Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and DIPHENHYDRAMINE HYRDOCHLORIDE Kit — NDC 80070-360-12 (Billing 80070-0360-12)
This is a package of Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and DIPHENHYDRAMINE HYRDOCHLORIDE Kit from Foundation Consumer Brands, marketed since Sep 2021 and currently FDA-listed, this package's marketing is listed to end Dec 2026. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 80070-360-12 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 80070 labeler · 360 product · 12 package
- Package marketed since
- Sep 15, 2021
- Package marketing ended
- Dec 31, 2026
- Sample package
- No — commercial package
- Barcode (UPC-A, from the NDC)
- 3 8007036012 0
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1090463
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 Substituted alkylamines class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Brompheniramine is used to treat allergy and cold symptoms: sneezing runny nose itching of the nose or throat red, itchy, watery eyes Brompheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Read the full MedlinePlus article ↗This kit contains over-the-counter products that combine several active ingredients typically used to manage cold and cough symptoms. Brompheniramine maleate and diphenhydramine hydrochloride are antihistamines commonly used to reduce sneezing, runny nose, and itching. Dextromethorphan hydrobromide is a cough suppressant typically used to reduce coughing. Phenylephrine hydrochloride is a nasal decongestant commonly used to relieve nasal congestion. The kit provides formulations labeled for daytime and nighttime use.
Patient education
Supplement & herbal interactions
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 each | 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 |
|---|---|---|---|---|
| 80070-0360-12 You're viewing this Main listing | 1 KIT in 1 CARTON * 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE | 2021-09-15 | Dec 31, 2026 | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestionthis 80070-0360-12 | Foundation | 1 kit | — | — | 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.
This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- 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 Brands labeler code 80070
- Anbesol Maximum Strength BENZOCAINE 200 mg/g Gel NDC 80070-220-33
- Anbesol Maximum Strength BENZOCAINE 200 mg/mL Solution NDC 80070-230-41
- Dimetapp Cold and Allergy BROMPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE 1 mg/5mL; 2.5 mg/5mL Elixir NDC 80070-300-04
- Dimetapp Cold and Cough BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE 1 mg/5mL; 5 mg/5mL; 2.5 mg/5mL Elixir NDC 80070-310-04
- Dimetapp Nighttime Cold and Congestion DIPHENHYDRAMINE HYDROCHLORIDE and PHENYLEPHRINE 6.25 mg/5mL; 2.5 mg/5mL Solution NDC 80070-340-04
- Dimetapp Cold and Cough and Nighttime Cold and Congestion DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, and DEXTROMETHORPHAN HYDROBROMIDE Kit NDC 80070-350-08
- Dristan 12 hr OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL Spray NDC 80070-400-05
- Fibercon CALCIUM POLYCARBOPHIL 625 mg Tablet NDC 80070-500-14
- Primatene EPHEDRINE HYDROCHLORIDE 12.5 mg Tablet NDC 80070-600-24
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: nasal congestion runny nose cough sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily restores freer breathing through the nose
Uses temporarily relieves: nasal congestion runny nose cough sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily restores freer breathing through the nose
⏱️ Dosage and Administration ▾
Directions do not take more than 6 doses in any 24-hour period 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 children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use
Directions do not take more than 6 doses in any 24-hour period 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 children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use
⚠️ Warnings ▾
Warnings Do not use to sedate a child or to make a child sleepy 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 you have heart disease high blood pressure thyroid disease diabetes 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 such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers When using this product do not use more than directed may cause marked drowsiness avoid alcoholic beverages 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 nervousness, dizziness or sleeplessness occurs symptoms do not get better within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.
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.
Warnings Do not use to sedate a child or to make a child sleepy 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 heart disease high blood pressure thyroid disease diabetes 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 you are taking any other oral nasal decongestant or stimulant 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 nervousness, dizziness or sleeplessness occurs symptoms do not get better within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.
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.
📦 Storage and Handling ▾
Other information each 10 mL contains: sodium 6 mg store at 20-25°C (68-77°F)
Other information each 10 mL contains: sodium 8 mg store at 20-25°C (68-77°F) do not refrigerate
🧪 Active Ingredient ▾
Active ingredients (in each 10 mL) Purposes Brompheniramine maleate, 2 mg Antihistamine Dextromethorphan HBr, 10 mg Cough suppressant Phenylephrine HCl, 5 mg Nasal decongestant
Active ingredients (in each 10 mL) Purposes Diphenhydramine HCl, 12.5 mg Antihistamine/cough suppressant Phenylephrine HCl, 5 mg Nasal decongestant
🧪 Inactive Ingredients ▾
Inactive ingredients anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
Inactive ingredients anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
🎯 Purpose ▾
Active ingredients (in each 10 mL) Purposes Brompheniramine maleate, 2 mg Antihistamine Dextromethorphan HBr, 10 mg Cough suppressant Phenylephrine HCl, 5 mg Nasal decongestant
Active ingredients (in each 10 mL) Purposes Diphenhydramine HCl, 12.5 mg Antihistamine/cough suppressant Phenylephrine HCl, 5 mg Nasal decongestant
📄 Do Not Use ▾
Do not use to sedate a child or to make a child sleepy 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.
Do not use to sedate a child or to make a child sleepy 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 ▾
Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes 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 such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes 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 you are taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers
Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers
📄 When Using This Product ▾
When using this product do not use more than directed may cause marked drowsiness avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
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 nervousness, dizziness or sleeplessness occurs symptoms do not get better within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not get better within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a health professional before use.
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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions or comments? Call 1-888-594-0828 weekdays 9 AM to 5 PM EST
Questions or comments? Call 1-888-594-0828 weekdays 9 AM to 5 PM EST
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - Kit Carton DAYTIME NIGHTTIME CHILDREN'S Dimetapp ® Cold & Cough BROMPHENIRAMINE MALEATE (Antihistamine) DEXTROMETHORPHAN HBr (Cough Suppressant) PHENYLEPHRINE HCl (Nasal Decongestant) Relieves + comforts: Stuffy, runny nose Itchy, watery eyes Sneezing Cough Grape Flavor Alcohol Free 6+ YRS 2 BOTTLES PHARMACIST RECOMMENDED 4 FL OZ (118 mL) EACH Nighttime Cold & Congestion DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant) PHENYLEPHRINE HCl (Nasal Decongestant) Relieves + comforts: Stuffy, runny nose Itchy, watery eyes Sneezing Cough 6+ YRS Grape Flavor Alcohol Free 1 BOTTLE 4 FL OZ (118 mL) 12 FL OZ (354 mL) TOTAL PRINCIPAL DISPLAY PANEL - Kit Carton
Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Where does this data come from?
About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
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. |