FDA.reportPublic FDA data

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
IngredientStrength
TETRACAINE20 mg/g
MINERAL OIL744 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0619F35CGVInternal UNII lookup
T5L8T28FGPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2685213Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1b2eae09-5de0-9219-e063-6294a90af046Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a26f29b9-6919-4f09-a354-491df8d2b97dProduct name120251021
122d1fa8-7b9e-49b4-89ce-b062ffd1d947Product name120181030
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83609-212-02Helocaine Cold Sore Fever Blister Treatment3 g in 1 TUBEOINTMENT32
83609-212-02Helocaine Cold Sore Fever Blister Treatment1 in 1 BOXOINTMENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83609-212HELOCAINE COLD SORE FEVER BLISTER TREATMENT (TETRACAINE, MINERAL) OINTMENT [PAGARI LIFE SCIENCE CORP.]1Current NDC, 2 package rows20240619_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 129 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ReliefMENTHOLLa Mend, Inc.1f92de3a-7180-5884-e063-6294a90aebf52024-08-01WarningsExact identifier
application number: M017
Meijer Medicated Foot PowderMENTHOLMeijer Distribution07ec6c20-73c4-e5e4-e063-6294a90a7e552024-07-29WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.e05ec3b7-e9ab-4eaa-8518-86304336697c2024-07-29WarningsExact identifier
application number: M017
Walgreens Roll-OnCAPSAISIN 0.1%Walgreens Co1e65bf31-15c7-5e6a-e063-6394a90ac9562024-07-29WarningsExact identifier
application number: M017
CamphotrexCAMPHOR, MENTHOLPureTek Corporation3b6c6eef-e92d-497d-afe8-82356637c2b82024-07-26WarningsExact identifier
application number: M017
CamphotrolCAMPHOR, MENTHOLPureTek Corporationccac9f37-a374-4765-e053-2a95a90ad2f72024-07-26WarningsExact identifier
application number: M017
Real Time Pain Relief FootMENTHOLReal Time Products Inc.29c8e06d-9b29-44f9-ac21-9160d06475cb2024-07-24WarningsExact identifier
application number: M017
Capsaicin 0.075 PercentCAPSAICINAlexso, Inc33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd2024-07-22WarningsExact identifier
application number: M017
TIDL Pain Relief CRYO Therapy Limited EditionPAIN RELIEF CRYO THERAPY LIMITED EDITIONShenzhen Sam Technology Co., Ltd.1d966b67-fd9c-eab6-e063-6294a90aa75e2024-07-19WarningsExact identifier
application number: M017
Fruit of the Earth Aloe Vera Cool BlueLIDOCAINE HYDROCHLORIDEFruit of the Earth, Inc.1d65bc34-2bc2-4f52-a9b3-1cb08324eb792024-07-19WarningsExact identifier
application number: M017
Ultra BalmMENTHOL AND METHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.de997baf-aa04-474e-b912-3fc67e720d0b2024-07-19WarningsExact identifier
application number: M017
Ling Nam Hak Kwai OilTURPENTINE OILLing Nam Medicine Factory (H.K.) Ltd.3f16cce3-366f-41f3-8829-6de4082a8c192024-07-19WarningsExact identifier
application number: M017
Koong Yick Hak Kwai OilTURPENTINE OILLing Nam Medicine Factory (H.K.) Ltd.bc33e185-3b42-98b5-e053-2995a90a63082024-07-18WarningsExact identifier
application number: M017
Koong Yick Hung FaMETHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.9c8a121d-6da2-4435-a2d7-a0b71d10740d2024-07-18WarningsExact identifier
application number: M017
Ling Nam Hung FarMETHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.b6916b6e-b7eb-1eb7-e053-2995a90ae6fb2024-07-18WarningsExact identifier
application number: M017
itch reliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEBionpharma Inc.178ed513-4f22-8f11-e063-6294a90a109b2024-07-16WarningsExact identifier
application number: M017
POWERECT Benzocaine Male Delay GelBENZOCAINESKINS SEXUAL HEALTH LIMITED2fafe1f2-a31e-4b2a-bc51-81e16b319c3a2024-07-16WarningsExact identifier
application number: M017
SKINS DELAY Climax Control Benzocaine GelBENZOCAINESKINS SEXUAL HEALTH LIMITED53730576-2609-4f28-8bfa-a1ceea698b832024-07-16WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray.PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAYShenzhen Sam Technology Co., Ltd.1d1a0346-3b00-4803-e063-6294a90aec6d2024-07-13WarningsExact identifier
application number: M017
Tidl Pain Relief Evening Therapy Spray.PAIN RELIEF EVENING THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d1a2f4a-7b25-e595-e063-6394a90a00d52024-07-13WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2685213mineral oil 74.4 % / tetracaine 2 % Topical OintmentPSN1b2eae09-5de0-9219-e063-6294a90af0462
2685213mineral oil 0.744 MG/MG / tetracaine 0.02 MG/MG Topical OintmentSCD1b2eae09-5de0-9219-e063-6294a90af0462
2685213mineral oil 74.4 % / tetracaine 2 % Topical OintmentSY1b2eae09-5de0-9219-e063-6294a90af0462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83609-212-02836090212021 TUBE in 1 BOX (83609-212-02) / 3 g in 1 TUBE1 tube2024-05-01NoNoCurrent