Over-the-counter drug · OTC MONOGRAPH DRUG
XtraCare Ice Cold Topical Analgesic Gel (Menthol) NDC 57337-052
Menthol 3 g/227g · Gel · Topical · Rejoice International
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57337-052-01 | 5733700520157337005201 | 227 g in 1 BOTTLE (57337-052-01)Marketed from Jan 30, 2014 | |
| 57337-052-02 | 5733700520257337005202 | 227 g in 1 TUBE (57337-052-02)Marketed from Jan 30, 2014 |
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)
- XtraCare Ice Cold Topical Analgesic Gel
- Generic name (nonproprietary)
- menthol
- Active ingredients
- Menthol — 3 g/227g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Rejoice InternationalNDC labeler code 57337
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Identifiers
- Product ID 57337-052_087f5ceb-0e96-0c3a-e063-6394a90acfc7SPL ID 087f5ceb-0e96-0c3a-e063-6394a90acfc7SPL set ID d38f3099-d940-44d8-aa7f-404157c5e0e3RxCUI 866128UNII L7T10EIP3AUPC 0849607059307
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
N457337005201followed by a unit qualifier and the quantityPackage 57337-0052-01. 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)
XtraCare® Ice Cold Topical Analgesic Gel Net Wt 8 oz (227 g)
Excerpt only. Read the full label for complete information.
About NDC 57337-052
- What is NDC 57337-052?
- 57337-052 is the product NDC for XtraCare Ice Cold Topical Analgesic Gel, Menthol 3 g/227g gel, listed with the FDA by Rejoice International. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- XtraCare Ice Cold Topical Analgesic Gel (Menthol).
- What is the active ingredient?
- Menthol.
- Who is the labeler?
- Rejoice International, NDC labeler code 57337. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for XtraCare Ice Cold Topical Analgesic Gel?
- 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 |
|---|---|---|---|---|
| COLD HOT CHINESE RED TIGER PAIN RELIEF GeI-Patchmenthol | Menthol .05 g/g | PatchTopical | Guangzhou Zhupuyou E-commerce Co., Ltd | 84165-004 |
| Subleef NUMBINGlidocaine4% numbing | Lidocaine 4 g/100g | CreamTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-052 |
| Richtofit Rapid Active Arthritismenthol and camphor | Menthol 5 g/100g; Camphor (Synthetic) 4 g/100g | GelTopical | RICHTOFIT LIMITED LIABILITY COMPANY | 87384-058 |
| Meijer Pain Relief Patcheslidocaine | Lidocaine 4 g/100g | PatchTopical | Meijer Distribution Inc | 41250-625 |
| Anti Itchhydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | HyVee Inc | 42507-319 |
| Praxpramoxine hydrochloride | Pramoxine hydrochloride 10 mg/mL | LotionTopical | AvPAK | 50268-682 |
| Itch Reliefdiphenhydramine hydrochloride, zinc acetate | Diphenhydramine hydrochloride 2 g/100g; Zinc acetate .1 g/100g | CreamTopical | CVS Pharmacy | 59779-708 |
| Instaflex Pain Relief Creammenthol | Menthol 12.5 mg/g | CreamTopical | Healthy Directions, LLC | 70015-665 |
| Lidocaine Pain Relief Gel Roll-Onlidocaine | Menthol .01 g/mL; Lidocaine .04 g/mL | GelTopical | Guangzhou Zhupuyou E-commerce Co., Ltd | 84165-003 |
| Pain Reliefmenthol methysalicylate | Menthol 10 g/100g; Methyl salicylate 15 g/100g | CreamTopical | Guchutang Biotechnology (Longyan) Co., Ltd | 87083-013 |
| Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skinhydrocortisone | Hydrocortisone .5 g/100g | CreamTopical | AmerisourceBergen | 24385-190 |
| Outgrobenzocaine | Benzocaine 18.6 g/100mL | LiquidTopical | Medtech Products Inc. | 63029-531 |
| Zensalidocaine | Lidocaine 4 g/100g | CreamTopical | Alera Skin Care Products Inc. | 69805-788 |
| Human Science Muscle Pain Reliefmethyl salicylate, menthol | Methyl salicylate 100 mg/mL; Menthol 100 mg/mL | CreamTopical | Human Science, LLC | 71356-818 |
| BiteMD External Analgesic First Aid Antisepticbenzocaine, camphor (synthetic), and phenol | Benzocaine .0524 mg/mL + 2 more ingredients | LiquidTopical | United Industries Corporation | 79364-0932 |
| Arctic Icementhol | Menthol 1.25 g/100g | GelTopical | PRIMAL ELEMENTS | 80801-105 |
| Stalliondelay creme | Benzocaine 5 g/100mL | CreamTopical | Novelties by Nasswalk, Inc. | 83608-100 |
| MedFreeze Naturally Cool Pain Reliefmenthol | Menthol 120 mg/mL | LiquidTopical | MEDKO LLC | 84443-487 |
| Hemp Magic Fast-Acting Pain Relief Creammenthol | Menthol 3 g/100g | CreamTopical | Nexxus Capital LLC | 85294-001 |
| Zkbb Arthritis Pain Reliefmethyl salicylate, camphor and capsaicin | Methyl salicylate 10 g/100g + 2 more ingredients | CreamTopical | Guchutang Biotechnology (Longyan) Co.,Ltd. | 87083-016 |
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