What is NDC 55758-056?

55758-056 is the product NDC for Sanatos Nighttime Multi Symptoms, Doxylamine succinate 12.5 mg/30mL + 2 more ingredients liquid, listed with the FDA by Pharmadel LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Sanatos Nighttime Multi Symptoms (Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate).

What is the active ingredient?

Doxylamine succinate, Dextromethorphan hydrobromide, Acetaminophen.

Pharmadel LLC, NDC labeler code 55758. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sanatos Nighttime Multi Symptoms?

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.

Sanatos Nighttime Multi Symptoms NDC 55758-056

NDC codes

FDA NDC Directory

Product NDC (as listed)55758-056Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55758-0056Add 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
55758-056-25	55758005625	177 mL in 1 BOTTLE, PLASTIC (55758-056-25)Marketed from Dec 1, 2014

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): Sanatos Nighttime Multi Symptoms
Generic name (nonproprietary): acetaminophen, dextromethorphan hbr, doxylamine succinate
Active ingredients: Doxylamine succinate — 12.5 mg/30mLDextromethorphan hydrobromide — 30 mg/30mLAcetaminophen — 650 mg/30mL
Dosage form: Liquid
Route: Oral
Labeler: Pharmadel LLCNDC labeler code 55758
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 013
Marketing start: Dec 1, 2014
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 55758-056_0abf71d1-f688-1218-e063-6294a90a436cSPL ID 0abf71d1-f688-1218-e063-6294a90a436cSPL set ID 0ab188f3-f7f9-d665-e063-6294a90a198aRxCUI 1043400UNII V9BI9B5YI2, 9D2RTI9KYH, 362O9ITL9D
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

N455758005625 followed by a unit qualifier and the quantity

Package 55758-0056-25. 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 Nov 22, 2023.

Indications (excerpt from the label)

Uses temporarily relieves these common cold/flu symptoms: sore throat headache minor aches and pains fever runny nose and sneezing 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 55758-056

What is NDC 55758-056?: 55758-056 is the product NDC for Sanatos Nighttime Multi Symptoms, Doxylamine succinate 12.5 mg/30mL + 2 more ingredients liquid, listed with the FDA by Pharmadel LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sanatos Nighttime Multi Symptoms (Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate).
What is the active ingredient?: Doxylamine succinate, Dextromethorphan hydrobromide, Acetaminophen.
Who is the labeler?: Pharmadel LLC, NDC labeler code 55758. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sanatos Nighttime Multi Symptoms?: 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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