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#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11822-0613-9 | 2025-08-12 | C162847 | 48780-1 | 2cef2736-9884-d83d-e063-dadaa90ab31f | 996f7989-17ce-5b28-e053-2995a90af8b8 |
| 11822-0613-9 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9884-d83d-e063-dadaa90ab31f | 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 |
|---|---|---|---|---|---|---|
| LidoTape | LIDOCAINE 4% | V2 Pharma LLC | ed18b4f7-6a2c-4dce-9b53-e485569093c5 | 2026-04-09 | Warnings | M017 |
| TheraCare Lidocaine Pain Relief | LIDOCAINE | Veridian Healthcare | 4f112ab2-b67a-a3e2-e063-6394a90acb60 | 2026-04-09 | Warnings | M017 |
| TheraCare Pain Relief | MENTHOL | Veridian Healthcare | 4f11aa1e-de53-a3b0-e063-6294a90a2fe4 | 2026-04-09 | Warnings | M017 |
| TheraCare 2X Medicated Pain Relief | LIDOCAINE, MENTHOL | Veridian Healthcare | 4f11fca1-1949-ab8e-e063-6394a90ac627 | 2026-04-09 | Warnings | M017 |
| TheraCare Medicated Pain Relief | CAMPHOR, MENTHOL, METHYL SALICYLATE | Veridian Healthcare | 4f125062-af89-40d3-e063-6394a90a27ef | 2026-04-09 | Warnings | M017 |
| DRMITSUI ECZEMA RELIEF | HYDROCORTISONE 1% ECZEMA RELIEF | Jiangxi Yudexi Pharmaceutical Co., LTD | 4eee7637-3a28-e0bd-e063-6294a90ae1a4 | 2026-04-08 | Warnings | M017 |
| SINSIN MULPAS | L-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR | Sinsin Pharmaceutical Co., Ltd. | 47c077c2-6e34-8e7a-e063-6294a90a21b5 | 2026-04-08 | Warnings | M017 |
| Yi Tiao Gen Pain Patch | PAIN PATCH | Sheng Chang Pharmaceutical Co, Ltd. Zhongli Factory | 4828fe70-f6f8-45e4-9c9a-a9e486dc65e5 | 2026-04-07 | Warnings | M017 |
| Dermatool Nerve Care | LIDOCAINE HCL, MENTHOL | Papalo Group, LLC | 4ee40c96-9350-4c68-e063-6294a90ac812 | 2026-04-07 | Warnings | M017 |
| Burn Relief | LIDOCAINE | CVS Pharmacy, Inc. | 42b3c341-f422-b2b4-e063-6294a90a47b2 | 2026-04-06 | Warnings | M017 |
| KinetiCream Pain Relieving Topical Analgesic | MENTHOL | Phoenix Bioperformance Products LLC | bb4c9e73-e62d-4b8c-a16c-b90db1a8b2a7 | 2026-04-06 | Warnings | M017 |
| KinetiCream Anti-Inflammatory and Pain Relief | MENTHOL | Phoenix Bioperformance Products LLC | 39a6d26b-b5f4-45d7-a9b5-6edbf42d7500 | 2026-04-06 | Warnings | M017 |
| Dr. Blue PainZaway Pain Relieving Roll-On | MENTHOL | Indiana Botanic Gardens | 4ecc8241-5a87-2f45-e063-6294a90aa30a | 2026-04-06 | Warnings | M017 |
| Sunburn Relief Gel | LIDOCAINE HCL | CVS Pharmacy, Inc. | d7f52394-5cc1-48a6-ae89-9fc63b515758 | 2026-04-06 | Warnings, Adverse reactions | M017 |
| Pain-Relieving Patch | CAMPHOR, MENTHOL, METHYL SALICYLATE | CVS Pharmacy | 4ecf4a6e-5c0f-7943-e063-6394a90a81cc | 2026-04-06 | Warnings | M017 |
| RAPID RELIEF | 0.025% CAPSAICIN PAIN PATCH | RAPID AID VIET NAM COMPANY LIMITED | 4edbaa1a-6e44-4865-e063-6394a90a8cc3 | 2026-04-06 | Warnings | M017 |
| Capsaicin 0.1% Cream | CAPSAICIN 0.1% | Puretek Corporation | 4e83441b-cb6a-beb0-e063-6394a90a1b54 | 2026-04-03 | Warnings | M017 |
| NeroCare Capsaicin Neuropathy Relief Cream | CAPSAICIN | Guangzhou Tata Biotechnology Co., Ltd. | 4e89b7eb-0d84-dc57-e063-6394a90a7dd9 | 2026-04-03 | Warnings | M017 |
| TheraCare Pain Relief Patch | LIDOCAINE 4% | Veridian Healthcare | 4e91da65-8191-6261-e063-6394a90a6bd5 | 2026-04-03 | Warnings | M017 |
| HealthWise Roll-On | LIDOCAINE, MENTHOL | Veridian Healthcare | 4e9306b5-949e-f7a9-e063-6394a90ae13a | 2026-04-03 | 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 |