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 |
|---|---|---|---|---|---|---|
| Sensodyne Extra Whitening Cool Mint | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | c977f2c4-e0f3-44d2-aa7a-845f0583af3e | 2024-03-04 | Warnings | M022 |
| Sensodyne Natural white | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 911ac7e4-2b92-43d5-af0b-b5f741b088fb | 2024-03-04 | Warnings | M022 |
| Sensodyne Nourish Healthy White | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | aca38560-2fd7-47be-9e93-2abc3214e856 | 2024-03-04 | Warnings | M022 |
| Sensodyne Nourish Gently Soothing | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 5403ab67-532c-4bdf-9b06-07b1866f37f1 | 2024-03-04 | Warnings | M022 |
| SENSODYNE PRONAMEL Active Shield Fresh Mint | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | e8684615-f544-4871-b935-0a0f93639d7d | 2024-03-04 | Warnings | M022 |
| Sensodyne Pronamel Gentle Whitening Fresh Mint | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 3dfa6827-3aae-4f19-93f6-2ded2faf2ddd | 2024-03-04 | Warnings | M022 |
| Made by Dentists Sensitive and Whitening Fresh Mint | POTASSIUM NITRATE, SODIUM FLUORIDE | MADE BY DENTISTS INC | 0d379c26-69ff-4666-9ad5-7618f0bd139f | 2024-02-27 | Warnings | M022 |
| Polident ProPartial | STANNOUS FLUORIDE | Haleon US Holdings LLC | 557eeb32-64f4-41e8-ada4-91bd39ae2920 | 2024-02-07 | Warnings | M022 |
| SENSODYNE PRONAMEL Daily Protection | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | edffce4d-108b-4ffd-9adf-e12cb42ffddd | 2024-01-24 | Warnings | M022 |
| Peppermint Twist | FLUORIDE | Caldwell Health LLC | 4b28cdd1-0dba-42f5-a9e8-06d9e75b2396 | 2024-01-17 | Warnings | M022 |
| The Natural Dentist Groovy Grape | FLUORIDE | Caldwell Consumer Health LLC | 087abbed-1f58-4b45-a76b-a950fa81c18c | 2024-01-16 | Warnings | M022 |
| Benzoin Tincture | BENZOIN RESIN | Pharma Nobis, LLC | e42fccc2-1b4f-e7f3-e053-2a95a90aef39 | 2023-12-26 | Warnings | M022 |
| Sunmark Benzoin Compound Tincture | BENZOIN RESIN | Strategic Sourcing Services LLC | 0c96d810-83dc-47d3-9a75-63a79feaad0a | 2023-12-19 | Warnings | M022 |
| Benzoin Tincture | BENZOIN RESIN | Humco Holding Group, Inc. | b33b5896-673b-498c-8a58-76ece8552f7a | 2023-12-15 | Warnings | M022 |
| Povidone Iodine | POVIDONE IODINE ORAL RINSE 0.5% | Humco Holding Group, Inc. | b83dbdd1-ff63-caf8-e053-2a95a90a5764 | 2023-12-15 | Warnings | M022 |
| Moon Whitening Gel Anticavity | SODIUM FLUORIDE | Moon Oral Care, LLC | 0c556a29-a697-3a66-e063-6394a90abfee | 2023-12-12 | Warnings | M022 |
| Moon Charcoal Whitening Anticavity | SODIUM FLUORIDE | Moon Oral Care, LLC | 0c55f7b3-fea1-58f3-e063-6394a90a3bde | 2023-12-12 | Warnings | M022 |
| ORCA Complete Menthol Pain Reliever | MENTHOL | ORCA Products, LLC | 99990e27-d66b-4d61-97f2-6a76066eb8b8 | 2023-12-08 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 0070858b-e02e-431f-a7c2-313fef01791b | 2023-12-07 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | d1802f08-80cb-41dd-b34d-9c576b101ddb | 2023-12-07 | 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 |