What is NDC 58602-867?

58602-867 is the product NDC for Ibuprofen and Diphenhydramine Citrate, Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 tablet, coated, listed with the FDA by Aurohealth LLC. It has 17 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Ibuprofen, Diphenhydramine citrate.

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 Ibuprofen and Diphenhydramine Citrate?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ibuprofen and Diphenhydramine Citrate NDC 58602-867

NDC codes

FDA NDC Directory

Product NDC (as listed)58602-867Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58602-0867Add 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
58602-867-09	5860208670958602086709	1 BOTTLE in 1 CARTON (58602-867-09) / 30 TABLET, COATED in 1 BOTTLEMarketed from May 31, 2022
58602-867-12	5860208671258602086712	1 BOTTLE in 1 CARTON (58602-867-12) / 40 TABLET, COATED in 1 BOTTLEMarketed from May 31, 2022
58602-867-14	5860208671458602086714	1 BOTTLE in 1 CARTON (58602-867-14) / 50 TABLET, COATED in 1 BOTTLEMarketed from May 31, 2022
58602-867-18	5860208671858602086718	1 BOTTLE in 1 CARTON (58602-867-18) / 80 TABLET, COATED in 1 BOTTLEMarketed from May 31, 2022
58602-867-21	5860208672158602086721	1 BOTTLE in 1 CARTON (58602-867-21) / 100 TABLET, COATED in 1 BOTTLEMarketed from May 31, 2022
58602-867-23	5860208672358602086723	1 BOTTLE in 1 CARTON (58602-867-23) / 120 TABLET, COATED in 1 BOTTLEMarketed from May 31, 2022
58602-867-27	5860208672758602086727	140 TABLET, COATED in 1 BOTTLE (58602-867-27)Marketed from May 31, 2022
58602-867-32	5860208673258602086732	180 TABLET, COATED in 1 BOTTLE (58602-867-32)Marketed from May 31, 2022
58602-867-34	5860208673458602086734	200 TABLET, COATED in 1 BOTTLE (58602-867-34)Marketed from May 31, 2022
58602-867-46	5860208674658602086746	140 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-46)Marketed from May 31, 2022
58602-867-70	5860208677058602086770	1 BOTTLE, PLASTIC in 1 CARTON (58602-867-70) / 40 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from May 31, 2022
58602-867-72	5860208677258602086772	1 BOTTLE, PLASTIC in 1 CARTON (58602-867-72) / 80 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from May 31, 2022
58602-867-73	5860208677358602086773	1 BOTTLE in 1 CARTON (58602-867-73) / 20 TABLET, COATED in 1 BOTTLEMarketed from May 31, 2022
58602-867-78	5860208677858602086778	1 BOTTLE, PLASTIC in 1 CARTON (58602-867-78) / 50 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from May 31, 2022
58602-867-80	5860208678058602086780	200 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-80)Marketed from May 31, 2022
58602-867-92	5860208679258602086792	180 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-92)Marketed from May 31, 2022
58602-867-97	5860208679758602086797	120 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-97)Marketed from May 31, 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): Ibuprofen and Diphenhydramine Citrate
Generic name (nonproprietary): ibuprofen and diphenhydramine citrate
Active ingredients: Ibuprofen — 200 mg/1Diphenhydramine citrate — 38 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Aurohealth LLCNDC labeler code 58602
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216204
Marketing start: May 31, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 58602-867_21c1f5c5-19fa-4a59-bad3-ea85fd37471bSPL ID 21c1f5c5-19fa-4a59-bad3-ea85fd37471bSPL set ID 21c1f5c5-19fa-4a59-bad3-ea85fd37471bRxCUI 895664UNII WK2XYI10QM, 4OD433S209
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

N458602086709 followed by a unit qualifier and the quantity

Package 58602-0867-09. 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 Jun 3, 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 58602-867

What is NDC 58602-867?: 58602-867 is the product NDC for Ibuprofen and Diphenhydramine Citrate, Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 tablet, coated, listed with the FDA by Aurohealth LLC. It has 17 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ibuprofen and Diphenhydramine Citrate.
What is the active ingredient?: Ibuprofen, Diphenhydramine citrate.
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 Ibuprofen and Diphenhydramine Citrate?: 2 other product NDCs are listed under this name. See all Ibuprofen and Diphenhydramine Citrate 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 Ibuprofen and Diphenhydramine Citrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ibuprofen and Diphenhydramine Citrate	Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1	Tablet, CoatedOral	Better Living Brands, LLC	21130-228	21130-0228-1221130-0228-1821130-0228-23+1 more
Ibuprofen and Diphenhydramine Citrate	Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1	TabletOral	Dr. Reddy's Laboratories Limited	55111-565	55111-0565-0555111-0565-1455111-0565-18+5 more

Other NDCs under ANDA 216204

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

FDA NDC Directory listings under ANDA 216204
Product	Strength	Form · route	Labeler	Product NDC
Amazon Basic Care Ibuprofen PMibuprofen and diphenhydramine citrate	Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1	Tablet, CoatedOral	Amazon.com Services LLC	72288-061
Ibuprofen and Diphenhydramine Citrate	Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1	Tablet, CoatedOral	Better Living Brands, LLC	21130-228
Ibuprofen PMibuprofen and diphenhydramine citrate	Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1	Tablet, CoatedOral	KROGER COMPANY	30142-278