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Dimetapp Cold and Allergy BROMPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE 1 mg/5mL; 2.5 mg/5mL Elixir — NDC 80070-0300-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dimetapp Cold and Allergy BROMPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE 1 mg/5mL; 2.5 mg/5mL Elixir — NDC 80070-300-04 (Billing 80070-0300-04)

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

This is a package of Dimetapp Cold and Allergy BROMPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE 1 mg/5mL; 2.5 mg/5mL Elixir from Foundation Consumer Brands, no longer marketed (first marketed Sep 2021), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 2 package sizes.

NDC 80070-0300-04
🏷️ FDA NDC (as labeled) 80070-300-04 billing pads the product segment with a zero
This package
Contains118 mL in 1 bottle Pack sizes2 compare ↓
Main listing for product 80070-300 · Also comes in: 237 mL 80070-300-08
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 6, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80070-300-04
Product NDC 80070-300
11-digit billing NDC 80070030004
RxCUI 1053258
UNII IXA7C9ZN03, 04JA59TNSJ
UPC 0850026660029
Application # M012
SPL Set ID 47317865-4310-4f07-8815-f3130963307d
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2021-09-15
Route ORAL
Dosage form ELIXIR
Substance BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1053258
Why two NDCs? The FDA registers this code as 80070-300-04 — 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 → 80070-0300-04. 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 Substituted alkylamines class.

Drug family (ATC) Substituted alkylamines
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 MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

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 ↗
🧪 What is this product?

Dimetapp Cold and Allergy is an over-the-counter oral elixir containing brompheniramine maleate, an antihistamine typically used to help relieve allergy and cold-related symptoms such as sneezing, runny nose, and itchy eyes, and phenylephrine hydrochloride, a decongestant commonly used to reduce nasal congestion. This product is marketed as an OTC monograph drug, meaning it follows FDA's established formula guidelines for this drug category rather than being individually approved through a separate application.

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.

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: 237 mL
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
80070-0300-04 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2021-09-15 — Discontinued by firm
80070-0300-08 80070-300-08 1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE 2021-09-15 — Discontinued by firm

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 Cold and Allergy BROMPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE 1 mg/5mL; 2.5 mg/5mL Elixir?
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
Dibromm Cold and Allergy Relief childrens 2 mg/10mL; 5 mg/10mL 62011-0443-01 Strategic 1 bottle $0.020 — Discontinued —
Childrens Cold and Allergy Relief 2 mg/10mL; 5 mg/10mL 70677-0101-01 Strategic 1 bottle $0.020 — FDA listed —
Dibromm Cold and Allergy 2 mg/10mL; 5 mg/10mL 83324-0156-04 QUALITY 1 bottle $0.025 — Availability likely —
Rynex Pe 1 mg/5mL; 2.5 mg/5mL 00485-0202-16 EDWARDS 473 ml $0.047 — Availability likely —
Childrens Wal Tap Elixer Cold and Allergy 2 mg/10mL; 5 mg/10mL 00363-0312-08 Walgreens 1 bottle — — FDA listed —
Dibromm Cold and Allergy Childrens 2 mg/10mL; 5 mg/10mL 63868-0241-04 QUALITY 1 bottle — — FDA listed —
Childrens Cold and Allergy 2 mg/10mL; 5 mg/10mL 63941-0012-04 Best 1 bottle — — FDA listed —
CVS Childrens Cold and Allergy 2 mg/10mL; 5 mg/10mL 69842-0639-04 CVS 1 bottle — — FDA listed —
Childrens Cold and Allergy 2 mg/10mL; 5 mg/10mL 69842-0779-04 CVS 1 bottle — — FDA listed —
Dimetapp Cold and Allergy 1 mg/5mL; 2.5 mg/5mLthis 80070-0300-04 Foundation 1 bottle — — Discontinued —
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

🏛️
2021
On the market since
Sep 2021
📍
2026
Currently FDA-listed
5 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 purple
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 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 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 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.

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

The official label also statesanhydrous 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

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 Brands
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code80070
First marketedSep 2021
Product typeHuman Otc Drug
Portfolio13 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

Uses temporarily relieves: nasal congestion runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily restores freer breathing through the nose

⏱️ Dosage and Administration 58 words ▾

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 218 words ▾

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 a breathing problem such as emphysema, asthma, or chronic bronchitis 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 drowsiness may occur 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 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 13 words ▾

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

🧪 Active Ingredient 18 words ▾

Active ingredients (in each 10 mL) Purposes Brompheniramine maleate, 2 mg Antihistamine Phenylephrine HCl, 5 mg Nasal decongestant

🧪 Inactive Ingredients 27 words ▾

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

🎯 Purpose 18 words ▾

Active ingredients (in each 10 mL) Purposes Brompheniramine maleate, 2 mg Antihistamine Phenylephrine HCl, 5 mg Nasal decongestant

📄 Do Not Use 65 words ▾

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 35 words ▾

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 a breathing problem such as emphysema, asthma, or chronic bronchitis

📄 Ask a Doctor or Pharmacist Before Use If 22 words ▾

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 39 words ▾

When using this product do not use more than directed drowsiness may occur 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 25 words ▾

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

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 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 53 words ▾

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton CHILDREN'S Dimetapp ® BROMPHENIRAMINE MALEATE (Antihistamine) PHENYLEPHRINE HCl (Nasal Decongestant) PHARMACIST RECOMMENDED Cold & Allergy Relieves + comforts: Stuffy, runny nose Itchy, watery eyes Sneezing 6+ YRS 4 FL OZ (118 mL) Grape Flavor • Alcohol Free PRINCIPAL DISPLAY PANEL - 118 mL Bottle 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 Cold and Allergy (this brand).

Top reported reactions

Cerebrovascular Accident124
Haemorrhagic Stroke31
Convulsion25
Drug Hypersensitivity18
Injury16
Headache15
Hemiparesis15

Age at onset

Infant1
Child3
Adult8
Elderly4

Reporter sex

358 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Disabling115
Hospitalization81
Death24
Life-threatening5
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 12 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 No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (80070-0300-08). 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 Brands 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.
← 80070-0230-41 · Foundation 80070-0310-04 · Foundation →
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.