helocaine cold sore fever blister treatment

Generic: tetracaine, mineral

Labeler: pagari life science corp.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name helocaine cold sore fever blister treatment
Generic Name tetracaine, mineral
Labeler pagari life science corp.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

mineral oil 744 mg/g, tetracaine 20 mg/g

Manufacturer
Pagari Life Science Corp.

Identifiers & Regulatory

Product NDC 83609-212
Product ID 83609-212_487041f0-3ef3-7c82-e063-6394a90aac74
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2027-12-31
Marketing Start 2024-05-01

Pharmacologic Class

Established (EPC)
ester local anesthetic [epc]
Chemical Structure
esters [cs]
Physiologic Effect
local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83609212
Hyphenated Format 83609-212

Supplemental Identifiers

RxCUI
2685213
UNII
T5L8T28FGP 0619F35CGV
NUI
N0000175683 M0007766 N0000175976

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name helocaine cold sore fever blister treatment (source: ndc)
Generic Name tetracaine, mineral (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 744 mg/g
  • 20 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (83609-212-02) / 3 g in 1 TUBE
source: ndc

Packages (1)

83609-212-02 1 TUBE in 1 BOX (83609-212-02) / 3 g in 1 TUBE

Ingredients (2)

mineral oil (744 mg/g) tetracaine (20 mg/g)

Linked Drug Pages (1)

Helocaine Cold Sore Fever Blister Treatment ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "487041f0-3ef3-7c82-e063-6394a90aac74", "openfda": {"nui": ["N0000175683", "M0007766", "N0000175976"], "unii": ["T5L8T28FGP", "0619F35CGV"], "rxcui": ["2685213"], "spl_set_id": ["1b2eae09-5de0-9219-e063-6294a90af046"], "pharm_class_cs": ["Esters [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Ester Local Anesthetic [EPC]"], "manufacturer_name": ["Pagari Life Science Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (83609-212-02)  / 3 g in 1 TUBE", "package_ndc": "83609-212-02", "marketing_start_date": "20240501"}], "brand_name": "Helocaine Cold Sore Fever Blister Treatment", "product_id": "83609-212_487041f0-3ef3-7c82-e063-6394a90aac74", "dosage_form": "OINTMENT", "pharm_class": ["Ester Local Anesthetic [EPC]", "Esters [CS]", "Local Anesthesia [PE]"], "product_ndc": "83609-212", "generic_name": "TETRACAINE, MINERAL", "labeler_name": "Pagari Life Science Corp.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Helocaine Cold Sore Fever Blister Treatment", "active_ingredients": [{"name": "MINERAL OIL", "strength": "744 mg/g"}, {"name": "TETRACAINE", "strength": "20 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240501", "listing_expiration_date": "20271231"}