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Daytime Severe Cold and Flu acetaminophen, dextromethorphan hydrobromide, Guaifenesin, phenylephrine hydrochloride 325 mg; 10 mg; 200 mg; 5 mg Capsule, Liquid Filled, 3,000-count — NDC 53345-021-01 (Billing 53345-0021-01)

by Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. · 1 BAG in 1 BOX / 3000 CAPSULE, LIQUID FILLED in 1 BAG

This is a package of 3,000 capsules of Daytime Severe Cold and Flu acetaminophen, dextromethorphan hydrobromide, Guaifenesin, phenylephrine hydrochloride 325 mg; 10 mg; 200 mg; 5 mg Capsule, Liquid Filled from Humanwell PuraCap Pharmaceutical (Wuhan), Ltd., marketed since Jul 2014 and currently FDA-listed. It is this product's only package size.

NDC 53345-0021-01
🏷️ FDA NDC (as labeled) 53345-021-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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) 53345-021-01
Product NDC 53345-021
11-digit billing NDC 53345002101
RxCUI 1656815
UNII 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Application # M012
SPL Set ID cbd3a905-1c41-4cb0-8df6-36784430d627
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 2014-07-11
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1656815
Why two NDCs? The FDA registers this code as 53345-021-01 — 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 → 53345-0021-01. 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 Anilides class.

Drug family (ATC) Anilides
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 is this product?

This is an over-the-counter liquid-filled capsule taken by mouth that combines four active ingredients commonly used for cold and flu symptom relief. Acetaminophen is typically used to reduce fever and relieve pain and aches. Dextromethorphan is commonly used to suppress cough. Guaifenesin functions as an expectorant to help thin mucus, and phenylephrine is a decongestant typically used to relieve nasal congestion. This product is marketed under FDA's OTC monograph rules for cough, cold, and flu remedies.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
53345-0021-01 You're viewing this Main listing 1 BAG in 1 BOX / 3000 CAPSULE, LIQUID FILLED in 1 BAG 2014-07-11 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Maximum Strength Mucinex Fast-Max Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63824-0518-08 Reckitt 8 capsules $0.737 — FDA listed —
Mucinex Fast-Max Cold, Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63824-0591-16 Reckitt 8 capsules $0.737 — FDA listed —
Mucinex Sinus-Max Pressure, Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63824-0693-08 Reckitt 8 capsules $0.737 — FDA listed —
Mucinex Fast-Max Cold and Flu Maximum Strength 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72854-0126-08 Reckitt 8 capsules $0.737 — FDA listed —
Mucinex Fast-Max Cold, Flu and Sore Throat Maximum Strength 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72854-0127-16 Reckitt 8 capsules $0.737 — FDA listed —
Mucinex Sinus-Max Pressure, Pain and Cough Maximum Strength 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72854-0202-08 Reckitt 8 capsules $0.737 — FDA listed —
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax 200 mg/1; 325 mg/1; 10 mg/1; 5 mg 00280-0061-01 Bayer 8 capsules — — FDA listed —
Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels 200 mg/1; 325 mg/1; 10 mg/1; 5 mg 00280-8294-24 Bayer 8 capsules — — FDA listed —
DAYTIME COLD AND FLU Maximum Strength 325 mg/1; 200 mg/1; 10 mg/1; 5 mg 00363-0109-24 Walgreens 12 capsules — — FDA listed —
SEVERE DAYTIME COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE 200 mg/1; 10 mg/1; 5 mg/1; 325 mg 00363-8996-24 Walgreens 12 capsules — — FDA listed —
COLD, Flu and Sore Throat 325 mg/1; 200 mg/1; 10 mg/1; 5 mg 00363-9016-16 Walgreens 8 capsules — — FDA listed —
Maximum Strength Cold and Flu 325 mg/1; 200 mg/1; 10 mg/1; 5 mg 00363-9017-16 Walgreens 8 capsules — — FDA listed —
Cold And Flu Daytime Severe 5 mg/1; 325 mg/1; 200 mg/1; 10 mg 11673-0972-16 TARGET 16 capsules — — FDA listed —
Maximum Strength Cold And Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 11673-0978-16 TARGET 8 capsules — — FDA listed —
Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr 5 mg/1; 10 mg/1; 325 mg/1; 200 mg 35916-0166-01 Softgel 12 capsules — — FDA listed —
Vicks DayQuil Severe Cold and Flu 5 mg/1; 325 mg/1; 10 mg/1; 200 mg 37000-0517-02 The 2 capsules — — FDA listed —
Daytime Severe Cold And Flu 5 mg/1; 200 mg/1; 325 mg/1; 10 mg 41226-0625-16 KROGER 8 capsules — — FDA listed —
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL 5 mg/1; 325 mg/1; 10 mg/1; 200 mg 41226-0628-16 Kroger 16 capsules — — FDA listed —
COLD FLU and SORE THROAT RELIEF 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 41520-0984-14 FOODHOLD 8 capsules — — FDA listed —
Severe sinus Congestion Relief 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 41520-0985-14 FOODHOLD 8 capsules — — FDA listed —
Daytime Severe Cold and Flu Relief 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 51013-0174-04 PuraCap 12 capsules — — FDA listed —
Daytime Severe Cold And Flu 10 mg/1; 5 mg/1; 200 mg/1; 325 mg 51316-0525-24 CVS 24 capsules — — FDA listed —
Daytime Severe Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mgthis 53345-0021-01 Humanwell 3000 capsules — — FDA listed —
Maximum Strength Cold And Flu 10 mg/1; 5 mg/1; 325 mg/1; 200 mg 55319-0628-16 FAMILY 16 capsules — — FDA listed —
Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl 325 mg/1; 200 mg/1; 10 mg/1; 5 mg 69729-0782-10 OPMX 10 capsules — — FDA listed —
Severe Cold Daytime 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 69842-0505-16 CVS 16 capsules — — FDA listed —
Maximum Strength Cold, Flu And Sore Throat 200 mg/1; 10 mg/1; 5 mg/1; 325 mg 69842-0616-16 CVS 8 capsules — — FDA listed —
Maximum Strength Cold And Flu 325 mg/1; 10 mg/1; 5 mg/1; 200 mg 69842-0789-16 CVS 8 capsules — — FDA listed —
Mucus Relief Cold Flu Sore Throat Maximum Strength 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 69842-0969-16 CVS 1 capsule — — Discontinued —
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgel 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 70692-0836-84 Strive 48 capsules — — FDA listed —
DayTime SEVERE Cold and Flu Relief SOFTGELS 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 76162-0636-24 Topco 12 capsules — — FDA listed —
TopCare Day Time SEVERE Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 76162-0811-24 Topco 12 capsules — — FDA listed —
Maximum Strength Non Drowsy Daytime Severe Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 79903-0162-24 Wal-Mart 12 capsules — — FDA listed —
equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELS 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 79903-0386-24 WALMART 12 capsules — — FDA listed —
QUALITY CHOICE DayTime Severe Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 83324-0037-24 Chain 12 capsules — — FDA listed —
QUALITY CHOICE Maximum Strength Daytime Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 83324-0162-24 Chain 12 capsules — — FDA listed —
HyVee Daytime Severe Cold and Flu SOFTGEL 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 42507-0836-24 HyVee 12 capsules — — 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

🏛️
2014
On the market since
Jul 2014
📍
2026
Currently FDA-listed
12 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code53345
First marketedJul 2014
Product typeHuman Otc Drug
Portfolio24 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 🤰 Pregnancy 🆘 Overdosage 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 66 words ▾

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

⏱️ Dosage and Administration 68 words ▾

Directions take only as directed - see Overdose warning do not exceed 4 doses per 24 hours adults & children 12 years of age and over 2 softgels with water every 4 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

⚠️ Warnings ~2 min read ▾

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts 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. Overdose warning Taking more than directed can cause serious health problems.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

🤰 Pregnancy 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

🆘 Overdosage 48 words ▾

Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 10 words ▾

Other information store at room temperature and avoid excessive heat

🧪 Active Ingredient 19 words ▾

Active ingredients (in each capsule) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine Hydrochloride 5 mg

🧪 Inactive Ingredients 31 words ▾

Inactive ingredients FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China

🎯 Purpose 10 words ▾

Purpose Pain reliever/ fever reducer Cough suppressant Expectorant Nasal decongestant

📄 Do Not Use 79 words ▾

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 47 words ▾

Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

📄 Ask a Doctor or Pharmacist Before Use If 16 words ▾

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

📄 When Using This Product 10 words ▾

When using this product do not use more than directed

📄 Stop Use and Ask a Doctor If 62 words ▾

Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Package Label / Principal Display Panel 54 words ▾

PRINCIPAL DISPLAY PANEL - Shipping Label DAYTIME SEVERE COLD AND FLU CAPSULES Quantity : 3000 Capsules NDC. No : 53345-021-01 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING" shipper label

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 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.
← 53345-0020-01 · Humanwell 53345-0022-01 · Humanwell →
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.