What is NDC 57237-305?

57237-305 is the product NDC for Diphenhydramine Oral Liquid (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 12.5 mg/5mL liquid, listed with the FDA by Rising Pharma Holdings, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Diphenhydramine Oral Liquid (Diphenhydramine Hydrochloride).

Rising Pharma Holdings, Inc., NDC labeler code 57237. 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 Oral Liquid?

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.

Diphenhydramine Oral Liquid NDC 57237-305

NDC codes

FDA NDC Directory

Product NDC (as listed)57237-305Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57237-0305Add 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
57237-305-12	5723703051257237030512	118 mL in 1 BOTTLE (57237-305-12)Marketed from Dec 19, 2022
57237-305-16	5723703051657237030516	473 mL in 1 BOTTLE (57237-305-16)Marketed from Dec 19, 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 Oral Liquid
Generic name (nonproprietary): diphenhydramine hydrochloride
Active ingredients: Diphenhydramine hydrochloride — 12.5 mg/5mL
Dosage form: Liquid
Route: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 57237
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M009.50
Marketing start: Dec 19, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 57237-305_952598aa-cb50-400d-85da-e8acab206e5aSPL ID 952598aa-cb50-400d-85da-e8acab206e5aSPL set ID d8462e6f-a9fb-4701-97e2-d81a47f3e196RxCUI 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

N457237030512 followed by a unit qualifier and the quantity

Package 57237-0305-12. 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 Oct 18, 2024.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57237-305

What is NDC 57237-305?: 57237-305 is the product NDC for Diphenhydramine Oral Liquid (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 12.5 mg/5mL liquid, listed with the FDA by Rising Pharma Holdings, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diphenhydramine Oral Liquid (Diphenhydramine Hydrochloride).
What is the active ingredient?: Diphenhydramine hydrochloride.
Who is the labeler?: Rising Pharma Holdings, Inc., NDC labeler code 57237. 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 Oral Liquid?: 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.

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
Diphenhydramine HCl Oral Solutiondiphenhydramine hcl oral	Diphenhydramine hydrochloride 12.5 mg/5mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-317
Diphenhydramine HCl Oral Solutiondiphenhydramine hcl oral	Diphenhydramine hydrochloride 25 mg/10mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-318
Meclizine HClmeclizine hydrochloride chewable	Meclizine hydrochloride 25 mg/1	Tablet, ChewableOral	Rising Pharma Holdings, Inc.	16571-824
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	Bryant Ranch Prepack	71335-9751

Diphenhydramine Oral Liquid (Diphenhydramine hydrochloride) NDC 57237-305