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 27 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SPARTAN LIDOCAINE TIV PRIME SRL 4e04146a-ed19-2271-e063-6394a90a50f0 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Lidocaine LIDOCAINE Walgreen Co. 41d5bdc4-66c8-31ab-e063-6394a90a1195 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Cool N Heat Patch LIDOCAINE, MENTHOL Walgreen Co. 41d64a88-90fc-27ca-e063-6294a90a602b 2026-03-27 Warnings Exact identifier application number: M017 Softlips Naturals Medicated CAMPHOR, MENTHOL The Mentholatum Company 4e05d134-6c7f-1501-e063-6294a90ad27d 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Cool N Heat Patch XL MENTHOL Walgreen Co. 41e92435-7f77-a593-e063-6394a90a4b38 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Cool N Heat Back Patch MENTHOL Walgreen Co. 41e81110-4b79-1fa6-e063-6394a90ae90c 2026-03-27 Warnings Exact identifier application number: M017 Softlips Naturals Medicated Elderberry Acai CAMPHOR, MENTHOL The Mentholatum Company 4e0743a6-d450-043b-e063-6394a90ad1c2 2026-03-27 Warnings Exact identifier application number: M017 QFSN Pain Relief Cream PAIN RELIEF CREAM Qiaofusheng Pharmaceuticals Co., Ltd. 4d215da1-87f5-d35d-e063-6394a90ac348 2026-03-27 Warnings Exact identifier application number: M017 FlexSport Roll On METHYL SALICYLATE Pharmadel LLC bf8de3da-7628-6112-e053-2995a90a8e16 2026-03-26 Warnings Exact identifier application number: M017 Kofal Original METHYL SALICYLATE Pharmadel LLC 984780fd-496b-150b-e053-2995a90aed77 2026-03-26 Warnings Exact identifier application number: M017 Kofal Fuerte METHYL SALICYLATE Pharmadel LLC 98488a07-eba0-2b4e-e053-2995a90ad6ab 2026-03-26 Warnings Exact identifier application number: M017 Kofal Max Power MENTHOL Pharmadel LLC fe1f1408-b0cb-67a4-e053-6394a90ad609 2026-03-26 Warnings Exact identifier application number: M017 Kofal METHYL SALICYLATE Pharmadel LLC 9cac377d-97bc-f0b7-e053-2a95a90a2e12 2026-03-26 Warnings Exact identifier application number: M017 Milagroso CAMPHOR Pharmadel LLC 12b0401c-84d5-07cd-e063-6394a90a052c 2026-03-26 Warnings Exact identifier application number: M017 Ubredol METHYL SALICYLATE Pharmadel LLC fe96eead-1722-c05d-e053-6394a90a850f 2026-03-26 Warnings Exact identifier application number: M017 DZUL PAIN FREEZE INSTANT PAIN RELIEF MENTHOL Caball Sales, Inc. 4df3abcc-17f3-17f2-e063-6294a90afcca 2026-03-26 Warnings Exact identifier application number: M017 Equate Cool and Heat Extra Strength MENTHOL Wal-Mart Stores Inc ca3088a7-e1ec-4e69-80d9-fd0051bde938 2026-03-25 Warnings Exact identifier application number: M017 Ultra Strength Muscle Rub - CVS Health Ultra Strength Muscle Rub CAMPHOR, MENTHOL, METHYL SALICYLATE CVS Pharmacy 2ea95529-ec4b-c2ce-e063-6394a90a0739 2026-03-25 Warnings Exact identifier application number: M017 NUMBING CREAMS MENTHOL LIDOCAINE Yongchun Lihui Trading Co., Ltd. 4dd38cdf-d644-6da0-e063-6294a90afb3d 2026-03-25 Warnings Exact identifier application number: M017 ANTIPHLAMINE L-MENTHOL, L-CAMPHOR, METHYL SALICYLATE Masaem Company 4dd3ab12-6cd3-1060-e063-6394a90a2dec 2026-03-25 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