Prescription drug · ANDA
Diphenhydramine HCL (Diphenhydramine hydrochloride) NDC 71741-511
Diphenhydramine hydrochloride 12.5 mg/5mL · Solution · Oral · Redmont Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71741-511-04 | 7174105110471741051104 | 118 mL in 1 BOTTLE (71741-511-04)Marketed from Jul 22, 2026 |
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
- Generic name (nonproprietary)
- diphenhydramine hydrochloride
- Active ingredients
- Diphenhydramine hydrochloride — 12.5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Redmont Pharmaceuticals, LLCNDC labeler code 71741
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 087513
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71741-511_b70e7c6f-aaf1-40dd-8e7b-09215db5b4acSPL ID b70e7c6f-aaf1-40dd-8e7b-09215db5b4acSPL set ID d8944f3c-acef-4ebe-9633-7d641ae95edfRxCUI 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
N471741051104followed by a unit qualifier and the quantityPackage 71741-0511-04. 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)
INDICATIONS AND USAGE Diphenhydramine hydrochloride in the oral form is effective for the following indications: Antihistaminic For allergic conjunctivitis due to foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. Motion Sickness For active and prophylactic treatment of motion sickness. Antiparkinsonism For parkinsonism (including drug-induced) in the elderly unable to tolerate more potent agents; mild cases of parkinsonism (including drug-induc…
Excerpt only. Read the full label for complete information.
About NDC 71741-511
- What is NDC 71741-511?
- 71741-511 is the product NDC for Diphenhydramine HCL (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 12.5 mg/5mL solution, listed with the FDA by Redmont Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diphenhydramine HCL (Diphenhydramine Hydrochloride).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Redmont Pharmaceuticals, LLC, NDC labeler code 71741. 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?
- 34 other product NDCs are listed under this name. See all Diphenhydramine HCL 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 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 HCldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/10mL | SolutionOral | Major Pharmaceuticals | 0904-7559 | 00904-7559-72 |
| Diphenhydramine HCldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-7560 | 00904-7560-70 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | AARNA USA INC. | 82568-0005 | 82568-0005-0182568-0005-02 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3877 | 68071-3877-0368071-3877-0568071-3877-06 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | Akron Pharma Inc. | 71399-1027 | 71399-1027-0171399-1027-02 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Akron Pharma Inc. | 71399-1028 | 71399-1028-0171399-1028-02 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | AARNA USA INC. | 82568-0004 | 82568-0004-0182568-0004-02 |
| Diphenhydramine HCldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | American Health Packaging | 60687-829 | 60687-0829-86 |
| Diphenhydramine HCldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/10mL | SolutionOral | American Health Packaging | 60687-830 | 60687-0830-0860687-0830-56 |
| Diphenhydramine HCL | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Belleview Biosciences | 84447-103 | 84447-0103-0184447-0103-0484447-0103-16 |
Other NDCs under ANDA 087513
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 Hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0489 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/10mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0978 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/10mL | SolutionOral | Medical Purchasing Solutions, LLC | 71872-7242 |