Over-the-counter drug · OTC MONOGRAPH DRUG
Dye Free Allergy Relief (Diphenhydramine hcl) NDC 76162-914
Diphenhydramine HCl 25 mg/1 · Capsule, Liquid filled · Oral · Topco Associates, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76162-914-24 | 7616209142476162091424 | 2 BLISTER PACK in 1 CARTON (76162-914-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Apr 7, 2025 |
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)
- Dye Free Allergy Relief
- Generic name (nonproprietary)
- diphenhydramine hcl
- Active ingredients
- Diphenhydramine HCl — 25 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Topco Associates, LLCNDC labeler code 76162
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 76162-914_4279e83d-bb78-a1f8-e063-6394a90a0238SPL ID 4279e83d-bb78-a1f8-e063-6394a90a0238SPL set ID 6ddf6b16-0ff3-4014-9f73-33e854397fe5RxCUI 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
N476162091424followed by a unit qualifier and the quantityPackage 76162-0914-24. 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 upper respiratory allergies: runny nose itchy, watery eyes sneezing 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.
About NDC 76162-914
- What is NDC 76162-914?
- 76162-914 is the product NDC for Dye Free Allergy Relief (diphenhydramine hcl), Diphenhydramine HCl 25 mg/1 capsule, liquid filled, listed with the FDA by Topco Associates, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dye Free Allergy Relief (Diphenhydramine HCl).
- What is the active ingredient?
- Diphenhydramine HCl.
- Who is the labeler?
- Topco Associates, LLC, NDC labeler code 76162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dye Free Allergy Relief?
- 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 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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