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 50 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PAIN RELIEF PATCHES LIDOCAINE Ahold U.S.A., Inc, 7e7a813e-424d-4a78-9c72-541c3c62606a 2025-12-28 Warnings Exact identifier application number: M017 Amazon Basics Cold and Hot Medicated Patch MENTHOL Amazon.com Services LLC e3b4db12-c846-b984-e053-2a95a90a8e9a 2025-12-28 Warnings Exact identifier application number: M017 Amazon Basics Pain Relief Patch with 4% Lidocaine LIDOCAINE Amazon.com Services LLC e3b4f9b1-ac6b-cb2a-e053-2a95a90a9e1e 2025-12-28 Warnings Exact identifier application number: M017 Absorbine Jr Neck and Shoulder ABSORBINE JR NECK AND SHOULDER Clarion Brands LLC 22f2f191-9146-3075-e063-6394a90aef5f 2025-12-28 Warnings Exact identifier application number: M017 Absorbine Jr. Pain Relieving Knee Patch ABSORBINE JR. PAIN RELIEVING KNEE PATCH Clarion Brands, LLC 22f71254-e521-2d82-e063-6394a90a12d8 2025-12-28 Warnings Exact identifier application number: M017 Absorbine Jr Back Patch ABSORBINE JR BACK PATCH Clarion Brands LLC. 22f5147e-ff2b-4ae8-e063-6394a90a4e54 2025-12-28 Warnings Exact identifier application number: M017 Absorbine Jr. Pro Rollon ABSORBINE JR. PRO ROLLON Clarion Brands, LLC 470efcd0-d350-3dc4-e063-6394a90ab8c1 2025-12-28 Warnings Exact identifier application number: M017 Med Rub Balm ACHES AND PAIN BALM Wellmetech Pharmaceutical Industries SDN BHD a5801566-6bbe-44f6-8761-9c1ce3096900 2025-12-27 Warnings Exact identifier application number: M017 N-Labs ArcticZen Pain Relief Knee CAMPHOR (SYNTHETIC), MENTHOL Nutriomo Labs PTE., LTD 46e92db7-a48b-2c7a-e063-6394a90a438e 2025-12-27 Warnings Exact identifier application number: M017 Absorbine Jr. Plus MENTHOL Clarion Brands, LLC 46f4ad3c-7418-a6bf-e063-6394a90a4eb8 2025-12-27 Warnings Exact identifier application number: M017 Equate Lidocaine Cool and Heat LIDOCAINE 4% PLUS MENTHOL 1% Walmart Stores Inc b86769c3-a0b4-c481-e053-2a95a90af38b 2025-12-27 Warnings Exact identifier application number: M017 Medicated Body Extra Strength Powder MENTHOL 0.80% Walmart Stores Inc b0786418-7b28-d316-e053-2995a90a3ab5 2025-12-27 Warnings Exact identifier application number: M017 Maximum Strength Medicated Foot Powder MEDICATED FOOT POWDER Walmart Stores Inc b0794d48-eb8b-55c9-e053-2995a90a5b38 2025-12-27 Warnings Exact identifier application number: M017 Walgreens 24-Hour Lidocaine Patch LIDOCAINE 4% Walgreens Company b8402924-b5fc-0acd-e053-2a95a90a1805 2025-12-27 Warnings Exact identifier application number: M017 Frankincense and Myrrh Foot Pain Relief MENTHOL WISE CONSUMER PRODUCTS CO. 115f1abc-34aa-3c20-e063-6294a90a9764 2025-12-26 Warnings Exact identifier application number: M017 Soothing Nerve Relief MENTHOL Wise Consumer Products 46e23c95-1a36-214e-e063-6394a90a98a8 2025-12-26 Warnings Exact identifier application number: M017 Frankincense and Myrrh Foot Pain Relief Combo Pack MENTHOL WISE CONSUMER PRODUCTS CO. 46e2c8b6-bd94-7100-e063-6294a90ac998 2025-12-26 Warnings Exact identifier application number: M017 Pain Patch Perfecto 24 Hours Lidocaine 4 % Patch LIDOCAINE Painpatchperfecto LLC a281c3e9-1c48-4905-98cc-3cedf6042adc 2025-12-25 Warnings Exact identifier application number: M017 Aloe UP SPF 33 Mineral ZINC OXIDE Aloe Care International, LLC 35aa6196-682d-8f32-e063-6394a90aad99 2025-12-24 Warnings Exact identifier application number: M017 ETADERM Numbing Cream LIDOCAINE NUEPHASE LLC 5292c6ff-b878-4e71-878b-4bf08207612e 2025-12-24 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