NDC codes

FDA NDC Directory
Product NDC (as listed)55319-641Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55319-0641Add 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 NDC11-digit (billing)PackageCopy
55319-641-085531906410855319064108237 mL in 1 BOTTLE, PLASTIC (55319-641-08)Marketed from Jul 31, 2024

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)
Severe Nighttime Cold and Flu Relief
Generic name (nonproprietary)
acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hci
Active ingredients
Acetaminophen — 650 mg/30mLDextromethorphan hydrobromide — 20 mg/30mLDoxylamine succinate — 12.5 mg/30mLPhenylephrine hydrochloride — 10 mg/30mL
Dosage form
Liquid
Route
Oral
Labeler
Family Dollar (FAMILY WELLNESS)NDC labeler code 55319
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 012
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha1-Agonists (Mechanism)Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers
Product ID 55319-641_b135042b-47eb-4018-8fdb-6e1b7d5a214cSPL ID b135042b-47eb-4018-8fdb-6e1b7d5a214cSPL set ID e5c90d6e-70aa-4886-bc81-293e0dcf5638RxCUI 1431245UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJUPC 0032251141188
Pharmacologic class
Antihistamine; 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

N455319064108 followed by a unit qualifier and the quantity

Package 55319-0641-08. 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 .

Indications (excerpt from the label)

Uses temporarily relieves common cold/flu symptoms: nasal congestion sore throat headache sinus congestion and pressure minor ache and pain runny nose and sneezing cough due to minor throat and bronchial irritation temporarily reduces fever cough to help you sleep swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55319-641

What is NDC 55319-641?
55319-641 is the product NDC for Severe Nighttime Cold and Flu Relief, Acetaminophen 650 mg/30mL + 3 more ingredients liquid, listed with the FDA by Family Dollar (FAMILY WELLNESS). It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Severe Nighttime Cold and Flu Relief (Acetaminophen Dextromethorphan HBr Doxylamine Succinate Phenylephrine HCI).
What is the active ingredient?
Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride.
Who is the labeler?
Family Dollar (FAMILY WELLNESS), NDC labeler code 55319. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Severe Nighttime Cold and Flu Relief?
1 other product NDC are listed under this name. See all Severe Nighttime Cold and Flu Relief NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Severe Nighttime Cold and Flu Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Severe Nighttime Cold and Flu Reliefacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hclAcetaminophen 325 mg/1 + 3 more ingredientsTablet, Film coatedOralRite Aid Corporation11822-067711822-0677-08

Other NDCs under M 012

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

FDA NDC Directory listings under M 012
ProductStrengthForm · routeLabelerProduct NDC
Cough Reliefdextromethorphan hydrobromideDextromethorphan hydrobromide 15 mg/1Capsule, Liquid filledOralAdvanced Rx LLC80513-311
TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr—KitTARGET CORPORATION82442-559
Geri-Dryl allergy reliefdiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralVerityRx83939-0683
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci—KitTARGET Corporation11673-420
Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxidePetrolatum 49 g/100g; Zinc oxide 15 g/100gCreamTopicalWelmedix LLC24330-410
topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralTopco Associates LLC36800-143
Allergy Childrensdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralH E B37808-012
Mucus Relief Cough Childrensdextromethorphan hbr, guaifensinDextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mLLiquidOralH E B37808-594
Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesinDextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1TabletOralStrategic Sourcing Services LLC49348-728
Dual Action Honey Lemon Cough Suppressant Oral AnestheticmentholMenthol 8.3 mg/1LozengeOralRicola Ag54305-323
Discount drug mart Extra Moisturizingoxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalDISCOUNT DRUG MART53943-720
Mucus ReliefguaifenesinGuaifenesin 400 mg/1TabletOralGeri-Care Pharmaceuticals, Corp57896-714
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hclAcetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mLLiquidOralHaleon US Holdings LLC0031-0101
Throat Comfort Orange Mint Cinnamon DropsmentholMenthol 3.6 mg/1LozengeOralRicola USA Inc.63667-342
Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coatedGuaifenesin 200 mg/1 + 2 more ingredientsTablet, Film coatedOralLil' Drug Store products, Inc.66715-5632
COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 3 more ingredientsCapsule, Liquid filledOralWalgreens0363-9016
Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hclAcetaminophen 650 mg/20mL + 2 more ingredientsLiquidOralWalgreens0363-9130
Pyrilamine Maleate and Dextromethorphan HydrobromideDextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mLLiquidOralWestminster Pharmaceuticals, LLC69367-398
Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hclAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralAptaPharma Inc.76281-604
Cough DropsmentholMenthol 5.8 mg/1PastilleOralTopco Associates LLC76162-016

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