What is NDC 57243-502?

57243-502 is the product NDC for Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY, Acetaminophen 650 mg/30mL + 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?

Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY (Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate).

What is the active ingredient?

Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate.

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 Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY?

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.

Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY NDC 57243-502

NDC codes

FDA NDC Directory

Product NDC (as listed)57243-502Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57243-0502Add 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
57243-502-25	57243050225	177 mL in 1 BOTTLE (57243-502-25)Marketed from Jan 31, 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): Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRYSuffix: COLD/FLU CHERRY
Generic name (nonproprietary): acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
Active ingredients: Acetaminophen — 650 mg/30mLDextromethorphan hydrobromide — 30 mg/30mLDoxylamine succinate — 12.5 mg/30mL
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: Jan 31, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 57243-502_21dee833-1f0b-4ac7-a662-169dc2fc6d0aSPL ID 21dee833-1f0b-4ac7-a662-169dc2fc6d0aSPL set ID e6c3e545-b2ad-47f0-8318-c134a8e24f5bRxCUI 1043400UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Pharmacologic class: Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate 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

N457243050225 followed by a unit qualifier and the quantity

Package 57243-0502-25. 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 cold/flu symptoms: sore throat minor aches and pain runny nose and sneezing cough due to minor sore throat and bronchial irritation headache fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57243-502

What is NDC 57243-502?: 57243-502 is the product NDC for Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY, Acetaminophen 650 mg/30mL + 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?: Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY (Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate).
What is the active ingredient?: Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate.
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 Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY?: 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
365 whole foods market acetaminophenacetaminophen	Acetaminophen 500 mg/1	TabletOral	Whole Foods Market, INC.	42681-0025
Acetaminophen	Acetaminophen 160 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0657
Acetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	PAI Holdings, LLC dba PAI Pharma	0121-0941
Acetaminophen	Acetaminophen 160 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1047
Acetaminophen	Acetaminophen 325 mg/10.15mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1314
Acetaminophen	Acetaminophen 325 mg/10.15mL	SuspensionOral	PAI Holdings, LLC dba PAI Pharma	0121-1882
Acetaminophen	Acetaminophen 650 mg/20.3mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1971
Acetaminophen	Acetaminophen 325 mg/10.15mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-2094
Acetaminophen	Acetaminophen 650 mg/20.3mL	SuspensionOral	PAI Holdings, LLC dba PAI Pharma	0121-2823
Acetaminophen	Acetaminophen 650 mg/20.3mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-3141
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	WALGREENS	0363-9538
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	WALGREEN CO.	0363-9595
Acetaminophen	Acetaminophen 160 mg/1	TabletOral	WALGREEN CO.	0363-9605
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	WALGREEN CO.	0363-9798
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Walgreens	0363-9810
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Rugby Laboratories	0536-1172
Acetaminophen	Acetaminophen 500 mg/1	Tablet, CoatedOral	Rugby Laboratories	0536-1292
Acetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	Rugby Laboratories	0536-1413
Acetaminophen	Acetaminophen 325 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8608
Acetaminophen	Acetaminophen 325 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8609

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