Home NDC 83609-212 Helocaine Cold Sore Fever Blister Treatment
Product NDC 83609-212
11-digit product format 836090212
Labeler code 83609
Product ID 83609-212_487041f0-3ef3-7c82-e063-6394a90aac74
Type HUMAN OTC DRUG
Nonproprietary name TETRACAINE, MINERAL
Dosage form OINTMENT
Route TOPICAL
Labeler Pagari Life Science Corp.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-01
Substance TETRACAINE; MINERAL OIL
Active strength 20; 744 mg/g; mg/g
Pharmacologic classes Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
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 Helocaine Cold Sore Fever Blister Treatment
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRACAINE 20 mg/g MINERAL OIL 744 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0619F35CGV Internal UNII lookup T5L8T28FGP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2685213 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 83609-212-02 Helocaine Cold Sore Fever Blister Treatment 3 g in 1 TUBE OINTMENT 3 2 83609-212-02 Helocaine Cold Sore Fever Blister Treatment 1 in 1 BOX OINTMENT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83609-212 HELOCAINE COLD SORE FEVER BLISTER TREATMENT (TETRACAINE, MINERAL) OINTMENT [PAGARI LIFE SCIENCE CORP.] 1 Current NDC, 2 package rows 20240619_1b2eae09-5de0-9219-e063-6294a90af046.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 149 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FEEL GOOD LABS NATURAL PAIN MENTHOL The Feel Good Lab 778b62a1-ebd3-4a30-8f76-6d6773b698c5 2023-11-05 Warnings Exact identifier application number: M017 FEEL GOOD LABS SPORT RECOVERY MENTHOL The Feel Good Lab 103c5e33-42fb-41ac-957e-bb46d85e204c 2023-11-05 Warnings Exact identifier application number: M017 INSTA RELIEF DM LIDOCAINE HYDROCHLORIDE, MENTHOL DM LAB CORP 6ef66fb9-9f49-409d-9503-175c7555ee9e 2023-11-05 Warnings Exact identifier application number: M017 DR. MIKES Ponos Pain Relief Cream Roll-On HISTAMINE DIHYDROCHLORIDE, MENTHOL Dr. Mike's Vitamins, LLC fcc45464-f1fe-4244-95a7-9b4288b0ce45 2023-11-05 Warnings Exact identifier application number: M017 AcuPlus Pain Relief MENTHOL Innovations for Wellness, LLC 7f222a4f-85a8-4f3d-aa97-5c695d4da37f 2023-11-05 Warnings Exact identifier application number: M017 Ana Cool Rapid Soothing Cooling Formula HYDROCORTISONE Ana-Cool, LLC 64b80cc2-e2d8-4535-aaf8-c031f4159cd1 2023-11-05 Warnings Exact identifier application number: M017 FEEL GOOD LABS SPORT RECOVERY MENTHOL THE FEEL GOOD LAB, LLC 19b08cbf-5f43-4f07-8f4d-8cddb1492ab8 2023-11-05 Warnings Exact identifier application number: M017 PlayMakar Roll On Cool Pain Relief MENTHOL PlayMakar Inc. a12c16e7-561f-45a7-93c6-34d693ffdc7c 2023-11-05 Warnings Exact identifier application number: M017 AcuPlus Advanced Therapy for Pain and Recovery MENTHOL INNOVATIONS FOR WELLNESS, LLC 840cfd15-4ea1-49bf-8c4f-86c12461d860 2023-11-05 Warnings Exact identifier application number: M017 SCLERA CARE Topical Anesthetic Gel LIDOCAINE HYDROCHLORIDE ScleraCare, LLC 488ace02-fc0b-4d13-ab89-0e1640e915e5 2023-11-05 Warnings Exact identifier application number: M017 IRELIEV ROLL ON COOL PAIN RELIEF MENTHOL Excel Health, Inc dab94995-7393-4d9c-b295-72611a90919b 2023-11-05 Warnings Exact identifier application number: M017 URIFLEX Fast Acting Analgesic Pain Relief MENTHOL Rejuvica LLC fb78f705-b838-461d-b42c-8c98d3ca5d09 2023-11-05 Warnings Exact identifier application number: M017 365 Medicated Lip Balm MEDICATED LIP BALM Whole Foods Market, Inc. 48309a7d-d2da-483c-8bf8-f59d9ad0bb73 2023-11-03 Warnings Exact identifier application number: M017 COOL BREEZE Pain Relief MENTHOL COOL BREEZE US LLC 14dcf4ee-6778-49d4-8601-9205737432ea 2023-11-01 Warnings Exact identifier application number: M017 Lidozen LIDOCAINE HYDROCHLORIDE, MENTHOL Proficient Rx LP 1ebb45e5-4541-4c95-abe1-661ef763a610 2023-11-01 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Cream LIDOCAINE 4% Walgreens ce1b55ed-f5c5-ea8b-e053-2a95a90acd40 2023-10-31 Warnings Exact identifier application number: M017 Walgreens pain relieving LIDOCAINE 4% Walgreens ce2b9e57-749d-715c-e053-2995a90aaf8d 2023-10-31 Warnings Exact identifier application number: M017 Walgreens Cool n heat LIDOCAINE 4% MENTHOL 1% Walgreens ce168ab7-ec4a-daea-e053-2995a90af829 2023-10-31 Warnings Exact identifier application number: M017 Methyl Salicylate 40 Percent METHYL SALICYLATE Alexso, Inc 53407aab-094c-4393-a2b9-54fd85321e3e 2023-10-31 Warnings Exact identifier application number: M017 Hydrocortisone Acetate HYDROCORTISONE ACETATE Bentlin Products LLC 4346351c-8e11-46ae-b428-98d17f55beb9 2023-10-30 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 Sample Exclude flag Status 83609-212-02 83609021202 1 TUBE in 1 BOX (83609-212-02) / 3 g in 1 TUBE 1 tube 2024-05-01 No No Current