Over-the-counter drug · OTC MONOGRAPH DRUG
Helocaine Cold Sore Fever Blister Treatment NDC 83609-212
tetracaine, mineral · 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 | 83609021202 | 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.
- 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.
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 |
|---|---|---|---|---|
| ZENSEZONE Arthmed Temporary Pain Relief Creamcapsaicin, menthol, methyl salicylate | Capsaicin .25 mg/mL + 2 more ingredients | CreamTopical | ZENSEZONE LLC | 82319-240 |
| Quality Choice Lidocaine Pain Relief Patchlidocaine | Lidocaine 4 g/100g | PatchTopical | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | 83324-257 |
| Opravamethyl salicylate, menthol, capsaicin | Methyl salicylate 10 g/100mL + 2 more ingredients | CreamTopical | Biological M.D. Solutions LLC | 83538-102 |
| LidoGuardlidocaine hcl | Lidocaine hydrochloride 4 g/100g | CreamTopical | ViolaCare, Inc. | 85231-200 |
| Kalaya Extra Strength Pain Relief Gel with Arnicamethyl salicylate, menthol, camphor | Methyl salicylate 11 g/100g + 2 more ingredients | GelTopical | Avaria Health & Beauty Corp | 43493-0012 |
| POINT RELIEF COLD SPOT Pain Relievingmenthol | Menthol 120 mg/mL | GelTopical | FABRICATION ENTERPRISES | 51452-450 |
| NeuroMed 7 Topical Pain Relieflidocaine hydrochloride | Lidocaine hydrochloride 4 g/100g | CreamTopical | Sambria Pharmaceuticals, LLC | 54723-175 |
| Solstice Pain Relievingcamphor, menthol, methyl salicylate | Camphor (Synthetic) 3.1 g/100g + 2 more ingredients | PatchTopical | MADISON ONE ACME INC | 55614-210 |
| Peviderm Pramoxine Hydrocholride 1%pramoxine hydrochloride | Pramoxine hydrochloride 1 mg/mL | LotionTopical | Stratus Pharmaceuticals Inc | 58980-913 |
| Stopain Clinicalmenthol | Menthol 100 mg/g | GelTopical | Troy Manufacturing, Inc. | 63936-9751 |
| Alocane Maxlidocaine hydrochloride and benzalkonium chloride | Lidocaine hydrochloride 4 g/100mL; Benzalkonium chloride .13 g/100mL | GelTopical | Quest Products LLC | 68229-406 |
| Lidocare 034% lidocaine | Lidocaine 4 g/1 | PatchTopical | Kingsway Pharmaceuticals dba NFI, LLC | 69993-400 |
| TheraCare Roll-on Lidocaine Pain Relief Liquid - Lavenderlidocaine hci | Lidocaine 4 g/mL | LiquidTopical | Veridian Healthcare | 71101-088 |
| Re-Lieved Lidocaine Patchlidocaine patch 4% | Lidocaine 18 mg/116cm2 | PatchTopical | Transfer Technology | 71662-000 |
| Nuvalu Ice Therapy Menthol Pain Relievingmenthol | Menthol 3 g/100g | GelTopical | JC SALES | 72520-207 |
| SANA SANA Menthol External Analgesicmenthol | Menthol 150 mg/g | GelTopical | Alquimia Najulam S de RL de CV | 72367-000 |
| Rugby Menthol Hot Cold Patchmenthol | Menthol, Unspecified form 5 g/100g | PatchTopical | RUGBY LABORATORIES | 0536-1332 |
| Careland Lidocaine Plus Menthol Pain Relieving Gel Patcheslidocaine, menthol | Lidocaine 40 mg/g; Menthol 10 mg/g | PatchTopical | Planet (Anhui) Pharmaceutical Co., Ltd. | 75568-051 |
| Lidocaine HCl | Lidocaine hydrochloride anhydrous 5 mg/g | GelTopical | Topco Associates LLC | 76162-034 |
| Itch Relief Gel | Diphenhydramine hydrochloride 2 mg/100mL | GelTopical | Pharma Nobis, LLC | 82645-901 |
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