Over-the-counter drug · OTC MONOGRAPH DRUG

Nighttime Sleep Aid (Diphenhydramine hcl) NDC 76162-200

Diphenhydramine hydrochloride 50 mg/30mL · Solution · Oral · TOPCO ASSOCIATES LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)76162-200Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76162-0200Add 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
76162-200-4576162020045177 mL in 1 BOTTLE, PLASTIC (76162-200-45)Marketed from Jan 11, 2023

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)
Nighttime Sleep Aid
Generic name (nonproprietary)
diphenhydramine hcl
Active ingredients
Diphenhydramine hydrochloride — 50 mg/30mL
Dosage form
Solution
Route
Oral
Labeler
TOPCO ASSOCIATES LLCNDC labeler code 76162
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 76162-200_babb23be-d0f5-46fd-946f-70db8dd74cfdSPL ID babb23be-d0f5-46fd-946f-70db8dd74cfdSPL set ID 9558cc42-d27d-42af-b0a7-44cad025165dRxCUI 1248354UNII TC2D6JAD40UPC 0036800375796
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

N476162020045 followed by a unit qualifier and the quantity

Package 76162-0200-45. 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 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 76162-200

What is NDC 76162-200?
76162-200 is the product NDC for Nighttime Sleep Aid (diphenhydramine hcl), Diphenhydramine hydrochloride 50 mg/30mL solution, listed with the FDA by TOPCO ASSOCIATES LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nighttime Sleep Aid (Diphenhydramine HCl).
What is the active ingredient?
Diphenhydramine hydrochloride.
Who is the labeler?
TOPCO ASSOCIATES LLC, NDC labeler code 76162. 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
CVS Health Nighttime Sleep-Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralCVS Pharmacy,Inc.59779-893
CVS Health Nighttime Sleep-Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralCVS Pharmacy,Inc.59779-893
Nighttime Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralRite Aid Corporation11822-8002
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralQUALITY CHOICE (Chain Drug Marketing Association)83324-151
ZzzQuil Nighttime Sleep-Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralThe Procter & Gamble Manufacturing Company84126-316
Sleep AidDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralAllegiant Health69168-917
Dormmy-Londiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1TabletOralHaendel Farma, S.A. de C.V.83164-000
Nighttime Sleep Aiddiphenhydramine hcl 50mgDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralGrocery Outlet85828-410
RiteAid Nighttime Sleep Aiddiphenhydramine hydrochloride and acetaminophenAcetaminophen 1000 mg/30mL; Diphenhydramine hydrochloride 50 mg/30mLLiquidOralRITE AID CORPORATION11822-8791
Walgreens Childrensnighttime coughChlorpheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 15 mg/10mLLiquidOralWALGREENS CO.0363-7560
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralCardinal Health 110, LLC. DBA Leader70000-0244
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralSafeway, Inc.21130-816
Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralWinCo Foods, LLC67091-413
Simply Sleepdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-843
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralTARGET Corporation11673-360
Sleep Aid Night Timediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralDOLGENCORP, LLC55910-772
Vicks PainQuil PM PAIN RELIEVER plus NIGHTTIME SLEEP-AIDacetaminophen, diphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mL; Acetaminophen 1000 mg/30mLLiquidOralThe Procter & Gamble Manufacturing Company84126-350
SleepAid (Diphenhydramine HCL)diphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralAPNAR PHARMA LP24689-154
Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralWalgreen Company0363-0367
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralGrocery Outlet, Inc.85828-793

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