Over-the-counter drug · OTC MONOGRAPH DRUG
Diphenhydramine HCl Oral Solution (Diphenhydramine hcl oral) NDC 57237-317
Diphenhydramine hydrochloride 12.5 mg/5mL · Solution · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-317-51 | 5723703175157237031751 | 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-317-51) / 5 mL in 1 CUP, UNIT-DOSE (57237-317-05)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 — 12.5 mg/5mL
- Dosage form
- Solution
- 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
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 57237-317_1478d628-1d0d-491f-b68f-5281dd2ced76SPL ID 1478d628-1d0d-491f-b68f-5281dd2ced76SPL set ID 7406e4e4-3093-4cd1-80ce-93f7b6db2a87RxCUI 1049906UNII TC2D6JAD40UPC 0357237317518
- 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
N457237031751followed by a unit qualifier and the quantityPackage 57237-0317-51. 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 .
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.
About NDC 57237-317
- What is NDC 57237-317?
- 57237-317 is the product NDC for Diphenhydramine HCl Oral Solution, Diphenhydramine hydrochloride 12.5 mg/5mL solution, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diphenhydramine HCl Oral Solution (Diphenhydramine HCl Oral).
- 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 HCl Oral Solution?
- 6 other product NDCs are listed under this name. See all Diphenhydramine HCl Oral Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diphenhydramine HCl Oral Solution products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diphenhydramine HCl Oral Solution | Diphenhydramine HCl 12.5 mg/5mL | SolutionOral | Kesin Pharma Corporation | 81033-029 | 81033-0029-16 |
| Diphenhydramine HCl Oral Solutiondiphenhydramine hcl oral | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Everpharm LLC | 84415-012 | 84415-0012-01 |
| Diphenhydramine HCl Oral Solutiondiphenhydramine hcl oral | Diphenhydramine hydrochloride 25 mg/10mL | SolutionOral | Everpharm LLC | 84415-013 | 84415-0013-01 |
| Diphenhydramine HCl Oral Solutiondiphenhydramine hcl oral | Diphenhydramine hydrochloride 25 mg/10mL | SolutionOral | Rising Pharma Holdings, Inc. | 57237-318 | 57237-0318-11 |
| Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Natco Pharma USA LLC | 69339-151 | 69339-0151-1769339-0151-19 |
| Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/10mL | SolutionOral | Natco Pharma USA LLC | 69339-152 | 69339-0152-1769339-0152-19 |
Other NDCs under M009.50
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Diphenhydramine HCl Oral Solutiondiphenhydramine hcl oral | Diphenhydramine hydrochloride 25 mg/10mL | SolutionOral | Rising Pharma Holdings, Inc. | 57237-318 |
| Diphenhydramine Oral Liquiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | Rising Pharma Holdings, Inc. | 57237-305 |
| 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 |