Over-the-counter drug · OTC MONOGRAPH DRUG

Sleep Aid (Diphenhydramine hcl 25 mg) NDC 69168-263

Diphenhydramine hydrochloride 25 mg/1 · Tablet · Oral · Allegiant Health

NDC codes

FDA NDC Directory
Product NDC (as listed)69168-263Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69168-0263Add 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
69168-263-30691680263306916802633030 TABLET in 1 BOTTLE (69168-263-30)Marketed from Mar 3, 2015
69168-263-5469168026354691680263541 BAG in 1 CARTON (69168-263-54) / 16458 TABLET in 1 BAGMarketed from May 8, 2025
69168-263-93691680263936916802639324 TABLET in 1 BOX (69168-263-93)Marketed from Mar 3, 2015
69168-263-986916802639869168026398200 TABLET in 1 BOTTLE (69168-263-98)Marketed from Jul 23, 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 25 mg
Active ingredients
Diphenhydramine hydrochloride — 25 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Allegiant HealthNDC labeler code 69168
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 012
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 69168-263_b9e7a97b-a3e9-427c-8cc5-9c94941409a1SPL ID b9e7a97b-a3e9-427c-8cc5-9c94941409a1SPL set ID dbbc535f-515a-4d9b-b799-34e60f5230bbRxCUI 1049630UNII 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

N469168026330 followed by a unit qualifier and the quantity

Package 69168-0263-30. 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 relief of occasional sleeplessness

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69168-263

What is NDC 69168-263?
69168-263 is the product NDC for Sleep Aid (diphenhydramine hcl 25 mg), Diphenhydramine hydrochloride 25 mg/1 tablet, listed with the FDA by Allegiant Health. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sleep Aid (Diphenhydramine HCl 25 mg).
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 012

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

FDA NDC Directory listings under M 012
ProductStrengthForm · routeLabelerProduct NDC
Cough Reliefdextromethorphan hydrobromideDextromethorphan hydrobromide 15 mg/1Capsule, Liquid filledOralAdvanced Rx LLC80513-311
TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr—KitTARGET CORPORATION82442-559
Geri-Dryl allergy reliefdiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralVerityRx83939-0683
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci—KitTARGET Corporation11673-420
Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxidePetrolatum 49 g/100g; Zinc oxide 15 g/100gCreamTopicalWelmedix LLC24330-410
topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralTopco Associates LLC36800-143
Allergy Childrensdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralH E B37808-012
Mucus Relief Cough Childrensdextromethorphan hbr, guaifensinDextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mLLiquidOralH E B37808-594
Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesinDextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1TabletOralStrategic Sourcing Services LLC49348-728
Dual Action Honey Lemon Cough Suppressant Oral AnestheticmentholMenthol 8.3 mg/1LozengeOralRicola Ag54305-323
Discount drug mart Extra Moisturizingoxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalDISCOUNT DRUG MART53943-720
Mucus ReliefguaifenesinGuaifenesin 400 mg/1TabletOralGeri-Care Pharmaceuticals, Corp57896-714
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hclAcetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mLLiquidOralHaleon US Holdings LLC0031-0101
Throat Comfort Orange Mint Cinnamon DropsmentholMenthol 3.6 mg/1LozengeOralRicola USA Inc.63667-342
Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coatedGuaifenesin 200 mg/1 + 2 more ingredientsTablet, Film coatedOralLil' Drug Store products, Inc.66715-5632
COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 3 more ingredientsCapsule, Liquid filledOralWalgreens0363-9016
Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hclAcetaminophen 650 mg/20mL + 2 more ingredientsLiquidOralWalgreens0363-9130
Pyrilamine Maleate and Dextromethorphan HydrobromideDextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mLLiquidOralWestminster Pharmaceuticals, LLC69367-398
Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hclAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralAptaPharma Inc.76281-604
Cough DropsmentholMenthol 5.8 mg/1PastilleOralTopco Associates LLC76162-016

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