Home NDC 11822-0614 4X Medicated Severe Toothache and Gum Cream
Product NDC 11822-0614
11-digit product format 118220614
Labeler code 11822
Product ID 11822-0614_437ff1ad-5461-e55c-e063-6394a90a258b
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form CREAM
Route ORAL
Labeler Rite Aid
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-05-06
Marketing end 2027-01-01
Substance BENZOCAINE; MENTHOL; ZINC CHLORIDE; BENZALKONIUM CHLORIDE
Active strength 20; .26; .15; .13 g/100g; 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 11822-0614 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 11822-0614 11822-0614-9 U Excluded because listing certification expired excluded / ndc_excluded.zip 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 4X Medicated Severe Toothache and Gum Cream Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 20 g/100g MENTHOL .26 g/100g ZINC CHLORIDE .15 g/100g BENZALKONIUM CHLORIDE .13 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2370903 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11822-0614-9 4X Medicated Severe Toothache and Gum Cream 1 in 1 CARTON CREAM 1 14 11822-0614-9 4X Medicated Severe Toothache and Gum Cream 9.4 g in 1 TUBE CREAM 9.4 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11822-0614 4X MEDICATED SEVERE TOOTHACHE AND GUM CREAM (BENZOCAINE) CREAM [RITE AID] 12 Current NDC, Legacy NDC, 2 package rows 20250121_996fdbeb-1fe3-77b6-e053-2995a90a25c7.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 26 of 39 · 779 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. a2591a96-ed66-45b1-abf6-6b26d0bb4f44 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. efe92e48-5086-4b61-a298-0d8ceefe100e 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. 1d6a1182-ab63-460a-ab91-8d4c2ae5d01e 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. e1db79a4-4a24-4c3f-9ee9-2af3f876ac96 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. d3b6669e-479f-4bc1-b533-5e9a0cc65213 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. e42a22ef-1035-4dd0-94b0-43625542d584 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. 3dca05de-cf63-4ca0-88be-473ea637e6b4 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. d6149dfd-f2a5-4bbd-913c-6a95efe5ffd2 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. c6eda1de-4490-4a28-8a31-cbf3e102e74e 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc 4261cd90-5087-44a3-bef9-72d33dbf0dfd 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc e70240a8-fa9d-4005-a3a0-5cca6188bf61 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc fda3d254-e103-4be9-9086-51ad022b2b3f 2025-01-09 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental c161da79-9ea5-4c7f-890c-4315129fe5bf 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental f7862ee9-117a-493d-83ee-5aef588a86de 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental 011c6a04-a489-41a5-ad2f-8ec281e07933 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental 45422b0f-f1ac-4bec-851a-c1394bc52fcc 2025-01-08 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043c336f-60e3-dc23-e063-6294a90a4b13 2025-01-08 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC e67b8def-c728-4952-9b35-874643cbe0f1 2025-01-08 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC e628bd9f-99e5-4c71-ba8a-caa6c337de54 2025-01-08 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC fef1f48c-e89d-4b75-9ba0-b1b068daf582 2025-01-08 Warnings Exact identifier application number: M022
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 11822-0614-9 11822061409 1 TUBE in 1 CARTON (11822-0614-9) / 9.4 g in 1 TUBE 1 tube 2020-05-06 2027-01-01 No No Current