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Cold and Cough Relief children Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl 2 mg/10mL; 10 mg/10mL; 5 mg/10mL Liquid — NDC 70677-0121-1 (Billing 70677-0121-01)

by Strategic Sourcing Services LLC · 1 BOTTLE, PLASTIC in 1 BOX / 118 mL in 1 BOTTLE, PLASTIC

This is a package of Cold and Cough Relief children Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl 2 mg/10mL; 10 mg/10mL; 5 mg/10mL Liquid from Strategic Sourcing Services LLC, no longer marketed (first marketed Oct 2020), no longer in the FDA NDC Directory; retail pharmacies pay about $0.0170 per mL (NADAC). It is this product's only package size.

NDC 70677-0121-01
🏷️ FDA NDC (as labeled) 70677-0121-1 billing pads the package segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 →

NDC database record

One package, one record: these facts belong to NDC 70677-0121-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70677 labeler · 0121 product · 1 package
Package marketed since
Oct 30, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0010939953995
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2026. 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) 70677-0121-1
Product NDC 70677-0121
11-digit billing NDC 70677012101
NCPDP billing unit ML — per mL (volume)
RxCUI 1090463
UNII IXA7C9ZN03, 9D2RTI9KYH, 04JA59TNSJ
UPC 0010939953995
Application # M012
SPL Set ID ae69e04f-577a-4326-b78e-c9441f4f53b5
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 2020-10-30
Route ORAL
Dosage form LIQUID
Substance BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE

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

GPI-14 43995803080910
GPI class SM Cold & Cough Childrens
GCN Seq No 060622
GCN 26808
HICL code 035368
Ingredient (HICL) Brompheniram/Phenylephrine/Dm
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3R
Therapeutic class — specific (HIC3) Non-Opioid Antitus-1St Gen.antihistamine-Decongest
AHFS code 04:04.20.00
AHFS class Propylamine Derivatives
FDB label name SM CHILDREN'S COLD-COUGH LIQ
FDB brand name Children's Cold-Cough
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 060622
  • GCN: 26808
  • GPI-14 (Medi-Span): 43995803080910
  • HICL (First Databank): 035368
  • AHFS class code: 04:04.20.00
  • RxCUI (RxNorm): 1090463
Why two NDCs? The FDA registers this code as 70677-0121-1 — 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 → 70677-0121-01. 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 SM CHILDREN'S COLD-COUGH LIQ Ingredient Brompheniram/Phenylephrine/Dm
📖 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?

This is an over-the-counter liquid medicine for children taken by mouth that contains three active ingredients commonly used together for cold and cough symptoms. Brompheniramine maleate is an antihistamine typically used to reduce sneezing, runny nose, and itchy eyes. Dextromethorphan hydrobromide is a cough suppressant commonly used to reduce coughing. Phenylephrine hydrochloride is a decongestant typically used to help relieve nasal congestion. This product is marketed under FDA's established rules for over-the-counter cold and cough medicines.

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 $0.017 $2.01 / 118 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Mar 2022 Jul 2022 Nov 2022 $0.017 $0.015
▲ Up 15% over the last 12 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
70677-0121-01 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 BOX / 118 mL in 1 BOTTLE, PLASTIC 2020-10-30 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cold and Cough Relief children 2 mg/10mL; 10 mg/10mL; 5 mg/10mLthis 70677-0121-01 Strategic 1 bottle $0.017 — Discontinued —
EndaCof DM 1 mg/5mL; 5 mg/5mL; 2.5 mg/5mL 68047-0143-16 Larken 473 ml $0.051 — Availability likely +201%
Good Sense Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 00113-0987-26 L. 1 bottle $0.075 — Availability likely +342%
Rynex DM 2.5 mg/5mL; 1 mg/5mL; 5 mg/5mL 00485-0204-04 Edwards 118 ml $0.075 — Availability likely +342%
dimaphen dm 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 00904-6463-20 Major 1 bottle $0.075 — Availability likely +342%
good neighbor pharmacy cold and cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 24385-0519-26 Amerisource 1 bottle $0.075 — Availability likely +342%
Signature Care Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 21130-0082-26 Safeway 1 bottle — — Discontinued —
Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 30142-0987-26 Kroger 1 bottle — — FDA listed —
cold and cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 37808-0987-26 H 1 bottle — — FDA listed —
equaline childrens cold and cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 41163-0987-26 United 1 bottle — — FDA listed —
CareOne Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 41520-0987-26 American 1 bottle — — Discontinued —
equate childrens cold and cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 49035-0082-34 Wal-Mart 1 bottle — — FDA listed —
Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 51316-0578-03 CVS 1 bottle — — FDA listed —
Childrens Dimetapp Cold And Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 51316-0645-08 CVS 1 bottle — — FDA listed —
Pediacare Childrens Cough and Cold Grape 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 52412-0920-01 RANDOB 1 bottle — — FDA listed —
Childrens Metapp Daytime 1 mg/5mL; 5 mg/5mL; 2.5 mg/5mL 53041-0577-03 Guardian 1 bottle — — FDA listed —
Cold and Cough DM 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 56062-0987-26 Publix 1 bottle — — FDA listed —
dimaphen dm 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 68788-8134-01 Preferred 1 bottle — — FDA listed —
Good Sense Childrens Cold and Cough 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 68788-8331-01 Preferred 1 bottle — — FDA listed —
Dimetapp Cold and Cough 1 mg/5mL; 5 mg/5mL; 2.5 mg/5mL 80070-0310-04 Foundation 1 bottle — — FDA listed —
TARGET CHILDRENs COLD and COUGH 2 mg/10mL; 10 mg/10mL; 5 mg/10mL 82442-0645-04 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

🏛️
2020
On the market since
Oct 2020
📍
2026
Currently FDA-listed
6 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.

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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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

LabelerStrategic Sourcing Services LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code70677
First marketedOct 2020
Product typeHuman Otc Drug
Portfolio316 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 59 words ▾

Uses temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily restores freer breathing through the nose

⏱️ Dosage and Administration 64 words ▾

Directions do not take more than 6 doses in a 24-hour period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours children 6 to 11 years 10 mL every 4 hours children under 6 years do not use

⚠️ Warnings ~1 min read ▾

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 glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such 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 marked 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 improve 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 (1-800-222-1222) right away.

📦 Storage and Handling 17 words ▾

Other information each 10 mL contains : sodium 5 mg store between 20-25ºC (68-77ºF). Do not refrigerate

🧪 Active Ingredient 18 words ▾

Active ingredients (in each 10 mL) Brompheniramine maleate 2 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients citric acid, FD&C blue #1, FD&C red 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

🎯 Purpose 6 words ▾

Purposes Antihistamine Cough suppressant 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 52 words ▾

Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such occurs with smoking, asthma, chronic bronchitis, or emphysema

📄 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 40 words ▾

When using this product do not use more than directed marked 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

🤰 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 (1-800-222-1222) right away.

📄 Questions or Comments 8 words ▾

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

📄 Package Label / Principal Display Panel 141 words ▾

Principal Display Panel COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S DIMETAPP® COLD & COUGH Children's Cold & Cough Relief Relieves itchy, watery eyes, cough, runny nose, sneezing, stuffy nose, itching of the nose or throat For ages 6 years and over Alcohol-free BROMPHENIRAMINE MALEATE 2 MG ANTIHISTAMINE DEXTROMETHORPHAN HBr 10 MG COUGH SUPPRESSANT PHENYLEPHRINE HCl 5 MG NASAL DECONGESTANT GRAPE FLAVOR fl oz (mL) Dosing Cup Included *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Children's Dimetapp® Cold & Cough.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. Distributed by McKesson Corp. 6555 State Highway 161 Irving, TX 75039 www.sunmarkbrand.com

Package Label SUNMARK Children's Cold & Cough Grape Flavor Brompheniramine maleate 2 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

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 Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl — the ingredient across all brands.

Top reported reactions

Intentional Product Misuse5
Somnolence4
Abnormal Behaviour3
Accidental Overdose3
Loss Of Consciousness3
Seizure3
Accidental Drug Intake By Child2

Age at onset

Child2

Reporter sex

0 reports

Serious outcomes

Hospitalization3
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
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.
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.
Who lists this product with the FDA?
Strategic Sourcing Services LLC 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.
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.