Diphenhydramine HCl and Ibuprofen NDC 58602-717

NDC codes

FDA NDC Directory

Product NDC (as listed)58602-717Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58602-0717Add 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	Copy
58602-717-30	58602071730	160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-717-30)Marketed from Dec 9, 2022

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): Diphenhydramine HCl and Ibuprofen
Generic name (nonproprietary): diphenhydramine hcl and ibuprofen
Active ingredients: Diphenhydramine hydrochloride — 25 mg/1Ibuprofen — 200 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Aurohealth LLC
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210676
Marketing start: Dec 9, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 58602-717_39af6dfa-e822-43a5-bd1a-338cf5da89ceSPL ID 39af6dfa-e822-43a5-bd1a-338cf5da89ceSPL set ID 39af6dfa-e822-43a5-bd1a-338cf5da89ceRxCUI 901814UNII TC2D6JAD40, WK2XYI10QM
Pharmacologic class: Histamine-1 Receptor Antagonist; Nonsteroidal Anti-inflammatory Drug

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

N458602071730 followed by a unit qualifier and the quantity

Package 58602-0717-30. 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 Dec 9, 2022.

Indications (excerpt from the label)

Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210676

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 210676
Product	Strength	Form · route	Labeler	Product NDC
Diphenhydramine HCl and Ibuprofen	Diphenhydramine hydrochloride 25 mg/1; Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Aurohealth LLC	58602-887
Diphenhydramine HCl and Ibuprofen	Diphenhydramine hydrochloride 25 mg/1; Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Aurohealth LLC	58602-814