Over-the-counter drug · OTC MONOGRAPH DRUG

Nighttime Sleep Aid (Diphenhydramine hydrochloride) NDC 68210-4160

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

NDC codes

FDA NDC Directory
Product NDC (as listed)68210-4160Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68210-4160Add 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
68210-4160-868210416008682104160081 BLISTER PACK in 1 CARTON (68210-4160-8) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Jun 14, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 50 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
Prodose, Inc.NDC labeler code 68210
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 68210-4160_494914ff-a952-e7f9-e063-6294a90a88e1SPL ID 494914ff-a952-e7f9-e063-6294a90a88e1SPL set ID c4bc3efd-8ca8-22fe-e053-2a95a90aed45RxCUI 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

N468210416008 followed by a unit qualifier and the quantity

Package 68210-4160-08. 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 68210-4160

What is NDC 68210-4160?
68210-4160 is the product NDC for Nighttime Sleep Aid (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 50 mg/1 capsule, liquid filled, listed with the FDA by Prodose, 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 hydrochloride).
What is the active ingredient?
Diphenhydramine hydrochloride.
Who is the labeler?
Prodose, Inc., NDC labeler code 68210. 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
Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophenDiphenhydramine hydrochloride 50 mg/30mL; Acetaminophen 1000 mg/30mLLiquidOralThe Procter & Gamble Manufacturing Company69423-985
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralBJWC (Berkley & Jensen / BJ's)68391-793
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-736
Diphenhydramine HCl 25mgsleep aidDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralAllegiant Health69168-002
berkley and jensen sleep aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralBJWC68391-186
AXIV - VroZzzdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralVivunt Pharma LLC82706-014
Revasol Sleep Aiddiphenhydramine hclDiphenhydramine HCl 50 mg/30mLLiquidOralRnv LLC84379-284
Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophenDiphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1Tablet, CoatedOralThe Procter & Gamble Manufacturing Company37000-974
Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralBest Choice (Valu Merchandisers Company)63941-860
Sleep Tabsdiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1TabletOralMajor Pharmaceuticals0904-4274
Nightime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralBETTER LIVING BRANDS LLC.21130-711
Diphenhydramine HClDiphenhydramine HCl 50 mg/30mLLiquidOralBI-MART37835-519
Sleep Aid NightTimediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-672
Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralBest Choice (Valu Merchandisers Company)63941-916
Nighttime Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralBIONPHARMA INC.69452-427
Diphenhydramine HydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralAAA Pharmaceutical, Inc.57344-091
Sleep AidDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralBetter Living Brands LLC21130-052
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-894
Quality Choice Nighttime Sleep-Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralChain Drug Marketing Association, Inc.63868-970
Nighttime Sleep Aiddiphenhydramine hcl 50mgDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralGrocery Outlet85828-410

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