Astra-dent Topical Anesthetic Gel
- Product NDC
- 71363-107
- 11-digit product format
- 713630107
- Labeler code
- 71363
- Product ID
- 71363-107_2b4802d3-e19f-3d39-e063-6294a90ae6bb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- GEL
- Route
- DENTAL
- Labeler
- Zag Usa Inc
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-07-01
- 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
- Astra-dent 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#
| Identifier | FDA.report destination |
|---|---|
| 238910 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f71b0ab5-0605-4807-b835-903e19aaf2a8 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71363-107-30 | Astra-dent Topical Anesthetic Gel | 28 g in 1 JAR | GEL | 28 | 4 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | WinCo Foods, LLC | 9417b340-942b-48bf-bbfd-4cd5154082b9 | 2025-02-12 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | b291811f-8fac-45e2-a9a2-b3ecc0813d0d | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | fea30599-5e3b-4163-9660-d41b3fcee143 | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 3be68966-199c-481e-8b9e-e994c41fd96a | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | ccdee0cc-2bc9-4165-a411-02f4f900d86a | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 0ca2b042-ea2c-4cbe-ae68-5a72a6bfa0b7 | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 69c4dd1b-a0db-4495-bfc3-faffdfdf59bf | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | d5ef3e65-35e8-4323-9f33-3076b561e105 | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 746df21c-e92e-4a71-b1c6-baf99785a43e | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 2345e614-c7b6-448c-8e07-31700bade91c | 2025-01-29 | Warnings | M022 |
| UltraCare Anesthetic Gel | BENZOCAINE | The Belport Company, Inc. DBA Gingi-Pak | 142062ca-6f8f-78d2-e063-6294a90a19d8 | 2025-01-29 | Warnings, Adverse reactions | M022 |
| CHLORASEPTIC MAX | MENTHOL AND BENZOCAINE | Prestige Brands Holdings, Inc. | edd12a2d-aa27-4f15-9ce6-862e4b6144c4 | 2025-01-23 | Warnings | M022 |
| meijer Sensitive FRESH MINT | POTASSIUM NITRATE, SODIUM FLUORIDE | Meijer, Inc. | bea36d55-1a5d-40c0-b422-92fb36043ee6 | 2025-01-23 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 159d412c-6d1a-45d4-88c0-8c93960f946e | 2025-01-21 | Warnings | M022 |
| SEACALL Mouthwash | MOUTHWASH | Guangdong Quadrant Ecological Technology Co., Ltd. | 2c1a7eed-6a7c-eeb2-e063-6394a90aafcc | 2025-01-19 | Warnings | M022 |
| BENZOCAINE Raspberry | BENZOCAINE | Darby Dental Supply, LLC | dd805400-26c5-4c18-ade2-821298233f9b | 2025-01-17 | Warnings | M022 |
| KAYLAAN | ZERO WASTE REFILL FOR TOOTHPASTE | Kaylaan LLC | c68fd8c7-7ec3-cc3f-e053-2995a90a4395 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | d22f7776-1b3c-4744-bcfe-8d9597218d73 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 9c6a26e8-1253-49f7-9ce2-45c0d39f05c5 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 48178733-7433-41ec-b178-1314e0edab1a | 2025-01-16 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 238910 | benzocaine 20 % Oral Gel | PSN | f71b0ab5-0605-4807-b835-903e19aaf2a8 | 4 |
| 238910 | benzocaine 0.2 MG/MG Oral Gel | SCD | f71b0ab5-0605-4807-b835-903e19aaf2a8 | 4 |
| 238910 | benzocaine 20 % (180-220 MG per 1 GM) Oral Gel | SY | f71b0ab5-0605-4807-b835-903e19aaf2a8 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71363-107-30 | 71363010730 | 28 g in 1 JAR (71363-107-30) | 28 g | 2018-08-01 | 0000-00-00 | No | No | Current |