Over-the-counter drug · OTC MONOGRAPH DRUG
Pain Be Gone (Menthol) NDC 82721-001
Menthol 9.6 mg/mL · Cream · Topical · Back to Earth Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82721-001-01 | 8272100010182721000101 | 50 mL in 1 TUBE (82721-001-01)Marketed from Jul 27, 2023 | |
| 82721-001-02 | 8272100010282721000102 | 120 mL in 1 TUBE (82721-001-02)Marketed from Jul 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)
- Pain Be Gone
- Generic name (nonproprietary)
- menthol
- Active ingredients
- Menthol — 9.6 mg/mL
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Back to Earth Inc.NDC labeler code 82721
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 014
- Marketing start
- Listing expires
- Identifiers
- Product ID 82721-001_2ce15484-38f2-014d-e063-6294a90aced2SPL ID 2ce15484-38f2-014d-e063-6294a90aced2SPL set ID f49e718b-ef89-b648-e053-2a95a90a96c8UNII 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
N482721000101followed by a unit qualifier and the quantityPackage 82721-0001-01. 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)
■ For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. For penetrating pain relief.
Excerpt only. Read the full label for complete information.
About NDC 82721-001
- What is NDC 82721-001?
- 82721-001 is the product NDC for Pain Be Gone (menthol), Menthol 9.6 mg/mL cream, listed with the FDA by Back to Earth Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pain Be Gone (Menthol).
- What is the active ingredient?
- Menthol.
- Who is the labeler?
- Back to Earth Inc., NDC labeler code 82721. 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 Be Gone?
- 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 014
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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