Oral Pain Relief
- Product NDC
- 52000-060
- 11-digit product format
- 520000060
- Labeler code
- 52000
- Product ID
- 52000-060_de98c97f-7c6f-4676-bf8e-797f3f24c598
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine and Benzalkonium Chloride
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Universal Distribution Center LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-01-05
- Substance
- BENZOCAINE; BENZALKONIUM CHLORIDE
- Active strength
- .2; .01 g/g; g/g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 product | product | 52000-060 | I | Inactivated by FDA | 2026-10-23 | ||
| excluded package | package | 52000-060 | 52000-060-01 | I | Inactivated by FDA | 2026-10-23 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52000-060-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52000-060-01 | f5e01cc5f278… | a2eaf40c39c3… |
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
- Oral Pain Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | .2 g/g |
| BENZALKONIUM CHLORIDE | .01 g/g |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52000-060-01 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2e7e-fb37-e063-e6dba90a4e07 | Oral Pain Relief Gel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52000-060-01 | Oral Pain Relief | 14 g in 1 TUBE | GEL | 14 | 4 | |
| 52000-060-01 | Oral Pain Relief | 1 in 1 CARTON | GEL | 1 | 4 | |
| 52000-060-02 | Oral Pain Relief | 14 g in 1 TUBE | GEL | 14 | 3 | |
| 52000-060-02 | Oral Pain Relief | 1 in 1 CARTON | GEL | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52000-060 | ORAL PAIN RELIEF (BENZOCAINE AND BENZALKONIUM CHLORIDE) GEL [UNIVERSAL DISTRIBUTION CENTER LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241212_baf0cf27-052e-4367-9a6e-75038b97a051.zip |
| 52000-060 | ORAL PAIN RELIEF (BENZOCAINE AND BENZALKONIUM CHLORIDE) GEL [UNIVERSAL DISTRIBUTION CENTER LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241218_18520f9b-4d35-1e9c-e063-6294a90aaa39.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 |
|---|---|---|---|---|---|---|
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 1163d248-d648-443e-bed0-ccb7fd26ba63 | 2023-12-07 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 88caabe2-a096-44d0-98d3-afad1935c012 | 2023-12-07 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | c1b02a2f-db1f-44f0-a74a-d02c085c5bd7 | 2023-12-07 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 39081585-fe6a-4ba1-93f8-d92d26fe75bc | 2023-12-07 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d7c69357-795c-03d8-e053-2a95a90a03a6 | 2023-12-06 | Warnings | M022 |
| Dr. Sheffield Sensitive Care | SENSITIVE TOOTH PASTE | Sheffield Pharmaceuticals LLC | 702a0dec-64cf-4834-8d80-f3d4f0c08a3a | 2023-11-30 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | f3bf106c-5320-ced2-e053-2a95a90a71ac | 2023-11-29 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 0b517321-25ed-2676-e063-6294a90ab4c9 | 2023-11-29 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 0b51b67c-03ac-5730-e063-6394a90a5060 | 2023-11-29 | Warnings | M022 |
| Pearl White | POTASSIUM NITRATE, SODIUM FLUORIDE | Beyond International Inc. | 51c79544-9536-5863-e054-00144ff8d46c | 2023-11-28 | Warnings | M022 |
| UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE | POTASSIUM NITRATE AND SODIUM FLUORIDE | Universal Distribution Center LLC | fcf59439-7e06-4129-a89f-cdeecdf8d488 | 2023-11-17 | Warnings | M022 |
| PerioRestore | HYDROGEN PEROXIDE | DEN-MAT HOLDINGS, LLC. | 97a07c36-1af8-a636-e053-2a95a90ad6db | 2023-11-13 | Warnings | M022 |
| Wild Horse 777 Oral | PHENOL | Wild Horse 777, Inc. | b0b517bb-969f-0c65-e053-2995a90a48b1 | 2023-11-10 | Warnings | M022 |
| ORCA Pain Reliever Putty with Menthol | MENTHOL | ORCA Products, LLC | 188cb01a-3d0f-43d9-983e-6475c0c5b06e | 2023-11-10 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 33fbdbc7-e10d-4181-926f-9b591b5b07e3 | 2023-11-08 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 0d2c8c0c-4c72-4400-b3b5-ed578fa35167 | 2023-11-08 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Degasa, S.A. de C.V. | 45ac0275-4c68-3897-e054-00144ff8d46c | 2023-11-05 | Warnings | M022 |
| Oral Pain Relief | BENZOCAINE | GERI-CARE PHARMACEUTICAL CORP | d294a39e-55f4-272d-e053-2995a90ab7f7 | 2023-10-31 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | e10c45e6-d37f-4650-b3e5-07719cc0ea49 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | 886d949b-8db1-499c-a277-174f8bc29f34 | 2023-10-11 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1595155 | benzocaine 20 % / benzalkonium chloride 0.1 % Oral Gel | PSN | baf0cf27-052e-4367-9a6e-75038b97a051 | 4 |
| 1595155 | benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel | SCD | baf0cf27-052e-4367-9a6e-75038b97a051 | 4 |
| 1595155 | benzalkonium chloride 0.1 % / benzocaine 20 % Oral Gel | SY | baf0cf27-052e-4367-9a6e-75038b97a051 | 4 |
| 1595155 | benzocaine 20 % / benzalkonium chloride 0.1 % Oral Gel | PSN | 18520f9b-4d35-1e9c-e063-6294a90aaa39 | 3 |
| 1595155 | benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel | SCD | 18520f9b-4d35-1e9c-e063-6294a90aaa39 | 3 |
| 1595155 | benzalkonium chloride 0.1 % / benzocaine 20 % Oral Gel | SY | 18520f9b-4d35-1e9c-e063-6294a90aaa39 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52000-060-01 | 52000006001 | 1 TUBE in 1 CARTON (52000-060-01) > 14 g in 1 TUBE | 1 tube | 2020-12-09 | 0000-00-00 | No | No | Current |
| 52000-060-02 | 52000006002 | 1 TUBE in 1 CARTON (52000-060-02) / 14 g in 1 TUBE | 1 tube | 2024-05-01 | No | No | Current |