What is NDC 58602-814?

58602-814 is the product NDC for Diphenhydramine HCl and Ibuprofen, Diphenhydramine hydrochloride 25 mg/1; Ibuprofen 200 mg/1 capsule, liquid filled, listed with the FDA by Aurohealth LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Diphenhydramine hydrochloride, Ibuprofen.

Aurohealth LLC, NDC labeler code 58602. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Diphenhydramine HCl and Ibuprofen?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diphenhydramine HCl and Ibuprofen NDC 58602-814

NDC codes

FDA NDC Directory

Product NDC (as listed)58602-814Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58602-0814Add 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
58602-814-10	5860208141058602081410	1 BOTTLE in 1 CARTON (58602-814-10) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Feb 14, 2019
58602-814-12	5860208141258602081412	1 BOTTLE in 1 CARTON (58602-814-12) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Feb 14, 2019
58602-814-18	5860208141858602081418	1 BOTTLE in 1 CARTON (58602-814-18) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Feb 14, 2019
58602-814-23	5860208142358602081423	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-814-23)Marketed from Feb 14, 2019
58602-814-30	5860208143058602081430	160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-814-30)Marketed from Feb 14, 2019
58602-814-73	5860208147358602081473	1 BOTTLE in 1 CARTON (58602-814-73) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Feb 14, 2019

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 LLCNDC labeler code 58602
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210676
Marketing start: Feb 14, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 58602-814_8cd3b0a3-8a94-4cca-a6a7-f144a826f122SPL ID 8cd3b0a3-8a94-4cca-a6a7-f144a826f122SPL set ID a656f8b0-8cb4-4802-b8d3-7b95c0265d56RxCUI 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

N458602081410 followed by a unit qualifier and the quantity

Package 58602-0814-10. 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 Feb 21, 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)

About NDC 58602-814

What is NDC 58602-814?: 58602-814 is the product NDC for Diphenhydramine HCl and Ibuprofen, Diphenhydramine hydrochloride 25 mg/1; Ibuprofen 200 mg/1 capsule, liquid filled, listed with the FDA by Aurohealth LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diphenhydramine HCl and Ibuprofen.
What is the active ingredient?: Diphenhydramine hydrochloride, Ibuprofen.
Who is the labeler?: Aurohealth LLC, NDC labeler code 58602. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Diphenhydramine HCl and Ibuprofen?: 2 other product NDCs are listed under this name. See all Diphenhydramine HCl and Ibuprofen NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Diphenhydramine HCl and Ibuprofen NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diphenhydramine HCl and Ibuprofen	Diphenhydramine hydrochloride 25 mg/1; Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Aurohealth LLC	58602-717	58602-0717-30
Diphenhydramine HCl and Ibuprofen	Diphenhydramine hydrochloride 25 mg/1; Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Aurohealth LLC	58602-887	58602-0887-1058602-0887-1258602-0887-18+3 more

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	58602-717
Diphenhydramine HCl and Ibuprofen	Diphenhydramine hydrochloride 25 mg/1; Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Aurohealth LLC	58602-887