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Sambucol Cold and Flu Relief Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum 6 [hp_X]/mg; 6 [hp_X]/mg; 3 [hp_X]/mg; 12 [hp_X]/mg; 2 [hp_X]/mg Tablet — NDC 52053-0004-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sambucol Cold and Flu Relief Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum 6 [hp_X]/mg; 6 [hp_X]/mg; 3 [hp_X]/mg; 12 [hp_X]/mg; 2 [hp_X]/mg Tablet — NDC 52053-0004-1 (Billing 52053-0004-01)

by PharmaCare US, Inc. · 4 BLISTER PACK in 1 CARTON / 4500 mg in 1 BLISTER PACK

This is a package of Sambucol Cold and Flu Relief Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum 6 [hp_X]/mg; 6 [hp_X]/mg; 3 [hp_X]/mg; 12 [hp_X]/mg; 2 [hp_X]/mg Tablet from PharmaCare US, Inc., marketed since Oct 2021 and currently FDA-listed. It is this product's only package size.

NDC 52053-0004-01
🏷️ FDA NDC (as labeled) 52053-0004-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 52053-0004-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
52053 labeler · 0004 product · 1 package
Package marketed since
Oct 4, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5205300041 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 52053-0004-1
Product NDC 52053-0004
11-digit billing NDC 52053000401
UNII T7J046YI2B, 639KR60Q1Q, CT03BSA18U, 70FD1KFU70, U6WSN5SQ1Z
SPL Set ID 7dace656-ee97-4931-869f-8c8022757abb
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-10-04
Route ORAL
Dosage form TABLET
Substance BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; ZINC GLUCONATE
Why two NDCs? The FDA registers this code as 52053-0004-1 — a 5-4-1 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 package segment → 52053-0004-01. 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.

Clinical

🧪 What is this product?

Sambucol Cold and Flu Relief is an oral homeopathic tablet containing bryonia alba root, gelsemium sempervirens root, sambucus nigra flowering top, sulfur, and zinc gluconate. In homeopathic practice, these plant and mineral substances are traditionally used to address symptoms associated with cold and flu. This is an unapproved homeopathic product marketed based on homeopathic tradition rather than FDA evaluation for effectiveness.

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 eachPer 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
52053-0004-01 You're viewing this Main listing 4 BLISTER PACK in 1 CARTON / 4500 mg in 1 BLISTER PACK 2021-10-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sambucol Cold and Flu Relief 6 [hp_X]/mg; 6 [hp_X]/mg; 3 [hp_X]/mg; 12 [hp_X]/mg; 2 [hp_X]/mgthis 52053-0004-01 PharmaCare 4500 mg — — 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

🏛️
2021
On the market since
Oct 2021
📍
2026
Currently FDA-listed
5 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

LabelerPharmaCare US, Inc.
Labeler code52053
First marketedOct 2021
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from PharmaCare US, Inc. labeler code 52053

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 52 words ▾

USES: • Temporarily relieves cold & flu symptoms.** • Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal & sinus congestion, minor sore throat and headache.** • Also temporarily relieves body aches associated with the flu.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

⏱️ Dosage and Administration 62 words ▾

DIRECTIONS: • For best results, use at the first sign of symptoms of a cold or flu and continue to use for an additional 48 hours after symptoms subside. Adults and children 12 years of age and older. Dissolve entire tablet in mouth. Do not chew. Do not swallow whole. Take one tablet at the outset of symptoms. Repeat every three hours.

⚠️ Warnings 121 words ▾

WARNINGS: Sore throat warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.

Stop use and ask a doctor if: • Symptoms worsen • Any new symptoms appear. • Fever lasts for more than three days. • Respiratory symptoms persist for more than seven days. If pregnant or breast feeding, ask a health professional before using. Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. • Do not use if blister seal is broken.

🧪 Active Ingredient 38 words ▾

ACTIVE INGREDIENTS: (in Each Tablet): Bryonia 6X,* Gelsemium Sempervirens 6X, 12X, 30X,* Sambucus Nigra 3X, 6X,* Sulphur 12X,* Zincum Gluconicum 2X, 6X.* *Indicates the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United States.

🧪 Inactive Ingredients 17 words ▾

INACTIVE INGREDIENTS: Black Carrot Extract (Colorant), Croscarmellose Sodium, Elderberry Flavor, Lactose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Sucrose.

🎯 Purpose 34 words ▾

PURPOSE: Bryonia - Muscle ache, headache, dry throat, cough, Gelsemium Sempervirens - Sneezing, Sambucus Nigra - Nasal congestion, coughing, Sulphur - Nasal congestion and pressure, headache, Zincum Gluconicum - Fatigue, nausea, minor sore throat

📄 Keep Out of Reach of Children 21 words ▾

KEEP OUT OF REACH OF CHILDREN: In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 15 words ▾

QUESTIONS: Manufactured Exclusively for PharmaCare US, Inc. San Diego, CA 92108 SambucolUSA.com or call 1-888-871-9098

📄 Package Label / Principal Display Panel 41 words ▾

PACKAGE LABEL DISPLAY: NDC 52053-0004-1 Sambucol BLACK ELDERBERRY COLD & FLU RELIEF FAST TEMPORARY RELIEF FROM: √ NASAL CONGESTION √ SORE THROAT √ FEVER + CHILLS √ HEADACHE √ RUNNY NOSE √ COUGH 60 TABLETS HOMEOPATHIC Sambucol COLD & FLU RELIEF

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 Homeopathic listing

About homeopathic listings

Sambucol Cold and Flu Relief Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum 6 [hp_X]/mg; 6 [hp_X]/mg; 3 [hp_X]/mg; 12 [hp_X]/mg; 2 [hp_X]/mg TABLET is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

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) — 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 "Unapproved Homeopathic". 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 PharmaCare US, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PharmaCare US, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 52053-0001-02 · PharmaCare 52063-0709-00 · GSCM →
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.