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 |
|---|---|---|---|---|---|---|
| DermaD ANTI-ITCH Therapeutic | SALICYLIC ACID | Chen Cohen Industries Inc. | 8f4a57cb-0a5b-42b0-a325-1f92f3942ad9 | 2025-05-29 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Sun Pharmaceutical Industries, Inc. | f7aecfb4-c194-4554-8d05-4e46005e654b | 2025-05-27 | Warnings | M017 |
| RockSauce Warming Massage | MENTHOL, METHYL SALICYLATE | Nantong Health & Beyond Hygienic Products Inc. | b679ed7b-9d88-4eff-9743-567affe0fe2b | 2025-05-27 | Warnings | M017 |
| RockSauce Warming Massage Roll On | MENTHOL, METHYL SALICYLATE | Nantong Health & Beyond Hygienic Products Inc. | 28eb8273-5789-4f33-bbbe-3a5ec7bc7929 | 2025-05-27 | Warnings | M017 |
| AUVON Pain Relief Cream | LIDOCAINE | SHENZHEN YUWEN E-COMMERCE CO., LTD. | 358c2632-3b90-1c54-e063-6294a90ad461 | 2025-05-22 | Warnings | M017 |
| WelAhead by Welmate Lidocaine 5% Roll-on | LIDOCAINE 5% | OTC PHARM LLC | 0b75e83e-8c7b-6247-e063-6294a90ac413 | 2025-05-21 | Warnings | M017 |
| Bliss Republic | LIDOCAINE NUMBING EXTRA STRENGTH CREAM | Sargass Group Limited Liability Company | 35aba13a-95e6-a395-e063-6294a90a5bdc | 2025-05-21 | Warnings | M017 |
| Xpect Stopain Clinical | MENTHOL | Cintas Corporation | e911478f-7153-4700-b945-92ec54972f45 | 2025-05-21 | Warnings | M017 |
| LidoPro Patch (Lidocaine 4%, Menthol 1%) | LIDOCAINE AND MENTHOL PATCH | Preferred Pharmaceuticals Inc. | 0976a898-8d79-4b85-b473-c8ad32b4fd00 | 2025-05-20 | Warnings | M017 |
| Numbing Cream | LIDOCAINE | 100 KARMA INC | 359884d6-188a-e503-e063-6294a90acab4 | 2025-05-20 | Warnings | M017 |
| AY BENDITO - THERMOACTIVE | CAMPHOR, MENTHOL | AY BENDITO - THERMOACTIVE LOTION | 835abc66-680f-be06-e053-2a91aa0a309e | 2025-05-19 | Warnings | M017 |
| Numbing Cream | LIDOCAINE | 100 KARMA INC | 35884644-d017-eda3-e063-6394a90a1f6c | 2025-05-19 | Warnings | M017 |
| QUIT SMOKING Proven Patches | NICOTINE | Jiashen International Trade Limited | 35570155-c769-dc4c-e063-6394a90a019d | 2025-05-17 | Warnings | M017 |
| VBBV Tattoo Numbing | LIDOCAINE | Jiashen International Trade Limited | 3557859e-f8b3-1049-e063-6394a90ad737 | 2025-05-17 | Warnings | M017 |
| Bliss Republic Lidocaine Numbing Cream | LIDOCAINE NUMBING CREAM | Sargass Group Limited Liability Company | 35415851-beba-5bb4-e063-6294a90a35c0 | 2025-05-16 | Warnings | M017 |
| Cold Hot Chinese Red Tiger Pain Relief Gel Roll-On | MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 352798e1-1e09-3d47-e063-6394a90ad404 | 2025-05-15 | Warnings | M017 |
| Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-On | MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 35285d62-c660-a056-e063-6294a90aabc8 | 2025-05-15 | Warnings | M017 |
| SionBiotext Hydrocortisone | HYDROCORTISONE ACETATE 1% | Sion Biotext Medical Ltd | 35073eae-26fe-2bb5-e063-6294a90ab56a | 2025-05-13 | Warnings | M017 |
| Bliss Republic Lidocaine Numbing Cream | LIDOCAINE NUMBING CREAM | Sargass Group Limited Liability Company | 3508ae14-d9c9-3c85-e063-6294a90a0098 | 2025-05-13 | Warnings | M017 |
| SORE NO MORE WARM THERAPY | MENTHOL AND CAMPHOR | SOMBRA COSMETICS INC. | cd86b56e-9b4c-4aca-9740-c8793cb12055 | 2025-05-12 | 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 |