Over-the-counter drug · OTC MONOGRAPH DRUG

Sleep Aid Maximum Strength (Diphenhydramine hcl) NDC 63868-415

Diphenhydramine hydrochloride 50 mg/1 · Capsule · Oral · QUALITY CHOICE (Chain Drug Marketing Association)

NDC codes

FDA NDC Directory
Product NDC (as listed)63868-415Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63868-0415Add 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
63868-415-3263868041532638680415321 BOTTLE, PLASTIC in 1 BOX (63868-415-32) / 32 CAPSULE in 1 BOTTLE, PLASTICMarketed from Dec 27, 2019

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)
Sleep Aid Maximum StrengthSuffix: Maximum Strength
Generic name (nonproprietary)
diphenhydramine hcl
Active ingredients
Diphenhydramine hydrochloride — 50 mg/1
Dosage form
Capsule
Route
Oral
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 63868-415_492b4206-5f87-4f5a-80f2-2c33b01f720aSPL ID 492b4206-5f87-4f5a-80f2-2c33b01f720aSPL set ID 29b49616-ee5a-4574-81f1-0052addb8f66RxCUI 1020477UNII TC2D6JAD40UPC 0635515996816
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

N463868041532 followed by a unit qualifier and the quantity

Package 63868-0415-32. 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)

Use for relief of occasional sleeplessness.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63868-415

What is NDC 63868-415?
63868-415 is the product NDC for Sleep Aid Maximum Strength (diphenhydramine hcl), Diphenhydramine hydrochloride 50 mg/1 capsule, listed with the FDA by QUALITY CHOICE (Chain Drug Marketing Association). It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sleep Aid Maximum Strength (Diphenhydramine HCL).
What is the active ingredient?
Diphenhydramine hydrochloride.
Who is the labeler?
QUALITY CHOICE (Chain Drug Marketing Association), NDC labeler code 63868. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sleep Aid Maximum Strength?
6 other product NDCs are listed under this name. See all Sleep Aid Maximum Strength NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sleep Aid Maximum Strength NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralWinCo Foods, LLC67091-41367091-0413-32
Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralH E B37808-86037808-0860-1237808-0860-32
Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralHarris Teeter, LLC69256-86069256-0860-32
Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralQUALITY CHOICE (Chain Drug Marketing Association)63868-90063868-0900-32
Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralP & L Development, LLC59726-76059726-0760-2959726-0760-6459726-0760-92
Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralP & L Development, LLC59726-81659726-0816-2959726-0816-6459726-0816-92

Other NDCs under M 010

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 010
ProductStrengthForm · routeLabelerProduct NDC
Diphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralSoftgel Healthcare Pvt Ltd35916-0472
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1TabletOralChain Drug Marketing Association63868-611
Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralShield Pharmaceuticals Corp83059-0075
Wal Som Nighttime Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralWalgreens0363-0860
Nighttime Sleep Aiddiphenhydramine hcl 25 mgDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralHealth Pharma USA LLC71679-110
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralQUALITY CHOICE (Chain Drug Marketing Association)83324-151
Nighttime Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralH E B37808-186
Nighttime Sleep AidDiphenhydramine hydrochloride 50 mg/30mLLiquidOralAllegiant Health69168-486
Sleep Aid Night Timediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralDOLGENCORP, LLC55910-687
Sleep AidDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralAllegiant Health69168-917
Nighttime Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1128
TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralTopco Associates LLC76162-438
Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralH E B37808-860
Nighttime Sleep Aid Alcohol Freediphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralWal-Mart Stores Inc49035-330
Somnitabsdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1TabletOralHARRIS TEETER72036-019
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralAmerisource Bergen46122-651
Vicks ZzzQuil Nighttime Sleep-Aiddiphenhydramine hydrochloride—KitThe Procter & Gamble Manufacturing Company84126-306
Nighttime SleepAiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralAMERIFOODS TRADING COMPANY61504-091
Pharbedryldiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralPharbest Pharmaceuticals, Inc.16103-347
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralCardinal Health 110, LLC. DBA Leader70000-0244

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