Over-the-counter drug · OTC MONOGRAPH DRUG
Diphenhydramine HCl NDC 55289-479
Diphenhydramine hydrochloride 25 mg/1 · Capsule · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)55289-479Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55289-0479Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55289-479-10 | 55289047910 | 10 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-10)Marketed from Mar 27, 2021 | |
| 55289-479-12 | 55289047912 | 12 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-12)Marketed from Mar 27, 2021 | |
| 55289-479-15 | 55289047915 | 15 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-15)Marketed from Mar 27, 2021 | |
| 55289-479-20 | 55289047920 | 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-20)Marketed from Mar 27, 2021 | |
| 55289-479-24 | 55289047924 | 24 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-24)Marketed from Mar 27, 2021 | |
| 55289-479-30 | 55289047930 | 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-30)Marketed from Jul 11, 2018 |
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 hcl
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 55289
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 010
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55289-479_30c8d0aa-5859-b584-e063-6394a90ac88eSPL ID 30c8d0aa-5859-b584-e063-6394a90ac88eSPL set ID 1ee41c86-6767-43ca-a5bb-fc685fa662cdRxCUI 1049909UNII 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
N455289047910followed by a unit qualifier and the quantityPackage 55289-0479-10. 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 associated with the common cold, hay fever, or other respiratory allergies: sneezing itching of the nose or throat runny nose itchy, watery eyes Temporarily relieves these symptoms due to common cold: runny nose sneezing
Excerpt only. Read the full label for complete information.
About NDC 55289-479
- What is NDC 55289-479?
- 55289-479 is the product NDC for Diphenhydramine HCl, Diphenhydramine hydrochloride 25 mg/1 capsule, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diphenhydramine HCl.
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 55289. 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?
- 35 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 12.5 mg/5mL | SolutionOral | Redmont Pharmaceuticals, LLC | 71741-511 | 71741-0511-04 |
| Diphenhydramine HCldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-7560 | 00904-7560-70 |
| Diphenhydramine HCldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/10mL | SolutionOral | Major Pharmaceuticals | 0904-7559 | 00904-7559-72 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | AARNA USA INC. | 82568-0005 | 82568-0005-0182568-0005-02 |
| Diphenhydramine HCl | Diphenhydramine HCl 50 mg/30mL | LiquidOral | BI-MART | 37835-519 | 37835-0519-12 |
| 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 | AARNA USA INC. | 82568-0004 | 82568-0004-0182568-0004-02 |
| 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 HCldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | American Health Packaging | 60687-829 | 60687-0829-86 |
Other NDCs under M 010
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 |
|---|---|---|---|---|
| CVS Nighttime Cold and Flu Reliefacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | CVS PHARMACY | 51316-692 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-091 |
| Nighttime Sleep Aiddiphenydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | TARGET CORPORATION | 11673-496 |
| KROGER Nighttime Sleep-Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | KROGER COMPANY | 41226-730 |
| Vicks ZzzQuil Soothing Sleep Nighttime Sleep-Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | The Procter & Gamble Manufacturing Company | 69423-830 |
| Sleep Aid Nighttimediphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Wal-Mart Stores Inc | 49035-367 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 53345-022 |
| Nighttime Severe Cold and Coughacetaminophen, diphenhydramine, phenylephrine | Acetaminophen 650 mg/1 + 2 more ingredients | Powder, For solutionOral | KROGER COMPANY | 41226-541 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 53345-027 |
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0073 |
| Kroger Nighttime Sleep-Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | THE KROGER CO | 30142-558 |
| Nighttime Sleep-Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | DISCOUNT DRUG MART, INC. | 53943-485 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Family Dollar (FAMILY WELLNESS) | 55319-564 |
| Nighttime Sleep-Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | VALU MERCHANDISERS COMPANY | 63941-604 |
| Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0075 |
| Night Time Sleep-Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Advanced Rx LLC | 80513-383 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Amerisource Bergen | 46122-651 |
| VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | The Procter & Gamble Manufacturing Company | 69423-795 |
| EZ Nite Sleepdiphenhyramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | KROGER COMPANY | 41226-613 |
| equate nighttime sleep aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | WALMART INC. | 79903-274 |
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