Over-the-counter drug · OTC MONOGRAPH DRUG

Sleep Aid (Diphenhydramine hydrochloride) NDC 76162-911

Diphenhydramine hydrochloride 25 mg/1 · Capsule, Liquid filled · Oral · Company name: Topco Associates, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)76162-911Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76162-0911Add 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
76162-911-1276162091112761620911121 BLISTER PACK in 1 CARTON (76162-911-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Sep 26, 2024
76162-911-2476162091124761620911242 BLISTER PACK in 1 CARTON (76162-911-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Sep 26, 2024
76162-911-4876162091148761620911484 BLISTER PACK in 1 CARTON (76162-911-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Sep 26, 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)
Sleep Aid
Generic name (nonproprietary)
diphenhydramine hydrochloride
Active ingredients
Diphenhydramine hydrochloride — 25 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
Company name: 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 76162-911_4279e0bd-a592-d469-e063-6294a90aff1bSPL ID 4279e0bd-a592-d469-e063-6294a90aff1bSPL set ID 7aec7b1b-39dc-4e99-9f92-d45af0a4a6ecRxCUI 1049909UNII 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

N476162091112 followed by a unit qualifier and the quantity

Package 76162-0911-12. 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 the 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 76162-911

What is NDC 76162-911?
76162-911 is the product NDC for Sleep Aid (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 25 mg/1 capsule, liquid filled, listed with the FDA by Company name: Topco Associates, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sleep Aid (Diphenhydramine hydrochloride).
What is the active ingredient?
Diphenhydramine hydrochloride.
Who is the labeler?
Company name: 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 Sleep Aid?
58 other product NDCs are listed under this name. See all 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 Sleep Aid NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralAmazon.com Services LLC72288-43272288-0432-01
Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralShield Pharmaceuticals Corp83059-007583059-0075-08
Sleep Aidaconitum napellus, aesculus hippocastanum, flos, arsenicum album, avena sativa, belladonna, camphora, cinchona officinalis, coffea cruda, cypripedium pubescens, hyoscyamus niger, ignatia amara, kali phosphoricum, passiflora incarnata, phosphorus, pulsatilla, and valeriana officinalis.Aconitum napellus whole 10 [hp_X]/59mL + 15 more ingredientsLiquidOralKing Bio Inc.57955-998657955-9986-02
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Chewable gelOralWalgreens0363-923600363-9236-50
Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Chewable gelOralWALMART INC. (see also Equate)79903-42679903-0426-24
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralTARGET Corporation82442-53082442-0530-3282442-0530-60
Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1CapsuleOralWALGREENS0363-613000363-6130-2400363-6130-48
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-36851316-0368-22
sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralPublix Super Markets Inc56062-44156062-0441-01
sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralWalgreen Company0363-346200363-3462-80

All 59 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
Nighttime Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1128
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

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