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 |
|---|---|---|---|---|---|---|
| A Health Itch Relief Gel | ITCH RELIEF GEL | Pharma Nobis, LLC | 4f80c403-c760-31ec-e063-6394a90a61c9 | 2026-04-15 | Warnings | M017 |
| Family Care Antibiotic Pain Relief 0.33oz | ANTIBIOTIC PAIN RELIEF | United Exchange Corp | 4f8405fc-3e38-05d9-e063-6394a90a4cda | 2026-04-15 | Warnings | M017 |
| BiteMD | INSECT BITE RELIEF | Wisconsin Pharmacal Company | 4f860c1e-a638-4923-e063-6294a90ae7e2 | 2026-04-15 | Warnings | M017 |
| LavaDerm AfterSun | MENTHOL | Young Living Essential Oils, LC. | 4fcddcf1-36db-2f1a-e054-00144ff8d46c | 2026-04-15 | Warnings | M017 |
| Arlun Numbing Cream | NUMBING CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 4f8b60f9-03e3-e731-e063-6294a90a3b0a | 2026-04-15 | Warnings | M017 |
| tuiwaro Numbing Cream | NUMBING CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 4f66178c-95d9-8c6a-e063-6294a90a2c09 | 2026-04-14 | Warnings | M017 |
| Lidocaine Pain Relief Roll-On | LIDOCAINE 4% | Pharma Nobis, LLC | 4f6d9a51-c42e-ca88-e063-6394a90a8659 | 2026-04-14 | Warnings | M017 |
| Hot/Cold Menthol 16% Roll-On | HOT/COLD MENTHOL 16% ROLL-ON | Pharma Nobis, LLC | 4f6f5a0b-3bfa-289e-e063-6294a90a94b3 | 2026-04-14 | Warnings | M017 |
| Sting Relief Swab | BENZOCAINE | 4 Visions LLC | 4f76a8c5-fde6-eee0-e063-6394a90a09f8 | 2026-04-14 | Warnings | M017 |
| Signature Pain Relief Cream | 4% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 4f555b8f-5193-e685-e063-6294a90a7ba2 | 2026-04-13 | Warnings | M017 |
| Deep Numbing Cream | MENTHOL | YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD | 7943559b-de10-4214-96dc-f9cbac828f46 | 2026-04-13 | Warnings | M017 |
| Hydrocortisone Cream 1% | HYDROCORTISONE CREAM 1% WITH ALOE | Publix Super Markets Inc. | 3c45a654-7fec-55b3-e063-6294a90a184b | 2026-04-13 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE CREAM 1% | AMERISOURCE BERGEN | 4f5aea1c-ae51-4e1a-e063-6294a90a6aa1 | 2026-04-13 | Warnings | M017 |
| ActivICE | MENTHOL | Medline Industries, LP | 8465b443-abe9-78fb-e053-2a91aa0ac1d8 | 2026-04-13 | Warnings | M017 |
| 4Jointz | MENTHOL | ARP(USA) Pty Ltd | 94a5b5f5-abf7-40b3-9dd7-43e2c22f138e | 2026-04-13 | Warnings | M017 |
| Sumifun Pain Relief Creams | METHYL SALICLATE CAPSAICIN CAMPHOR | Guchutang Biotechnology (Longyan) Co., Ltd | 4f3dd96a-d843-d810-e063-6394a90a188e | 2026-04-12 | Warnings | M017 |
| BonicaEaseX 24 Hour Menthol Pain Relieving | MENTHOL, UNSPECIFIED FORM | Planet (Anhui) Pharmaceutical Co., Ltd. | 17fc0cd1-710d-45e6-9513-d7100e3adb42 | 2026-04-10 | Warnings | M017 |
| BonicaEaseX Colorless Roll-On Menthol Pain Relieving | MENTHOL, UNSPECIFIED FORM | Planet (Anhui) Pharmaceutical Co.,Ltd | acf460b4-1b41-4b30-a74a-6c3613119d8e | 2026-04-10 | Warnings | M017 |
| BonicaEaseX Menthol Pain Relieving | MENTHOL, UNSPECIFIED FORM | Planet (Anhui) Pharmaceutical Co.,Ltd | 4d84b4fb-8f55-4b2b-b261-858edb7f3144 | 2026-04-10 | Warnings | M017 |
| HealthWise Pain Relief Gel Patch | CAPSAICIN, MENTHOL | Veridian Healthcare | f5484151-b6da-4f64-867f-87160a4ec2d6 | 2026-04-10 | 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 |