NDC codes

FDA NDC Directory
Product NDC (as listed)41415-661Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41415-0661Add 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
41415-661-054141506610550 TABLET in 1 BOTTLE (41415-661-05)Marketed from Aug 2, 2024
41415-661-1041415066110100 TABLET in 1 BOTTLE (41415-661-10)Marketed from Aug 2, 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

Generic name (nonproprietary)
acetaminophen and diphenhydramine hcl
Active ingredients
Diphenhydramine — 25 mg/1Acetaminophen — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
PUBLIX SUPERMARKETS, INCNDC labeler code 41415
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 41415-661_465302f5-b590-5105-e063-6394a90aa9d0SPL ID 465302f5-b590-5105-e063-6394a90aa9d0SPL set ID 08f549cf-042a-7bf2-e063-6394a90a83efRxCUI 1092189UNII 8GTS82S83M, 362O9ITL9D
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

N441415066105 followed by a unit qualifier and the quantity

Package 41415-0661-05. 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 temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 41415-661

What is NDC 41415-661?
41415-661 is the product NDC for Acetaminophen and Diphenhydramine HCL, Diphenhydramine 25 mg/1; Acetaminophen 500 mg/1 tablet, listed with the FDA by PUBLIX SUPERMARKETS, INC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Acetaminophen and Diphenhydramine HCL.
What is the active ingredient?
Diphenhydramine, Acetaminophen.
Who is the labeler?
PUBLIX SUPERMARKETS, INC, NDC labeler code 41415. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acetaminophen and Diphenhydramine HCL?
1 other product NDC are listed under this name. See all Acetaminophen and Diphenhydramine HCL 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 Acetaminophen and Diphenhydramine HCL NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Acetaminophen and Diphenhydramine HCLAcetaminophen 500 mg/1; Diphenhydramine 25 mg/1TabletOralSAFEWAY21130-66121130-0661-1021130-0661-2021130-0661-24

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
Acetaminophen Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralFSA STORE INC.81522-070
AcetaminophenAcetaminophen 325 mg/1TabletOralMajor Pharmaceuticals0904-6773
MAX Cold, Flu, and Sore Throatacetaminophen,dextromethorphan hydrobromide, guaifenesin , phenylephrine hclAcetaminophen 650 mg/20mL + 3 more ingredientsLiquidOralH E B37808-316
CVS AcetaminophenacetaminophenAcetaminophen 500 mg/1CapsuleOralCVS Pharmacy51316-185
Headache Relief, Extra Strength 24/7 Life by 7-Elevenacetaminophen, aspirin, caffeine tablet, film coatedAcetaminophen 250 mg/1 + 2 more ingredientsTablet, Film coatedOralLil' Drug Store Products, Inc.66715-5641
Acetaminophen , Caffeine and pyrilamine maleateCaffeine 60 mg/1 + 2 more ingredientsCapsuleOralSoftgel Healthcare Pvt Ltd35916-1234
VitapirenaacetaminophenAcetaminophen 500 mg/1Granule, For solutionOralPharmadel LLC55758-012
Headache Relief Extra Strengthacetaminophen, aspirin and caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTablet, Film coatedOralSalado Sales, Inc.57243-334
pain relieveracetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralWalgreen Company0363-1502
Acetaminophen Diphenhydramine HCLAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1TabletOralWALGREENS CO.0363-9664
CVS Effervescent Antacid and Pain Relieveraspirin, anhydrous citric acid, sodium bicarbonateAspirin 325 mg/1 + 2 more ingredientsTablet, EffervescentOralCVS Pharmacy69842-421
Rugby AspirinaspirinAspirin 81 mg/1Tablet, ChewableOralRugby Laboratories0536-1008
Topcare Pain ReliefacetaminophenAcetaminophen 500 mg/1TabletOralTopco Associates LLC36800-484
Regular Strength Pain RelieveracetaminophenAcetaminophen 325 mg/1TabletOralINGLES MARKETS, INC.62936-0102
Childrens Pain Relief Dye-FreeacteaminophenAcetaminophen 160 mg/5mLSuspensionOralWinCo Foods, LLC67091-119
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgAcetaminophen 250 mg/1 + 2 more ingredientsTabletOralWALGREENS CO.0363-1320
Chewable AspirinaspirinAspirin 81 mg/1Tablet, ChewableOralRETAIL BUSINESS SERVICES , LLC.72476-205
Acetaminophen PMacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralFSA STORE INC.81522-095
Unisom PM Pain Nighttime Sleep Aid and Pain Relieveracetaminophen and diphenhydramine hydrochlorideAcetaminophen 325 mg/1; Diphenhydramine hydrochloride 50 mg/1Tablet, Film coatedOralChattem, Inc.41167-0040
CVS AcetaminophenacetaminophenAcetaminophen 500 mg/1CapsuleOralCVS Pharmacy51316-188

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