What is NDC 80513-201?

80513-201 is the product NDC for Puregen Labs Allergy Relief (diphenhydramine hcl), Diphenhydramine hydrochloride 12.5 mg/5mL liquid, listed with the FDA by Advanced Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Puregen Labs Allergy Relief (Diphenhydramine HCl).

Advanced Rx LLC, NDC labeler code 80513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Puregen Labs Allergy Relief?

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.

Puregen Labs Allergy Relief NDC 80513-201

NDC codes

FDA NDC Directory

Product NDC (as listed)80513-201Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80513-0201Add 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
80513-201-16	8051302011680513020116	473 mL in 1 BOTTLE (80513-201-16)Marketed from Dec 1, 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

Brand name (proprietary): Puregen Labs Allergy Relief
Generic name (nonproprietary): diphenhydramine hcl
Active ingredients: Diphenhydramine hydrochloride — 12.5 mg/5mL
Dosage form: Liquid
Route: Oral
Labeler: Advanced Rx LLCNDC labeler code 80513
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Dec 1, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 80513-201_4745d501-fbad-b33f-e063-6294a90a0753SPL ID 4745d501-fbad-b33f-e063-6294a90a0753SPL set ID 4745d4f9-bbdf-a4a6-e063-6294a90a15b2RxCUI 1049906UNII TC2D6JAD40UPC 0380513000552
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

N480513020116 followed by a unit qualifier and the quantity

Package 80513-0201-16. 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 Dec 31, 2025.

Indications (excerpt from the label)

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80513-201

What is NDC 80513-201?: 80513-201 is the product NDC for Puregen Labs Allergy Relief (diphenhydramine hcl), Diphenhydramine hydrochloride 12.5 mg/5mL liquid, listed with the FDA by Advanced Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Puregen Labs Allergy Relief (Diphenhydramine HCl).
What is the active ingredient?: Diphenhydramine hydrochloride.
Who is the labeler?: Advanced Rx LLC, NDC labeler code 80513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Puregen Labs Allergy Relief?: 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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Puregen Labs Allergy Relief (Diphenhydramine hcl) NDC 80513-201