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Childrens HoneyWorks Plus Nighttime Cough Syrup dextromethorphan hbr, doxylamine succinate 15 mg/10mL; 6.25 mg/10mL Solution — NDC 68163-0661-04 package photo

Childrens HoneyWorks Plus Nighttime Cough Syrup dextromethorphan hbr, doxylamine succinate 15 mg/10mL; 6.25 mg/10mL Solution

by RARITAN PHARMACEUTICALS INC · 1 BOTTLE in 1 CARTON (68163-661-04) / 118 mL in 1 BOTTLE
NDC 68163-0661-04
🏷️ FDA NDC (as labeled) 68163-661-04 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 68163-661-04
Product NDC 68163-661
11-digit billing NDC 68163066104
RxCUI 1115329
UNII 9D2RTI9KYH, V9BI9B5YI2
Application # M012
SPL Set ID 43230b3b-2984-4924-b46d-dc73a8194d23
Established class (EPC) Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Histamine Receptor Antagonists; 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 2023-02-01
Route ORAL
Dosage form SOLUTION
Substance DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Why two NDCs? The FDA registers this code as 68163-661-04 — 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 → 68163-0661-04. 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.

🏭 Manufacturer & labeler

LabelerRARITAN PHARMACEUTICALS INC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code68163
First marketedFeb 2023
Product typeHuman Otc Drug
Portfolio35 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.

🩺 Clinical

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

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

This is an over-the-counter oral liquid cough syrup for children containing dextromethorphan and doxylamine. Dextromethorphan is a cough suppressant typically used to reduce cough reflex. Doxylamine is a sedating antihistamine commonly used to help with nighttime symptom relief and sleep. The product is marketed under FDA's over-the-counter monograph rules for cough and cold medicines in this category.

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.

🧪 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 Y9H1V576FH
    Honey is a natural sweetener made by bees from flower nectar. In medicines, it adds sweetness to improve taste and may help soothe throat irritation in lozenges or syrups.
  • 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 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.

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

The official label also statesInactive ingredients citric acid, natural flavor, organic honey, purified water, sodium benzoate,

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Robitussin Maximum Strength Nighttime Cough DM 30 mg/20mL; 12.5 mg/20mL 00031-8718-13 Haleon 1 bottle — — FDA listed —
Robitussin Honey Maximum Strength Nighttime Cough DM 30 mg/20mL; 12.5 mg/20mL 00031-8758-12 Haleon 1 bottle — — FDA listed —
Childrens Robitussin Honey Nighttime Cough DM 15 mg/10mL; 6.25 mg/10mL 00031-8762-12 Haleon 1 bottle — — FDA listed —
Walgreens Adult Nighttime Wal Tussin DM Max Maximum Strength 30 mg/20mL; 12.5 mg/20mL 00363-0758-04 WALGREEN 1 bottle — — FDA listed —
Tussin DM Max NIGHTTIME 30 mg/20mL; 12.5 mg/20mL 00363-1043-19 Walgreen 1 bottle — — FDA listed —
tussin nighttime cough 30 mg/20mL; 12.5 mg/20mL 11822-6005-00 Rite 1 bottle — — FDA listed —
topcare tussin dm max 30 mg/20mL; 12.5 mg/20mL 36800-0788-26 Topco 1 bottle — — FDA listed —
meijer Maximum Strength Nighttime Cough DM 30 mg/20mL; 12.5 mg/20mL 41250-0758-04 MEIJER 1 bottle — — FDA listed —
careone tussin dm 30 mg/20mL; 12.5 mg/20mL 41520-0826-26 American 1 bottle — — FDA listed —
tussin dm nighttime max 30 mg/20mL; 12.5 mg/20mL 42507-0689-26 HyVee 1 bottle — — FDA listed —
Tussin DM Max Nighttime 30 mg/20mL; 12.5 mg/20mL 49035-0943-19 Wal-Mart 1 bottle — — FDA listed —
Nighttime Cough DM 30 mg/20mL; 12.5 mg/20mL 50844-0043-36 L.N.K. 1 bottle — — FDA listed —
Nighttime Cough 30 mg/20mL; 12.5 mg/20mL 51316-0062-26 CVS 1 bottle — — FDA listed —
Tussin DM Nighttime 30 mg/20mL; 12.5 mg/20mL 51316-0430-36 CVS 1 bottle — — FDA listed —
Cough DM Nighttime 30 mg/20mL; 12.5 mg/20mL 51316-0431-36 CVS 1 bottle — — FDA listed —
Safetussin PM Nighttime Cough relief 7.5 mg/5mL; 3.125 mg/5mL 55505-0221-33 Kramer 1 bottle — — Discontinued —
dg health tussin 30 mg/20mL; 12.5 mg/20mL 55910-0709-26 Dolgencorp, 1 bottle — — FDA listed —
Childrens HoneyWorks Plus Nighttime Cough Syrup 15 mg/10mL; 6.25 mg/10mLthis 68163-0661-04 RARITAN 1 bottle — — FDA listed —
Tussin DM 30 mg/20mL; 12.5 mg/20mL 69842-0699-26 CVS 1 bottle — — FDA listed —
AMAZON Maximim Strength Adult Nighttime Cough DM 30 mg/20mL; 12.5 mg/20mL 72288-0587-04 AMAZON.COM 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

🏛️
2023
On the market since
Feb 2023
📍
2026
Currently FDA-listed
3 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68163-0661-04 You're viewing this 1 BOTTLE in 1 CARTON (68163-661-04) / 118 mL in 1 BOTTLE 2023-02-01 Active

🧭 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 FDA registers it as 68163-661-04, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68163-0661-04, written without dashes as 68163066104. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68163-0661-04, the first segment (68163) is the labeler code FDA assigned to RARITAN PHARMACEUTICALS INC; the middle segment (0661) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
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 RARITAN PHARMACEUTICALS INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
RARITAN PHARMACEUTICALS 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.

📄 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
🎯 Indications and Usage 51 words ▾

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat controls the impulse to cough to help you sleep

⏱️ Dosage and Administration 58 words ▾

Directions measure only with dosing cup provided keep dosing cup with product ml = milliliter do not take more than 4 doses in any 24-hour period age dose children under 6 years do not use children 6 to under 12 years 10 ml every 6 hours adults and children 12 years and older 20 ml every 6 hours

⚠️ 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 trouble urinating due to an enlarged prostate gland glaucoma a cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis 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 marked 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 Stop use and ask a doctor if 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 right away.

📦 Storage and Handling 13 words ▾

Other information each 10 ml contains: sodium 2 mg store at room temperature

🧪 Active Ingredient 20 words ▾

Active ingredients (in each 10 ml) Purposes Dextromethorphan HBr, USP 15 mg Cough suppressant Doxylamine Succinate, USP 6.25 mg Antihistamine

🧪 Inactive Ingredients 12 words ▾

Inactive ingredients citric acid, natural flavor, organic honey, purified water, sodium benzoate,

🎯 Purpose 20 words ▾

Active ingredients (in each 10 ml) Purposes Dextromethorphan HBr, USP 15 mg Cough suppressant Doxylamine Succinate, USP 6.25 mg Antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68163-0660-08 · RARITAN 68163-0695-04 · RARITAN →
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.