Over-the-counter drug · OTC MONOGRAPH DRUG

Sleep Aid (Diphenhydramine hcl) NDC 69168-431

Diphenhydramine hydrochloride 25 mg/1 · Capsule, Liquid filled · Oral · Allegiant Health

NDC codes

FDA NDC Directory
Product NDC (as listed)69168-431Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69168-0431Add 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
69168-431-036916804310369168043103250 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-431-03)Marketed from Apr 30, 2023
69168-431-8669168043186691680431861 BLISTER PACK in 1 CARTON (69168-431-86) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Sep 21, 2021
69168-431-96691680431966916804319696 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-431-96)Marketed from Sep 21, 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)
Sleep Aid
Generic name (nonproprietary)
diphenhydramine hcl
Active ingredients
Diphenhydramine hydrochloride — 25 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
Allegiant HealthNDC labeler code 69168
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 011
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 69168-431_8f729339-eda6-456a-bdc5-445eff09ff66SPL ID 8f729339-eda6-456a-bdc5-445eff09ff66SPL set ID 9746911a-36bc-45eb-adfd-e96439d7a865RxCUI 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

N469168043103 followed by a unit qualifier and the quantity

Package 69168-0431-03. 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)

Use(s) 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 69168-431

What is NDC 69168-431?
69168-431 is the product NDC for Sleep Aid (diphenhydramine hcl), Diphenhydramine hydrochloride 25 mg/1 capsule, liquid filled, listed with the FDA by Allegiant Health. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sleep Aid (Diphenhydramine HCl).
What is the active ingredient?
Diphenhydramine hydrochloride.
Who is the labeler?
Allegiant Health, NDC labeler code 69168. 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 011

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 011
ProductStrengthForm · routeLabelerProduct NDC
NoDoz Alertness Aidcaffeine tablet, film-coatedCaffeine 200 mg/1Tablet, Film coatedOralLil' Drug Store Products, Inc.66715-9899
Yolakepe Smelling Saltssmelling saltsMenthol 15 g/100gInhalantRespiratory (Inhalation)Shenzhen TeLaFaErJiaLuo Technology Co., Ltd.85795-005
Stay AwakecaffeineCaffeine 200 mg/1TabletOralUnited Natural Foods, Inc. dba UNFI41163-226
Awake Maximum StrengthcaffeineCaffeine 200 mg/1Tablet, Film coatedOralWalgreen Company0363-3440
Topcare Stay Awake Maximum StrengthcaffeineCaffeine 200 mg/1Tablet, CoatedOralTopCo Associates, LLC76162-002
Stay AwakecaffeineCaffeine 200 mg/1TabletOralAAA Pharmaceutical, Inc.57344-220
Stay AwakecaffeineCaffeine 200 mg/1TabletOralARMY AND AIR FORCE EXCHANGE SERVICE55301-226
Stay AwakecaffeineCaffeine 200 mg/1TabletOralChain Drug Marketing Association, Inc.83324-074
Uplift ChewablecaffeineCaffeine 1 g/108.27gChewable gelOralCarolina Cannabis Creations LLC82876-832
Uplift ChewablecaffeineCaffeine 1 g/108.27gChewable gelOralCarolina Cannabis Creations LLC82876-833
Stay Awake Maximum StrengthcaffeineCaffeine 200 mg/1Tablet, Film coatedOralUnited Natural Foods, Inc. dba UNFI41163-434
Earthmed Uplift Chewable OrangecaffeineCaffeine 1 g/108.27gChewable gelOralEarthmed LLC82876-977
Stay AwakecaffeineCaffeine 200 mg/1TabletOralKROGER COMPANY30142-284
Earthmed Uplift Chewable StrawberrycaffeineCaffeine 1 g/108.27gChewable gelOralEarthmed LLC82876-978
Earthmed Uplift Chewable WatermeloncaffeineCaffeine 1 g/108.27gChewable gelOralEarthmed LLC82876-979
Earthmed Uplift Chewable CherrycaffeineCaffeine 1 g/108.27gChewable gelOralEarthmed LLC82876-980
Stay AwakecaffeineCaffeine 200 mg/1TabletOralSalado Sales, Inc.57243-226
Stay AwakecaffeineCaffeine 200 mg/1Tablet, CoatedOralAllegiant Health69168-076
Stay AwakecaffeineCaffeine 200 mg/1TabletOralWinCo Foods, LLC67091-117
VivarincaffeineCaffeine 200 mg/1TabletOralVespyr Brands LLC71179-018

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