Alpha-Caine
- Product NDC
- 55346-2901
- 11-digit product format
- 553462901
- Labeler code
- 55346
- Product ID
- 55346-2901_42c88f44-2eda-edae-e063-6294a90a51d4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- GEL
- Route
- DENTAL; PERIODONTAL
- Labeler
- Dental Technologies, Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1999-12-31
- 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
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
- Alpha-Caine
- Brand name suffix
- Topical Anesthetic
- 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 |
|---|---|
| 719743f9-21fc-4568-b879-acdfa4639464 | 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 |
|---|---|---|---|---|---|---|
| 55346-2901-1 | Alpha-CaineTopical Anesthetic | 30 g in 1 BOTTLE, PLASTIC | GEL | 30 | 8 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Benzocaine | ACTIVE INGREDIENT | U3RSY48JW5 | ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| Benzocaine | ACTIVE MOIETY | U3RSY48JW5 | ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| Polyethylene Glycol 3350 | INACTIVE INGREDIENT | G2M7P15E5P | ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| Polyethylene Glycol 400 | INACTIVE INGREDIENT | B697894SGQ | ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55346-2901 | ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20231216_719743f9-21fc-4568-b879-acdfa4639464.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#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1297832 | ALPHA-CAINE 20 % Oral Gel | PSN | 719743f9-21fc-4568-b879-acdfa4639464 | 8 |
| 238910 | benzocaine 20 % Oral Gel | PSN | 719743f9-21fc-4568-b879-acdfa4639464 | 8 |
| 1297832 | benzocaine 0.2 MG/MG Oral Gel [Alpha-caine] | SBD | 719743f9-21fc-4568-b879-acdfa4639464 | 8 |
| 238910 | benzocaine 0.2 MG/MG Oral Gel | SCD | 719743f9-21fc-4568-b879-acdfa4639464 | 8 |
| 1297832 | Alpha-caine 0.2 MG/MG Oral Gel | SY | 719743f9-21fc-4568-b879-acdfa4639464 | 8 |
| 1297832 | Alpha-caine 20 % Oral Gel | SY | 719743f9-21fc-4568-b879-acdfa4639464 | 8 |
| 238910 | benzocaine 20 % (180-220 MG per 1 GM) Oral Gel | SY | 719743f9-21fc-4568-b879-acdfa4639464 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55346-2901-1 | 55346290101 | 30 g in 1 BOTTLE, PLASTIC (55346-2901-1) | 30 g | 1999-12-31 | 0000-00-00 | No | No | Current |