What is NDC 68016-654?

68016-654 is the product NDC for Acetaminophen Diphenhydramine HCl, Acetaminophen 500 mg/1; Diphenhydramine 25 mg/1 tablet, listed with the FDA by Chain Drug Consortium,LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Chain Drug Consortium,LLC, NDC labeler code 68016. 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 Diphenhydramine HCl?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Acetaminophen Diphenhydramine HCl NDC 68016-654

NDC codes

FDA NDC Directory

Product NDC (as listed)68016-654Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68016-0654Add 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 NDC	11-digit (billing)	Package	Copy
68016-654-05	6801606540568016065405	50 TABLET in 1 BOTTLE (68016-654-05)Marketed from Feb 25, 2016
68016-654-10	6801606541068016065410	100 TABLET in 1 BOTTLE (68016-654-10)Marketed from Feb 25, 2016

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): Acetaminophen Diphenhydramine HCl
Generic name (nonproprietary): acetaminophen diphenhydramine hcl
Active ingredients: Acetaminophen — 500 mg/1Diphenhydramine — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Chain Drug Consortium,LLCNDC labeler code 68016
Product type: Over-the-counter drug
Marketing category: OTC monograph (not final)Application part343
Marketing start: Feb 25, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 68016-654_47f839b9-ac8b-161c-e054-00144ff8d46cSPL ID 47f839b9-ac8b-161c-e054-00144ff8d46cSPL set ID 47f839b9-ac8a-161c-e054-00144ff8d46cRxCUI 1092189UNII 362O9ITL9D, 8GTS82S83MUPC 0840986031847, 0840986031830
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

N468016065405 followed by a unit qualifier and the quantity

Package 68016-0654-05. 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 Feb 7, 2017.

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 68016-654

What is NDC 68016-654?: 68016-654 is the product NDC for Acetaminophen Diphenhydramine HCl, Acetaminophen 500 mg/1; Diphenhydramine 25 mg/1 tablet, listed with the FDA by Chain Drug Consortium,LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acetaminophen Diphenhydramine HCl.
What is the active ingredient?: Acetaminophen, Diphenhydramine.
Who is the labeler?: Chain Drug Consortium,LLC, NDC labeler code 68016. 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 Diphenhydramine HCl?: 7 other product NDCs are listed under this name. See all Acetaminophen 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 Diphenhydramine HCl NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Acetaminophen Diphenhydramine HCL	Acetaminophen 500 mg/1; Diphenhydramine 25 mg/1	TabletOral	Dr. Reddy's Laboratories Inc.	75907-431	75907-0431-0175907-0431-30
Acetaminophen Diphenhydramine HCL	Acetaminophen 500 mg/1; Diphenhydramine 25 mg/1	TabletOral	Walgreens	0363-9661	00363-9661-1500363-9661-25
Acetaminophen Diphenhydramine HCL	Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1	TabletOral	WALGREEN CO.	0363-9799	00363-9799-75
Acetaminophen Diphenhydramine HCl	Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1	TabletOral	BETTER LIVING BRANDS LLC.	21130-354	21130-0354-0221130-0354-08
Acetaminophen Diphenhydramine HCL	Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1	TabletOral	WALGREENS CO.	0363-9664	00363-9664-3700363-9664-60
Acetaminophen Diphenhydramine HCl	Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1	TabletOral	Granules USA, Inc.	69848-014	69848-0014-0269848-0014-0569848-0014-15
Acetaminophen, Diphenhydramine HCl	Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1	Tablet, Film coatedOral	CVS Pharmacy, Inc.	69842-572	69842-0572-0269842-0572-0869842-0572-12

Other NDCs under part343

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

FDA NDC Directory listings under part343
Product	Strength	Form · route	Labeler	Product NDC
aspirin low dose enteric coatedaspirin	Aspirin 81 mg/1	Tablet, CoatedOral	Time-Cap Labs, Inc	49483-387
aspirin low dose enteric coatedaspirin	Aspirin 81 mg/1	TabletOral	Time-Cap Labs, Inc	49483-390
Acetaminophen Capletsacetaminophen	Acetaminophen 500 mg/1	TabletOral	Breeden Brothers, LLC	70729-001
Acetaminophen Capletsacetaminophen	Acetaminophen 500 mg/1	TabletOral	Breeden Brothers, LLC	70729-175
Geritrex Aspirinaspirin	Aspirin 325 mg/1	Tablet, CoatedOral	Geritrex LLC	54162-940
Pain Relief PMacetaminophen pm	Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1	TabletOral	Velocity Pharma	76168-119
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Velocity Pharma LLC	76168-120
CounterAct PMacetaminophen and diphenhydramine	Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1	TabletOral	Melaleuca, Inc.	54473-304
Acetaminophen	Acetaminophen 325 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-238
Broncochem Expectorant IIacetaminophen-chlorpheniramine maleate-dextromethorphan hbr-guaifenesin-phenylephrine hcl	Acetaminophen 250 mg/10mL + 4 more ingredients	SyrupOral	LABORATORIO MAGNACHEM INTERNATIONAL SRL	65131-116
Aspirin	Aspirin 325 mg/1	TabletOral	Advance Pharmaceutical Inc.	17714-010
Aspirin	Aspirin 325 mg/1	TabletOral	Advance Pharmaceutical Inc.	17714-011
Acetaminophen	Acetaminophen 325 mg/1	TabletOral	Advance Pharmaceutical Inc.	17714-012
Apapacetaminophen	Acetaminophen 500 mg/1	TabletOral	Advance Pharmaceutical Inc.	17714-013
Apapacetaminophen	Acetaminophen 500 mg/1	TabletOral	Advance Pharmaceutical Inc.	17714-014
Aspirin	Aspirin 81 mg/1	TabletOral	Advance Pharmaceutical Inc.	17714-121
Extra Strength Acetaminophenacetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	PuraCap Pharmaceutical LLC	51013-320
Doans Extra Strengthmagnesium salicylate	Magnesium salicylate 580 mg/1	TabletOral	Dr. Reddy's Laboratories Inc.	55741-224
Extra Strength Acetaminophenacetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	CVS PHARMACY, INC.	69842-390
Childrens Tukol Acetaminophen Fever Reducer Pain Reduceracetaminophen	Acetaminophen 160 mg/5mL	LiquidOral	Genomma Lab USA, Inc.	50066-525

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