What is NDC 50580-338?

50580-338 is the product NDC for IMODIUM Multi-Symptom Relief, Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 tablet, listed with the FDA by Kenvue Brands LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

IMODIUM Multi-Symptom Relief (Loperamide hydrochloride and dimethicone).

What is the active ingredient?

Loperamide hydrochloride, Dimethicone.

Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for IMODIUM Multi-Symptom 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.

IMODIUM Multi-Symptom Relief NDC 50580-338

NDC codes

FDA NDC Directory

Product NDC (as listed)50580-338Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50580-0338Add 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 NDC	11-digit (billing)	Package
50580-338-06	50580033806	1 BLISTER PACK in 1 CARTON (50580-338-06) / 6 TABLET in 1 BLISTER PACKMarketed from Mar 31, 2025
50580-338-12	50580033812	2 BLISTER PACK in 1 CARTON (50580-338-12) / 6 TABLET in 1 BLISTER PACKMarketed from Jul 1, 2008
50580-338-18	50580033818	3 BLISTER PACK in 1 CARTON (50580-338-18) / 6 TABLET in 1 BLISTER PACKMarketed from Jul 1, 2008
50580-338-61	50580033861	4 BLISTER PACK in 1 CARTON (50580-338-61) / 6 TABLET in 1 BLISTER PACKMarketed from Jun 24, 2019
50580-338-64	50580033864	4 BLISTER PACK in 1 CARTON (50580-338-64) / 6 TABLET in 1 BLISTER PACKMarketed from Feb 26, 2024

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): IMODIUM Multi-Symptom ReliefSuffix: Multi-Symptom Relief
Generic name (nonproprietary): loperamide hydrochloride and dimethicone
Active ingredients: Loperamide hydrochloride — 2 mg/1Dimethicone — 125 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Kenvue Brands LLCNDC labeler code 50580
Product type: Over-the-counter drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021140
Marketing start: Jul 1, 2008
Listing expires: Dec 31, 2027
Other FDA classes: Opioid Agonists (Mechanism)Skin Barrier Activity (Physiologic effect)
Identifiers: Product ID 50580-338_598d9530-ac42-e032-e063-6394a90a1edcSPL ID 598d9530-ac42-e032-e063-6394a90a1edcSPL set ID ecb91e47-2b0c-47c8-9256-4623d8bc825eRxCUI 978001, 1426827UNII 77TI35393C, 92RU3N3Y1OUPC 0300450212627
Pharmacologic class: Opioid Agonist

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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450580033806 followed by a unit qualifier and the quantity

Package 50580-0338-06. 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 Aug 25, 2026.

Indications (excerpt from the label)

Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50580-338

What is NDC 50580-338?: 50580-338 is the product NDC for IMODIUM Multi-Symptom Relief, Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 tablet, listed with the FDA by Kenvue Brands LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: IMODIUM Multi-Symptom Relief (Loperamide hydrochloride and dimethicone).
What is the active ingredient?: Loperamide hydrochloride, Dimethicone.
Who is the labeler?: Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for IMODIUM Multi-Symptom 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.

IMODIUM Multi-Symptom Relief (Loperamide hydrochloride and dimethicone) NDC 50580-338