Dimetapp Multi-Symptom Cold and Flu acetaminophen, diphenhydramine hydrochloride 320 mg/10mL; 12.5 mg/10mL Solution — NDC 69536-0335-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dimetapp Multi-Symptom Cold and Flu acetaminophen, diphenhydramine hydrochloride 320 mg/10mL; 12.5 mg/10mL Solution — NDC 69536-335-04 (Billing 69536-0335-04)

by Foundation Consumer Healthcare · 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE

This is a package of Dimetapp Multi-Symptom Cold and Flu acetaminophen, diphenhydramine hydrochloride 320 mg/10mL; 12.5 mg/10mL Solution from Foundation Consumer Healthcare, marketed since Jun 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 69536-0335-04
🏷️ FDA NDC (as labeled) 69536-335-04 billing pads the product segment with a zero
This package
Contains118 mL in 1 bottle Pack sizes2 compare ↓
Main listing for product 69536-335 · Also comes in: 2 bottles 69536-335-08
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 69536-335-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69536 labeler · 335 product · 04 package
Package marketed since
Jun 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0850026660050
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69536-335-04
Product NDC 69536-335
11-digit billing NDC 69536033504
RxCUI 2683420
UNII 362O9ITL9D, TC2D6JAD40
UPC 0850026660050
Application # M012
SPL Set ID 178fe95b-e1ed-43b2-e063-6294a90a7a78
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action 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 2024-06-01
Route ORAL
Dosage form SOLUTION
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 2683420
Why two NDCs? The FDA registers this code as 69536-335-04 — 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 → 69536-0335-04. 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.

Clinical

📖 About the active ingredient: Acetaminophen; Diphenhydramine Hydrochloride 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?

Dimetapp Multi-Symptom Cold and Flu is an over-the-counter liquid cold and flu medicine taken by mouth. It contains acetaminophen, which is typically used to reduce fever and ease pain, and diphenhydramine hydrochloride, an antihistamine commonly used to help relieve allergy and cold symptoms such as runny nose and sneezing. This product is marketed under the FDA's OTC monograph rules for its category of cold and flu remedies.

1
Nutrient depletion considerations

Acetaminophen, Diphenhydramine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

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.
Try another pack size: 2 bottles
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69536-0335-04 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2024-06-01 — Active
69536-0335-08 69536-335-08 2 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2025-11-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 118 ml in 1 bottle.
What NDC number is used to bill for this package of Dimetapp Multi-Symptom Cold and Flu acetaminophen, diphenhydramine hydrochloride 320 mg/10mL; 12.5 mg/10mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dimetapp Multi-Symptom Cold and Flu 320 mg/10mL; 12.5 mg/10mLthis 69536-0335-04 Foundation 1 bottle — — 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
Jun 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.

What it looks like

Color red
FlavorGrape
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 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 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 L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 8D4SNN7V92
    Propyl gallate is a synthetic antioxidant derived from gallic acid. It prevents oils and fats in the medicine from oxidizing and spoiling, helping the product stay stable and effective during storage.
  • 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

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

The official label also statesanhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

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.

Manufacturer & labeler

LabelerFoundation Consumer Healthcare
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code69536
First marketedJun 2024
Product typeHuman Otc Drug
Portfolio11 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.

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 29 words ▾

Uses temporarily relieves these common cold and flu symptoms: minor aches and pains headache sore throat cough runny nose sneezing temporarily alleviates the intensity of coughing temporarily reduces fever

⏱️ Dosage and Administration 86 words ▾

Directions do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. measure only with dosage cup provided keep dosage cup with product mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours do not take more than 6 doses in any 24-hour period children 6 to under 12 years 10 mL every 4 hours do not give more than 5 doses in any 24-hour period children under 6 years do not use

⚠️ Warnings ~2 min read ▾

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if adult takes more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 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 to sedate a child or to make a child sleepy in a child under 6 years of age with any other drug containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if user has liver disease trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if user is taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not use more than directed may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children 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 new symptoms occur cough comes back or occurs with fever, 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.

📦 Storage and Handling 17 words ▾

Other information each 10 mL contains: sodium 6 mg store at 20-25°C (68-77°F) read and keep carton

🧪 Active Ingredient 19 words ▾

Active ingredients (in each 10 mL) Purposes Acetaminophen, 320 mg Pain reliever/fever reducer Diphenhydramine HCl, 12.5 mg Antihistamine/cough suppressant

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients anhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

🎯 Purpose 19 words ▾

Active ingredients (in each 10 mL) Purposes Acetaminophen, 320 mg Pain reliever/fever reducer Diphenhydramine HCl, 12.5 mg Antihistamine/cough suppressant

📄 Do Not Use 56 words ▾

Do not use to sedate a child or to make a child sleepy in a child under 6 years of age with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin

📄 Ask a Doctor Before Use If 45 words ▾

Ask a doctor before use if user has liver disease trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

📄 Ask a Doctor or Pharmacist Before Use If 20 words ▾

Ask a doctor or pharmacist before use if user is taking the blood thinning drug warfarin taking sedatives or tranquilizers

📄 When Using This Product 40 words ▾

When using this product do not use more than directed may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children

📄 Stop Use and Ask a Doctor If 60 words ▾

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 new symptoms occur cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 43 words ▾

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.

📄 Questions or Comments 12 words ▾

Questions or comments? Call 1-888-594-0828 weekdays 9 AM to 5 PM EST

📄 Package Label / Principal Display Panel 58 words ▾

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton NEW FORMULA CHILDREN'S Dimetapp ® ACETAMINOPHEN (Pain Reliever/Fever Reducer) DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant) PHARMACIST RECOMMENDED Multi- Symptom Cold & Flu Relieves + comforts: Fever Head & body aches Cough Runny nose Sneezing Sore throat 6+ YRS 4 FL OZ (118 mL) Red Grape Flavor • Alcohol Free Dimetapp 4oz Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Dimetapp Multi-Symptom Cold and Flu (this brand).

Top reported reactions

Cerebrovascular Accident123
Haemorrhagic Stroke31
Convulsion23
Drug Hypersensitivity17
Injury17
Hemiparesis15
Headache13

Age at onset

Infant1
Child2
Adult3
Elderly4

Reporter sex

335 reports

Serious outcomes

Disabling116
Hospitalization80
Death33
Life-threatening5
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 10 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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Foundation Consumer Healthcare. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 2 bottles (69536-0335-08). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Foundation Consumer Healthcare 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.
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.