Over-the-counter drug · OTC MONOGRAPH DRUG

nighttime sleep-aid (Diphenhydramine hcl) NDC 69452-322

Diphenhydramine hydrochloride 50 mg/1 · Capsule, Liquid filled · Oral · Bionpharma Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)69452-322Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69452-0322Add 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
69452-322-796945203227969452032279160 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-322-79)Marketed from Apr 27, 2021

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/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
Bionpharma Inc.NDC labeler code 69452
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 69452-322_0d63c644-46c2-b4c0-e063-6394a90a9dd3SPL ID 0d63c644-46c2-b4c0-e063-6394a90a9dd3SPL set ID c0074c77-287e-6c26-e053-2995a90a4d31RxCUI 1020477UNII 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

N469452032279 followed by a unit qualifier and the quantity

Package 69452-0322-79. 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 69452-322

What is NDC 69452-322?
69452-322 is the product NDC for nighttime sleep-aid (diphenhydramine hcl), Diphenhydramine hydrochloride 50 mg/1 capsule, liquid filled, listed with the FDA by Bionpharma Inc.. 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?
Bionpharma Inc., NDC labeler code 69452. 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?
74 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 75 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
Nighttime Sleep Aid maximum strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralCardinal Health (Leader) 7000070000-0527
Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralBetter Living Brands, LLC21130-763
Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophenDiphenhydramine hydrochloride 50 mg/30mL; Acetaminophen 1000 mg/30mLLiquidOralThe Procter & Gamble Manufacturing Company69423-985
CVS NightTime Coldacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochlorideAcetaminophen 650 mg/30mL + 3 more ingredientsSolutionOralCVS PHARMACY51316-641
Nighttime Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralDISCOUNT DRUG MART, INC.53943-485
nighttime sleep aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralAmazon.com Services LLC72288-765
Nighttime Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralCare One (Retail Business Services, LLC.)72476-916
CalmCo Sleep Aid Gummy Bitediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Bar, ChewableOralCalmCo LLC73282-2518
Diphenhydramine Hydrochloridediphenhydramine hydrochloride capsule, liquid filledDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralAMZ789 LLC73629-007
Nightime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralBETTER LIVING BRANDS LLC.21130-711
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralWalgreen Company0363-8020
Nighttime Sleep Aiddiphenhydramine hcl 50mgDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralGrocery Outlet85828-410
Sleep Aid NightTimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-672
Good Sense Sleep Timediphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralL. Perrigo Company0113-0186
Diphenhydramine HClDiphenhydramine HCl 50 mg/30mLLiquidOralBI-MART37835-519
Calmco Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/5mLSolutionOralCalmCo LLC73282-2525
berkley and jensen sleep aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralBJWC68391-186
Nighttime Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralBIONPHARMA INC.69452-427
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralFamily Dollar (FAMILY WELLNESS)55319-564
Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralQUALITY CHOICE (Chain Drug Marketing Association)63868-900

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