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	5724305022557243050225	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
Childrens Acetaminophenacetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Grocery Outlet, Inc.	85828-922
Pain Relief Regular Strengthacetaminophen	Acetaminophen 325 mg/1	TabletOral	CHAIN DRUG MARKETING ASSOCIATION INC	83324-076
equate pain and fever childrensacetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Wal-Mart Stores Inc	49035-042
good neighbor pharmacy childrens pain and feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Amerisource Bergen	46122-210
Aspirin	Aspirin 81 mg/1	Tablet, Delayed releaseOral	GOODSENSE	50804-880
Tylenol PM Extra Strengthacetaminophen and diphenhydramine hydrochloride	Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Morning Star OTC	53209-1002
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Cardinal Health 107, LLC	55154-7897
Headache Formula Extra Strengthacetaminophen, aspirin, caffeine	Acetaminophen 250 mg/1 + 2 more ingredients	Tablet, Film coatedOral	ARMY AND AIR FORCE EXCHANGE SERVICE	55301-334
childrens pain and feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Walgreen Company	0363-1239
Tylenol PMacetaminophen, diphenhydramine hydrochloride	Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Savings Distributors LLC	73097-013
Alka-Seltzer Originalanhydrous citric acid, aspirin, and sodium bicarbonate	Anhydrous citric acid 1000 mg/1 + 2 more ingredients	Tablet, EffervescentOral	Bayer HealthCare LLC.	0280-4000
Aspirin Low Doseaspirin	Aspirin 81 mg/1	Tablet, Delayed releaseOral	Strategic Sourcing Services LLC	70677-1260
basic care infants pain and feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Amazon.com Services LLC	72288-946
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Sportpharm LLC	85766-223
Pain Relief Aspirin Low Doseaspirin	Aspirin 81 mg/1	Tablet, Delayed releaseOral	Rite Aid Corporation	11822-0600
Equaline Effervescent Antacid and Pain Reliefaspirin, citric acid, sodium bicarbonate	Aspirin 325 mg/1 + 2 more ingredients	Tablet, EffervescentOral	United Natural Foods, Inc. dba UNFI	41163-421
Night Time Severe Cold and Cough Reliefacetaminophen, diphenhydramine hcl, phenylephrine hcl	Acetaminophen 325 mg/15mL + 2 more ingredients	LiquidOral	Chain Drug Consortium, LLC	68016-154
Tension Headache Relief	Acetaminophen 500 mg/1; Caffeine 65 mg/1	Capsule, CoatedOral	Allegiant Health	69168-001
Childrens Acetaminophenacetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Proficient Rx LP	71205-263
Chewable Aspirinaspirin	Aspirin 81 mg/1	Tablet, ChewableOral	Chain Drug Marketing Association, Inc.	83324-075

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