3X Medicated Toothache and Gum Gel
- Product NDC
- 11822-0613
- 11-digit product format
- 118220613
- Labeler code
- 11822
- Product ID
- 11822-0613_47b7b1c8-6965-dd9c-e063-6294a90a6417
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- GEL
- Route
- ORAL
- Labeler
- Rite Aid
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-05-06
- Marketing end
- 2027-11-01
- Substance
- BENZOCAINE; MENTHOL; ZINC CHLORIDE
- Active strength
- 20; .26; .15 g/100g; g/100g; g/100g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 11822-0613-9 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 11822-0613-9 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 11822-0613-9 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 11822-0613-9 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 11822-0613-9 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 11822-0613-9 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 11822-0613-9 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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
- 3X Medicated Toothache and Gum Gel
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 20 g/100g |
| MENTHOL | .26 g/100g |
| ZINC CHLORIDE | .15 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
| 86Q357L16B | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2362013 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 996f7989-17ce-5b28-e053-2995a90af8b8 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2025-08-12 | 996f7989-17ce-5b28-e053-2995a90af8b8 |
| 2025-08-12 | 996f7989-17ce-5b28-e053-2995a90af8b8 |
| 2025-01-30 | 996f7989-17ce-5b28-e053-2995a90af8b8 |
| 2025-01-30 | 996f7989-17ce-5b28-e053-2995a90af8b8 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-0613-9 | 3X Medicated Toothache and Gum Gel | 1 in 1 CARTON | GEL | 1 | 5 | |
| 11822-0613-9 | 3X Medicated Toothache and Gum Gel | 11.7 g in 1 TUBE | GEL | 11.7 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-0613 | 3X MEDICATED TOOTHACHE AND GUM GEL (BENZOCAINE) GEL [RITE AID] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230115_996f7989-17ce-5b28-e053-2995a90af8b8.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 |
|---|---|---|---|---|---|---|
| Alocane Max | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products LLC | 0a35221a-2fcb-2735-e063-6294a90a88ca | 2025-12-04 | Warnings | M017 |
| Pain Relieving | TROLAMINE SALICYLATE | CARDINAL HEALTH 110, LLC. DBA LEADER | b813262e-57c6-4d2c-8cc0-7a17f6f59343 | 2025-12-04 | Warnings | M017 |
| Gold Bond Medicated Extra Strength Body | MENTHOL | Gold Bond Co LLC | 7b75b7de-9c0b-4edf-b923-320f7d2bb1e6 | 2025-12-04 | Warnings | M017 |
| Lidocaine Patch | LIDOCAINE | Shenzhen Finona Information Technology Co., Ltd | 38767081-7011-6602-e063-6394a90a2784 | 2025-12-03 | Warnings | M017 |
| 4% Lidocaine Maximum Strength Pain Relief | LIDOCAINE | Shenzhen Finona Information Technology Co., Ltd | 3e5a5165-a773-0501-e063-6294a90ae2f4 | 2025-12-03 | Warnings | M017 |
| Leader Lidocaine | LIDOCAINE HCL | CARDINAL HEALTH | cece6765-0e2f-5ce9-e053-2995a90a3758 | 2025-12-03 | Warnings | M017 |
| Westlake Lidocaine | LIDOCAINE HCL | Westlake Pharma LLC | 0c586a14-1a2a-9f42-e063-6294a90a16c1 | 2025-12-03 | Warnings | M017 |
| CVS Lidocaine Maximum Strength | LIDOCAINE HCL | CVS Pharmacy | 87490c0f-a4d9-740e-e053-2a95a90a4724 | 2025-12-03 | Warnings | M017 |
| CVS Maximum Strength Burn | LIDOCAINE HYDROCHLORIDE 4% | CVS Pharmacy | 4510f379-c5a4-92c3-e063-6294a90a0a32 | 2025-12-03 | Warnings | M017 |
| LidoPatch Pain Relief | LIDOCAINE, MENTHOL | JAR Laboratories | 07289aa1-43ed-df31-e063-6394a90a764a | 2025-12-03 | Warnings | M017 |
| Equate Pain Relief Cream | 4% LIDOCAINE HCL | Walmart, Inc | 7d8e8a9a-5474-4c7b-e053-2991aa0a29f5 | 2025-12-03 | Warnings | M017 |
| Solarcaine Burn Pain Relief 4oz | SOLARCAINE BURN PAIN RELIEF 4OZ | WellSpring Pharmaceutical Corporation | 14f23c28-c713-4868-9f46-66363bf94b2c | 2025-12-03 | Warnings | M017 |
| ElixirCortiRelief | HYDROCORTISONE | ELIXIR HEALTHCARE USA, LLC. | a6ca66f3-9759-4c98-a758-45700bc08352 | 2025-12-02 | Warnings | M017 |
| Pain Relief Gel-Patch | LIDOCAINE 4% | Trifecta Pharmaceuticals USA, LLC. | 12a27ce7-c547-7134-e063-6394a90a94bd | 2025-12-02 | Warnings | M017 |
| 5Kind DMSO | MENTHOL, METHYL SALICYLATE | 5KIND TRADING LTD | 6a6c7241-f544-4784-9581-f5b172fdbec7 | 2025-12-02 | Warnings | M017 |
| PEDIADERMICS ECZEMA 2 | HYDROCORTISONE | RENU LABORATORIES, LLC | da840bf6-ed65-bafc-e053-2a95a90a92d5 | 2025-12-02 | Warnings | M017 |
| Thera Plus Maximum Strength Hydrocortisone | HYDROCORTISONE | Fourstar Group USA, Inc | 7d4e21d1-2914-4690-9084-a52abeab0958 | 2025-12-02 | Warnings | M017 |
| Rugby Capsaicin Cream | CAPSAICIN | Rugby Laboratories | 9eca34f1-e91a-3ac1-e053-2a95a90a9bd9 | 2025-12-02 | Warnings | M017 |
| Leader Capsaicin Pain Relief Cream | CAPSAICIN | Cardinal Health 110 dba LEADER | a5620709-0fed-4979-e053-2a95a90ac654 | 2025-12-02 | Warnings | M017 |
| Hydrocortisone Acetate Antipruritic (Anti-Itch) | HYDROCORTISONE ACETATE | Sun Pharmaceutical Industries, Inc. | 9f0b09e7-6cfd-4fd6-8631-67799edf4e08 | 2025-12-02 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2362013 | benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Gel | PSN | 996f7989-17ce-5b28-e053-2995a90af8b8 | 5 |
| 2362013 | benzocaine 0.2 MG/MG / menthol 0.0026 MG/MG / zinc chloride 0.0015 MG/MG Oral Gel | SCD | 996f7989-17ce-5b28-e053-2995a90af8b8 | 5 |
| 2362013 | benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Gel | SY | 996f7989-17ce-5b28-e053-2995a90af8b8 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11822-0613-9 | 11822061309 | 1 TUBE in 1 CARTON (11822-0613-9) / 11.7 g in 1 TUBE | 1 tube | 2020-05-06 | 2027-11-01 | No | No | Current |