Over-the-counter drug · OTC MONOGRAPH DRUG
Helocaine Cold Sore Fever Blister Treatment (Tetracaine, mineral) NDC 83609-212
Tetracaine 20 mg/g; Mineral oil 744 mg/g · Ointment · Topical · Pagari Life Science Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83609-212-02 | 8360902120283609021202 | 1 TUBE in 1 BOX (83609-212-02) / 3 g in 1 TUBEMarketed from May 1, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Helocaine Cold Sore Fever Blister Treatment
- Generic name (nonproprietary)
- tetracaine, mineral
- Active ingredients
- Tetracaine — 20 mg/gMineral oil — 744 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Pagari Life Science Corp.NDC labeler code 83609
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Other FDA classes
- Esters (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 83609-212_487041f0-3ef3-7c82-e063-6394a90aac74SPL ID 487041f0-3ef3-7c82-e063-6394a90aac74SPL set ID 1b2eae09-5de0-9219-e063-6294a90af046RxCUI 2685213UNII 0619F35CGV, T5L8T28FGP
- Pharmacologic class
- Ester Local Anesthetic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N483609021202followed by a unit qualifier and the quantityPackage 83609-0212-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses for the temporary relief of pain and itching associated with fever blisters and cold sores helps prevent and temporarily protects chapped or cracked lips helps prevent and protect from the drying effects of wind and cold weather
Excerpt only. Read the full label for complete information.
About NDC 83609-212
- What is NDC 83609-212?
- 83609-212 is the product NDC for Helocaine Cold Sore Fever Blister Treatment, Tetracaine 20 mg/g; Mineral oil 744 mg/g ointment, listed with the FDA by Pagari Life Science Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Helocaine Cold Sore Fever Blister Treatment (Tetracaine, Mineral).
- What is the active ingredient?
- Tetracaine, Mineral oil.
- Who is the labeler?
- Pagari Life Science Corp., NDC labeler code 83609. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Helocaine Cold Sore Fever Blister Treatment?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 017
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Stopain Extra Strength Continuousmenthol | Menthol 80 mg/mL | SprayTopical | Troy Manufacturing, Inc. | 63936-4850 |
| Fast Freeze Pain Relievingmenthol, unspecified form | Menthol, Unspecified form 33 mg/mL | GelTopical | NATURAL ESSENTIALS, INC. | 66902-116 |
| Walgreens Pain Reliefbenzocaine | Benzocaine 200 mg/g | GelOral | Walgreens Company | 0363-5061 |
| Blt 2lidocaine hcl | Lidocaine hydrochloride 4 g/100g | OintmentTopical | CENTURA PHARMACEUTICALS INC | 70372-728 |
| Lidocaine 4% Patchlidocaine 4% | Lidocaine 40 mg/g | PatchTopical | V2 Pharma, LLC | 72835-400 |
| Just Cbd Roll-On Coolingmenthol | Menthol 4 g/100mL | GelTopical | Just Brands LLC | 73647-400 |
| Magsoothium Body Cooling Formulamenthol | Menthol 5 g/100mL | CreamTopical | Ubu/Elements, Inc. | 83262-002 |
| Rapid Reliefpain relief patch camphor 110mg menthol 33mg capsicum extract 22mg | Levomenthol .3 g/100g + 2 more ingredients | PatchTopical | RAPID AID VIET NAM COMPANY LIMITED | 83569-015 |
| Terramed Just Think Comfort Hydrocortisone 1% Creamhydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Rida LLC | 83004-051 |
| Tktalker Numbingnumbing | Lidocaine 4 g/100g | CreamTopical | Shenzhen Shandian Jingling Technology Co., Ltd. | 83804-113 |
| Herb Street Backache and Sore Muscle Reliefmenthol | Menthol .1 g/g | StickTopical | Balassa Laboratories Inc. | 10107-432 |
| CBD Pain Relief Creamtrolamine salicylate | Trolamine salicylate 100 mg/g | CreamTopical | Allure Labs | 62742-4198 |
| 3X Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | Rite Aid | 11822-0613 |
| Hush Anestheticlidocaine | Lidocaine 40 mg/g | GelTopical | HUSH Anesthetic | 49947-002 |
| Jointivatrolamine salicylate 10% | Trolamine salicylate 10 g/100g | CreamTopical | Rising Pharma Holdings, Inc. | 57237-355 |
| Stopain Clinicalmenthol, unspecified form | Menthol, Unspecified form 100 mg/g | GelTopical | Troy Manufacturing, Inc. | 63936-0975 |
| Coralite Lidocaine 4% Flexible Pain Relief Patch 1ctlidocaine pain patch | Lidocaine 40 mg/g | PatchTopical | United Exchange Corp | 65923-579 |
| Desert Harvest RELEVEUMlidocaine | Lidocaine 40 mg/mL | CreamTopical | Desert Harvest Inc. | 69145-201 |
| A Health Itch Relief Gelitch relief gel | Diphenhydramine hydrochloride 2 mg/100mL | GelTopical | Bionpharma, Inc. | 69452-496 |
| Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylatetrolamine salicylate | Trolamine salicylate 10 g/100g | CreamTopical | TELEBRANDS CORP | 73287-032 |
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