NDC codes

FDA NDC Directory
Product NDC (as listed)0363-1175Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-1175Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0363-1175-2400363117524003631175242 BLISTER PACK in 1 CARTON (0363-1175-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Oct 22, 2023
0363-1175-4800363117548003631175484 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

N400363117524 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under 505G(a)(3)
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MediChoice PVP Prep Solutionpovidone-iodinePovidone-iodine 100 mg/mLSolutionTopicalO&M HALYARD, INC.39892-0841
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Covex Antibacterial Bar Active Protectionbenzalkonium chlorideBenzalkonium chloride 1.3 mg/gSoapTopicalDALAN KIMYA ENDUSTRI ANONIM SIRKETI51209-017
everyone hand sanitizer wipes ruby grapefruitethyl alcoholAlcohol 62 mL/100mLClothTopicalEO Products, LLC54748-703
Povidone-Iodine Prep Sterilepovidone-iodinePovidone-iodine 100 mg/gSpongeTopicalChangzhou Maokang Medical Products Co., Ltd59050-658
Anti Bacterial Hand Gel Bright Christmas MorningalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-6758
Iced Lemon Pound Cake Pistachio Milk and HoneyalcoholAlcohol 71 mL/100mLGelTopicalBath & Body Works, Inc.62670-7018
Hy-Vee LHSbenzalkonium chlorideBenzalkonium chloride 130 mg/100mLLiquidTopicalApollo Health and Beauty Care63148-316
Smart Care 2 HAND SANITIZERS 1.35 FL OZ (PUMPKIN SPICE, FRESH RAIN)ethyl alcohol—KitAshtel Studios, Inc.70108-372

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