Over-the-counter drug · OTC MONOGRAPH DRUG

Nighttime Sleep Aid (Diphenhydramine hydrochloride) NDC 0363-8989

Diphenhydramine hydrochloride 25 mg/1 · Capsule, Liquid filled · Oral · WALGREEN COMPANY

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-8989Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-8989Add 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
0363-8989-12003638989121 BLISTER PACK in 1 CARTON (0363-8989-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Dec 22, 2020
0363-8989-24003638989242 BLISTER PACK in 1 CARTON (0363-8989-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Dec 22, 2020
0363-8989-48003638989484 BLISTER PACK in 1 CARTON (0363-8989-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Dec 22, 2020

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)
Nighttime Sleep Aid
Generic name (nonproprietary)
diphenhydramine hydrochloride
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 M 010
Marketing start
Marketing end
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 0363-8989_48c1da66-5540-2aeb-e063-6394a90a1cebSPL ID 48c1da66-5540-2aeb-e063-6394a90a1cebSPL set ID f000d0b5-8ee8-4db0-99fe-aae5ed20c98eRxCUI 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

N400363898912 followed by a unit qualifier and the quantity

Package 00363-8989-12. 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 0363-8989

What is NDC 0363-8989?
0363-8989 is the product NDC for Nighttime Sleep Aid (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 25 mg/1 capsule, liquid filled, listed with the FDA by WALGREEN COMPANY. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nighttime Sleep Aid (Diphenhydramine hydrochloride).
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 Nighttime Sleep Aid?
75 other product NDCs are listed under this name. See all Nighttime 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 Nighttime Sleep Aid NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralKroger41226-79341226-0793-02
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralShield Pharmaceuticals Corp83059-007383059-0073-08
nighttime sleep aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralAmazon.com Services LLC72288-76572288-0765-40
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralGrocery Outlet85828-43985828-0439-38
Nighttime Sleep Aiddiphenhydramine hcl 50mgDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralGrocery Outlet85828-41085828-0410-38
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralGrocery Outlet, Inc.85828-79385828-0793-01
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralShield Pharmaceuticals Corp83059-0122—
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralBJWC (Berkley & Jensen / BJ's)68391-61368391-0613-92
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralBJWC (Berkley & Jensen / BJ's)68391-79368391-0793-09
Nighttime Sleep AidDiphenhydramine hydrochloride 50 mg/30mLLiquidOralAllegiant Health69168-48669168-0486-39

All 76 Nighttime Sleep Aid NDCs

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
meijer NIGHTTIME Sleep Aid SOFTGELdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralMeijer, Inc.79481-0779
Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralShield Pharmaceuticals Corp83059-0075
Nighttime Sleep Aiddiphenhyramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralTARGET CORPORATION11673-703
CVS Nighttime Cold and Flu Reliefacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsSolutionOralCVS PHARMACY51316-692
Sleep Aiddiphenhydramine hcl 25 mgDiphenhydramine hydrochloride 25 mg/1TabletOralPioneer Life Sciences, LLC72090-020
Nighttime Sleep-aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1TabletOralNORTHEAST PHARMA80136-785
Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralQUALITY CHOICE (Chain Drug Marketing Association)63868-900
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralShield Pharmaceuticals Corp83059-0073
Rest Simplydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralHYVEE INC42507-291
ZzzQuil ULTRA, Lil Drug Storedoxylamine succinateDoxylamine succinate 25 mg/1TabletOralLil' Drug Store Products, Inc.66715-9751
Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-367
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralWALGREEN COMPANY0363-1174
Rest Simplydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralChain Drug Marketing Association63868-772
Nighttime Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralVALU MERCHANDISERS COMPANY63941-683
Nighttime Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralP & L Development, LLC59726-916
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralBJWC (Berkley & Jensen / BJ's)68391-793
good sense nighttime sleep aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralL. Perrigo Company0113-0431
Sleep AidDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralGood Sense50804-410
Nighttime Severe Cold and Coughacetaminophen, diphenhydramine, phenylephrineAcetaminophen 650 mg/1 + 2 more ingredientsPowder, For solutionOralKROGER COMPANY41226-541
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralAmerisource Bergen46122-651

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