Childrens Allergy Relief NDC 55315-354

NDC codes

FDA NDC Directory

Product NDC (as listed)55315-354Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55315-0354Add 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
55315-354-31	55315035431	1 BOTTLE in 1 CARTON (55315-354-31) / 120 mL in 1 BOTTLEMarketed from Jan 31, 2015

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): Childrens Allergy Relief
Generic name (nonproprietary): cetirizine hydrochloride
Active ingredients: Cetirizine hydrochloride — 1 mg/mL
Dosage form: Solution
Route: Oral
Labeler: Fred's, Inc.
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090750
Marketing start: Jan 31, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 55315-354_17d2db07-4de0-4e02-8e2e-0082c275faabSPL ID 17d2db07-4de0-4e02-8e2e-0082c275faabSPL set ID 55e799b2-e325-4286-aa9a-b88e99ab1146RxCUI 1014673UNII 64O047KTOAUPC 0084579127580
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

N455315035431 followed by a unit qualifier and the quantity

Package 55315-0354-31. 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 13, 2020.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090750

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

FDA NDC Directory listings under ANDA 090750
Product	Strength	Form · route	Labeler	Product NDC
Childrens Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	C.D.M.A., Inc.	63868-865
Childrens Cetirizine Hydrochloride Hives Reliefcetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Aurohealth LLC	58602-036
Childrens Cetirizine Hydrochloride Allergycetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Aurohealth LLC	58602-028
Childrens Cetirizine Hydrochloride Hives Reliefcetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Aurohealth LLC	58602-030
Childrens Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Aurohealth LLC	58602-422

Childrens Allergy Relief (cetirizine hydrochloride) NDC 55315-354