Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
NO DRIP NASAL phenylephrine hydrochloride 10 mg/mL Spray — NDC 51316-648-10 (Billing 51316-0648-10)
by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · 1 BOTTLE, SPRAY in 1 CARTON / 30 mL in 1 BOTTLE, SPRAY
This is a package of NO DRIP NASAL phenylephrine hydrochloride 10 mg/mL Spray from CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, marketed since Jun 2026 and currently FDA-listed. It is this product's only package size.
NDC 51316-0648-10
🏷️ FDA NDC (as labeled)
51316-648-10
billing pads the product segment with a zero
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 51316-648-10 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 51316 labeler · 648 product · 10 package
- Package marketed since
- Jun 22, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 5131664810 4
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
51316-648-10
Product NDC
51316-648
11-digit billing NDC
51316064810
RxCUI
1087043
UNII
04JA59TNSJ
Application #
M012
SPL Set ID
7a866cdf-1c0c-403a-afc8-0e99e0ce81aa
Established class (EPC)
alpha-1 Adrenergic Agonist
Mechanism of action
Adrenergic alpha1-Agonists
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-06-22
Route
NASAL
Dosage form
SPRAY
Substance
PHENYLEPHRINE HYDROCHLORIDE
Quick answers
- RxCUI (RxNorm): 1087043
Why two NDCs?
The FDA registers this code as 51316-648-10 — 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 → 51316-0648-10. 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 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the alpha-1 Adrenergic Agonist class.
Pharmacologic class
alpha-1 Adrenergic Agonist
Drug family (ATC)
Sympathomimetics excl. antiglaucoma preparations, Adrenergic and dopaminergic agents, Other agents for treatment of hemorrhoids and anal fissures for topical use
How it works
Adrenergic alpha1-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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
📖 What it is MedlinePlus · NLM
Phenylephrine nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine nasal spray will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- It works as a decongestant — it temporarily shrinks the swollen blood vessels inside your nose and sinuses so you can breathe more freely. It won't treat the underlying cold or all...
- What exactly does phenylephrine nasal spray do?
- If you're 12 or older, you can use 2 or 3 sprays in each nostril up to every 4 hours. But here's the important part: don't use it for more than 3 days in a row. Using it longer tha...
- How often can I use it, and for how long?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Phenylephrine Hydrochloride — tap one for details:
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 3, 2026
💬 Questions about phenylephrine hydrochloride?
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.
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 4, 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 |
|---|---|---|---|---|
| 51316-0648-10 You're viewing this Main listing | 1 BOTTLE, SPRAY in 1 CARTON / 30 mL in 1 BOTTLE, SPRAY | 2026-06-22 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Good Sense Nasal Four 1 g/100mL 00113-0648-10 | L. | 1 bottle | $0.067 | — | Availability likely | — |
| Extra Strength Sinus Relief Nasal Decongestant 1 g/100mL 70000-0132-01 | CARDINAL | 1 bottle | $0.070 | — | Availability likely | — |
| Quality Choice 1 g/100mL 83324-0215-01 | CHAIN | 1 bottle | $0.070 | — | Availability likely | — |
| good neighbor pharmacy nasal four 1 g/100mL 46122-0689-03 | Amerisource | 1 bottle | $0.084 | — | Availability likely | — |
| 4 Way Fast Acting 10 mg/mL 00067-2086-01 | Haleon | 1 bottle | — | — | FDA listed | — |
| Neo-Synephrine Maximum 1 g/100mL 00225-0810-47 | BF | 15 ml | — | — | FDA listed | — |
| Neo-Synephrine Severe 1 g/100mL 00225-0811-47 | BF | 15 ml | — | — | FDA listed | — |
| nasal 1 g/100mL 00363-0717-10 | Walgreen | 1 bottle | — | — | FDA listed | — |
| Better Living 1 g/100mL 21130-0728-30 | BETTER | 1 bottle | — | — | FDA listed | — |
| nasal 1 g/100mL 30142-0539-10 | Kroger | 1 bottle | — | — | FDA listed | — |
| Topcare Nasal Four 1 g/100mL 36800-0648-10 | Topco | 1 bottle | — | — | FDA listed | — |
| heb nasal 1 g/100mL 37808-0728-30 | H | 1 bottle | — | — | FDA listed | — |
| equaline nasal 1 g/100mL 41163-0648-10 | United | 1 bottle | — | — | FDA listed | — |
| Publix 1 g/100mL 41415-0728-30 | PUBLIX | 1 bottle | — | — | FDA listed | — |
| CareOne Fast Acting Nasal 1 g/100mL 41520-0729-10 | American | 1 bottle | — | — | FDA listed | — |
| Nasal Four 1 g/100mL 42507-0648-10 | HyVee | 1 bottle | — | — | FDA listed | — |
| Equate Nasal 1 g/100mL 49035-0648-10 | Wal-Mart | 1 bottle | — | — | FDA listed | — |
| No Drip Nasal 10 mg/mLthis 51316-0648-10 | CVS | 1 bottle | — | — | FDA listed | — |
| dg health nasal four 1 g/100mL 55910-0802-10 | Dolgencorp, | 1 bottle | — | — | FDA listed | — |
| Dollar General 1 g/100mL 55910-0827-30 | DOLGENCORP, | 1 bottle | — | — | FDA listed | — |
| CVS Health Four Actions Nasal Decongestant 10 mg/mL 59779-0838-30 | CVS | 1 bottle | — | — | FDA listed | — |
| Quality Choice 1 g/100mL 63868-0697-30 | CHAIN | 1 bottle | — | — | FDA listed | — |
| Extra Strength Nasal 1 g/100mL 69842-0443-30 | CVS | 1 bottle | — | — | FDA listed | — |
| Nasal 1 g/100mL 69842-0648-10 | CVS | 1 bottle | — | — | FDA listed | — |
| basic care nasal 1 g/100mL 72288-0648-10 | Amazon.com | 1 bottle | — | — | FDA listed | — |
| Nasal 1 g/100mL 79481-0101-00 | Meijer, | 1 bottle | — | — | FDA listed | — |
| Equate Nasal 10 mg/mL 79903-0276-01 | WALMART | 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 Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2026
On the market since
Jun 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 Oct 3, 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 F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
-
UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
-
UNII K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
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 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 FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
-
UNII 3980JIH2SW
A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
-
UNII VTK01UQK3G
Sodium sulfite is a salt preservative derived from sulfur. It prevents discoloration and microbial growth in medicines, helping keep products stable during storage.
-
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.
11 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesbenzalkonium chloride solution, benzyl alcohol, carboxymethylcellulose sodium, edetate disodium, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, purified water, sodium sulfite
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 3, 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 marketedJun 2026
Product typeHuman Otc Drug
Portfolio119 products on file
More NDCs from CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED labeler code 51316
- Extra Strength Antacid Calcium Carbonate, 750mg Calcium carbonate chewable tablets 750 mg Tablet, Chewable NDC 51316-636-25
- Calcium Carbonate 1000 mg 1000 mg Tablet, Chewable NDC 51316-639-66
- CVS NightTime Cold acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL Solution NDC 51316-641-12
- Dye Free Infants Pain and Fever Acetaminophen 160 mg/5mL Suspension NDC 51316-643-04
- CHILDRENS DIMETAPP COLD AND COUGH brompheniramine maleate, dextromethorphan HBr, phenylephrine HCl 2 mg/10mL; 10 mg/10mL; 5 mg/10mL Liquid NDC 51316-645-08
- Daytime, Nighttime Severe Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Guaifenesin, Phenylephrine HCl Kit NDC 51316-647-22
- CVS Childrens COLD PLUS COUGH PLUS SORE THROAT Acetaminophen and Dextromethorphan Hydrobromide 160 mg/5mL; 5 mg/5mL Suspension NDC 51316-650-04
- Docusate Sodium 50MG Softgel (RED) 50 mg Capsule, Liquid Filled NDC 51316-651-01
- Docusate Sodium softgels 50mg (Dye Free) 50 mg Capsule, Liquid Filled NDC 51316-652-03
- Acne Treatment Cream BENZOYL PEROXIDE 1 mg/100g Cream NDC 51316-654-01
- Childrens Antacid Calcium carbonate 400 mg/5mL Liquid NDC 51316-657-03
- CVS Health Fast Acting Lubricant Eye Drops Polyethylene glycol 400, Propylene .3 g/100mL; 400 .4 g/100mL Solution/ Drops NDC 51316-659-01
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
📄 Ask a Doctor Before Use If
📄 When Using This Product
📄 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 nasal congestion due to: • common cold • hay fever • upper respiratory allergies • temporarily relieves sinus congestion and pressure • shrinks swollen nasal membranes so you can breathe more freely
⏱️ Dosage and Administration ▾
Directions • adults and children 12 years of age and over: 2 or 3 sprays in each nostril not more often than every 4 hours. • children under 12 years of age: ask a doctor To Use: Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using the first time, prime pump by depressing pump firmly several times.
To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply.
Wipe nozzle clean after use. Secure cap after use.
⚠️ Warnings ▾
Warnings Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland When using this product • do not use more than directed • do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. • temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur • use of this container by more than one person may spread infection Stop use and ask a doctor if symptoms persist If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
🧪 Active Ingredient ▾
Active ingredient Phenylephrine hydrochloride 1%
🧪 Inactive Ingredients ▾
Inactive ingredients benzalkonium chloride solution, benzyl alcohol, carboxymethylcellulose sodium, edetate disodium, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, purified water, sodium sulfite
🎯 Purpose ▾
Purpose Nasal decongestant
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland
📄 When Using This Product ▾
When using this product • do not use more than directed • do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. • temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur • use of this container by more than one person may spread infection
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if symptoms persist
🤰 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. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
📄 Other Information ▾
Other information • store at 20-25°C (68-77°F) • retain carton for future reference on full labeling
📄 Questions or Comments ▾
Questions or comments? 1-800-719-9260
📄 Package Label / Principal Display Panel ▾
Package/Label Principal Display Panel CVS ™ FAST ACTING Decongestant NO DRIP NASAL SPRAY Phenylephrine HCl 1% Nasal Decongestant Compare to 4 Way ® Nasal Spray active ingredient Fast Acting Relief of: Nasal congestion Sinus congestion Sinus pressure Swollen nasal membranes 1 FL OZ (30 mL) cvs-no-drip-nasal-spray-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 ↗
Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for NO DRIP NASAL (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 12%
Female · 88%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
About this NDC listing & data coverage
Over-the-counter (OTC) product
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.
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.