Over-the-counter drug · OTC MONOGRAPH DRUG
PURE EASE Joint Muscle lnstant Pain Relief (Capsaicin, menthol) NDC 83676-435
Capsaicin .25 mg/mL; Menthol 80 mg/mL · Cream · Topical · SERENU, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83676-435-00 | 83676043500 | 60 mL in 1 JAR (83676-435-00)Marketed from Nov 27, 2023 |
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)
- PURE EASE Joint Muscle lnstant Pain Relief
- Generic name (nonproprietary)
- capsaicin, menthol
- Dosage form
- Cream
- Route
- Topical
- Labeler
- SERENU, INC.NDC labeler code 83676
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Identifiers
- Product ID 83676-435_0a063d7f-23a2-c949-e063-6294a90a5b57SPL ID 0a063d7f-23a2-c949-e063-6294a90a5b57SPL set ID 42bf129c-5c84-4331-b6d0-78e3be71a985UNII S07O44R1ZM, L7T10EIP3AUPC 9145550944204
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
N483676043500followed by a unit qualifier and the quantityPackage 83676-0435-00. 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 minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains. Provides cooling pain relief.
Excerpt only. Read the full label for complete information.
About NDC 83676-435
- What is NDC 83676-435?
- 83676-435 is the product NDC for PURE EASE Joint Muscle lnstant Pain Relief, Capsaicin .25 mg/mL; Menthol 80 mg/mL cream, listed with the FDA by SERENU, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- PURE EASE Joint Muscle lnstant Pain Relief (Capsaicin, Menthol).
- What is the active ingredient?
- Capsaicin, Menthol.
- Who is the labeler?
- SERENU, INC., NDC labeler code 83676. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for PURE EASE Joint Muscle lnstant Pain Relief?
- 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 |
|---|---|---|---|---|
| 0.5% Lidocaine Burn Relieflidocaine hydrochloride | Lidocaine hydrochloride .5 g/100g | GelTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-099 |
| 0.5% Lidocaine Burn Relieflidocaine hydrochloride | Lidocaine hydrochloride .5 g/100g | GelTopical | Universal Distribution Center LLC | 52000-437 |
| 1% Hydrocortisone Anti-itch | Hydrocortisone 10 mg/g | CreamTopical | ALAINA HEALTHCARE PRIVATE LIMITED | 73492-291 |
| 10% Methyl Salicylate Pain Relief Patch10% methyl salicylate | Methyl salicylate 10 mg/100mg | TapeTopical | Akron Coating & Adhesives | 65604-222 |
| 11681168 burn spray | Lidocaine hydrochloride .02 mg/mL | SprayTopical | Dynarex Corporation | 67777-013 |
| 2.0% Lidocaine Burnlidocaine hydrochloride | Lidocaine hydrochloride 2 g/100mL | SprayTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-097 |
| 2.0% Lidocaine Burnlidocaine hydrochloride | Lidocaine hydrochloride 2 g/100mL | SprayTopical | Universal Distribution Center LLC | 52000-441 |
| 2.5% Menthol PAIN RELIEFmenthol | Menthol, Unspecified form 25 mg/g | GelTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-096 |
| 2.5% Menthol PAIN RELIEFmenthol | Menthol, Unspecified form 25 mg/g | GelTopical | Universal Distribution Center LLC | 52000-440 |
| 24 7 Relief and Recovery Pain Relievingmenthol, unspecified form | Menthol, Unspecified form 37 mg/mL | CreamTopical | Triplicare Inc | 87656-964 |
| 2677 First Aid Burn Cream | Benzalkonium chloride 13 mg/10000mg; Lidocaine hydrochloride 50 mg/10000mg | CreamTopical | ProStat First Aid LLC | 58228-2677 |
| 2nd CHANCE MOBILITY Pain Reliefhistamine dihydrochloride | Histamine dihydrochloride .5 mg/g | CreamTopical | ALPHA NUTRITION, LLC | 83984-441 |
| 365 Medicated Lip Balmmedicated lip balm | Camphor (Natural) .0578 g/4.25g | StickTopical | Whole Foods Market, Inc. | 42681-0001 |
| 3X Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | Rite Aid | 11822-0613 |
| 4 Lidocaine Topical Anestheticlidocaine | Lidocaine 40 mg/g | CreamTopical | RUGBY LABORATORIES | 0536-1267 |
| 4% Lidocaine Maximum Strength Pain Relieflidocaine | Lidocaine .04 g/1 | PatchTopical | Shenzhen Finona Information Technology Co., Ltd | 85839-011 |
| 4% Lidocaine Pain Relief Patchlidocaine 4% | Lidocaine .04 g/1 | PatchTransdermal | Guangxi Keyun E-commerce Co., Ltd. | 87278-003 |
| 4% Lidocaine Pain Relief Patchlidocaine 4% | Lidocaine .04 g/1 | PatchTransdermal | Guangxi Keyun E-commerce Co., Ltd. | 87278-020 |
| 4% Lidocaine Patches4% lidocaine | Lidocaine 40 mg/1 | PatchTopical | Shenzhen Huayuan Hengsheng Technology Co., Ltd. | 87394-002 |
| 4% Lidocaine Patches | Lidocaine 4 g/1001 | PatchTopical | Shenzhen Chaoxiji Technology Co.,Ltd. | 87794-006 |
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