NDC codes

FDA NDC Directory
Product NDC (as listed)58368-002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58368-0002Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
58368-002-02583680002025836800020256.7 g in 1 BOTTLE, PUMP (58368-002-02)Marketed from Feb 1, 2017

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

Generic name (nonproprietary)
topical gel for muscle cramping and restlessness
Active ingredients
Causticum — 4 [hp_X]/gJatropha curcas seed — 8 [hp_X]/gFrangula californica bark — 4 [hp_X]/gRuta graveolens flowering top — 4 [hp_X]/gArnica montana — 4 [hp_X]/gAtropa belladonna root — 4 [hp_X]/gBlack cohosh — 4 [hp_X]/gArtemisia cina pre-flowering top — 8 [hp_X]/gPseudognaphalium obtusifolium — 4 [hp_X]/gHypericum perforatum — 4 [hp_X]/gStrychnos ignatii seed — 4 [hp_X]/gPotassium bromide — 4 [hp_X]/gPotassium carbonate — 4 [hp_X]/gLycopodium clavatum spore — 4 [hp_X]/gScutellaria lateriflora — 4 [hp_X]/gTaraxacum officinale — 4 [hp_X]/gValerian — 8 [hp_X]/gVeratrum album root — 8 [hp_X]/g
Dosage form
Gel
Route
Topical
Labeler
BioLyte Laboratories, LLCNDC labeler code 58368
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Identifiers
Product ID 58368-002_4960b345-0a8e-7316-e063-6394a90abe8fSPL ID 4960b345-0a8e-7316-e063-6394a90abe8fSPL set ID 46da3f0e-9dd1-6495-e054-00144ff8d46cUNII DD5FO1WKFU, J0F5GM8LA8, 1LZ13MQR0S, N94C2U587S, O80TY208ZW, 6MW97Q6E8M, K73E24S6X9, 28M1820ACT, 36XQ854NWW, XK4IUX8MNB, 1NM3M2487K, OSD78555ZM, BQN1B9B9HA, C88X29Y479, 7BP4DH5PDC, 39981FM375, JWF5YAW3QW, QNS6W5US1Z

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

N458368000202 followed by a unit qualifier and the quantity

Package 58368-0002-02. 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 occasional muscle cramps, restlessness and twitching

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58368-002

What is NDC 58368-002?
58368-002 is the product NDC for Neorelief For Muscle Crampling And Restlessness, Causticum 4 [hp_X]/g + 17 more ingredients gel, listed with the FDA by BioLyte Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Neorelief For Muscle Crampling And Restlessness (Topical gel for muscle cramping and restlessness).
What is the active ingredient?
Causticum, Jatropha curcas seed, Frangula californica bark, Ruta graveolens flowering top, Arnica montana, Atropa belladonna root, Black cohosh, Artemisia cina pre-flowering top, Pseudognaphalium obtusifolium, Hypericum perforatum, Strychnos ignatii seed, Potassium bromide, Potassium carbonate, Lycopodium clavatum spore, Scutellaria lateriflora, Taraxacum officinale, Valerian, Veratrum album root.
Who is the labeler?
BioLyte Laboratories, LLC, NDC labeler code 58368. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Neorelief For Muscle Crampling And Restlessness?
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.

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