Home › NDC Lookup › Ingredients › Dextromethorphan Hbr Guaifenesin › 51316-0304-19
Tussin DM Daytime Dextromethorphan HBr, Guaifenesin 20 mg/20mL; 400 mg/20mL Solution — NDC 51316-0304-19 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tussin DM Daytime Dextromethorphan HBr, Guaifenesin 20 mg/20mL; 400 mg/20mL Solution — NDC 51316-304-19 (Billing 51316-0304-19)

by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · 1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC

This is a package of Tussin DM Daytime Dextromethorphan HBr, Guaifenesin 20 mg/20mL; 400 mg/20mL Solution from CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, marketed since Apr 2023 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 51316-0304-19
🏷️ FDA NDC (as labeled) 51316-304-19 billing pads the product segment with a zero
This package
Contains118 mL in 1 bottle, plastic Pack sizes2 compare ↓
Main listing for product 51316-304 · Also comes in: 237 mL 51316-304-36
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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) 51316-304-19
Product NDC 51316-304
11-digit billing NDC 51316030419
RxCUI 1020138
UNII 9D2RTI9KYH, 495W7451VQ
Application # M012
SPL Set ID 432d4833-2eaf-4f7c-b6b4-41043a6b7e2a
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-04-18
Marketing end 2028-01-31
Route ORAL
Dosage form SOLUTION
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Quick answers
  • RxCUI (RxNorm): 1020138
Why two NDCs? The FDA registers this code as 51316-304-19 — 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 → 51316-0304-19. 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

📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • It helps loosen mucus and makes coughs more productive. It also temporarily eases cough from minor throat and bronchial irritation, like with a cold or inhaled irritants.
  • Swallow them whole with a full glass of water. Don’t crush, chew or break them. You can take them with or without food, about every 12 hours as your label directs.
  • How do I take the extended-release tablets?
  • The extended-release tablets are not for children under 12. Some liquid products are made for children, so check that product’s label and ask me if you’re unsure.
📖 Read our full Dextromethorphan / Guaifenesin guide →
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.
Try another pack size: 237 mL
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
51316-0304-19 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC 2023-04-18 — Active
51316-0304-36 51316-304-36 1 BOTTLE, PLASTIC in 1 CARTON / 237 mL in 1 BOTTLE, PLASTIC 2023-04-18 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of Tussin DM Daytime Dextromethorphan HBr, Guaifenesin 20 mg/20mL; 400 mg/20mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good neighbor pharmacy tussin dm max 20 mg/20mL; 400 mg/20mL 46122-0541-34 Amerisource 1 bottle $0.018 — Availability likely —
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 70000-0565-01 Cardinal 177 ml $0.020 — Discontinued —
Mucus Relief DM 20 mg/20mL; 400 mg/20mL 70000-0707-01 Cardinal 177 ml $0.021 — Availability likely —
QCH Maximum Strength Mucus Relief DM 628 20 mg/20mL; 400 mg/20mL 83324-0026-06 Chain 177 ml $0.021 — Availability likely —
Good Sense Tussin DM Max 20 mg/20mL; 400 mg/20mL 00113-0927-26 L. 1 bottle $0.023 — Availability likely —
Good Neighbor Childrens Cough Relief Cherry Flavor 5 mg/5mL; 100 mg/5mL 46122-0786-29 AMERISOURCE 1 bottle $0.023 — Availability likely —
Tussin DM 20 mg/20mL; 400 mg/20mL 70000-0628-01 Cardinal 1 bottle $0.023 — Availability likely —
Foster and Thrive Adult Tussin DM MAX 20 mg/20mL; 400 mg/20mL 70677-1036-01 Strategic 1 bottle $0.023 — Availability likely —
Childrens Delsym Cough Plus Chest Congestion DM 5 mg/5mL; 100 mg/5mL 63824-0214-64 Reckitt 1 bottle $0.059 — FDA listed —
Mucinex Childrens Cough 5 mg/5mL; 100 mg/5mL 63824-0946-03 Reckitt 1 bottle $0.059 — FDA listed —
Delsym Cough Plus Chest Congestion DM 20 mg/20mL; 400 mg/20mL 63824-0213-66 Reckitt 180 ml $0.062 — FDA listed —
Mucinex Fast-Max DM Max Honey and Berry Flavor 20 mg/20mL; 400 mg/20mL 63824-0535-66 Reckitt 180 ml $0.062 — FDA listed —
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM 20 mg/20mL; 400 mg/20mL 00031-2097-01 Haleon 1 bottle — — FDA listed —
Childrens Robitussin Elderberry Cough and Chest Congestion DM 20 mg/20mL; 400 mg/20mL 00031-2098-01 Haleon 1 bottle — — FDA listed —
Childrens Robitussin Cough and Chest Congestion DM 5 mg/5mL; 100 mg/5mL 00031-8715-10 Haleon 1 bottle — — FDA listed —
Robitussin Maximum Strength Cough Plus Chest Congestion Dm 20 mg/20mL; 400 mg/20mL 00031-8739-12 Haleon 1 bottle — — FDA listed —
Robitussin Honey Maximum Strength Cough and Chest Congestion DM 20 mg/20mL; 400 mg/20mL 00031-8756-12 Haleon 1 bottle — — FDA listed —
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 00363-0505-06 Walgreens 177 ml — — Discontinued —
Cough and Chest Congestion DM Maximum Strength 20 mg/20mL; 400 mg/20mL 00363-0506-06 Walgreens 177 ml — — FDA listed —
tussin dm max 20 mg/20mL; 400 mg/20mL 00363-1144-26 Walgreen 1 bottle — — FDA listed —
Mucus Relief Cough Childrens 5 mg/5mL; 100 mg/5mL 00363-5527-04 Walgreens 1 bottle — — FDA listed —
Mucus Relief DM Honey and Berry Flavor 20 mg/20mL; 400 mg/20mL 00363-6005-06 WALGREENS 180 ml — — FDA listed —
Walgreen Cough and Chest Congestion 20 mg/20mL; 400 mg/20mL 00363-7296-06 WALGREEN 180 ml — — FDA listed —
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 00363-7390-06 WALGREENS 180 ml — — FDA listed —
Walgreens Daytime Childrens 5 mg/5mL; 100 mg/5mL 00363-7550-04 WALGREENS 118 ml — — FDA listed —
Adult Cough plus Chest Congestion DM with Honey 20 mg/20mL; 400 mg/20mL 00363-7754-04 WALGREEN 1 bottle — — FDA listed —
DM Max 20 mg/20mL; 400 mg/20mL 00363-8031-45 Walgreen 177 ml — — FDA listed —
7 Select Maximum Strength 20 mg/20mL; 400 mg/20mL 10202-0740-04 7-ELEVEN 1 bottle — — FDA listed —
up and up cough plus chest congestion 20 mg/20mL; 400 mg/20mL 11673-0627-26 Target 1 bottle — — Discontinued —
tussin cough chest congestion 20 mg/20mL; 400 mg/20mL 11822-1332-01 Rite 1 bottle — — FDA listed —
Mucus DM 20 mg/20mL; 400 mg/20mL 11822-5050-06 Rite 177 ml — — Discontinued —
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 21130-0505-06 Safeway, 177 ml — — Discontinued —
tussin 20 mg/20mL; 400 mg/20mL 21130-0707-26 Safeway 1 bottle — — FDA listed —
Mucus Relief DM 20 mg/20mL; 400 mg/20mL 30142-0508-06 The 177 ml — — FDA listed —
tussin dm max 20 mg/20mL; 400 mg/20mL 30142-0843-26 Kroger 1 bottle — — FDA listed —
Mucus Relief DM Max Maximum Strength 20 mg/20mL; 400 mg/20mL 36800-0605-06 TOP 177 ml — — FDA listed —
topcare tussin dm max 20 mg/20mL; 400 mg/20mL 36800-0847-26 Topco 1 bottle — — FDA listed —
Maximum Strength DM MAX 20 mg/20mL; 400 mg/20mL 37808-0518-25 H 177 ml — — FDA listed —
Mucus Relief Cough Childrens 5 mg/5mL; 100 mg/5mL 37808-0594-04 H 1 bottle — — FDA listed —
tussin 20 mg/20mL; 400 mg/20mL 37808-0639-26 H 1 bottle — — FDA listed —
equaline tussin 20 mg/20mL; 400 mg/20mL 41163-0704-26 United 1 bottle — — FDA listed —
KROGER Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 41226-0739-06 KROGER 180 ml — — FDA listed —
adult dm max cough and chest congestion 20 mg/20mL; 400 mg/20mL 41250-0261-34 Meijer 1 bottle — — FDA listed —
Meijer Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 41250-0748-06 MEIJER, 180 ml — — FDA listed —
careone tussin dm 20 mg/20mL; 400 mg/20mL 41520-0931-26 American 1 bottle — — FDA listed —
Maximum Strength Mucus Relief 20 mg/20mL; 400 mg/20mL 42507-0630-58 Hyvee 177 ml — — FDA listed —
Good Neighbor Pharmacy Mucus Relief Dm Maximum Strength 20 mg/20mL; 400 mg/20mL 46122-0840-29 AMERISOURCE 180 ml — — FDA listed —
equate adult tussin dm max 20 mg/20mL; 400 mg/20mL 49035-0705-26 Wal-Mart 1 bottle — — FDA listed —
Childrens Cough 5 mg/5mL; 100 mg/5mL 49035-0773-03 Wal-Mart 1 bottle — — FDA listed —
Maximum Strength Mucus Relief DM 20 mg/20mL; 400 mg/20mL 49035-0839-06 Wal-Mart 180 ml — — FDA listed —
Tussin DM Max 20 mg/20mL; 400 mg/20mL 49035-0930-19 Wal-Mart 1 bottle — — FDA listed —
Tussin DM Daytime 20 mg/20mL; 400 mg/20mLthis 51316-0304-19 CVS 1 bottle — — FDA listed —
Cough and Chest Congestion DM Daytime 20 mg/20mL; 400 mg/20mL 51316-0305-19 CVS 1 bottle — — FDA listed —
DM Maximum 20 mg/20mL; 400 mg/20mL 51316-0310-45 CVS 177 ml — — FDA listed —
Cough and Chest Congestion DM 20 mg/20mL; 400 mg/20mL 51316-0389-45 CVS 177 ml — — FDA listed —
Cough and Congestion 20 mg/20mL; 400 mg/20mL 51316-0500-19 CVS 1 bottle — — FDA listed —
Childrens Mucus and Cough Relief 5 mg/5mL; 100 mg/5mL 51316-0552-03 CVS 1 bottle — — FDA listed —
CVS Maximum Strength 20 mg/20mL; 400 mg/20mL 51316-0740-04 CVS 1 bottle — — FDA listed —
CVS Adult Cough plus Chest Congestion DM Max with Honey 20 mg/20mL; 400 mg/20mL 51316-0775-08 CVS 1 bottle — — FDA listed —
daytime cough and chest congestion dm 20 mg/20mL; 400 mg/20mL 51316-0826-26 CVS 1 bottle — — FDA listed —
Pediacare Childrens Cough and Congestion Grape 5 mg/5mL; 100 mg/5mL 52412-0992-01 RANDOB 1 bottle — — FDA listed —
Maximum strength Tussnex FM DM Max 20 mg/20mL; 400 mg/20mL 53041-0628-58 Guardian 177 ml — — FDA listed —
DM Max CONGESTION and COUGH 20 mg/20mL; 400 mg/20mL 53942-0518-25 DeMoulas 177 ml — — FDA listed —
Childrens Cough Mucus Relief 5 mg/5mL; 100 mg/5mL 53943-0512-24 Discount 118 ml — — FDA listed —
Maxium Strength Dm Max 20 mg/20mL; 400 mg/20mL 53943-0518-25 Discount 117 ml — — FDA listed —
Mucus Relief DM Max 20 mg/20mL; 400 mg/20mL 55319-0731-45 Family 177 ml — — FDA listed —
Maximum Strength Adult Cough plus Chest Congestion DM 20 mg/20mL; 400 mg/20mL 55319-0740-04 FAMILY 1 bottle — — FDA listed —
Childrens Mucus and Cough Relief 5 mg/5mL; 100 mg/5mL 55319-0924-03 Family 1 bottle — — FDA listed —
SanaTos Children Cough and Congestion Cherry 100 mg/5mL; 5 mg/5mL 55758-0013-04 Pharmadel 1 bottle — — FDA listed —
SanaTos Mucus Relief Cold Toddlers 50 mg/2.5mL; 2.5 mg/2.5mL 55758-0307-02 Pharmadel 59 ml — — FDA listed —
Mucus Relief DM Max 20 mg/20mL; 400 mg/20mL 55910-0146-95 DOLGENCORP, 266 ml — — FDA listed —
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 55910-0505-08 Dolgencorp, 266 ml — — FDA listed —
rexall dm cough and congestion relief 20 mg/20mL; 400 mg/20mL 55910-0755-26 Dolgencorp, 1 bottle — — FDA listed —
GeriCare Tussin DM Max 20 mg/20mL; 400 mg/20mL 57896-0591-08 GERI-CARE 237 ml — — FDA listed —
Mucinex Fast-Max DM Max 20 mg/20mL; 400 mg/20mL 63824-0019-22 Reckitt 2 bottles — — Discontinued —
Mucus Relief DM Max Maximum Strength 20 mg/20mL; 400 mg/20mL 63868-0235-06 QUALITY 177 ml — — Discontinued —
Childrens Mucus and Cough Relief 5 mg/5mL; 100 mg/5mL 63868-0771-04 Chain 1 bottle — — FDA listed —
DM Max 20 mg/20mL; 400 mg/20mL 63941-0518-25 Best 177 ml — — FDA listed —
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 67091-0342-06 WINCO 180 ml — — FDA listed —
Premier Value Maximum Strength 20 mg/20mL; 400 mg/20mL 68016-0740-04 PHARMACY 1 bottle — — FDA listed —
Mucus Relief DM Honey and Berry Flavor 20 mg/20mL; 400 mg/20mL 68163-0605-06 RARITAN 180 ml — — FDA listed —
berkley and jensen tussin dm 20 mg/20mL; 400 mg/20mL 68391-0299-34 BJWC 1 bottle — — FDA listed —
Berkley and Jensen Tussin DM Max 20 mg/20mL; 400 mg/20mL 68391-0711-34 BJWC 1 bottle — — FDA listed —
Mucus Relief DM Max Maximum Strength 20 mg/20mL; 400 mg/20mL 69256-0505-06 Harris 177 ml — — FDA listed —
Tussin DMMax 20 mg/20mL; 400 mg/20mL 69618-0072-58 RELIABLE 1 bottle — — FDA listed —
Kids Cough and Chest Congestion 100 mg/5mL; 5 mg/5mL 69676-0037-09 Genexa 1 bottle — — FDA listed —
CVS Childrens Cough Relief 5 mg/5mL; 100 mg/5mL 69842-0577-04 CVS 1 bottle — — FDA listed —
tussin dm 20 mg/20mL; 400 mg/20mL 69842-0819-26 CVS 1 bottle — — FDA listed —
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 69842-0904-06 CVS 177 ml — — FDA listed —
Cough and Chest Congestion DM Adult 20 mg/20mL; 400 mg/20mL 69842-0926-06 CVS 177 ml — — FDA listed —
CVS Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 69842-0937-06 CVS 180 ml — — FDA listed —
Childrens Mucus and Cough Relief 5 mg/5mL; 100 mg/5mL 70000-0630-01 CARDINAL 1 bottle — — FDA listed —
basic care tussin dm max 20 mg/20mL; 400 mg/20mL 72288-0293-34 Amazon.com 1 bottle — — FDA listed —
Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum Strength 400 mg/1; 20 mg 72854-0159-66 Reckitt 180 liquids — — FDA listed —
Dr Kids Cough and Chest Congestion 100 mg/5mL; 5 mg/5mL 73282-2523-02 CalmCo 18 vials — — FDA listed —
Childrens Mucus Relief Cough Cherry Liquid 5 mg/5mL; 100 mg/5mL 76162-0294-04 Topco 1 bottle — — FDA listed —
Maximum Strength Mucus Relief DM Max 20 mg/20mL; 400 mg/20mL 76162-0628-58 Topco 177 ml — — FDA listed —
TOPCO Childrens Cough Relief 5 mg/5mL; 100 mg/5mL 76162-0751-04 Topco 1 bottle — — FDA listed —
Childrens Mucus Relief Cough - Cherry Flavor 5 mg/5mL; 100 mg/5mL 76281-0512-24 AptaPharma 1 bottle — — FDA listed —
Target Childrens Cough Relief 5 mg/5mL; 100 mg/5mL 82442-0751-04 TARGET 1 bottle — — FDA listed —
Mucus Relief Cough and Congestion Childrens 5 mg/5mL; 100 mg/5mL 82673-0102-04 KinderFarms, 1 bottle — — FDA listed —
AXIM DM Max 20 mg/20mL; 400 mg/20mL 82706-0013-01 VIVUNT 177 ml — — FDA listed —
AXIV DM Max 20 mg/20mL; 400 mg/20mL 82706-0024-01 VIVUNT 177 ml — — FDA listed —
Mucus Relief DM 20 mg/20mL; 400 mg/20mL 83324-0323-06 Chain 177 ml — — FDA listed —
Tussin DM 20 mg/20mL; 400 mg/20mL 83324-0324-04 Chain 1 bottle — — FDA listed —
Dr. Simi Children s Cough 5 mg/5mL; 100 mg/5mL 85786-0604-04 Farmacias 1 bottle — — FDA listed —
Target Cough plus Chest Congestion DM Max with Honey 20 mg/20mL; 400 mg/20mL 11673-0775-08 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

🏛️
2023
On the market since
Apr 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.

What it looks like

Color red
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.

💡 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 XY6UN3QB6S
    A sweetener made from corn starch that contains fructose and glucose. It sweetens the medicine to improve taste and may help preserve the product.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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 B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesanhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

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 WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code51316
First marketedApr 2023
Product typeHuman Otc Drug
Portfolio119 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 29 words ▾

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

⏱️ Dosage and Administration 50 words ▾

Directions do not take more than directed do not take more than 6 doses in any 24-hour period mL = milliliter only use the dose cup provided adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours children under 12 years: do not use

⚠️ Warnings 151 words ▾

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. Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough persists more than 7 days, tends to recur, or is accompanied by a 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 27 words ▾

Other information each 20 mL contains: sodium 16 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

🧪 Active Ingredient 13 words ▾

Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg

🧪 Inactive Ingredients 36 words ▾

Inactive ingredients anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

🎯 Purpose 4 words ▾

Purpose Cough suppressant Expectorant

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
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 it is currently marketed — but CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED has reported a marketing end date of 2028-01-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (51316-0304-36). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 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.
← 51316-0303-19 · CVS 51316-0305-19 · 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.