Home › NDC Lookup › Ingredients › Dextromethorphan Hbr, Guaifenesin, Pheny... › 49035-0938-04
Daytime Nighttime Childrens Multi-symptom Cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl Kit — NDC 49035-0938-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Daytime Nighttime Childrens Multi-symptom Cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl Kit — NDC 49035-938-04 (Billing 49035-0938-04)

by Wal-Mart Stores, Inc. · 1 KIT in 1 KIT * 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE

This is a package of Daytime Nighttime Childrens Multi-symptom Cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl Kit from Wal-Mart Stores, Inc., marketed since Nov 2024 and currently FDA-listed. It is this product's only package size.

NDC 49035-0938-04
🏷️ FDA NDC (as labeled) 49035-938-04 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 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) 49035-938-04
Product NDC 49035-938
11-digit billing NDC 49035093804
RxCUI 1043543, 1375932, 2637728
Application # M012
SPL Set ID 177e3247-402d-98e4-e063-6294a90ae068
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-11-26
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 1043543
Why two NDCs? The FDA registers this code as 49035-938-04 — 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 → 49035-0938-04. 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 Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives
How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists
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.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is an over-the-counter combination kit designed for children's cold symptoms, sold under FDA's OTC monograph rules. It contains two separate formulations: a daytime product with dextromethorphan (a cough suppressant), guaifenesin (an expectorant to help thin mucus), phenylephrine (a nasal decongestant), and acetaminophen (for pain and fever); and a nighttime product that adds diphenhydramine (an antihistamine that causes drowsiness). The kit allows caregivers to choose the appropriate formulation based on the time of day and symptom management needs.

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 eachPer 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
49035-0938-04 You're viewing this Main listing 1 KIT in 1 KIT * 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2024-11-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Daytime Nighttime Childrens Multi-symptom Coldthis 49035-0938-04 Wal-Mart 1 kit — — FDA listed —
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength 69842-0462-12 CVS 1 kit — — 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

🏛️
2024
On the market since
Nov 2024
📍
2026
Currently FDA-listed
2 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 Red / Blue
FlavorBerry
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.

From the label’s inactive-ingredient sectionDAYTIME citric acid anhydrous, D&C red # 33, dextrose, edetate disodium, FD&C blue # 1, FD&C Red #40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum. NIGHTTIME citric acid anhydrous, edetate disodium, FD&C blue # 1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
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

LabelerWal-Mart Stores, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code49035
First marketedNov 2024
Product typeHuman Otc Drug
Portfolio83 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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 99 words ▾

USE(S) DAYTIME helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep nasal congestion due to a cold stuffy nose NIGHTTIME temporarily relieves these common cold and flu symptoms: cough sore throat nasal congestion runny nose minor aches and pains headache sinus congestion and pressure sneezing temporarily reduces fever controls cough to help your child get to sleep

⏱️ Dosage and Administration 180 words ▾

DIRECTIONS DAYTIME do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor Age Dose children 6 years to under 12 years 10 mL every 4 hours children 4 years to under 6 years 5 mL every 4 hours children under 4 years do not use mL = milliliter NIGHTTIME this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning) shake well before use do not give more than 5 doses in any 24-hour period if needed, repeat dose every 4 hours while symptoms last do not give more than 5 days unless directed by a doctor measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter children 6 to under 12 years of age: 10 mL in dosing cup provided. children under 6 years of age: do not use.

⚠️ Warnings 95 words ▾

WARNINGS NIGHTTIME Liver warning : This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Allergy alert : acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning : if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

🧪 Active Ingredient 37 words ▾

ACTIVE INGREDIENT(S) FOR DAYTIME (in each 5 mL) Dextromethorphan HBr 5mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg

ACTIVE INGREDIENT(S) FOR NIGHTTIME (in each 10 mL) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 70 words ▾

INACTIVE INGREDIENTS DAYTIME citric acid anhydrous, D&C red # 33, dextrose, edetate disodium, FD&C blue # 1, FD&C Red #40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum. NIGHTTIME citric acid anhydrous, edetate disodium, FD&C blue # 1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

🎯 Purpose 18 words ▾

PURPOSE FOR DAYTIME Cough Suppressant Expectorant Nasal decongestant

PURPOSE FOR NIGHTTIME Pain reliever/fever reducer Antihistamine/Cough Suppressant Nasal decongestant

📄 Do Not Use 153 words ▾

DO NOT USE DAYTIME in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. NIGHTTIME with any other drug containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. to make a child sleepy with any other product containing diphenhydramine, even one used on the skin in a child who is 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 MAOI drug. If you do not know if your child prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

📄 Ask a Doctor Before Use If 70 words ▾

ASK A DOCTOR BEFORE USE IF CHILD HAS DAYTIME heart disease high blood pressure thyroid disease diabetes persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) NIGHTTIME liver disease thyroid disease diabetes heart disease high blood pressure glaucoma a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus)

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

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD NIGHTTIME is taking the blood thinning drug warfarin taking sedatives or tranquilizers

📄 When Using This Product 37 words ▾

WHEN USING THIS PRODUCT DAYTIME do not use more than directed NIGHTTIME do not use more than directed (see Overdose warning) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness

📄 Stop Use and Ask a Doctor If 106 words ▾

STOP USE AND ASK DOCTOR IF DAYTIME your child gets nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. NIGHTTIME nervousness, dizziness or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with fever, rash or headache that lasts.

These could be signs of a serious condition.

📄 Keep Out of Reach of Children 66 words ▾

KEEP OUT OF REACH OF CHILDREN DAYTIME In case of overdose, get medical help or contact a Poison Control Center right away. NIGHTTIME Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

📄 Other Information 42 words ▾

OTHER INFORMATION DAYTIME each 5 mL contains : potassium 5 mg, sodium 5 mg store between 15-30°C (59-86°F) do not refrigerate dosing cup provided NIGHTTIME each 10 mL contains: sodium 10 mg store between 15-30°C (59-86°F) do not refrigerate dosing cup provided

📄 Questions or Comments 5 words ▾

QUESTIONS OR COMMENTS? call 1-888-287-1915

📄 Package Label / Principal Display Panel 122 words ▾

PRINCIPAL DISPLAY PANEL DAY & NIGHT VALUE PACK NDC 49035-938-04 equate TM Compare to Children's Mucinex®Multi-Symptom Cold Active Ingredients* Daytime Ages 4-12 years Children's Multi-Symptom Cold Dextromethorphan HBr 5mg - Cough Suppressant Guaifenesin 100mg - Expectorant Phenylephrine HCl 2.5 mg - Nasal Decongestant Relieves Stuffy Nose Soothes Cough Relieves Chest Congestion Thins & loosens Mucus Very Berry Flavored Dosage cup included NIGHTTIME Ages 6-12 years Children's Multi-Symptom Cold Acetaminophen 325mg - Pain reliever/fever reducer Diphenhydramine HCl 12.5mg - Antihistamine/cough suppressan t Phenylephrine HCl 5 mg - Nasal Decongestant Temporarily reduces fever Soothes cough & sore throat Relieves nasal congestion & sneezing Mixed berry flavored Dosage Cup Included TWO 4 FL OZ (118 mL) BOTTLES / 8 FL OZ (236 mL) TOTAL 615-623-combo-sleeve.jpg

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

About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 Wal-Mart Stores, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Wal-Mart Stores, 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.
← 49035-0934-83 · Walmart 49035-0943-19 · Wal-Mart →
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.