Over-the-counter drug · OTC MONOGRAPH DRUG
BRONSON SOOTHE Pain Relief (Capsaicin) NDC 83158-387
Capsaicin .25 mg/mL · Cream · Topical · BRONSON NUTRITIONALS, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83158-387-02 | 83158038702 | 59 mL in 1 TUBE (83158-387-02)Marketed from Dec 26, 2022 | |
| 83158-387-04 | 83158038704 | 118 mL in 1 TUBE (83158-387-04)Marketed from Dec 26, 2022 |
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)
- BRONSON SOOTHE Pain Relief
- Generic name (nonproprietary)
- capsaicin
- Active ingredients
- Capsaicin — .25 mg/mL
- Dosage form
- Cream
- Route
- Topical
- Labeler
- BRONSON NUTRITIONALS, LLCNDC labeler code 83158
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Identifiers
- Product ID 83158-387_0976edf3-b97e-fff9-e063-6294a90a2c4eSPL ID 0976edf3-b97e-fff9-e063-6294a90a2c4eSPL set ID cedf8f43-b9a3-4a06-b3a1-cf82668541f8RxCUI 198555UNII S07O44R1ZMUPC 0716563614041, 0716563614010
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
N483158038702followed by a unit qualifier and the quantityPackage 83158-0387-02. 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 temporary relief of minor aches and pains of the muscles and joints associted with simple backache, arthritis, strains, bruises and sprains.
Excerpt only. Read the full label for complete information.
About NDC 83158-387
- What is NDC 83158-387?
- 83158-387 is the product NDC for BRONSON SOOTHE Pain Relief (capsaicin), Capsaicin .25 mg/mL cream, listed with the FDA by BRONSON NUTRITIONALS, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- BRONSON SOOTHE Pain Relief (Capsaicin).
- What is the active ingredient?
- Capsaicin.
- Who is the labeler?
- BRONSON NUTRITIONALS, LLC, NDC labeler code 83158. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for BRONSON SOOTHE 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 |
|---|---|---|---|---|
| Dr.Harry COMFORT ZONE Creamlidocaine 4% phenylephrine hcl 0.25% comfort zone cream | Phenylephrine hydrochloride .25 g/100g; Lidocaine 4 g/100g | CreamTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-162 |
| Itch Relief Gel | Diphenhydramine hydrochloride 2 mg/100mL | GelTopical | Pharma Nobis, LLC | 82645-901 |
| Cintheralidocaine | Lidocaine .04 g/g | OintmentCutaneous | Strand Health Group | 83295-8000 |
| Trojan Extended Pleasurebenzocaine | Benzocaine 4.5 g/60mL | SprayTopical | Church & Dwight Co., Inc. | 10237-200 |
| Lightning Products BURN RELIEFlidocaine hydrochloride | Lidocaine hydrochloride 2 g/100mL | SprayTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-070 |
| Methyl Salicylate | Methyl salicylate 250 mg/g | CreamTopical | Alexso, Inc | 50488-1015 |
| Pramoxine Itch reliefpramoxine hcl 1% | Pramoxine hydrochloride 1 g/100g | CreamTopical | CVS | 51316-141 |
| Hydrocortisone with Aloehydrocortisone cream 1/2% | Hydrocortisone .5 g/100g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-5335 |
| Biofreeze Mentholmenthol, unspecified form | Menthol, Unspecified form .05 g/g | PatchTopical | Reckitt Benckiser LLC | 59316-992 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/g | GelTopical | Safetec of America, Inc. | 61010-5000 |
| Family Care Anti-Itchhydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | United Exchange Corp. | 65923-494 |
| Hydrocortisonehydrocortisone 1% | Hydrocortisone 1 g/100g | CreamTopical | Pharmacy Value Alliance LLC | 68016-149 |
| GeriGentle FrostyHeat Pain Relief Patch Backmenthol | Menthol 50 mg/mL | PatchTopical | Geri-Gentle Corporation | 69771-012 |
| Lidocare Arm, Neck, Leg4% lidocaine | Lidocaine 11 mg/1 | PatchTopical | Kingsway Pharmaceuticals dba NFI, LLC | 69993-450 |
| HealthWise Lidocaine Plus Menthol Patchlidocaine and menthol | Lidocaine 4 g/100g; Menthol 1 g/100g | PatchTopical | Veridian Healthcare | 71101-062 |
| Careland Plantar Fasciitis Hydrogel Pain Patcheslidocaine, menthol | Lidocaine 40 mg/g; Menthol 10 mg/g | PatchTopical | Planet (Anhui) Pharmaceutical Co., Ltd. | 75568-017 |
| Reinreude Back Pain Therapycamphor 80mg menthol 24mg capsicum extract 16mg back pain therapy | Capsicum 16 mg/1001 + 2 more ingredients | PatchTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-159 |
| Toast Screamin Hotcapsaicin | Capsaicin .1 g/100g | CreamTopical | IDEAZ, LLC | 78983-102 |
| PUREGEN LABS Pain Relief 4 Lidocainelidocaine | Lidocaine 40 mg/g | PatchTopical | Advanced Rx LLC | 80513-814 |
| Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skinhydrocortisone | Hydrocortisone .5 g/100g | CreamTopical | AmerisourceBergen | 24385-190 |
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