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SanaTos Severe Cold Relief Nighttime Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride 25 mg; 10 mg; 650 mg Granule, For Solution, 6-count — NDC 55758-0385-06 package photo

SanaTos Severe Cold Relief Nighttime Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride 25 mg; 10 mg; 650 mg Granule, For Solution, 6-count

by Pharmadel LLC · 6 GRANULE, FOR SOLUTION in 1 CARTON (55758-385-06)
NDC 55758-0385-06
🏷️ FDA NDC (as labeled) 55758-385-06 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) 55758-385-06
Product NDC 55758-385
11-digit billing NDC 55758038506
RxCUI 1659960
UNII TC2D6JAD40, 04JA59TNSJ, 362O9ITL9D
Application # M012
SPL Set ID 144aafcc-6ec2-a322-e063-6294a90afc27
Established class (EPC) Histamine-1 Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-03-31
Route ORAL
Dosage form GRANULE, FOR SOLUTION
Substance DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN
Why two NDCs? The FDA registers this code as 55758-385-06 — 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 → 55758-0385-06. 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 applicationM012 (OTC MONOGRAPH DRUG)
Labeler code55758
First marketedMar 2024
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 Severe Cold Relief Nighttime is an over-the-counter granule product meant to be mixed with water and taken by mouth. It combines acetaminophen, which is typically used to reduce fever and relieve pain; diphenhydramine, an antihistamine commonly used to ease cold and allergy symptoms and promote drowsiness; and phenylephrine, a decongestant typically used to help relieve nasal and sinus congestion. This combination is marketed as a nighttime cold relief product under FDA's over-the-counter drug monograph rules.

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

FlavorLemon
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 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • 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 Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • 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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 91D9GV0Z28
    A mineral salt made from calcium and phosphate. It acts as a filler to add bulk to the tablet or capsule, and helps bind ingredients together so the medicine holds its shape.
  • 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.

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

The official label also statesacesulfame potassium, anhydrous citric acid, aspartame, D&C yellow #10, eucalyptus honey lemon flavors, FD&C blue #1, FD&C red #40, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

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
Quality Choice Severe Cold and Cough Nighttime 650 mg/1; 25 mg/1; 10 mg 63868-0291-06 Chain 6 packets $0.482 — FDA listed —
Theraflu Powerpods Nighttime Severe Cold 650 mg/1; 25 mg/1; 10 mg 00067-6095-01 Haleon 8 pouches — — FDA listed —
Theraflu Severe Cold Relief Nighttime 650 mg/237mL; 25 mg/237mL; 10 mg/237mL 00067-6803-02 Haleon 6 packets — — FDA listed —
Theraflu Nighttime Severe Cold And Cough 650 mg/237mL; 25 mg/237mL; 10 mg/237mL 00067-7918-06 Haleon 6 packets — — FDA listed —
Theraflu Severe Cold Relief Nighttime with Honey Elderberry Flavor 650 mg/1; 25 mg/1; 10 mg 00067-8212-01 Haleon 6 packets — — FDA listed —
Nighttime Wal Flu Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 00363-5410-06 WALGREEN 6 powders — — FDA listed —
up and up nighttime flu and severe cold and cough 650 mg/1; 25 mg/1; 10 mg 11673-0113-07 Target 6 powders — — FDA listed —
Nighttime Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 41226-0541-06 KROGER 6 powders — — FDA listed —
Equate Flu and Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 49035-0964-91 Wal-Mart 6 powders — — FDA listed —
SanaTos Severe Cold Relief Nighttime 25 mg/1; 10 mg/1; 650 mgthis 55758-0385-06 Pharmadel 6 granules — — FDA listed —
dg health flu and severe cold and cough 650 mg/1; 25 mg/1; 10 mg 55910-0964-91 Dolgencorp, 6 powders — — FDA listed —
Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion 10 mg/5g; 650 mg/5g; 25 mg/5g 58933-0551-01 Procter 5 g — — FDA listed —
Severe Cold and Cough Nighttime 650 mg/1; 25 mg/1; 10 mg 67091-0323-06 WinCo 6 packets — — FDA listed —
Nighttime Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 68163-0541-06 RARITAN 6 packets — — FDA listed —
Basic Care severe cold and cough 650 mg/1; 25 mg/1; 10 mg 72288-0964-91 Amazon.com 6 packets — — 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

🏛️
2024
On the market since
Mar 2024
📍
2026
Currently FDA-listed
2 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 Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride — the ingredient across all brands.

Top reported reactions

Hallucination2
Covid-191
Disease Recurrence1
Inappropriate Affect1
Nasopharyngitis1
Nightmare1
Pneumonia1

Reporter sex

6 reports
Male · 50%
Female · 50%
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1 0
Most recent year is provisional (FAERS lags ~3 months).
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
55758-0385-06 You're viewing this 6 GRANULE, FOR SOLUTION in 1 CARTON (55758-385-06) 2024-03-31 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 55758-385-06, 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: 55758-0385-06, written without dashes as 55758038506. 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 55758-0385-06, the first segment (55758) is the labeler code FDA assigned to Pharmadel LLC; the middle segment (0385) 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 33 words ▾

Uses Temporarily relieves common cold/flu symptoms: minor aches and pains sore throat headache nasal congestion runny nose itchy nose and throat cough due to minor throat & bronchial irritation and temporarily reduces fever

⏱️ Dosage and Administration 78 words ▾

Directions dissolve one packet in an 8 fl oz glass of hot water. If using a microwave; add content into a glass of cool water and stir briskly before and after heating. Do not overheat. Sip while hot and consume the entire drink within 10-15 minutes adults and children 12 years of age and older: one (1) packet every 4 hours, do not exceed 6 packets per 24 hours children under 12 years of age: do not use

⚠️ Warnings ~2 min read ▾

Warnings Liver warning: This product contains acetaminophen . Severe liver damage may occur if you take more than 6 doses in 24 hours , which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:  skin reddening blisters rash.

If a skin reaction occurs, stop use and seek medical help right away. 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. with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have liver disease have heart disease have high blood pressure have thyroid disease have diabetes have glaucoma have a breathing problem such as emphysema have difficulty urinating due to an enlarged prostate gland have a breathing problem such as emphysema or chronic bronchitis are taking sedatives or tranquilizers Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage may cause excitability, especially in children use caution when driving a motor vehicle or operating machinery may cause marked drowsiness Stop use and ask doctor if nervousness, dizziness, or sleeplessness occur redness or swelling is present pain, cough, or nasal congestion persists or gets worse or last more than 7 days fever gets worse or lasts more than 3 days 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. Kepp out of reach of children.

In case of accidental 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.

📦 Storage and Handling 33 words ▾

Other information each packet contains: potassium 10 mg, sodium 27 mg phenylketonurics: contains phenylalanine 13 mg per packet store at room temperature 68-77°F (20-25°C) do not use if packets are punctured or torn.

🧪 Active Ingredient 30 words ▾

Active ingredients & Purposes Active Ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/ fever reducer Diphenhydramine HCL 25 mg Antihistamine/ cough suppressant Phenylephrine HCL 10 mg Nasal decongestant

🧪 Inactive Ingredients 33 words ▾

Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow #10, eucalyptus honey lemon flavors, FD&C blue #1, FD&C red #40, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

🎯 Purpose 26 words ▾

Active Ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/ fever reducer Diphenhydramine HCL 25 mg Antihistamine/ cough suppressant Phenylephrine HCL 10 mg Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 55758-0384-06 · Pharmadel 55758-0407-12 · 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.