Home › NDC Lookup › Ingredients › Brompheniramine Maleate, Dextromethorpha... › 70000-0715-01
🧴image loading
(from DailyMed)

Leader Childrens Cold and Cough brompheniramine maleate, dextromethorphan hydrobromide 2 mg/10mL; 10 mg/10mL Solution — NDC 70000-0715-1 (Billing 70000-0715-01)

by Cardinal Health 110, LLC. dba Leader · 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE

This is a package of Leader Childrens Cold and Cough brompheniramine maleate, dextromethorphan hydrobromide 2 mg/10mL; 10 mg/10mL Solution from Cardinal Health 110, LLC. dba Leader, marketed since Jan 2025 and currently FDA-listed; retail pharmacies pay about $0.0181 per mL (NADAC). It is this product's only package size.

NDC 70000-0715-01
🏷️ FDA NDC (as labeled) 70000-0715-1 billing pads the package segment with a zero
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0715-1
Product NDC 70000-0715
11-digit billing NDC 70000071501
RxCUI 2683421
UNII IXA7C9ZN03, 9D2RTI9KYH
Application # M012
SPL Set ID 207b2677-aaad-4fe4-a96d-963b7dcfba70
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-06
Route ORAL
Dosage form SOLUTION
Substance BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 087316
GCN 57197
HICL code 000393
Ingredient (HICL) Bromphenir Mal/Dextrometh Hbr
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B4
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.1)
HIC3 code B4E
Therapeutic class — specific (HIC3) Non-Opioid Antitussive-1St Gen Antihistamine Comb.
AHFS code 48:08.00.00
AHFS class Antitussives
FDB label name CHILDRENS COLD AND COUGH LIQ
FDB brand name Childrens Cold And Cough
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 087316
  • GCN: 57197
  • HICL (First Databank): 000393
  • AHFS class code: 48:08.00.00
  • RxCUI (RxNorm): 2683421
Why two NDCs? The FDA registers this code as 70000-0715-1 — a 5-4-1 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 package segment → 70000-0715-01. 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

Label name CHILDRENS COLD AND COUGH LIQ Ingredient Bromphenir Mal/Dextrometh Hbr
🧪 What is this product?

Leader Childrens Cold and Cough is an over-the-counter liquid medicine taken by mouth that combines two active ingredients commonly used to manage cold symptoms in children. Brompheniramine maleate is an antihistamine typically used to reduce sneezing, itching, and runny nose. Dextromethorphan hydrobromide is a cough suppressant commonly used to help reduce coughing. This product is marketed under FDA's over-the-counter monograph rules for cold and cough medicines.

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 $0.018 $2.14 / 118 ml
Medicaid paysCMS SDUD · 12 mo $0.0924 $10.90 / 118 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.019 $0.018
▼ Down 6% over the last 10 months.
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
70000-0715-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2025-01-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense childrens cold cough 2 mg/10mL; 10 mg/10mL 00113-6019-26 L. 1 bottle $0.018 — Availability likely —
childrens cold and cough 2 mg/10mL; 10 mg/10mL 00904-7531-20 Major 1 bottle $0.018 — Availability likely —
good neighbor pharmacy childrens cold and cough 2 mg/10mL; 10 mg/10mL 46122-0813-29 Amerisource 1 bottle $0.018 — Availability likely —
Leader Childrens Cold and Cough 2 mg/10mL; 10 mg/10mLthis 70000-0715-01 Cardinal 1 bottle $0.018 — Availability likely —
Foster and Thrive childrens cold cough relief dm 2 mg/10mL; 10 mg/10mL 70677-1287-01 Strategic 1 bottle $0.018 — Availability likely —
childrens cold and cough relief dm 2 mg/10mL; 10 mg/10mL 00363-3611-26 Walgreen 1 bottle — — FDA listed —
Childrens Cold And Cough 2 mg/10mL; 10 mg/10mL 30142-0780-26 Kroger 1 bottle — — FDA listed —
Equaline childrens cold and cough 2 mg/10mL; 10 mg/10mL 41163-0260-26 United 1 bottle — — FDA listed —
childrens cold and cough 2 mg/10mL; 10 mg/10mL 42507-0727-26 HyVee 1 bottle — — FDA listed —
childrens cold cough 2 mg/10mL; 10 mg/10mL 51316-0513-26 CVS 1 bottle — — FDA listed —
childrens cold cough dm 2 mg/10mL; 10 mg/10mL 56062-0502-26 Publix 1 bottle — — FDA listed —
Childrens Cold And Cough 2 mg/10mL; 10 mg/10mL 59640-0200-26 H 1 bottle — — FDA listed —
good sense childrens cold cough 2 mg/10mL; 10 mg/10mL 68788-4094-01 Preferred 1 bottle — — FDA listed —
Dimetapp Cold and Cough 2 mg/10mL; 10 mg/10mL 69536-0315-04 Foundation 1 bottle — — FDA listed —
Careone Childrens Cold Cough 2 mg/10mL; 10 mg/10mL 72476-0199-26 Retail 1 bottle — — FDA listed —
topcare childrens cold cough 2 mg/10mL; 10 mg/10mL 76162-0099-26 Topco 1 bottle — — FDA listed —
childrens cold cough 2 mg/10mL; 10 mg/10mL 79481-1200-00 Meijer, 1 bottle — — FDA listed —
equate childrens cold cough 2 mg/10mL; 10 mg/10mL 79903-0349-04 WALMART 1 bottle — — FDA listed —
TARGET Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL 82442-0654-04 TARGET 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
Jan 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerCardinal Health 110, LLC. dba Leader
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio163 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 🧪 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 words ▾

Uses • temporarily relieves: • cough • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever (or other upper respiratory allergies) • temporarily alleviates the intensity of coughing

⏱️ Dosage and Administration 61 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 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 ~1 min read ▾

Warnings Do not use • 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. • to make a child sleepy Ask a doctor before use if you have • trouble urinating due to an enlarged prostate gland • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are 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 cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

A persistent cough may be a sign 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 (1-800-222-1222).

🧪 Active Ingredient 14 words ▾

Active ingredients (in each 10 mL) Brompheniramine maleate 2 mg Dextromethorphan HBr 10 mg

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution

🎯 Purpose 4 words ▾

Purposes Antihistamine Cough suppressant

📄 Do Not Use 62 words ▾

Do not use • 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. • to make a child sleepy

📄 Ask a Doctor Before Use If 53 words ▾

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

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

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

📄 When Using This Product 46 words ▾

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 36 words ▾

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 22 words ▾

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

📄 Other Information 15 words ▾

Other information • each 10 mL contains: sodium 4 mg • store at 20°-25°C (68°-77°F)

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-719-9260

📄 Package Label / Principal Display Panel 64 words ▾

Package/Label Principal Display Panel LEADER ™ Children’s Cold & Cough Brompheniramine Maleate Antihistamine Dextromethorphan HBr Cough Suppressant Grape Flavor For Ages 6 yrs and Over Relieves: Runny Nose Itchy, Watery Eyes Coughing Sneezing COMPARE TO CHILDREN’S DIMETAPP ® COLD & COUGH active ingredients Alcohol-Free 100% Money Back Guarantee 4 FL OZ (118 mL) SAFE AND EFFECTIVE RELIEF WITHOUT PHENYLEPHRINE Children's Cold & Cough Carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q4 2025 – Q1 2026 · 2 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
16
Units reimbursed last 4 qtrs
2.5K
Gross reimbursed last 4 qtrs
$229.04
Avg / prescription
$14.32
Avg / unit
$0.0924
Latest quarter Q1 2026
0Rx
Medicaid pays / mL
$0.0924
gross reimbursed
vs
NADAC / mL
$0.0181
acquisition cost
=
Spread
+$0.0743
+410% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 16 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 2,478 units · 84.3 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
84.384.3
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Mississippi 84.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 Brompheniramine maleate, dextromethorphan hydrobromide — the ingredient across all brands.

Top reported reactions

Cerebrovascular Accident123
Haemorrhagic Stroke31
Convulsion23
Drug Hypersensitivity16
Injury16
Hemiparesis15
Headache13

Age at onset

Infant1
Child4
Adolescent1
Adult2
Elderly3

Reporter sex

335 reports
Male · 43%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization76
Death22
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.
← 70000-0713-01 · Cardinal 70000-0716-01 · CARDINAL →
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.