Over-the-counter drug · OTC MONOGRAPH DRUG

Allergy (Diphenhydramine hydrochloride) NDC 41226-160

Diphenhydramine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Kroger Company

NDC codes

FDA NDC Directory
Product NDC (as listed)41226-160Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41226-0160Add 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
41226-160-0141226016001412260160011 BOTTLE in 1 CARTON (41226-160-01) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from May 11, 2021
41226-160-4041226016040412260160401 BOTTLE in 1 CARTON (41226-160-40) / 400 TABLET, FILM COATED in 1 BOTTLEMarketed from May 11, 2021
41226-160-4241226016042412260160421 BLISTER PACK in 1 CARTON (41226-160-42) / 12 BLISTER PACK in 1 BLISTER PACK / 12 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 11, 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)
Allergy
Generic name (nonproprietary)
diphenhydramine hydrochloride
Active ingredients
Diphenhydramine hydrochloride — 25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Kroger CompanyNDC labeler code 41226
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 41226-160_3860490c-68ee-ea49-e063-6394a90af03aSPL ID 3860490c-68ee-ea49-e063-6394a90af03aSPL set ID bc019c9e-8fac-5fd3-e053-2a95a90a7ccdRxCUI 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

N441226016001 followed by a unit qualifier and the quantity

Package 41226-0160-01. 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 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itchy nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 41226-160

What is NDC 41226-160?
41226-160 is the product NDC for Allergy (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Kroger Company. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Allergy (Diphenhydramine hydrochloride).
What is the active ingredient?
Diphenhydramine hydrochloride.
Who is the labeler?
Kroger Company, NDC labeler code 41226. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Allergy?
25 other product NDCs are listed under this name. See all Allergy 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 Allergy NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Allergymometasone furoateMometasone furoate monohydrate 50 ug/1Spray, MeteredNasalAmazon.com Services LLC72288-50672288-0506-02
Allergyfexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-71672288-0716-0072288-0716-39
allergymometasone furoate monohydrateMometasone furoate monohydrate 50 ug/1Spray, MeteredNasalHyVee Inc42507-18242507-0182-02
Allergydiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralPublix Super Markets Inc56062-92356062-0923-0856062-0923-12
Allergymometasone furoate monohydrateMometasone furoate monohydrate 50 ug/1Spray, MeteredNasalRite Aid Corporation11822-709911822-7099-01
allergymometasone furoate monohydrateMometasone furoate monohydrate 50 ug/1Spray, MeteredNasalCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-11751316-0117-11
Allergyallium cepa, ambrosia, arsenicum alb, carbo veg, euphrasia, nux vom, phosphorus, pulsatilla, sulphur, solidagoOnion 30 [hp_C]/mL + 8 more ingredientsLiquidOralZorex International81825-000781825-0007-01
Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralKroger Company41226-69241226-0692-1441226-0692-6541226-0692-70
Allergyallium sat, anacardium, apis mel, gambogia, merc solub, nat carb, nitricum ac, nux vom, phosphorus, pulsatilla, sulphurGarlic 12 [hp_X]/59.1mL + 10 more ingredientsLiquidOralNet Remedies61626-010961626-0109-04
Allergydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1TabletOralVelocity Pharma LLC76168-12176168-0121-12

All 26 Allergy NDCs

Other NDCs under M 013

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

FDA NDC Directory listings under M 013
ProductStrengthForm · routeLabelerProduct NDC
Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralATLANTIC BIOLOGICALS CORP.17856-3086
Childrens TYLENOLacetaminophenAcetaminophen 160 mg/5mLSuspensionOralKenvue Brands LLC50580-614
Acetaminophen Regular strengthacetaminophenAcetaminophen 325 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.55289-563
Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralTOP CARE (Topco Associates LLC)36800-466
Acetaminophen 325 MgacetaminophenAcetaminophen 325 mg/1TabletOralProficient Rx LP71205-456
AcetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralHarris Teeter72036-170
Topcare AspirinaspirinAspirin 81 mg/1Tablet, ChewableOralTopco Associates LLC36800-467
Pain ReliefacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralHYVEE INC42507-592
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralMARC GLASSMAN, INC.68998-392
AcetaminophenAcetaminophen 500 mg/1TabletOralTrifecta Pharmaceuticals USA LLC69396-140
Goodnow Pain ReliefacetaminophenAcetaminophen 500 mg/1TabletOralGobrands, Inc82501-0484
Tension Headache Pain Relieving Aidacetaminophen,caffeineAcetaminophen 500 mg/1; Caffeine 65 mg/1TabletOralWAL-MART STORES INC79903-373
Acetaminophen , Aspirin and CaffeineAspirin 250 mg/1 + 2 more ingredientsCapsuleOralSoftgel Healthcare Pvt Ltd35916-0709
AcetaminophenAcetaminophen 160 mg/5mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-0941
CareOne Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmerican Sales Company41520-615
Childrens TYLENOLacetaminophenAcetaminophen 160 mg/5mLSuspensionOralKenvue Brands LLC50580-612
Adwe Feverx Acetaminophen Caplets, 500 mg Extra StrengthacetaminophenAcetaminophen 500 mg/1TabletOralAurex Laboratories Limited Liability Company71009-109
Acetaminophen PMacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralHarris Teeter72036-171
Basic Care Childrens Pain and FeveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmazon.com Services LLC72288-130
good neighbor pharmacy aspirinaspirinAspirin 81 mg/1Tablet, ChewableOralAmerisource Bergen24385-278

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