Over-the-counter drug · OTC MONOGRAPH DRUG

Night Time Sleep-Aid (Diphenhydramine hcl) NDC 80513-383

Diphenhydramine hydrochloride 25 mg/1 · Tablet · Oral · Advanced Rx LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80513-383Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80513-0383Add 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
80513-383-228051303832280513038322220 TABLET in 1 BOTTLE (80513-383-22)Marketed from Aug 1, 2024

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)
Night Time Sleep-Aid
Generic name (nonproprietary)
diphenhydramine hcl
Active ingredients
Diphenhydramine hydrochloride — 25 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Advanced Rx LLCNDC labeler code 80513
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 010
Marketing start
Marketing end
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 80513-383_38ec4df3-7635-3adf-e063-6394a90a0cecSPL ID 38ec4df3-7635-3adf-e063-6394a90a0cecSPL set ID 07c69e63-deb1-4607-9f7f-1cf0cd05cc82RxCUI 1049630UNII TC2D6JAD40UPC 0380513000934
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

N480513038322 followed by a unit qualifier and the quantity

Package 80513-0383-22. 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 for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80513-383

What is NDC 80513-383?
80513-383 is the product NDC for Night Time Sleep-Aid (diphenhydramine hcl), Diphenhydramine hydrochloride 25 mg/1 tablet, listed with the FDA by Advanced Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Night Time Sleep-Aid (Diphenhydramine HCl).
What is the active ingredient?
Diphenhydramine hydrochloride.
Who is the labeler?
Advanced Rx LLC, NDC labeler code 80513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Night Time Sleep-Aid?
4 other product NDCs are listed under this name. See all Night Time Sleep-Aid 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 Night Time Sleep-Aid NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Night Time Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLLiquidOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-11455910-0114-12
Night Time Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLLiquidOralDiscount Drug Mart53943-52253943-0522-2553943-0522-28
Night Time Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralHyVee Inc42507-95942507-0959-40
Night Time Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralAdvanced Rx LLC80513-37180513-0371-25

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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