Over-the-counter drug · OTC MONOGRAPH DRUG

Nighttime Sleep Aid (Diphenhydramine hcl) NDC 70677-1128

Diphenhydramine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Strategic Sourcing Services LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)70677-1128Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70677-1128Add 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
70677-1128-170677112801706771128012 BLISTER PACK in 1 CARTON (70677-1128-1) / 12 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 18, 2023

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 hcl
Active ingredients
Diphenhydramine hydrochloride — 25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Strategic Sourcing Services LLCNDC labeler code 70677
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 70677-1128_e0e47664-4cf3-4a1a-8f24-719634571544SPL ID e0e47664-4cf3-4a1a-8f24-719634571544SPL set ID e68d96c8-21c5-406c-b22c-3e384027c79fRxCUI 1049630UNII TC2D6JAD40UPC 0010939957801
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

N470677112801 followed by a unit qualifier and the quantity

Package 70677-1128-01. 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 70677-1128

What is NDC 70677-1128?
70677-1128 is the product NDC for Nighttime Sleep Aid (diphenhydramine hcl), Diphenhydramine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Strategic Sourcing Services 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?
Strategic Sourcing Services LLC, NDC labeler code 70677. 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
Diphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralSoftgel Healthcare Pvt Ltd35916-0472
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1TabletOralChain Drug Marketing Association63868-611
Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralShield Pharmaceuticals Corp83059-0075
Wal Som Nighttime Sleep Aid Nighttimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralWalgreens0363-0860
Nighttime Sleep Aiddiphenhydramine hcl 25 mgDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralHealth Pharma USA LLC71679-110
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralQUALITY CHOICE (Chain Drug Marketing Association)83324-151
Nighttime Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralH E B37808-186
Nighttime Sleep AidDiphenhydramine hydrochloride 50 mg/30mLLiquidOralAllegiant Health69168-486
Sleep Aid Night Timediphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralDOLGENCORP, LLC55910-687
Sleep AidDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralAllegiant Health69168-917
TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralTopco Associates LLC76162-438
Sleep Aid Maximum Strengthdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralH E B37808-860
Nighttime Sleep Aid Alcohol Freediphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralWal-Mart Stores Inc49035-330
Somnitabsdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1TabletOralHARRIS TEETER72036-019
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralAmerisource Bergen46122-651
Vicks ZzzQuil Nighttime Sleep-Aiddiphenhydramine hydrochloride—KitThe Procter & Gamble Manufacturing Company84126-306
Nighttime SleepAiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralAMERIFOODS TRADING COMPANY61504-091
Pharbedryldiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralPharbest Pharmaceuticals, Inc.16103-347
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralCardinal Health 110, LLC. DBA Leader70000-0244
KROGER Nighttime Sleep-Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralKROGER COMPANY41226-730

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