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.
| 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.
| 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 |
|---|---|
| BENZOCAINE | 200 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e67b8def-c728-4952-9b35-874643cbe0f1 | Available on FDA.report |
DailyMed Product Concepts#
| 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 | Form | Quantity | Strength | 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 | 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 | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| 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 | 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.
| 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 | M022 |
| Amosan Oral Wound Cleanser Spearmint | SODIUM PERBORATE MONOHYDRATE | Vintage Brands Limited | 7ac6c649-758f-4128-9920-466c0967b86a | 2024-05-21 | Warnings | M022 |
| Sensodyne | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 9e8e7b9f-3ccd-4935-b886-93f3a5045b67 | 2024-05-15 | Warnings | M022 |
| Sensodyne Extra Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 1ed4a62b-f1d3-4740-8150-b94e02398740 | 2024-05-15 | Warnings | M022 |
| Attitude Adult Fluoride-free - Sensitive - Spearmint | POTASSIUM NITRATE | 9055-7588 Qubec Inc. DBA Attitude | 46d5c908-f0e3-444c-9d96-461feef39137 | 2024-05-14 | Warnings | M022 |
| sensodyne | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 16225f06-1d40-416a-aaec-7890e398fe4b | 2024-05-13 | Warnings | M022 |
| Sore Throat Cherry | PHENOL | QUALITY CHOICE (Chain Drug Marketing Association) | 9162ae27-ddbb-4336-9655-487995919de4 | 2024-05-01 | Warnings | M022 |
| BIO SPECTRA ATTITUDE | SODIUM FLUORIDE AND POTASSIUM NITRATE | 9055-7588 Quebec Inc. DBA Attitude | 42b79ec5-f37f-4dc9-9631-c8b1c153fe88 | 2024-04-26 | Warnings | 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 | 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 | M022 |
| Aquafresh Extreme Clean Pure Breath Action | SODIUM FLUORIDE | Haleon US Holdings LLC | 462eb309-deca-4464-b13a-7ae314e53ede | 2024-04-08 | Warnings | M022 |
| Sore Throat Cherry | PHENOL | Family Dollar (FAMILY WELLNESS) | 7806fac7-736e-44b0-baa2-42feb7237417 | 2024-03-27 | Warnings | M022 |
| Sucrets | DYCLONINE HCL, MENTHOL, AND PECTIN | Insight Pharmaceuticals LLC | 2a2839ea-11d3-4390-930d-0da912a9c6f5 | 2024-03-20 | Warnings | M022 |
| Sucrets Sore Throat Wild Cherry | DYCLONINE HYDROCHLORIDE | Insight Pharmaceuticals LLC | da4967c7-ee18-42e7-8c97-8919f3bb1b7d | 2024-03-20 | Warnings | M022 |
| NATEAN Clean plus Sensitivity Relief | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | cea6f992-8a44-4eb8-baea-97b7b181b227 | 2024-03-19 | Warnings | M022 |
| NATEAN Clean and Whiten | SODIUM FLUORIDE | Haleon US Holdings LLC | 71b95962-2693-49f5-94d2-f2a035b5e0c8 | 2024-03-19 | Warnings | M022 |
| SENSODYNE Sensitivity and Gum Mint | STANNOUS FLUORIDE | Haleon US Holdings LLC | ed093acd-255c-40ff-a010-d276f5844453 | 2024-03-07 | Warnings | M022 |
| SENSODYNE Sensitivity Gum and Enamel Mint | STANNOUS FLUORIDE | Haleon US Holdings LLC | d4e9e5cf-d058-4c3f-ab5e-0b5a20a012e2 | 2024-03-07 | Warnings | M022 |
| Sensodyne True white | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 671f8f45-389c-4375-be43-f5500ee21a0e | 2024-03-07 | Warnings | 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 | M022 |
DailyMed RxNorm Mappings#
Packages#
| 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 |