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 |
|---|---|---|---|---|---|---|
| Overtime | METHYL SALICYLATE, MENTHOL AND CAPSAICIN | Physicians Science & Nature Inc. | 25fec070-8587-42d1-ba6f-1a9c150acc98 | 2025-11-10 | Warnings | M017 |
| Dendracin Neurodendraxcin | METHYL SALICYLATE, MENTHOL AND CAPSAICIN | Physicians Science & Nature Inc. | 05742cd5-ece2-4007-bdf0-46b76d23df74 | 2025-11-10 | Warnings | M017 |
| Anal Blu | DESENSITIZER | Novelties by Nasswalk, Inc. | 03b9555b-c3ff-4baa-e063-6394a90afb2c | 2025-11-10 | Warnings | M017 |
| Stallion | DELAY CREME | Novelties by Nasswalk, Inc. | 0261ec88-8fe4-d5f8-e063-6294a90ab3d4 | 2025-11-10 | Warnings | M017 |
| ANAL-ESE | DESENSITIZER | Novelties by Nasswalk, Inc. | 03b89eed-b433-a263-e063-6294a90a675b | 2025-11-10 | Warnings | M017 |
| Instant Erection | ULTIMATE ERECTION ENHANCER | Novelties by Nasswalk, Inc. | 03a444f9-7052-0c38-e063-6294a90a4e56 | 2025-11-10 | Warnings | M017 |
| STA-HARD | DESENSITIZING LUBRICANT | Novelties by Nasswalk, Inc. | 02ef794b-8e70-5c26-e063-6294a90a28d1 | 2025-11-10 | Warnings | M017 |
| ANAL-ESE | DESENSITIZER | Novelties by Nasswalk, Inc. | 03a4a7ce-4cff-a608-e063-6294a90ad65d | 2025-11-10 | Warnings | M017 |
| FOOTSPA PEDI | ALCOHOL | CHEMCO CORPORATION | 04de4392-74f6-7df8-e063-6294a90ae3b1 | 2025-11-08 | Warnings | M017 |
| Johnson and Johnson All Purpose First Aid Kit | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | 5cdb47c5-7951-4279-8a05-0a3199d3dd45 | 2025-11-06 | Warnings | M017 |
| Johnson and Johnson First Aid Travel Ready 80 CT | ACETAMINOPHEN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | f388f105-48ba-4616-e053-2a95a90a0049 | 2025-11-06 | Warnings | M017 |
| Johnson and Johnson First Aid All Purpose 160 CT | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | f3933330-2550-4a88-e053-2a95a90a3997 | 2025-11-06 | Warnings | M017 |
| Foot and Leg Pain Relief | LIDOCAINE | Premier Brands of America Inc. | 42f23e2f-11c6-da49-e063-6294a90ac720 | 2025-11-06 | Warnings | M017 |
| HEALING TREE CALMING ANTI-ITCH | HYDROCORTISONE | Renu Laboratories, LLC | fc8bcde9-26e8-a35f-e053-6394a90a3300 | 2025-11-06 | Warnings | M017 |
| Calamine Plus | CALAMINE PLUS PRAMOXINE HCL | Chain Drug Marketing Association Inc | 1a3f8819-58cf-8923-e063-6394a90a37af | 2025-11-06 | Warnings | M017 |
| Extra Strength Itch Relief | DIPHENHYDRAMINE HCL AND ZINC ACETATE | Chain Drug Marketing Association Inc | 1a2997bc-7741-e658-e063-6394a90af6fd | 2025-11-06 | Warnings | M017 |
| Diphenhydramine HCl and Zinc Acetate | EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY | Topco Associates LLC | 8026c7dd-eb7b-ebea-e053-2991aa0a1b0f | 2025-11-06 | Warnings | M017 |
| Diphenhydramine HCl and Zinc Acetate | EXTRA STRENGTH ITCH RELIEF | Walgreen Company | 6057b4ff-6adc-4688-893c-62d237d7d1ae | 2025-11-06 | Warnings | M017 |
| BANPINGHUA Glucosamine Chondroitin Patch | PEPPERMINT, CAMPHOR, BORNEOL | Henan Lijitang Medical Technology Co., Ltd. | 42f8c2ae-50a2-2358-e063-6394a90a5979 | 2025-11-06 | Warnings | M017 |
| PAINGEL | CAMPHOR, MENTHOL | NACOR BUSINESS GROUP LLC | 42fa2397-b61a-3b16-e063-6294a90a5fed | 2025-11-06 | 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 |