Over-the-counter drug · OTC MONOGRAPH DRUG
Free and Pure Allergy Relief Dye Free (Diphenhydramine hcl) NDC 0363-1175
Diphenhydramine hydrochloride 25 mg/1 · Capsule, Liquid filled · Oral · WALGREEN COMPANY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-1175-24 | 0036311752400363117524 | 2 BLISTER PACK in 1 CARTON (0363-1175-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Oct 22, 2023 | |
| 0363-1175-48 | 0036311754800363117548 | 4 BLISTER PACK in 1 CARTON (0363-1175-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Oct 22, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Free and Pure Allergy Relief Dye FreeSuffix: Dye Free
- Generic name (nonproprietary)
- diphenhydramine hcl
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- WALGREEN COMPANYNDC labeler code 0363
- 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 0363-1175_4279aaad-dde8-08be-e063-6394a90ad40bSPL ID 4279aaad-dde8-08be-e063-6394a90ad40bSPL set ID 93182db8-05bc-4eb5-aa14-cef58de25359RxCUI 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
N400363117524followed by a unit qualifier and the quantityPackage 00363-1175-24. 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: sneezing, runny nose, itchy, watery eyes, itching of the nose or throat temporarily relieves these symptoms due to common cold: runny nose, sneezing
Excerpt only. Read the full label for complete information.
About NDC 0363-1175
- What is NDC 0363-1175?
- 0363-1175 is the product NDC for Free and Pure Allergy Relief Dye Free, Diphenhydramine hydrochloride 25 mg/1 capsule, liquid filled, listed with the FDA by WALGREEN COMPANY. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Free and Pure Allergy Relief Dye Free (Diphenhydramine HCl).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- WALGREEN COMPANY, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Free and Pure Allergy Relief Dye Free?
- 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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