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 |
|---|---|---|---|---|---|---|
| CHLORASEPTIC | MENTHOL AND BENZOCAINE | Prestige Brands Holdings, Inc. | b30e4b32-89dd-4e53-81d5-1415105361d4 | 2024-10-25 | Warnings | M022 |
| Finafta MultiOral | BENZOCAINE | Efficient Laboratories Inc. | 28c5a993-fb5f-4091-af15-32ccae4b9a7d | 2024-10-14 | Warnings | M022 |
| Rexall Sensitive Freshmint | POTASSIUM NITRATE, SODIUM FLUORIDE | Old East Main CO. | 7e715bb9-666e-4de4-ba70-1c84f5243443 | 2024-10-14 | Warnings | M022 |
| Rexall Sensitive Extra Whitening | POTASSIUM NITRATE, SODIUM FLUORIDE | Old East Main CO. | 2daf18a3-f71e-4585-8128-4663eff7eb6d | 2024-10-14 | Warnings | M022 |
| Anadent Kanka Gel | BENZOCAINE | BELMORA LLC | e0f73d78-5db1-43b4-8f58-e5410ca4560f | 2024-10-04 | Warnings | M022 |
| Listerine Cool Mint Antiseptic | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Navajo Manufacturing Company Inc. | f5f26e2f-8a1f-4687-e053-2a95a90ae378 | 2024-10-03 | Warnings | M022 |
| Colgate Great Regular Flavor | SODIUM MONOFLUOROPHOSPHATE | Navajo Manufacturing Company Inc. | f89bf259-b738-8229-e053-6394a90a0c59 | 2024-10-03 | Warnings | M022 |
| Colgate Total SF Clean Mint | STANNOUS FLUORIDE | Navajo Manufacturing Company Inc. | f71c53e0-e2dd-16f9-e053-6394a90accff | 2024-10-03 | Warnings | M022 |
| Crest Pro Health | CETYLPYRIDINIUM CHLORIDE | Navajo Manufacturing Company Inc. | 65bf17a9-21ad-27cb-e053-2991aa0afc40 | 2024-10-02 | Warnings | M022 |
| Sensodyne Pronamel Gentle Whitening Advanced | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 94e07979-943b-45bb-8e2b-90d686f3692e | 2024-09-04 | Warnings | M022 |
| Sensodyne Pronamel Gentle Whitening Advanced Plus | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | 6eb304dd-2a24-4fa0-9d39-71264e88dd16 | 2024-08-29 | Warnings | M022 |
| Sensodyne Pronamel Clinical Enamel Strength Deep Clean | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | cfda7efa-86fa-470d-a79f-81907e31778a | 2024-08-14 | Warnings | M022 |
| Sensodyne Pronamel Kids Bubble Twist | SODIUM FLUORIDE | Haleon US Holdings LLC | e403529a-0fac-4dab-b75c-46906add096b | 2024-08-13 | Warnings | M022 |
| Calcium Carbonate Assorted Flavors | ANTACID TABLETS | NuCare Pharmaceuticals,Inc. | af10dfb6-fef3-3410-e053-2995a90a9130 | 2024-07-17 | Warnings | M022 |
| SENSODYNE Advanced Whitening Plus | POTASSIUM NITRATE | Haleon US Holdings LLC | f757ccdd-b316-4799-a34a-10edbb73da6b | 2024-07-12 | Warnings | M022 |
| dentalux SENSITIVE ANTI-CAVITY FLUORIDE | POTASSIUM NITRATE, SODIUM FLUORIDE | Lidl US, LLC | baef7f15-8082-4e61-8c08-8beda8ad40c0 | 2024-07-03 | Warnings | M022 |
| 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 |
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 |