Diphenhydramine HCl Oral Solution NDC 57237-318

NDC codes

FDA NDC Directory

Product NDC (as listed)57237-318Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57237-0318Add 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
57237-318-11	57237031811	100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-318-11) / 10 mL in 1 CUP, UNIT-DOSE (57237-318-01)Marketed from Dec 15, 2023

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 Oral Solution
Generic name (nonproprietary): diphenhydramine hcl oral
Active ingredients: Diphenhydramine hydrochloride — 25 mg/10mL
Dosage form: Solution
Route: Oral
Labeler: Rising Pharma Holdings, Inc.
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M009.50
Marketing start: Dec 15, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 57237-318_deb36161-32a5-4e95-9837-fd12ca2c3778SPL ID deb36161-32a5-4e95-9837-fd12ca2c3778SPL set ID 8f0ba9e5-a31d-4d77-8155-c16c7e74edefRxCUI 1049906UNII TC2D6JAD40
Pharmacologic class: Histamine-1 Receptor Antagonist

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

N457237031811 followed by a unit qualifier and the quantity

Package 57237-0318-11. 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 Jul 1, 2025.

Indications (excerpt from the label)

Uses • Temporarily relieves these symptoms due to hay fever or other respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under M009.50

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

FDA NDC Directory listings under M009.50
Product	Strength	Form · route	Labeler	Product NDC
Meclizine HClmeclizine hydrochloride	Meclizine hydrochloride 12.5 mg/1	TabletOral	Rising Pharma Holdings, Inc.	57237-333
Meclizine HClmeclizine hydrochloride chewable	Meclizine hydrochloride 25 mg/1	Tablet, ChewableOral	Rising Pharma Holdings, Inc.	16571-824
Meclizine HClmeclizine hydrochloride chewable	Meclizine hydrochloride 25 mg/1	Tablet, ChewableOral	Bryant Ranch Prepack	71335-9751
Diphenhydramine Oral Liquiddiphenhydramine hydrochloride	Diphenhydramine hydrochloride 12.5 mg/5mL	LiquidOral	Rising Pharma Holdings, Inc.	57237-305
Diphenhydramine HCl Oral Solutiondiphenhydramine hcl oral	Diphenhydramine hydrochloride 12.5 mg/5mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-317