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CVS PHARMACY Childrens Cold and Allergy Brompheniramine maleate 2 mg/10mL Liquid — NDC 51316-0693-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CVS PHARMACY Childrens Cold and Allergy Brompheniramine maleate 2 mg/10mL Liquid — NDC 51316-693-04 (Billing 51316-0693-04)

by CVS PHARMACY, INC. · 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE

This is a package of CVS PHARMACY Childrens Cold and Allergy Brompheniramine maleate 2 mg/10mL Liquid from CVS PHARMACY, INC., marketed since Feb 2025 and currently FDA-listed. It is this product's only package size.

NDC 51316-0693-04
🏷️ FDA NDC (as labeled) 51316-693-04 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 51316-693-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
51316 labeler · 693 product · 04 package
Package marketed since
Feb 24, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5131669304 3
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51316-693-04
Product NDC 51316-693
11-digit billing NDC 51316069304
RxCUI 2685263
UNII IXA7C9ZN03
Application # M012
SPL Set ID 004e104b-d6ff-48d5-8685-cd1bff45399a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-24
Route ORAL
Dosage form LIQUID
Substance BROMPHENIRAMINE MALEATE
Quick answers
  • RxCUI (RxNorm): 2685263
Why two NDCs? The FDA registers this code as 51316-693-04 — 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 → 51316-0693-04. 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

📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves hay fever symptoms. That means runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes. It treats symptoms for a short time.
  • The label directs a dose about every 4 hours, but no more than 6 doses in 24 hours. Use only the dosage cup that comes with it, and follow the age-based directions on your bottle....
  • It might. Drowsiness can happen, so be careful driving or using machinery. Avoid alcohol, sedatives, and tranquilizers because they can make it worse.
  • No. The label says never to use it to sedate a child or make a child sleepy. Some children get excitable instead of drowsy.
📖 Read our full Brompheniramine guide →

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.
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
51316-0693-04 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2025-02-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
CVS PHARMACY Childrens Cold and Allergy 2 mg/10mLthis 51316-0693-04 CVS 1 bottle — — FDA listed —
Dimetapp Cold and Allergy 2 mg/10mL 69536-0305-04 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

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year 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.

🧪 Avoiding an ingredient? See Brompheniramine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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 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.

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

The official label also statescitric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, 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

LabelerCVS PHARMACY, INC.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code51316
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio129 products on file

More NDCs from CVS PHARMACY, INC. labeler code 51316

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 🧪 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 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 24 words ▾

Uses ▪ temporarily relieves: ▪ runny nose ▪ sneezing ▪ itchy, watery eyes due to hay fever ▪ itching of the nose or throat

⏱️ Dosage and Administration 62 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 137 words ▾

Warnings Do not use ▪ to sedate a child or to make a child sleepy Ask a doctor before use if you have ▪ trouble urinating due to an enlarged prostate gland ▪ glaucoma ▪ a breathing problem such as emphysema, or chronic bronchitis. Ask a doctor or pharmacist before use if you are ▪ taking sedatives or tranquilizers When using this product ▪ do not use more than directed ▪ drowsiness may occur ▪ 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 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 at 1-800-222-1222.

🧪 Active Ingredient 11 words ▾

Active Ingredients (in each 10 mL) Brompheniramine maleate, USP 2 mg

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose

🎯 Purpose 2 words ▾

Purposes Antihistamine

📄 Do Not Use 14 words ▾

Do not use ▪ to sedate a child or to make a child sleepy

📄 Ask a Doctor Before Use If 29 words ▾

Ask a doctor before use if you have ▪ trouble urinating due to an enlarged prostate gland ▪ glaucoma ▪ a breathing problem such as emphysema, or chronic bronchitis.

📄 Ask a Doctor or Pharmacist Before Use If 15 words ▾

Ask a doctor or pharmacist before use if you are ▪ taking sedatives or tranquilizers

📄 When Using This Product 45 words ▾

When using this product ▪ do not use more than directed ▪ drowsiness may occur ▪ 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

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 23 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-866-467-2748

📄 Package Label / Principal Display Panel 110 words ▾

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label Compare to the active ingredients in Children’s Dimetapp® Cold & Allergy* NDC# 51316-693-04 Children's Cold & Allergy Brompheniramine Maleate USP (Antihistamine) Relieves + comforts: • Runny Nose • Itchy, Watery Eyes • Sneezing • Itchy throat For Ages 6 Years and Over Grape Flavor Naturally and Artificially Flavored No Added Alcohol No Added Sugar 4 FL OZ (118 ml) IMPORTANT: Keep this carton for future reference on full labeling. Distributed by: *This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children’s Dimetapp® Cold & Allergy.

CVS Childrens Cold and Allergy Relief 4 FL OZ 118 ml

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 CVS PHARMACY Childrens Cold and Allergy (this brand).

Top reported reactions

Anxiety5
Alopecia3
Arthralgia3
Asthenia3
Dyspnoea3
Fatigue3
Nasopharyngitis3

Age at onset

Adult6
Elderly1

Reporter sex

29 reports
Male · 27%
Female · 73%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7 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 CVS PHARMACY, INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CVS PHARMACY, INC. 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.
← 51316-0692-12 · CVS 51316-0695-04 · CVS →
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.