Over-the-counter drug · OTC MONOGRAPH DRUG
Pain Release (Menthol) NDC 70983-004
Menthol 1.6 mg/g · Granule · Topical · Saje Natural Business Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70983-004-05 | 7098300040570983000405 | 300 g in 1 BOTTLE, PLASTIC (70983-004-05)Marketed from Jun 29, 2020 | |
| 70983-004-06 | 7098300040670983000406 | 620 g in 1 BOTTLE, PLASTIC (70983-004-06)Marketed from Oct 16, 2016 | |
| 70983-004-07 | 7098300040770983000407 | 1 POUCH in 1 PACKET (70983-004-07) / 120 g in 1 POUCHMarketed from Oct 16, 2016 |
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)
- Pain Release
- Generic name (nonproprietary)
- menthol
- Active ingredients
- Menthol — 1.6 mg/g
- Dosage form
- Granule
- Route
- Topical
- Labeler
- Saje Natural Business Inc.NDC labeler code 70983
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Identifiers
- Product ID 70983-004_484f674c-ba73-e18f-e063-6394a90a896bSPL ID 484f674c-ba73-e18f-e063-6394a90a896bSPL set ID 1ac2ed54-194c-4de2-8e7f-6e74ca32aa40UNII L7T10EIP3A
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
N470983000405followed by a unit qualifier and the quantityPackage 70983-0004-05. 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)
Directions Adults and children 12 years of age and older: Apply to affected area by dissolving 2 teaspoons of salt soak in warm water and soaking area
Excerpt only. Read the full label for complete information.
About NDC 70983-004
- What is NDC 70983-004?
- 70983-004 is the product NDC for Pain Release (menthol), Menthol 1.6 mg/g granule, listed with the FDA by Saje Natural Business Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pain Release (Menthol).
- What is the active ingredient?
- Menthol.
- Who is the labeler?
- Saje Natural Business Inc., NDC labeler code 70983. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pain Release?
- 7 other product NDCs are listed under this name. See all Pain Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pain Release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pain Releasementhol | Menthol 1.6 mg/g | GranuleTopical | Natures Formulae Health Products Ltd. | 69204-005 | 69204-0005-0669204-0005-0769204-0005-08 |
| Pain Releasementhol | Menthol 17.62 mg/mL | OilTopical | Natures Formulae Health Products Ltd. | 69204-007 | 69204-0007-0369204-0007-0469204-0007-05 |
| Pain Releasementhol | Menthol 12.18 mg/mL | OilTopical | Natures Formulae Health Products Ltd. | 69204-008 | 69204-0008-1069204-0008-1169204-0008-12 |
| Pain Releasementhol | Menthol 2.23 mg/mL | LiquidTopical | Saje Natural Business Inc. | 70983-005 | 70983-0005-08 |
| Pain Releasementhol | Menthol 17.62 mg/mL | OilTopical | Saje Natural Business Inc. | 70983-006 | 70983-0006-0370983-0006-0470983-0006-05 |
| Pain Releasementhol | Menthol 12.18 mg/mL | OilTopical | Saje Natural Business Inc. | 70983-007 | 70983-0007-0970983-0007-1070983-0007-11 |
| Pain Releasementhol | — | Kit | Saje Natural Business Inc. | 70983-010 | 70983-0010-12 |
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 |
|---|---|---|---|---|
| Extra Strength Itch Reliefdiphenhydramine hcl and zinc acetate | Diphenhydramine hydrochloride 20 mg/g; Zinc acetate 1 mg/g | SprayTopical | Meijer Distribution Inc | 79481-0598 |
| 3X Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | Rite Aid | 11822-0613 |
| Meijer Pain Relieving Balm Analgesictrolamine salicylate | Trolamine salicylate 10 mg/g | CreamTopical | Meijer Distribution, Inc | 41250-356 |
| Ralli Rapid Pain Relief Roll onmenthol | Menthol 100 mg/mL | GelTopical | Troy Manufacturing, Inc. | 63936-9527 |
| CVS Health Pain Relievingcamphor (synthetic), menthol (unspecified form), methyl salicylate | Camphor (Synthetic) 28 mg/1 + 2 more ingredients | PatchTransdermal | Natural Essentials, Inc. | 66902-280 |
| Pbz Otctripelennamine hcl 1% | Tripelennamine 1 g/100g | CreamTopical | Kingsway Pharmaceuticals dba NFI, LLC | 69993-151 |
| Hydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Henry Schein | 0404-0166 |
| American Safety and First Aidhydrocortisone acetate | Hydrocortisone acetate 10 mg/g | CreamTopical | Orazen Inc | 71927-015 |
| MyDerm Bite Reliefbenzocaine | Benzocaine 5 g/100g | OintmentTopical | Inspec Solutions LLC. | 72667-019 |
| Thera Plus Maximum Strength Hydrocortisonehydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Fourstar Group USA, Inc | 80684-197 |
| Lidocaine 4% | Lidocaine 400 mg/10g | PatchTransdermal | Marcella Health | 85096-201 |
| Tough Love Pain Relievinglidocaine hcl | Lidocaine 4 g/100g | CreamTopical | Allure Labs | 62742-4222 |
| Stopain Extra Strength Gelmenthol | Menthol 80 mg/mL | GelTopical | Troy Manufacturing, Inc. | 63936-9506 |
| Fast Freeze Lidocaine Roll-Onlidocaine hydrochloride, benzyl alcohol | Lidocaine hydrochloride 40 mg/mL; Benzyl alcohol 10 mg/mL | LiquidTopical | Natural Essentials, Inc. | 66902-235 |
| Walgreens pain relievinglidocaine 4% | Lidocaine 4 g/100g | Aerosol, SprayTopical | Walgreens | 0363-3038 |
| Bikini Zone Medicated Cremelidocaine | Lidocaine 2 g/100g | CreamTopical | Kingsway Pharmaceuticals dba NFI, LLC | 69993-043 |
| American Safety First Aidlidocaine hcl | Lidocaine hydrochloride 20 mg/mL | SprayTopical | Orazen Inc | 71927-012 |
| ACOLYE Lidocaine Cream Topical Analgesia Creamlidocaine,menthol | Lidocaine 4 g/100g; Menthol 1 g/100g | CreamTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-617 |
| Healmusz Eczemahydrocortisone 1% eczema | Hydrocortisone 1 g/100g | CreamTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-203 |
| ELAIMEI Numbing Creamlidocaine 4% | Lidocaine 4 g/100mL | CreamTopical | Shenzhen Shandian Jingling Technology Co., Ltd. | 83804-005 |
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