Home NDC 11822-0613 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.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table 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 table Ingredient Strength BENZOCAINE 20 g/100g MENTHOL .26 g/100g ZINC CHLORIDE .15 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup L7T10EIP3A Internal UNII lookup 86Q357L16B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2362013 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table 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 table 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.
Matched openFDA labels page 89 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aloe Up SPF 50 Mineral ZINC OXIDE Aloe International, LLC 35bc3621-f4e4-42d3-e063-6394a90a7aad 2025-06-18 Warnings Exact identifier application number: M017 Aloe Up SPF 50 Kids Mineral ZINC OXIDE, TITANIUM DIOXIDE Aloe Care International, LLC 35cd16b0-bd81-8f68-e063-6294a90a3d8c 2025-06-18 Warnings Exact identifier application number: M017 Aloe Up SPF 50 Kids Mineral ZINC OXIDE Aloe International, LLC 35cd5542-947d-a042-e063-6394a90a13f8 2025-06-18 Warnings Exact identifier application number: M017 Relieve Your Pain MENTHOL Proximity Capital Partners LLC dba Asutra c12369dd-8305-edaf-e053-2995a90a0d3d 2025-06-18 Warnings Exact identifier application number: M017 Melt Pain Away CAPSAICIN Proximity Capital Partners LLC dba Asutra a95a11d7-a2ae-6654-e053-2a95a90a802c 2025-06-18 Warnings Exact identifier application number: M017 Recovery Roll-On MENTHOL, CAMPHOR PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA ebc9630f-6d8b-e4f0-e053-2995a90a0b49 2025-06-18 Warnings Exact identifier application number: M017 ProCure Hydrocortisone 1% HYDROCORTISONE Twin Med LLC 37cdfabc-1fdb-246a-e063-6394a90a008a 2025-06-17 Warnings Exact identifier application number: M017 ProCure Hydrocortisone 1% HYDROCORTISONE Twin Med LLC 37ce6c35-b211-43de-e063-6294a90ab773 2025-06-17 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE CREAM 1% Sun Pharmaceutical Industries, Inc. 312ddc8d-100e-cfac-e063-6294a90acd09 2025-06-16 Warnings Exact identifier application number: M017 Curist 5% Lidocaine LIDOCAINE 5% Little Pharma, Inc. f20241a2-c5b1-f124-e053-2995a90a891b 2025-06-16 Warnings Exact identifier application number: M017 Toast Screamin Menthol MENTHOL IDEAZ, LLC 37b48b1a-ef3d-afdc-e063-6294a90a6610 2025-06-16 Warnings Exact identifier application number: M017 Toast Freezin Cold MENTHOL, METHYL SALICYLATE IDEAZ, LLC 37b4d363-0099-8cd3-e063-6394a90a18d6 2025-06-16 Warnings Exact identifier application number: M017 Earths Care Anti-Itch CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM DLC Laboratories, Inc. ba65f58a-d590-498a-b8e7-a3d78935d880 2025-06-13 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Stratus Pharmaceuticals Inc 5eb6574c-2066-4390-befc-8e5d2dd6ede2 2025-06-12 Warnings Exact identifier application number: M017 CHINESE RED TIGER LIDOCAINE PATCHES 4% LIDOCAINE, 1%MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 36b9a7a2-5832-4ce5-e063-6294a90aed12 2025-06-12 Warnings Exact identifier application number: M017 PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis) MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 375bc794-3289-e610-e063-6294a90a4f9b 2025-06-12 Warnings Exact identifier application number: M017 Methyl Salicylate 10% Pain Relieving METHYL SALICYLATE PureTek Corporation 376493eb-5142-db6d-e063-6294a90a1e73 2025-06-12 Warnings Exact identifier application number: M017 Free and Pure Cold Therapy Pain Relief MENTHOL Walgreen Co. 22cbbffc-f876-411e-e063-6394a90a1b38 2025-06-12 Warnings Exact identifier application number: M017 Methylten 25% Pain Relieving METHYL SALICYLATE PureTek Corporation 3767b97e-ab0c-ac26-e063-6394a90a00cf 2025-06-12 Warnings Exact identifier application number: M017 SPF 50 Mineral Sunscreen ZINC OXIDE Inspec Solutions, LLC 36af9a0a-536b-ee1a-e063-6394a90aace4 2025-06-11 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table 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