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
80513-383-2280513038322220 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
ADWE dye-free childrens allergydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLSyrupOralRARITAN PHARMACEUTICALS INC68163-710
Allergy Relief 25 mgdiphenhydramine hcl 25mgDiphenhydramine hydrochloride 25 mg/1CapsuleOralUlai Health LLC73057-348
AXIV - VroZzzdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralVivunt Pharma LLC82706-014
basic care nighttime sleep aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralAmazon.com Services LLC72288-186
berkley and jensen sleep aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralBJWC68391-186
Best Choice Childrens Allergy Relief Bubblegum flavordiphenhydramine hclDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralBEST CHOICE (VALU MERCHANDISERS COMPANY)63941-710
Betr sleep aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralLive Betr LLC80267-431
Calmco Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/5mLSolutionOralCalmCo LLC73282-2525
CalmCo Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Chewable gelOralCalmCo LLC73282-2527
CalmCo Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Chewable gelOralCalmCo LLC73282-2528
CalmCo Sleep Aid Gummy Bitediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Bar, ChewableOralCalmCo LLC73282-2518
careone nighttime sleep aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralAmerican Sales Company41520-431
CVS Childrens Nighttime Multi Symptom Coldacetaminophen , diphenhydramine hydrochloride,phenylephrine hydrochlorideAcetaminophen 325 mg/10mL + 2 more ingredientsLiquidOralCVS PHARMACY51316-733
CVS Health Nighttime Sleep-Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralCVS Pharmacy,Inc.59779-893
CVS Nighttime Childrens Cold and Cough Multi-Symptom Reliefchlorpheniramine maleate and dextromethorphan hydrobromideChlorpheniramine maleate 2 mg/15mL; Dextromethorphan hydrobromide 15 mg/15mLSolutionOralCVS PHARMACY51316-752
CVS NightTime Coldacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochlorideAcetaminophen 650 mg/30mL + 3 more ingredientsSolutionOralCVS PHARMACY51316-641
CVS Nighttime Cold and Flu Reliefacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsSolutionOralCVS PHARMACY51316-692
CVS Nighttime Sleep Aiddiphenhydramine hydrochloride and acetaminophenAcetaminophen 1000 mg/30mL; Diphenhydramine hydrochloride 50 mg/30mLLiquidOralCVS PHARMACY69842-448
dg health sleep aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralDolgencorp, LLC55910-186
dg health sleep aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralDolgencorp Inc55910-431

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