Over-the-counter drug · OTC MONOGRAPH DRUG
Icy Hot Medicated, Back (Menthol) NDC 62168-0853
Menthol, Unspecified form 428.5 mg/1 · Patch · Topical · Lead Chemical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62168-0853-1 | 6216808530162168085301 | 100 POUCH in 1 CARTON (62168-0853-1) / 5 PATCH in 1 POUCHMarketed from May 19, 2021 | |
| 62168-0853-2 | 6216808530262168085302 | 240 POUCH in 1 CARTON (62168-0853-2) / 1 PATCH in 1 POUCHMarketed from Jun 28, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Icy Hot Medicated, BackSuffix: Medicated, Back
- Generic name (nonproprietary)
- menthol
- Active ingredients
- Menthol, Unspecified form — 428.5 mg/1
- Dosage form
- Patch
- Route
- Topical
- Labeler
- Lead Chemical Co., Ltd.NDC labeler code 62168
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 62168-0853_911ddb13-82db-4388-9693-368d35b0707cSPL ID 911ddb13-82db-4388-9693-368d35b0707cSPL set ID 03d36a89-d055-4cff-aa9f-f8de25c57f77RxCUI 420222UNII 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
N462168085301followed by a unit qualifier and the quantityPackage 62168-0853-01. 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)
Uses – Single Patch Pouch temporarily relieves minor aches and pains of muscles and joints associated with: • arthritis • simple backache • strains • sprains • bruises
Excerpt only. Read the full label for complete information.
About NDC 62168-0853
- What is NDC 62168-0853?
- 62168-0853 is the product NDC for Icy Hot Medicated, Back (menthol), Menthol, Unspecified form 428.5 mg/1 patch, listed with the FDA by Lead Chemical Co., Ltd.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Icy Hot Medicated, Back (Menthol).
- What is the active ingredient?
- Menthol, Unspecified form.
- Who is the labeler?
- Lead Chemical Co., Ltd., NDC labeler code 62168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Icy Hot Medicated, Back?
- 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 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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