Home › NDC Lookup › Ingredients › Acetaminophen Dextromethorphan Hbr Doxyl... › 55758-0416-06
Sanatos Multi Symptoms Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate 650 mg/30mL; 12.5 mg/30mL; 30 mg/30mL Liquid, 177 mL — NDC 55758-0416-06 package photo

Sanatos Multi Symptoms Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate 650 mg/30mL; 12.5 mg/30mL; 30 mg/30mL Liquid, 177 mL

by Pharmadel LLC · 177 mL in 1 BOTTLE, PLASTIC (55758-416-06)
NDC 55758-0416-06
🏷️ FDA NDC (as labeled) 55758-416-06 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 55758-416-06
Product NDC 55758-416
11-digit billing NDC 55758041606
RxCUI 1043400
UNII 362O9ITL9D, V9BI9B5YI2, 9D2RTI9KYH
Application # M013
SPL Set ID 0a60326a-a17b-e843-e063-6394a90ac211
Established class (EPC) Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Histamine Receptor Antagonists; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-01
Route ORAL
Dosage form LIQUID
Substance ACETAMINOPHEN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE
Why two NDCs? The FDA registers this code as 55758-416-06 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 55758-0416-06. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anilides class.

Drug family (ATC) Anilides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPharmadel LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code55758
First marketedDec 2023
Product typeHuman Otc Drug
Portfolio67 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
🧪 What is this product?

Sanatos Multi Symptoms Nighttime is a liquid medicine taken by mouth that combines three active ingredients commonly used for cold and flu symptoms, especially at night. Acetaminophen is used to reduce fever and ease pain. Dextromethorphan is a cough suppressant, while doxylamine succinate is an antihistamine that functions as a sleep aid. This is an over-the-counter monograph product, meaning it follows FDA guidelines for this category of medicine.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color green
FlavorAnise
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII 3P3ONR6O1S
    A synthetic green dye approved by the FDA for use in medicines and foods. It serves as a colorant to make the pill or liquid visually distinctive and help with product identification.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 8KW3E207O2
    A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

12 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statescitric acid, D&C yellow#10, FD&C Green# 3, FD&C yellow# 6, flavor, glycerin, polythylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 70000-0183-01 Cardinal 355 ml $0.009 — Discontinued —
foster and thrive nighttime cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 70677-1032-01 Strategic 355 ml $0.011 — Availability likely —
Leader Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 70000-0184-01 Cardinal 237 ml $0.015 — FDA listed —
good sense night time 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00113-0335-34 L. 237 ml $0.015 — Availability likely —
all nite 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00904-6465-09 Major 237 ml $0.015 — Availability likely —
good neighbor pharmacy night time 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 46122-0136-34 Amerisource 237 ml $0.015 — Availability likely —
good neighbor pharmacy night time cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 46122-0198-34 Amerisource 237 ml $0.015 — Availability likely —
foster and thrive nighttime cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 70677-1033-01 Strategic 237 ml $0.015 — Availability likely —
good sense nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00113-0459-34 L. 237 ml — — FDA listed —
Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00363-0401-34 Walgreen 237 ml — — Discontinued —
Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00363-0566-34 Walgreen 237 ml — — Discontinued —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00363-3430-12 Walgreens 355 ml — — FDA listed —
Walgreen High Blood Pressure Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00363-6210-08 WALGREENS 236 ml — — FDA listed —
Cold and Flu Night 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00363-9913-02 Walgreen 355 ml — — FDA listed —
Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00363-9975-08 Walgreens 237 ml — — FDA listed —
Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 00363-9976-08 Walgreens 237 ml — — FDA listed —
Coricidin HBP Nighttime Multi-Symptom Cold 6.25 mg/15mL; 325 mg/15mL; 15 mg/15mL 11523-4358-01 Bayer 355 ml — — FDA listed —
up and up nighttime cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 11673-0019-40 Target 355 ml — — Discontinued —
Nighttime Cold and Flu Liquid 650 mg/30mL; 12.5 mg/30mL; 30 mg/30mL 11673-0287-01 TARGET 354 ml — — FDA listed —
Nighttime Cherry Cold and Flu 30 mg/30mL; 650 mg/30mL; 12.5 mg/30mL 11673-0312-01 TARGET 354 ml — — FDA listed —
Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 11822-3318-00 Rite 355 ml — — FDA listed —
Cold and Flu Relief Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 11822-5832-01 Rite 237 ml — — FDA listed —
Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 21130-0044-08 Safeway, 237 ml — — FDA listed —
Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 21130-0343-08 Safeway, 237 ml — — FDA listed —
Cold And Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 21130-0603-40 Safeway 355 ml — — FDA listed —
Nighttime Cherry Cold And Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 21130-0907-02 BETTER 2 bottles — — FDA listed —
Nighttime Cold and Flu 12.5 mg/30mL; 650 mg/30mL; 30 mg/30mL 21130-0951-06 BETTER 236 ml — — FDA listed —
Kroger Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 30142-0292-12 Kroger 354 ml — — FDA listed —
Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 30142-0335-40 Kroger 354 ml — — FDA listed —
NightTime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 30142-0459-40 Kroger 354 ml — — Discontinued —
Night Time Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 30142-0634-12 The 355 ml — — Discontinued —
topcare nite time cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 36800-0335-34 Topco 237 ml — — FDA listed —
topcare nite time cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 36800-0459-34 Topco 237 ml — — FDA listed —
night time cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 37808-0335-34 H 237 ml — — FDA listed —
night time 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 37808-0459-38 H 296 ml — — Discontinued —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 37835-0524-02 Bi-Mart 355 ml — — FDA listed —
Nighttime Cold And Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 37835-0525-12 BI-MART 355 ml — — FDA listed —
equaline nighttime cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 41163-0335-40 United 355 ml — — FDA listed —
Nighttime Cold and Flu 30 mg/30mL; 12.5 mg/30mL; 650 mg/30mL 41226-0750-01 Kroger 354 ml — — FDA listed —
Nighttime Cold and Flu 12.5 mg/30mL; 650 mg/30mL; 30 mg/30mL 41226-0782-01 Kroger 354 ml — — FDA listed —
nitetime cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 41250-0335-40 Meijer 355 ml — — FDA listed —
nitetime cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 41250-0459-40 Meijer 355 ml — — FDA listed —
CareOne Night TIme Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 41520-0084-40 American 355 ml — — FDA listed —
CareOne Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 41520-0712-34 American 237 ml — — Discontinued —
cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 42507-0001-40 HyVee 355 ml — — FDA listed —
Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 42507-0401-40 HyVee 355 ml — — FDA listed —
NiteTime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 49035-0044-12 EQUATE 355 ml — — FDA listed —
equate nighttime cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 49035-0324-34 Wal-Mart 237 ml — — Discontinued —
equate nighttime cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 49035-0609-40 Wal-Mart 355 ml — — FDA listed —
Night Time Cold and Flu ReadyInCase 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 49580-0343-02 P 355 ml — — FDA listed —
Nighttime Cold and Flu ReadyInCase 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 49580-0346-02 P 355 ml — — FDA listed —
Tukol Honey Nighttime Cold and Flu 21.667 mg/mL; 1 mg/mL; .4167 mg/mL 50066-0303-04 Genomma 1 bottle — — FDA listed —
Cold and Flu Nighttime Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 50844-0252-02 L.N.K. 355 ml — — FDA listed —
Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 51316-0343-08 CVS 237 ml — — FDA listed —
Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 51316-0344-12 CVS 355 ml — — FDA listed —
CVS Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 51316-0692-12 CVS 354 ml — — FDA listed —
Nighttime Cold And Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 51316-0884-40 CVS 355 ml — — FDA listed —
NIGHT-TIME MULTI-SYMPTOM COLD/FLU Original 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 53942-0501-28 DeMoulas 354 ml — — FDA listed —
NIGHT-TIME MULTI-SYMPTOM COLD/FLU Cherry 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 53942-0502-28 DeMoulas 354 ml — — FDA listed —
Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 53943-0501-28 Discount 354 ml — — FDA listed —
Night-Time Multi-Symptom Cold/Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 53943-0502-28 Discount 354 ml — — FDA listed —
Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 55301-0310-02 ARMY 355 ml — — FDA listed —
Family Dollar Nighttime Cold and Flu Relief Original Flavor 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 55319-0692-12 FAMILY 354 ml — — FDA listed —
Family Dollar Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 55319-0926-12 FAMILY 354 ml — — FDA listed —
Sanatos Nighttime Multi Symptoms 12.5 mg/30mL; 30 mg/30mL; 650 mg/30mL 55758-0056-25 Pharmadel 177 ml — — FDA listed —
Sanatos Multi Symptoms Nighttime 650 mg/30mL; 12.5 mg/30mL; 30 mg/30mLthis 55758-0416-06 Pharmadel 177 ml — — FDA listed —
dg health night time cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 55910-0335-34 Dolgencorp 237 ml — — FDA listed —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 55910-0443-12 Dolgencorp, 355 ml — — FDA listed —
dg health cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 55910-0459-34 Dolgencorp 237 ml — — FDA listed —
Nitetime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 56062-0335-40 Publix 355 ml — — FDA listed —
nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 56062-0459-40 Publix 355 ml — — FDA listed —
Nite-Time COLD/FLU ORIGINAL 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 57243-0501-25 Salado 177 ml — — FDA listed —
Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 57243-0502-25 Salado 177 ml — — FDA listed —
Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 59779-0335-34 CVS 237 ml — — Discontinued —
nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 59779-0459-34 CVS 237 ml — — Discontinued —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 63868-0140-08 QUALITY 237 ml — — FDA listed —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 63868-0234-08 QUALITY 237 ml — — FDA listed —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 63941-0343-08 Best 237 ml — — FDA listed —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 63941-0344-08 Best 237 ml — — FDA listed —
Circle K Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 66715-5534-04 Lil' 237 ml — — FDA listed —
24-7 Life BY 7-ELEVEN Nighttime Cold and Flu 30 mg/30mL; 650 mg/30mL; 12.5 mg/30mL 66715-6416-04 Lil' 355 ml — — FDA listed —
Nighttime Relief, Cold and Flu, 24-7 Life by 7-Eleven 650 mg/30mL; 12.5 mg/30mL; 30 mg/30mL 66715-6616-04 Lil' 177 ml — — FDA listed —
Nighttime Cold and Flu Lil Drug Store Products 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 66715-6934-04 Lil' 237 ml — — FDA listed —
Cold and Flu Relief Multi Symptom Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 67091-0258-23 WinCo 237 ml — — FDA listed —
Cold and Flu Relief Multi Symptom Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 67091-0260-23 WinCo 237 ml — — FDA listed —
Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 69256-0343-12 Harris 355 ml — — FDA listed —
Night Time Cold and Flu original 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 69256-0344-12 Harris 355 ml — — FDA listed —
Vicks NyQuil Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 69423-0789-08 The 236 ml — — FDA listed —
Vicks NyQuil Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 69423-0791-08 The 236 ml — — FDA listed —
Vicks NyQuil HIGH BLOOD PRESSURE Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 69423-0973-06 The 177 ml — — FDA listed —
Nighttime HBP Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 69842-0086-02 CVS 355 ml — — FDA listed —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 70000-0673-01 Cardinal 355 ml — — FDA listed —
Cold and Flu Nighttime 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 71141-0180-32 Lidl 355 ml — — FDA listed —
basic care nighttime cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 72288-0335-34 Amazon.com 237 ml — — FDA listed —
basic care nighttime cold and flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 72288-0459-34 Amazon.com 237 ml — — FDA listed —
Nighttime Cold And Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 72288-0670-00 Amazon.com 237 ml — — FDA listed —
Nighttime Cold And Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 72288-0990-01 Amazon.com 355 ml — — FDA listed —
XL-3 Xtreme 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 76281-0305-28 AptaPharma 354 ml — — FDA listed —
XL-3 Xtreme 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 76281-0307-25 AptaPharma 177 ml — — FDA listed —
Nite-Time COLD/FLU Medicine 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 76281-0501-25 AptaPharma 177 ml — — FDA listed —
Nite-Time COLD/FLU Medicine Cherry 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 76281-0502-25 AptaPharma 177 ml — — FDA listed —
Meijer Nitetime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 79481-6921-02 MEIJER 354 ml — — FDA listed —
Nighttime Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 79903-0173-08 WALMART 237 ml — — FDA listed —
Nighttime Cold and Flu Liquid Cherry 30 mg/30mL; 12.5 mg/30mL; 650 mg/30mL 81660-0555-01 Grimann, 30 ml — — FDA listed —
Nighttime Cold and Flu 30 mg/30mL; 12.5 mg/30mL; 650 mg/30mL 81660-0777-01 Grimann, 30 ml — — FDA listed —
AXIM Night Time - Liquid 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 82706-0012-01 VIVUNT 355 ml — — FDA listed —
AXIV Night Time - Liquid 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 82706-0023-01 VIVUNT 355 ml — — FDA listed —
Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 83324-0158-12 QUALITY 355 ml — — FDA listed —
Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 83324-0159-08 QUALITY 237 ml — — FDA listed —
Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 83324-0163-12 QUALITY 355 ml — — FDA listed —
Nighttime Cold and Flu Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 83324-0164-08 QUALITY 237 ml — — FDA listed —
Vicks NyQuil Cold and Flu Nighttime Relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 84126-0314-04 The 118 ml — — FDA listed —
Vicks NyQuil Cold and Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 84126-0342-04 The 118 ml — — FDA listed —
Revasol Nighttime Cold And Flu 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 84379-0276-04 Rnv 118 ml — — FDA listed —
XL-3 Night Time 12.5 mg/30mL; 650 mg/30mL; 30 mg/30mL 84379-0444-06 Rnv 177 ml — — FDA listed —
foster and thrive nighttime cold and flu relief 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL 85766-0177-24 Sportpharm 237 ml — — FDA listed —
Nighttime Cold and Flu 30 mg/30mL; 12.5 mg/30mL; 650 mg/30mL 85828-0750-01 Grocery 354 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Sanatos Multi Symptoms Nighttime (this brand).

Top reported reactions

Contusion1
Dehydration1
Drug Toxicity1
Hepatic Necrosis1
Hepatic Steatosis1

Reporter sex

0 reports
Male · 100%

Serious outcomes

Death1
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
55758-0416-06 You're viewing this 177 mL in 1 BOTTLE, PLASTIC (55758-416-06) 2023-12-01 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 55758-416-06, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 55758-0416-06, written without dashes as 55758041606. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 55758-0416-06, the first segment (55758) is the labeler code FDA assigned to Pharmadel LLC; the middle segment (0416) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Pharmadel LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pharmadel LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 29 words ▾

Uses Temporarily relieves common cold/flu symptoms associated with minor aches and pains headache sore throat runny nose cough due to minor throat and bronchial irritation sneezing temoprarily reduces fever

⏱️ Dosage and Administration 52 words ▾

Directions use only dosing cup provided shake well before use if you are taking other cold/flu products, read complete labeling adults & children 12 years & over 30 mL every 4 hours, do not exceed (child) 3 doses and (adult) 4 doses in 24 hours children under 12 years ask a doctor

⚠️ Warnings ~2 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: adults take more than 4 doses in 24 hours, which is the maxium daily amount child takes more than 3 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if user has a sodium-restricted diet has liver disease has glaucoma has cough that occurs with too much phlegm (mucus) has a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema has trouble urinating due to enlarged prostate gland is a child with pain of arthritis Ask a doctor or pharmacist before use if user is taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product excitability may occur, especially in children may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms occur cough comes back, or occurs with rash or headache that lasts.

These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

🧪 Active Ingredient 29 words ▾

Active ingredients & Purposes Active ingredients (in each 30 mL) Purposes Acetaminophen 650 mg Pain reliever/ fever reducer Dextromethorphan HBr 30 mg Cough suppressant Doxylamine succinate 12.5 mg Antihistamine

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients citric acid, D&C yellow#10, FD&C Green# 3, FD&C yellow# 6, flavor, glycerin, polythylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

🎯 Purpose 25 words ▾

Active ingredients (in each 30 mL) Purposes Acetaminophen 650 mg Pain reliever/ fever reducer Dextromethorphan HBr 30 mg Cough suppressant Doxylamine succinate 12.5 mg Antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 55758-0415-06 · Pharmadel 55758-0417-02 · Pharmadel →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.