What is NDC 57243-501?

57243-501 is the product NDC for Nite-Time COLD/FLU ORIGINAL, 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-Time COLD/FLU ORIGINAL (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-Time COLD/FLU ORIGINAL?

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-Time COLD/FLU ORIGINAL NDC 57243-501

NDC codes

FDA NDC Directory

Product NDC (as listed)57243-501Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57243-0501Add 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
57243-501-25	5724305012557243050125	177 mL in 1 BOTTLE (57243-501-25)Marketed from Jan 16, 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-Time COLD/FLU ORIGINALSuffix: COLD/FLU ORIGINAL
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 16, 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 57243-501_99da41d1-ae1e-4a3a-b51a-11bed23be8bfSPL ID 99da41d1-ae1e-4a3a-b51a-11bed23be8bfSPL set ID fcd24753-b42b-4d05-8379-0ec0351ab217RxCUI 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

N457243050125 followed by a unit qualifier and the quantity

Package 57243-0501-25. 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 57243-501

What is NDC 57243-501?: 57243-501 is the product NDC for Nite-Time COLD/FLU ORIGINAL, 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-Time COLD/FLU ORIGINAL (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-Time COLD/FLU ORIGINAL?: 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
Acetaminophen	Acetaminophen 500 mg/1	Tablet, CoatedOral	COSTCO WHOLESALE CORPORATION	63981-019
Extra Strength Pain Releifacetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	Strategic Sourcing Services, LLC	70677-1242
Aspirin 81 mgaspirin	Aspirin 81 mg/1	Tablet, Delayed releaseOral	H E B	37808-600
TYLENOL Extra Strengthacetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	Morning Star OTC	53209-1001
Extra Strength Pain Relieveracetaminophen tablets 500 mg	Acetaminophen 500 mg/1	TabletOral	WALGREENS	0363-0669
Pain Relieveracetaminophen capsules 500mg (minis-red opaque)	Acetaminophen 500 mg/1	Capsule, Liquid filledOral	Walgreens	0363-6684
Mommys Bliss Childrens Pain and Feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Mom Enterprises, LLC.	71444-793
Childrens Pain and Feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	CVS Pharmacy	59779-126
Good Neighbor Pharmacy childrens pain and feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Amerisource Bergen	46122-211
Acetaminophen	Acetaminophen 160 mg/5mL	LiquidOral	A-S Medication Solutions	50090-6059
Members Mark Acetaminophenacetaminophen	Acetaminophen 500 mg/1	TabletOral	Sam's West Inc	68196-606
Mommys Bliss Infants Pain and Feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Mom Enterprises, LLC.	71444-893
Thompson Extra Strength Non-Aspirinacetaminophen	Acetaminophen 500 mg/1	TabletOral	Thompson	73408-174
Aspirin 81 mg Low Doseaspirin	Aspirin 81 mg/1	Tablet, Delayed releaseOral	CHAIN DRUG MARKETING ASSOCIATION, INC.	83324-089
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	ASCLEMED USA INC.	87063-222
Pain Relief Aspirin Low Doseaspirin	Aspirin 81 mg/1	Tablet, Delayed releaseOral	Rite Aid Corporation	11822-0600
equate pain and fever childrensacetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Wal-Mart Stores Inc	49035-042
Pain and Fever Childrensacetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	P & L Development, LLC	49580-0282
Dye Free Pain and Fever Childrensacetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Walgreens	0363-0285
Pain Reliever Extra Strengthacetaminophen	Acetaminophen 500 mg/1	Tablet, CoatedOral	Walgreen Company	0363-0519

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