03-07	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Strong and Bright Enamel Mint	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	be1ae382-0e01-4db8-90d7-fdadec2ff861	2024-03-06	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	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	27
996288	HurriCaine 20 % Oral Gel	PSN	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	27
996288	benzocaine 0.2 MG/MG Oral Gel [Hurricaine]	SBD	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	27
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	27
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	27
996288	Hurricaine 0.2 MG/MG Oral Gel	SY	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	27
996288	Hurricaine 20 % Dental Gel	SY	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	27
238910	benzocaine 20 % Oral Gel	PSN	e628bd9f-99e5-4c71-ba8a-caa6c337de54	26
996288	HurriCaine 20 % Oral Gel	PSN	e628bd9f-99e5-4c71-ba8a-caa6c337de54	26
996288	benzocaine 0.2 MG/MG Oral Gel [Hurricaine]	SBD	e628bd9f-99e5-4c71-ba8a-caa6c337de54	26
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	e628bd9f-99e5-4c71-ba8a-caa6c337de54	26
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	e628bd9f-99e5-4c71-ba8a-caa6c337de54	26
996288	Hurricaine 0.2 MG/MG Oral Gel	SY	e628bd9f-99e5-4c71-ba8a-caa6c337de54	26
996288	Hurricaine 20 % Dental Gel	SY	e628bd9f-99e5-4c71-ba8a-caa6c337de54	26
238910	benzocaine 20 % Oral Gel	PSN	113cdb83-0fdd-40f2-8ee6-b771dca99713	25
996288	HurriCaine 20 % Oral Gel	PSN	113cdb83-0fdd-40f2-8ee6-b771dca99713	25
996288	benzocaine 0.2 MG/MG Oral Gel [Hurricaine]	SBD	113cdb83-0fdd-40f2-8ee6-b771dca99713	25
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	113cdb83-0fdd-40f2-8ee6-b771dca99713	25
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	113cdb83-0fdd-40f2-8ee6-b771dca99713	25
996288	Hurricaine 0.2 MG/MG Oral Gel	SY	113cdb83-0fdd-40f2-8ee6-b771dca99713	25
996288	Hurricaine 20 % Dental Gel	SY	113cdb83-0fdd-40f2-8ee6-b771dca99713	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0283-0871-01	00283087101	5.25 g in 1 TUBE	5.25 g					Historical
0283-0871-12	00283087112	12 BOX in 1 CELLO PACK (0283-0871-12) / 1 TUBE in 1 BOX (0283-0871-75) / 5.25 g in 1 TUBE (0283-0871-01)	12 box	1971-08-15	0000-00-00	No	No	Current
0283-0871-31	00283087131	1 BOTTLE, PLASTIC in 1 BOX (0283-0871-31) / 28.4 g in 1 BOTTLE, PLASTIC		1971-08-15	0000-00-00	No	No	Current
0283-0871-43	00283087143	1 g in 1 PACKET (0283-0871-43)	1 g	2019-01-28	0000-00-00	No	No	Current
0283-0871-45	00283087145	0.5 g in 1 CUP, UNIT-DOSE	0.5 g					Historical
0283-0871-59	00283087159	60 CUP, UNIT-DOSE in 1 BOX (0283-0871-59) / .5 g in 1 CUP, UNIT-DOSE (0283-0871-45)		2021-01-31	0000-00-00	No	No	Current
0283-0871-75	00283087175	1 in 1 BOX						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HurriCaine Gel W/C Tubes	Beutlich Pharmaceuticals, LLC \| Dental Technologies, Inc.	2025-08-12	HUMAN OTC DRUG LABEL	25
HurriCaine Unit Dose Gel and Swab - Cherry	Beutlich Pharmaceuticals, LLC \| Centrix Inc \| Dental Technologies, Inc.	2025-01-08	HUMAN OTC DRUG LABEL	26
HurriCaine Gel - Cherry 1oz	Beutlich Pharmaceuticals, LLC \| Speciality Pharma Manufacturing, LLC \| Dental Technologies Inc.	2024-10-28	HUMAN OTC DRUG LABEL	27