Home NDC 41250-411-01 Maximum Strength Cold Sore Treatment
Product NDC 41250-411
Requested package NDC 41250-411-01
11-digit product format 412500411
Labeler code 41250
Product ID 41250-411_ed54cd45-c7cf-4437-8773-95c4c3d37390
Type HUMAN OTC DRUG
Nonproprietary name Camphor, Menthol, Phenol, White Petrolatum
Dosage form GEL
Route TOPICAL
Labeler Meijer Distribution Inc
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-09-09
Substance CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PHENOL; PETROLATUM
Active strength 30; 10; 15; 892 mg/g; mg/g; mg/g; mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 Maximum Strength Cold Sore Treatment
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAMPHOR (SYNTHETIC) 30 mg/g MENTHOL, UNSPECIFIED FORM 10 mg/g PHENOL 15 mg/g PETROLATUM 892 mg/g
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 2175793 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41250-411-01 Maximum Strength Cold Sore Treatment 2 g in 1 TUBE GEL 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41250-411 MAXIMUM STRENGTH COLD SORE TREATMENT (CAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUM) GEL [MEIJER DISTRIBUTION INC] 6 Current NDC, Legacy NDC, 1 package rows 20241128_9220772c-b3b7-4855-e053-2a95a90a94f6.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 34 of 40 · 782 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Orajel 2X Medicated Gel ORAL PAIN RELIEVER Church & Dwight Co., Inc. 262be295-4eaf-3136-e063-6294a90a7dcc 2024-11-05 Warnings Exact identifier application number: M022 BIOTENE Fresh Mint Original SODIUM FLUORIDE Haleon US Holdings LLC 1101c17f-c848-4cd5-a7cd-679b59dbe1bf 2024-11-05 Warnings Exact identifier application number: M022 biotene SODIUM MONOFLUOROPHOSPHATE Haleon US Holdings LLC a47a6502-efb2-4072-9562-cbe293531c2b 2024-11-04 Warnings Exact identifier application number: M022 Amosan Oral Wound Cleanser Cherry SODIUM PERBORATE MONOHYDRATE Vintage Brands Limited a0e145c8-6b08-40be-ae4f-5678c4a78b1e 2024-10-30 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043bfbc3-c33b-78b7-e063-6294a90a1a5a 2024-10-29 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043bfbc3-c33a-78b7-e063-6294a90a1a5a 2024-10-29 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043a3cb4-f560-0ffd-e063-6394a90a2ff6 2024-10-29 Warnings Exact identifier application number: M022 Amosan Oral Wound Cleanser Mint SODIUM PERBORATE MONOHYDRATE Vintage Brands Limited be57ca56-834f-4170-a407-f193484d8b0a 2024-10-29 Warnings Exact identifier application number: M022 SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint SODIUM FLUORIDE Haleon US Holdings LLC 817c0dad-d109-428e-adb5-3354604acc94 2024-10-28 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 1f3d68f6-afd6-42e7-b3e5-210228c8e7de 2024-10-28 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals LLC 0dd15227-6603-42ac-9a5f-f2dc49e0382a 2024-10-28 Warnings, Adverse reactions Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 0605d5d6-82bd-415e-b5cb-e273f934a4a7 2024-10-28 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Liquid BENZOCAINE Beutlich Pharmaceuticals, LLC f70fa3fc-cd65-4a80-9efd-129e98fd3998 2024-10-28 Warnings Exact identifier application number: M022 Sore Throat Relief Menthol PHENOL Chain Drug Consortium af661ef0-cdc3-4146-8ae5-59795aa49650 2024-10-28 Warnings Exact identifier application number: M022 Sore Throat Relief Cherry Flavor PHENOL Chain Drug Consortium a9cf9829-4b70-44fa-9719-240b65c06724 2024-10-28 Warnings Exact identifier application number: M022 Ear Wax Removal Aid Drops CARBAMIDE PEROXIDE PHARMACY VALUE ALLIANCE, LLC 85ae80c1-2bc2-4c90-9559-63510d03e739 2024-10-28 Warnings Exact identifier application number: M022 Chloraspetic MENTHOL AND BENZOCAINE Prestige Brands Holdings, Inc. 2b1808b2-2574-4ab8-a762-5733251848ce 2024-10-25 Warnings Exact identifier application number: M022 Chloraseptic Warming Sore Throat PHENOL Prestige Brands Holdings, Inc. a197fab2-70ce-4a6c-9add-29d7368a75c5 2024-10-25 Warnings Exact identifier application number: M022 Gly-Oxide CARBAMIDE PEROXIDE Medtech Products Inc. 086a0b82-e947-41c9-89e7-ba06483960c9 2024-10-25 Warnings Exact identifier application number: M022 CHLORASEPTIC MENTHOL AND BENZOCAINE Prestige Brands Holdings, Inc. d500f423-b9f2-4d98-8f2a-8bab7c05737c 2024-10-25 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 41250-411-01 41250041101 2 g in 1 TUBE (41250-411-01) 2 g 2019-09-09 0000-00-00 No No Current