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)
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 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
- RxCUI (RxNorm): 2683420
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Anilides class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 ↗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.
Patient education
Supplement & herbal interactions
Acetaminophen, Diphenhydramine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per 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. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 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?
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?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dimetapp Multi-Symptom Cold and Flu 320 mg/10mL; 12.5 mg/10mLthis 69536-0335-04 | Foundation | 1 bottle | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Foundation Consumer Healthcare labeler code 69536
- Alavert Allergy LORATADINE 10 mg Tablet, Orally Disintegrating NDC 69536-195-20
- Take Action levonorgestrel 1.5 mg Tablet NDC 69536-200-88
- Bronkaid Max EPHEDRINE SULFATE 25 mg Tablet, Coated NDC 69536-250-24
- St. Joseph Chewable Low Dose Aspirin 81 mg Tablet, Chewable NDC 69536-281-10
- Dimetapp Cold and Allergy BROMPHENIRAMINE MALEATE 2 mg/10mL Solution NDC 69536-305-04
- Dimetapp Cold and Cough BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE 2 mg/10mL; 10 mg/10mL Solution NDC 69536-315-04
- Dimetapp Nighttime Cold and Cough DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/10mL Solution NDC 69536-345-04
- Dimetapp Cold and Cough and Nighttime Cold and Cough DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, and DEXTROMETHORPHAN HYDROBROMIDE Kit NDC 69536-355-08
- Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Cough BROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and DIPHENHYDRAMINE HYRDOCHLORIDE Kit NDC 69536-365-12
- Dimetapp Cough and Allergy DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg Tablet, Chewable NDC 69536-370-24
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
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 ▾
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 ▾
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 ▾
Other information each 10 mL contains: sodium 6 mg store at 20-25°C (68-77°F) read and keep carton
🧪 Active Ingredient ▾
Active ingredients (in each 10 mL) Purposes Acetaminophen, 320 mg Pain reliever/fever reducer Diphenhydramine HCl, 12.5 mg Antihistamine/cough suppressant
🧪 Inactive Ingredients ▾
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 ▾
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 ▾
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 ▾
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 ▾
Ask a doctor or pharmacist before use if user is taking the blood thinning drug warfarin taking sedatives or tranquilizers
📄 When Using This Product ▾
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 ▾
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 ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
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 ▾
Questions or comments? Call 1-888-594-0828 weekdays 9 AM to 5 PM EST
📄 Package Label / Principal Display Panel ▾
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
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
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. |