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 |
|---|---|---|---|---|---|---|
| Avant | BENZOCAINE | Dharma Research, Inc. | fc8194af-2e77-4ad1-ae75-461dce3ed604 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | baf7d184-07ed-4491-a1fc-9a377b4b0110 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | 033034af-c86c-4dbf-90eb-009c117024c6 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | 658ada18-2334-4b4e-b08e-702fa127aa14 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | cad932e5-8d7f-4f20-b1c2-febd328152f0 | 2023-10-11 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 2c9519ab-320d-49da-9deb-97a6168fb088 | 2023-10-10 | Warnings | M022 |
| Ioline | BENZOCAINE | Dharma Research, Inc. | b862c974-c024-42c3-986e-b65069437c7b | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 651ea978-081d-4c59-b177-6049a69d9415 | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | db763237-2910-45b9-be72-da092edc951b | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 34316f93-10b4-41cc-8654-625283f0044c | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 142a8824-657e-492a-8e5a-b15eb73383c9 | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 414cbec9-94e2-4bca-908b-1e79f8db0b27 | 2023-10-10 | Warnings | M022 |
| Sore throat cherry | PHENOL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | de634cf1-ed39-4d8a-8855-006c69b7aee9 | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | e4b2d22b-00b3-45a6-9b7d-8ee719587059 | 2023-10-09 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | a0e284f6-292f-4231-8596-f7cee4e0a12f | 2023-10-09 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | fe92637a-c88a-f9dd-e053-6294a90a7fa3 | 2023-07-01 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | c979e958-2042-471a-bf03-e84e68620106 | 2023-06-20 | Warnings | M022 |
| Orajel Gum Pain 3X Medicated | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 9a1632ad-2b47-5653-e053-2995a90ae0d9 | 2023-01-20 | Warnings | M022 |
| KOLORZ TOPICAL ANESTHETIC TRIPLE MINT | BENZOCAINE | DMG AMERICA, LLC | 0f90b227-f938-4e1a-a79e-1967b1a0477e | 2021-10-01 | 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 |