Over-the-counter drug · OTC MONOGRAPH DRUG

Nighttime Sleep-Aid (Diphenhydramine hcl) NDC 69452-427

Diphenhydramine hydrochloride 50 mg/1 · Capsule, Liquid filled · Oral · BIONPHARMA INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)69452-427Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69452-0427Add 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
69452-427-106945204271032 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-427-10)Marketed from Mar 21, 2024
69452-427-176945204271760 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-427-17)Marketed from Mar 21, 2024
69452-427-7969452042779160 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-427-79)Marketed from Mar 21, 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)
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 69452-427_44e7a512-282e-a87b-e063-6394a90aebf2SPL ID 44e7a512-282e-a87b-e063-6394a90aebf2SPL set ID 141b00b7-a283-40ab-e063-6294a90aec77RxCUI 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

N469452042710 followed by a unit qualifier and the quantity

Package 69452-0427-10. 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 69452-427

What is NDC 69452-427?
69452-427 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 3 package NDCs, 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?
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
Wal Som Nighttime Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralWalgreens0363-0860
sleep aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralRite Aid Corporation11822-0672
Nighttime Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralWhole Foods Market, INC.42681-0051
Nighttime Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralCare One (Retail Business Services, LLC.)72476-860
Nighttime Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralUnited Natural Foods, Inc. dba UNFI41163-367
CalmCo Sleep Aid Gummy Bitediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Bar, ChewableOralCalmCo LLC73282-2518
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralPUBLIX SUPER MARKETS INC56062-091
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralVALU MERCHANDISERS COMPANY63941-091
RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgeldiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralStrive Pharmaceuticals Inc.70692-834
CVS Nighttime Sleep Aiddiphenhydramine hydrochloride and acetaminophenAcetaminophen 1000 mg/30mL; Diphenhydramine hydrochloride 50 mg/30mLLiquidOralCVS PHARMACY69842-448
Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Chewable gelOralWALMART INC. (see also Equate)79903-426
Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophenDiphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1Tablet, CoatedOralThe Procter & Gamble Manufacturing Company37000-974
Nighttime Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralBi-Mart37835-319
Meijer Nighttime Sleep Aid Non Habit Formingdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralMEIJER DISTRIBUTION INC41250-853
ZzzQuil ULTRA, Travel BASIXdoxylamine succinateDoxylamine succinate 25 mg/1TabletOralLil' Drug Store Products, Inc.66715-6451
Rest Simplydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralHarris Teeter72036-091
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-736
Sleep Tabsdiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1TabletOralMajor Pharmaceuticals0904-4274
Diphenhydramine HClDiphenhydramine HCl 50 mg/30mLLiquidOralBI-MART37835-519
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralDOLGENCORP, LLC55910-614

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