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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1b2eae09-5de0-9219-e063-6294a90af046	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a26f29b9-6919-4f09-a354-491df8d2b97d	Product name	1	20251021
122d1fa8-7b9e-49b4-89ce-b062ffd1d947	Product name	1	20181030
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

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 28 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LIDOGUARD	LIDOCAINE 4%	ViolaCare, Inc.	d8b021b6-cf71-4f7e-9d27-92d0982bd34f	2026-03-25	Warnings	Exact identifier application number: M017
LactiGo	MENTHOL	LactiGo, Inc.	4dda6ac4-d849-69a6-e063-6394a90a3c54	2026-03-25	Warnings	Exact identifier application number: M017
Alocane Max	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products LLC	0a33f9a9-1fdc-7cdf-e063-6294a90adca1	2026-03-25	Warnings	Exact identifier application number: M017
EjaGuard	LIDOCAINE	MOLANSPACE INC	475f64ef-d636-7e87-e063-6294a90ae32f	2026-03-25	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	ProStat First Aid	4e53d29c-ed3c-f481-e063-6294a90a3181	2026-03-25	Warnings	Exact identifier application number: M017
Topicaine Ultra	TOPICAINE ULTRA	Oncora Pharma, LLC	e052f718-700a-44e0-8770-65451b812ee1	2026-03-24	Warnings	Exact identifier application number: M017
Hot Pap Cataplasma	METHYL SALICYLATE, VANILLYL NONYLAMIDE	Masaem Company	4dbeda13-b198-0cf0-e063-6294a90a8180	2026-03-24	Warnings	Exact identifier application number: M017
Barmicil Anti-itch	HYDROCORTISONE	OPMX LLC	850084c3-1dd4-eb8d-e053-2a91aa0a130b	2026-03-24	Warnings	Exact identifier application number: M017
Jeil Hangbang Paff Soo S Cataplasma	GLYCOL SALICYLATE, L-MENTHOL	Masaem Company	4dd040db-07cf-361a-e063-6394a90a8001	2026-03-24	Warnings	Exact identifier application number: M017
Zenol Double Action	METHYL SALICYLATE, L-MENTHOL	BA TRADE INC	4da998fc-75a3-583f-e063-6394a90a59c7	2026-03-23	Warnings	Exact identifier application number: M017
Ultra Strength Topical Pain Relief Cream	CAMPHOR, MENTHOL, METHYL SALICYLATE	J C UDEOZOR & SONS GLOBAL INDUSTRIES LTD	4db9ae57-4ab4-8fe4-e063-6394a90a7e51	2026-03-23	Warnings	Exact identifier application number: M017
DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ON	ALIVIO TOTAL ROLL ON	EVI LABS	4da01338-8739-08a8-e063-6294a90ae157	2026-03-22	Warnings	Exact identifier application number: M017
DR SANA ALIVIO TOTAL ALIVIO TOTAL	ALIVIO TOTAL	EVI LABS	4da1c3b8-9af2-6e9f-e063-6394a90a86ae	2026-03-22	Warnings	Exact identifier application number: M017
SORE NO MORE	MENTHOL CAMPHOR	SOMBRA COSMETICS INC.	80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd	2026-03-20	Warnings	Exact identifier application number: M017
CVS Health Antiseptic Wound Wash	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	CVS Pharmacy	53ac017a-eccb-3b24-e054-00144ff88e88	2026-03-20	Warnings	Exact identifier application number: M017
Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2%	ANTI ITCH GEL	Walgreens	3d6e8c62-2fcc-51c2-e063-6394a90a33f7	2026-03-20	Warnings	Exact identifier application number: M017
ANIXIKE Numbing	MENTHOL 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4d5c52d7-8e81-b62f-e063-6394a90ad03e	2026-03-19	Warnings	Exact identifier application number: M017
SYLVIRENE NUMBING	MENTHOL 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4d47e8c7-d293-bf63-e063-6294a90a5fd9	2026-03-18	Warnings	Exact identifier application number: M017
Antibiotic and Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	f7aa9330-c47c-4d2f-b784-11b831d919d6	2026-03-18	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	99726aa3-3b45-4175-8471-279419af5457	2026-03-18	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0619F35CGV	TETRACAINE	94-24-6	TETRACAINE
T5L8T28FGP	MINERAL OIL	8042-47-5	MINERAL OIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2685213	mineral oil 74.4 % / tetracaine 2 % Topical Ointment	PSN	1b2eae09-5de0-9219-e063-6294a90af046	2
2685213	mineral oil 0.744 MG/MG / tetracaine 0.02 MG/MG Topical Ointment	SCD	1b2eae09-5de0-9219-e063-6294a90af046	2
2685213	mineral oil 74.4 % / tetracaine 2 % Topical Ointment	SY	1b2eae09-5de0-9219-e063-6294a90af046	2

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Helocaine Cold Sore Fever Blister Treatment	Pagari Life Science Corp.	2026-01-15	HUMAN OTC DRUG LABEL	2