Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
COUGH AND CHEST CONGESTION DM dextromethorphan hydrobromide, guaifenesin 20 mg/20mL; 200 mg/20mL Solution — NDC 51316-473-26 (Billing 51316-0473-26)
by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
This is a package of COUGH AND CHEST CONGESTION DM dextromethorphan hydrobromide, guaifenesin 20 mg/20mL; 200 mg/20mL Solution from CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, marketed since Feb 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC 51316-0473-26
🏷️ FDA NDC (as labeled)
51316-473-26
billing pads the product segment with a zero
This package
Contains118 mL in 1 bottle
Pack sizes2 compare ↓
Main listing for product 51316-473 · Also comes in:
237 mL 51316-473-34
🗂️ 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
51316-473-26
Product NDC
51316-473
11-digit billing NDC
51316047326
Application #
M012
SPL Set ID
214977df-4892-479d-ad50-db9143339b6f
Established class (EPC)
Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; Uncompetitive NMDA Receptor Ant
Mechanism of action
Sigma-1 Receptor Agonists
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
2026-02-16
Route
ORAL
Dosage form
SOLUTION
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Why two NDCs?
The FDA registers this code as 51316-473-26 — 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 → 51316-0473-26. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
📗 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.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about dextromethorphan hydrobromide, guaifenesin?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 51316-0473-34 51316-473-34 | 1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE | 2026-02-16 | — | Active |
| 51316-0473-26 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE | 2026-08-17 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 118 ml in 1 bottle.
What NDC number is used to bill for this package of COUGH AND CHEST CONGESTION DM dextromethorphan hydrobromide, guaifenesin 20 mg/20mL; 200 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion 20 mg/20mL; 200 mg/20mL 46122-0783-34 | AMERISOURCE | 1 bottle | $0.015 | — | Availability likely | — |
| rugby cough syrup 20 mg/20mL; 200 mg/20mL 00536-1348-97 | Rugby | 1 bottle | $0.017 | — | Availability likely | — |
| Tussin DM 200 mg/20mL; 20 mg/20mL 70677-1185-01 | Strategic | 1 bottle | $0.020 | — | Availability likely | — |
| good sense tussin dm 20 mg/20mL; 200 mg/20mL 00113-1725-26 | L. | 1 bottle | $0.021 | — | Availability likely | — |
| robafen dm 20 mg/20mL; 200 mg/20mL 00904-7223-20 | Major | 1 bottle | $0.021 | — | Availability likely | — |
| Robafen DM Cough 20 mg/20mL; 200 mg/20mL 00904-7441-20 | Major | 1 bottle | $0.021 | — | Availability likely | — |
| good neighbor pharmacy adult tussin DM 20 mg/20mL; 200 mg/20mL 46122-0704-26 | Amerisource | 1 bottle | $0.021 | — | Availability likely | — |
| Good Neighbor Sugar Free Adult Tussin DM Cough and Chest Congestion 20 mg/20mL; 200 mg/20mL 46122-0782-29 | AMERISOURCE | 1 bottle | $0.021 | — | Availability likely | — |
| Tussin DM 20 mg/20mL; 200 mg/20mL 70000-0670-01 | Cardinal | 1 bottle | $0.021 | — | Availability likely | — |
| foster and thrive adult tussin dm 20 mg/20mL; 200 mg/20mL 70677-1035-01 | Strategic | 1 bottle | $0.021 | — | Availability likely | — |
| Tussin DM 20 mg/20mL; 200 mg/20mL 70677-1261-01 | Strategic | 1 bottle | $0.021 | — | Availability likely | — |
| QCH Adult Tussin DM 542 20 mg/20mL; 200 mg/20mL 83324-0023-04 | Chain | 1 bottle | $0.021 | — | Availability likely | — |
| QCH Adult Tussin DM Sugar free 545 20 mg/20mL; 200 mg/20mL 83324-0025-04 | Chain | 1 bottle | $0.021 | — | Availability likely | — |
| Childrens Robitussin Cough and Chest Congestion DM 20 mg/20mL; 200 mg/20mL 00031-8702-13 | Haleon | 1 bottle | — | — | FDA listed | — |
| Robitussin Cough Plus Chest Congestion Dm 20 mg/20mL; 200 mg/20mL 00031-8757-12 | Haleon | 1 bottle | — | — | FDA listed | — |
| Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM 20 mg/20mL; 200 mg/20mL 00031-8759-12 | Haleon | 1 bottle | — | — | FDA listed | — |
| Childrens Robitussin Honey Cough and Chest Congestion DM 10 mg/10mL; 100 mg/10mL 00031-8760-12 | Haleon | 1 bottle | — | — | FDA listed | — |
| adult tussin dm 20 mg/20mL; 200 mg/20mL 00363-1603-26 | Walgreen | 1 bottle | — | — | FDA listed | — |
| Walgreen Adult Cough Plus Chest Congestion Dm 20 mg/20mL; 200 mg/20mL 00363-7440-08 | WALGREEN | 1 bottle | — | — | FDA listed | — |
| Walgreens Grape Flavor 20 mg/20mL; 200 mg/20mL 00363-7470-04 | WALGREENS | 1 bottle | — | — | FDA listed | — |
| tussin cough and chest congestion 20 mg/20mL; 200 mg/20mL 11822-1630-00 | Rite | 1 bottle | — | — | FDA listed | — |
| equaline adult tussin 20 mg/20mL; 200 mg/20mL 41163-0813-26 | United | 1 bottle | — | — | FDA listed | — |
| Robafen Dm 20 mg/20mL; 200 mg/20mL 50090-6747-00 | A-S | 1 bottle | — | — | FDA listed | — |
| good sense tussin dm 20 mg/20mL; 200 mg/20mL 50090-7257-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Cough And Chest Congestion 20 mg/20mL; 200 mg/20mL 51316-0082-34 | CVS | 1 bottle | — | — | FDA listed | — |
| Cough And Chest Congestion Dm 20 mg/20mL; 200 mg/20mLthis 51316-0473-26 | CVS | 1 bottle | — | — | FDA listed | — |
| Cvs Adult Cough Plus Chest Congestion Dm 20 mg/20mL; 200 mg/20mL 51316-0744-08 | CVS | 1 bottle | — | — | FDA listed | — |
| dg health adult tussin 20 mg/20mL; 200 mg/20mL 55910-0776-26 | Dolgencorp | 1 bottle | — | — | FDA listed | — |
| adult tussin dm 20 mg/20mL; 200 mg/20mL 56062-0607-26 | Publix | 1 bottle | — | — | FDA listed | — |
| tussin 20 mg/20mL; 200 mg/20mL 59640-0100-26 | H | 1 bottle | — | — | FDA listed | — |
| Premier Value 20 mg/20mL; 200 mg/20mL 68016-0744-04 | PHARMACY | 1 bottle | — | — | FDA listed | — |
| DRx Choice Children daytime Cough and Chest Congestion 20 mg/20mL; 200 mg/20mL 68163-0747-04 | RARITAN | 1 bottle | — | — | FDA listed | — |
| robafen dm 20 mg/20mL; 200 mg/20mL 68788-8268-01 | Preferred | 1 bottle | — | — | FDA listed | — |
| good sense tussin dm 20 mg/20mL; 200 mg/20mL 68788-8300-01 | Preferred | 1 bottle | — | — | FDA listed | — |
| rugby cough syrup 20 mg/20mL; 200 mg/20mL 68788-8303-01 | Preferred | 1 bottle | — | — | FDA listed | — |
| adult tussin dm 20 mg/20mL; 200 mg/20mL 69842-0513-26 | CVS | 1 bottle | — | — | FDA listed | — |
| leader tussin dm 20 mg/20mL; 200 mg/20mL 70000-0596-01 | Cardinal | 1 bottle | — | — | FDA listed | — |
| Tussin DM Cough plus Chest Congestion 20 mg/20mL; 200 mg/20mL 70000-0713-01 | Cardinal | 1 bottle | — | — | FDA listed | — |
| basic care tussin dm 20 mg/20mL; 200 mg/20mL 72288-0631-26 | Amazon.com | 1 bottle | — | — | FDA listed | — |
| careone tussin dm 20 mg/20mL; 200 mg/20mL 72476-0630-26 | Retail | 1 bottle | — | — | FDA listed | — |
| topcare tussin dm 20 mg/20mL; 200 mg/20mL 76162-0600-26 | Topco | 1 bottle | — | — | FDA listed | — |
| adult cough and chest congestion 20 mg/20mL; 200 mg/20mL 79481-0063-00 | Meijer, | 1 bottle | — | — | FDA listed | — |
| Meijer Children Cough and Chest Congestion DM Grape Flavor 20 mg/20mL; 200 mg/20mL 79481-7470-08 | MEIJER | 1 bottle | — | — | FDA listed | — |
| equate adult cough and chest congestion dm 20 mg/20mL; 200 mg/20mL 79903-0095-08 | WALMART | 1 bottle | — | — | FDA listed | — |
| Tussin DM 20 mg/20mL; 200 mg/20mL 83324-0327-04 | Chain | 1 bottle | — | — | FDA listed | — |
| Tussin 20 mg/20mL; 200 mg/20mL 21130-0454-34 | Safeway | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Color
Red
FlavorFruit
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.
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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 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 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 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
-
UNII 8KW3E207O2
A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
-
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 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.
10 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesanhydrous citric acid, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, 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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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 marketedFeb 2026
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Stop Use and Ask a Doctor If
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Other Information
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
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 ▾
Directions • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years do not use
⚠️ Warnings ▾
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) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.
A persistent cough may be a sign of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
🧪 Active Ingredient ▾
Active ingredients (in each 20 mL) Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg
🧪 Inactive Ingredients ▾
Inactive ingredients anhydrous citric acid, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum
🎯 Purpose ▾
Purposes Cough suppressant Expectorant
📄 Do Not Use ▾
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 ▾
Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
📄 Other Information ▾
Other information • each 20 mL contains: sodium 14 mg • store at 20-25°C (68-77°F). Do not refrigerate.
📄 Questions or Comments ▾
Questions or comments? 1-800-719-9260
📄 Package Label / Principal Display Panel ▾
Package/Label Principal Display Panel CVS ™ Raspberry Flavor Non-Drowsy COUGH & CHEST CONGESTION DM Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Compare to Robitussin ® Cough + Chest Congestion DM active ingredients Relieves: Cough, Chest congestion, Mucus For Adults | Ages 12 & Over | See New Dosing 8 FL OZ (237 mL) cvs-cough-&-chest-congestion-dm-carton-image.jpg
No label section mentions that — try another word, or open the full label on DailyMed below.
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: this package is listed as actively marketed, with no marketing end date reported by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. Listing status can change — 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 (51316-0473-34). 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.
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.