What is NDC 69168-002?

69168-002 is the product NDC for Diphenhydramine HCl 25mg (sleep aid), Diphenhydramine hydrochloride 25 mg/1 tablet, coated, listed with the FDA by Allegiant Health. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Diphenhydramine HCl 25mg (Sleep Aid).

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 Diphenhydramine HCl 25mg?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diphenhydramine HCl 25mg NDC 69168-002

NDC codes

FDA NDC Directory

Product NDC (as listed)69168-002Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69168-0002Add 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
69168-002-93	69168000293	24 TABLET, COATED in 1 CARTON (69168-002-93)Marketed from Nov 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): Diphenhydramine HCl 25mg
Generic name (nonproprietary): sleep aid
Active ingredients: Diphenhydramine hydrochloride — 25 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Allegiant HealthNDC labeler code 69168
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 010
Marketing start: Nov 23, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 69168-002_36c028e5-005a-42eb-958c-9fed406827b3SPL ID 36c028e5-005a-42eb-958c-9fed406827b3SPL set ID 2890e4ba-d642-437d-8a86-24996a74e027RxCUI 1049630UNII TC2D6JAD40UPC 0852510005774
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

N469168000293 followed by a unit qualifier and the quantity

Package 69168-0002-93. 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 Nov 23, 2021.

Indications (excerpt from the label)

Use(s) for relief of occasional sleeplessness

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69168-002

What is NDC 69168-002?: 69168-002 is the product NDC for Diphenhydramine HCl 25mg (sleep aid), Diphenhydramine hydrochloride 25 mg/1 tablet, coated, listed with the FDA by Allegiant Health. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diphenhydramine HCl 25mg (Sleep Aid).
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 Diphenhydramine HCl 25mg?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 010

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

FDA NDC Directory listings under M 010
Product	Strength	Form · route	Labeler	Product NDC
ADWE dye-free childrens allergydiphenhydramine hydrochloride	Diphenhydramine hydrochloride 12.5 mg/5mL	SyrupOral	RARITAN PHARMACEUTICALS INC	68163-710
Allergy Relief 25 mgdiphenhydramine hcl 25mg	Diphenhydramine hydrochloride 25 mg/1	CapsuleOral	Ulai Health LLC	73057-348
AXIV - VroZzzdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	Vivunt Pharma LLC	82706-014
basic care nighttime sleep aiddiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/30mL	SolutionOral	Amazon.com Services LLC	72288-186
berkley and jensen sleep aiddiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/30mL	SolutionOral	BJWC	68391-186
Best Choice Childrens Allergy Relief Bubblegum flavordiphenhydramine hcl	Diphenhydramine hydrochloride 12.5 mg/5mL	LiquidOral	BEST CHOICE (VALU MERCHANDISERS COMPANY)	63941-710
Betr sleep aiddiphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Live Betr LLC	80267-431
Calmco Sleep Aiddiphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/5mL	SolutionOral	CalmCo LLC	73282-2525
CalmCo Sleep Aiddiphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/1	Chewable gelOral	CalmCo LLC	73282-2527
CalmCo Sleep Aiddiphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/1	Chewable gelOral	CalmCo LLC	73282-2528
CalmCo Sleep Aid Gummy Bitediphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/1	Bar, ChewableOral	CalmCo LLC	73282-2518
careone nighttime sleep aiddiphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	American Sales Company	41520-431
CVS Childrens Nighttime Multi Symptom Coldacetaminophen , diphenhydramine hydrochloride,phenylephrine hydrochloride	Acetaminophen 325 mg/10mL + 2 more ingredients	LiquidOral	CVS PHARMACY	51316-733
CVS Health Nighttime Sleep-Aiddiphenhydramine hydrochloride	Diphenhydramine hydrochloride 50 mg/30mL	LiquidOral	CVS Pharmacy,Inc.	59779-893
CVS Nighttime Childrens Cold and Cough Multi-Symptom Reliefchlorpheniramine maleate and dextromethorphan hydrobromide	Chlorpheniramine maleate 2 mg/15mL; Dextromethorphan hydrobromide 15 mg/15mL	SolutionOral	CVS PHARMACY	51316-752
CVS NightTime Coldacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride	Acetaminophen 650 mg/30mL + 3 more ingredients	SolutionOral	CVS PHARMACY	51316-641
CVS Nighttime Cold and Flu Reliefacetaminophen, dextromethorphan hbr, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	SolutionOral	CVS PHARMACY	51316-692
CVS Nighttime Sleep Aiddiphenhydramine hydrochloride and acetaminophen	Acetaminophen 1000 mg/30mL; Diphenhydramine hydrochloride 50 mg/30mL	LiquidOral	CVS PHARMACY	69842-448
dg health sleep aiddiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/30mL	SolutionOral	Dolgencorp, LLC	55910-186
dg health sleep aiddiphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Dolgencorp Inc	55910-431

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Diphenhydramine HCl 25mg (Sleep aid) NDC 69168-002