What is NDC 82568-0016?

82568-0016 is the product NDC for Diphenhydramine HCl 12.5 Mg Per 5 Ml, Diphenhydramine 12.5 mg/5mL solution, listed with the FDA by AARNA USA INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.

AARNA USA INC., NDC labeler code 82568. 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 12.5 Mg Per 5 Ml?

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 12.5 Mg Per 5 Ml NDC 82568-0016

NDC codes

FDA NDC Directory

Product NDC (as listed)82568-0016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82568-0016Add 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
82568-0016-4	8256800160482568001604	118 mL in 1 BOTTLE (82568-0016-4)Marketed from Apr 14, 2025
82568-0016-6	8256800160682568001606	473 mL in 1 BOTTLE (82568-0016-6)Marketed from Apr 14, 2025
82568-0016-8	8256800160882568001608	236 mL in 1 BOTTLE (82568-0016-8)Marketed from Apr 14, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 12.5 Mg Per 5 Ml
Generic name (nonproprietary): diphenhydramine hcl 12.5 mg per 5 ml
Active ingredients: Diphenhydramine — 12.5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: AARNA USA INC.NDC labeler code 82568
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Apr 14, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 82568-0016_3404aa22-166f-5501-e063-6394a90a1e7aSPL ID 3404aa22-166f-5501-e063-6394a90a1e7aSPL set ID 32c26835-f54e-d7e5-e063-6294a90ae1c0RxCUI 1049906UNII 8GTS82S83M
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

N482568001604 followed by a unit qualifier and the quantity

Package 82568-0016-04. 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 Apr 30, 2025.

Indications (excerpt from the label)

Directions do not take more than 6 doses in any 24 hours take every 4 to 6 hours, or as directed by a doctor mL = milliliter keep dosing cup with product find the right dose on the chart below Age (yr) Dose (mL) children 6 to 11 years 5 mL to 10 mL children 2 to 5 years Do not use unless directed by a doctor children under 2 years Do not use

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82568-0016

What is NDC 82568-0016?: 82568-0016 is the product NDC for Diphenhydramine HCl 12.5 Mg Per 5 Ml, Diphenhydramine 12.5 mg/5mL solution, listed with the FDA by AARNA USA INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diphenhydramine HCl 12.5 Mg Per 5 Ml.
What is the active ingredient?: Diphenhydramine.
Who is the labeler?: AARNA USA INC., NDC labeler code 82568. 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 12.5 Mg Per 5 Ml?: 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 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
Product	Strength	Form · route	Labeler	Product NDC
Cough Reliefdextromethorphan hydrobromide	Dextromethorphan hydrobromide 15 mg/1	Capsule, Liquid filledOral	Advanced Rx LLC	80513-311
TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr	—	Kit	TARGET CORPORATION	82442-559
Geri-Dryl allergy reliefdiphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/1	Tablet, CoatedOral	VerityRx	83939-0683
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci	—	Kit	TARGET Corporation	11673-420
Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxide	Petrolatum 49 g/100g; Zinc oxide 15 g/100g	CreamTopical	Welmedix LLC	24330-410
topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate	Acetaminophen 325 mg/1 + 2 more ingredients	Capsule, Liquid filledOral	Topco Associates LLC	36800-143
Allergy Childrensdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 12.5 mg/5mL	LiquidOral	H E B	37808-012
Mucus Relief Cough Childrensdextromethorphan hbr, guaifensin	Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL	LiquidOral	H E B	37808-594
Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesin	Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1	TabletOral	Strategic Sourcing Services LLC	49348-728
Dual Action Honey Lemon Cough Suppressant Oral Anestheticmenthol	Menthol 8.3 mg/1	LozengeOral	Ricola Ag	54305-323
Discount drug mart Extra Moisturizingoxymetazoline hydrochloride	Oxymetazoline hydrochloride .05 g/100mL	SprayNasal	DISCOUNT DRUG MART	53943-720
Mucus Reliefguaifenesin	Guaifenesin 400 mg/1	TabletOral	Geri-Care Pharmaceuticals, Corp	57896-714
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hcl	Acetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mL	LiquidOral	Haleon US Holdings LLC	0031-0101
Throat Comfort Orange Mint Cinnamon Dropsmenthol	Menthol 3.6 mg/1	LozengeOral	Ricola USA Inc.	63667-342
Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coated	Guaifenesin 200 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Lil' Drug Store products, Inc.	66715-5632
COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 3 more ingredients	Capsule, Liquid filledOral	Walgreens	0363-9016
Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hcl	Acetaminophen 650 mg/20mL + 2 more ingredients	LiquidOral	Walgreens	0363-9130
Pyrilamine Maleate and Dextromethorphan Hydrobromide	Dextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mL	LiquidOral	Westminster Pharmaceuticals, LLC	69367-398
Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hcl	Acetaminophen 325 mg/1 + 2 more ingredients	Capsule, Liquid filledOral	AptaPharma Inc.	76281-604
Cough Dropsmenthol	Menthol 5.8 mg/1	PastilleOral	Topco Associates LLC	76162-016

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