What is NDC 57243-506?

57243-506 is the product NDC for Daytime Non-Drowsy COLD/FLU, Acetaminophen 325 mg/15mL + 2 more ingredients liquid, listed with the FDA by Salado Sales, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Daytime Non-Drowsy COLD/FLU (Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride).

What is the active ingredient?

Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride.

Salado Sales, Inc., NDC labeler code 57243. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Daytime Non-Drowsy COLD/FLU?

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.

Daytime Non-Drowsy COLD/FLU NDC 57243-506

NDC codes

FDA NDC Directory

Product NDC (as listed)57243-506Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57243-0506Add 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
57243-506-25	57243050625	177 mL in 1 BOTTLE (57243-506-25)Marketed from Sep 5, 2012

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): Daytime Non-Drowsy COLD/FLUSuffix: Non-Drowsy COLD/FLU
Generic name (nonproprietary): acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
Active ingredients: Acetaminophen — 325 mg/15mLDextromethorphan hydrobromide — 10 mg/15mLPhenylephrine hydrochloride — 5 mg/15mL
Dosage form: Liquid
Route: Oral
Labeler: Salado Sales, Inc.NDC labeler code 57243
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 013
Marketing start: Sep 5, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 57243-506_49c1c962-2dba-479b-b98a-a70e9d7dd68bSPL ID 49c1c962-2dba-479b-b98a-a70e9d7dd68bSPL set ID e181b371-78c7-4163-865d-acc064be33caRxCUI 1113705UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJUPC 0761706161135
Pharmacologic class: Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist

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

N457243050625 followed by a unit qualifier and the quantity

Package 57243-0506-25. 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 29, 2023.

Indications (excerpt from the label)

Uses temporarily relieves these common cold/flu symptoms: minor aches and pains ● headache ● sore throat ● fever nasal congestion ● cough due to minor throat and bronchial irritation

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57243-506

What is NDC 57243-506?: 57243-506 is the product NDC for Daytime Non-Drowsy COLD/FLU, Acetaminophen 325 mg/15mL + 2 more ingredients liquid, listed with the FDA by Salado Sales, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Daytime Non-Drowsy COLD/FLU (Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride).
What is the active ingredient?: Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride.
Who is the labeler?: Salado Sales, Inc., NDC labeler code 57243. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Daytime Non-Drowsy COLD/FLU?: 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 013

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

FDA NDC Directory listings under M 013
Product	Strength	Form · route	Labeler	Product NDC
Best Choice Effervescent Pain Reliever 36aspirin	Aspirin 325 mg/1	Tablet, EffervescentOral	VALU MERCHANDISERS COMPANY	63941-241
Aspirin Packsaspirin	Aspirin 325 mg/1	Tablet, Film coatedOral	Sina Health Inc	70385-2006
Back and Body Extra Strengthaspirin, caffeine	Aspirin 500 mg/1; Caffeine 32.5 mg/1	Tablet, Film coatedOral	Cardinal Health 110, LLC. DBA Leader	70000-0127
foster and thrive aspirinaspirin	Aspirin 81 mg/1	Tablet, ChewableOral	Strategic Sourcing Services LLC	70677-1134
Medique Pain Offacetaminophen, aspirin, caffeine	Caffeine 65 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Unifirst First Aid Corporation	47682-238
Acetaminophen Extra Strengthacetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	Wal-Mart Stores Inc	49035-175
Low Dose Aspirinaspirin	Aspirin 81 mg/1	Tablet, CoatedOral	A-S Medication Solutions	50090-4830
Childrens Pain Relief	Acetaminophen 160 mg/5mL	LiquidOral	Allegiant Health	69168-455
Aspirin Low Doseaspirin	Aspirin 81 mg/1	Tablet, CoatedOral	MAJOR PHARMACEUTICALS	0904-6783
equaline acetaminophenacetaminophen	Acetaminophen 500 mg/1	TabletOral	United Natural Foods, Inc. dba UNFI	41163-363
Chewable Aspirinaspirin	Aspirin 81 mg/1	Tablet, ChewableOral	HARRIS TEETER	72036-205
Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochloride	Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1	Tablet, CoatedOral	Chain Drug Marketing Association	63868-325
Excedrin Extra Strength and Excedrin Tension Headacheacetaminophen, aspirin (nsaid), and caffeine	—	Kit	Haleon US Holdings LLC	0067-8151
Enteric Coated Aspirin Regular Strengthaspirin	Aspirin 325 mg/1	Tablet, Delayed releaseOral	Safeway	21130-081
Headache Relief Extra Strengthacetaminophen, aspirin, caffeine	Acetaminophen 250 mg/1 + 2 more ingredients	TabletOral	H E B	37808-586
DrKids Childrens Pain and Feveracetaminophen 80mg/piece	Acetaminophen 80 mg/1	Bar, ChewableOral	CalmCo LLC	73282-2480
CAREALL Non-Aspirin PM Extra Strengthacetaminophen, diphenhydramine hcl	Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1	TabletOral	New World Imports, Inc	51824-069
dg health pain reliefacetaminophen	Acetaminophen 500 mg/1	TabletOral	Dolgencorp Inc	55910-661
Extra Strength Acetaminophenacetaminophen	Acetaminophen 500 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4065
Aspirin 81mg Dye-Freeaspirin 81mg	Aspirin 81 mg/1	Tablet, Film coatedOral	Allegiant Health	69168-457

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