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Rehydrate Avena Sativa, Equisetum Hyemale, Hypericum Perforatum, Ulmus Fulva, Glycyrrhiza Glabra, Silicea, Pueraria Lobata, Carlsbad Aqua, Adenosinum Triphosphoricum Dinatrum, Germanium Sesquioxide, Hydrogen, Oxygen, Wiesbaden 3 [hp_X]/mL; 4 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 8 [hp_C]/mL; 12 [ Liquid, 60 mL — NDC 54638-0003-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Rehydrate Avena Sativa, Equisetum Hyemale, Hypericum Perforatum, Ulmus Fulva, Glycyrrhiza Glabra, Silicea, Pueraria Lobata, Carlsbad Aqua, Adenosinum Triphosphoricum Dinatrum, Germanium Sesquioxide, Hydrogen, Oxygen, Wiesbaden 3 [hp_X]/mL; 4 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 8 [hp_C]/mL; 12 [ Liquid, 60 mL — NDC 54638-0003-1 (Billing 54638-0003-01)

by ParaDocs All Natural, Inc. · 60 mL in 1 BOTTLE, DROPPER

This is a package of 60 mL of Rehydrate Avena Sativa, Equisetum Hyemale, Hypericum Perforatum, Ulmus Fulva, Glycyrrhiza Glabra, Silicea, Pueraria Lobata, Carlsbad Aqua, Adenosinum Triphosphoricum Dinatrum, Germanium Sesquioxide, Hydrogen, Oxygen, Wiesbaden 3 [hp_X]/mL; 4 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 8 [hp_C]/mL; 12 [ Liquid from ParaDocs All Natural, Inc., marketed since Feb 2015 and currently FDA-listed. It is this product's only package size.

NDC 54638-0003-01
🏷️ FDA NDC (as labeled) 54638-0003-1 billing pads the package 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) 54638-0003-1
Product NDC 54638-0003
11-digit billing NDC 54638000301
UNII MA9CQJ3F7F, 59677RXH25, XK4IUX8MNB, 91QY4PXU8Q, 2788Z9758H, ETJ7Z6XBU4 +6 more
SPL Set ID 648fab10-c46b-420f-a42c-6642009d83fb
Established class (EPC) Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens; Dietary Proteins; Plant Proteins
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-02-12
Route ORAL
Dosage form LIQUID
Substance AVENA SATIVA FLOWERING TOP; EQUISETUM HYEMALE; HYPERICUM PERFORATUM; ULMUS RUBRA BARK; GLYCYRRHIZA GLABRA; SILICON DIOXIDE; PUERARIA MONTANA VAR. LOBATA ROOT; WATER; ADENOSINE TRIPHOSPHATE DISODIUM; GERMANIUM SESQUIOXIDE; HYDROGEN; OXYGEN
Why two NDCs? The FDA registers this code as 54638-0003-1 — 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 → 54638-0003-01. 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?

Rehydrate is an unapproved homeopathic liquid product taken by mouth. It contains multiple plant extracts, minerals, and elements such as oat tops, horsetail, St. John's wort, slippery elm bark, and licorice root, along with adenosine triphosphate and germanium compounds. In homeopathic tradition, these ingredients are used to support general wellness and skin health, though homeopathic products are marketed based on historical use 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 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
54638-0003-01 You're viewing this Main listing 60 mL in 1 BOTTLE, DROPPER 2016-07-07 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rehydrate 3 [hp_X]/mL; 4 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 8 [hp_C]/mL; 12 [this 54638-0003-01 ParaDocs 60 ml — — 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

🏛️
2015
On the market since
Feb 2015
📍
2026
Currently FDA-listed
11 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII N487KM8COK
    A natural red colorant derived from beets. It's used to give medicines their color and help patients identify the correct dosage form.
  • UNII NJN80GZ34N
    A plant extract from blessed thistle flowers used as a natural flavoring or botanical ingredient. It may help add taste or provide traditional plant material to herbal formulations.
  • UNII 7E889U5RNN
    A plant material derived from greater celandine, used as a natural extract or botanical ingredient. It may function as a colorant, flavoring agent, or contribute to the overall formulation's botanical composition.
  • 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 58FMD0Q0EV
    A plant extract used as a natural flavoring and coloring agent in medicines. It adds taste appeal and may provide a mild green tint to the final product.
  • UNII Q4EWM09M3O
    A plant extract from the boldo tree, native to South America. It's used in some formulations as a flavoring agent or natural ingredient to add taste or aroma to the medicine.
  • UNII 9DE5YCO0RU
    A plant extract from dandelion root traditionally used in herbal preparations. In medications, it may serve as a flavor enhancer, natural colorant, or bitter component that supports formulation taste and appearance.

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

The official label also statesDemineralized Water, Ethanol 9%, Glycerin, Propriety Extract blend of Beet (Root), Blessed Thistle (Leaf, Stem, Flower), Boldo (Leaf), Celandine (Leaf, Stem, Flower), Dandelion (Root), Parsley (Leaf)

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerParaDocs All Natural, Inc.
Labeler code54638
First marketedFeb 2015
Product typeHuman Otc Drug
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 6 words ▾

INDICATIONS: To aid with proper hydration.

⏱️ Dosage and Administration 20 words ▾

DIRECTIONS: One drop per ounce of pure water. Consult a physician for use in children under 12 years of age.

⚠️ Warnings 49 words ▾

WARNINGS: 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. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

🧪 Active Ingredient 38 words ▾

ACTIVE INGREDIENTS: Avena Sativa 3X, Equisetum Hyemale 4X, Hypericum Perforatum 6X, Ulmus Fulva 6X, Glycyrrhiza Glabra 12X, Silicea 12X, Pueraria Lobata 8C, Carlsbad Aqua 12C, Adenosinum Triphosphoricum Dinatrum 30C, Germanium Sesquioxide 30C, Hydrogen 30C, Oxygen 30C, Wiesbaden 30C.

🧪 Inactive Ingredients 28 words ▾

INACTIVE INGREDIENTS: Demineralized Water, Ethanol 9%, Glycerin, Propriety Extract blend of Beet (Root), Blessed Thistle (Leaf, Stem, Flower), Boldo (Leaf), Celandine (Leaf, Stem, Flower), Dandelion (Root), Parsley (Leaf)

🎯 Purpose 6 words ▾

INDICATIONS: To aid with proper hydration.

📄 Keep Out of Reach of Children 27 words ▾

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.

📄 Questions or Comments 16 words ▾

QUESTIONS: MFD. FOR: ParaDocs All Natural Inc. 2640 E. Oakland Park Blvd. Ft. Lauderdale, FL 33306

📄 Package Label / Principal Display Panel 11 words ▾

PACKAGE LABEL DISPLAY: ReHydrate Homeopathic 2 FL OZ (60 ml) ReHydrate

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

Rehydrate Avena Sativa, Equisetum Hyemale, Hypericum Perforatum, Ulmus Fulva, Glycyrrhiza Glabra, Silicea, Pueraria Lobata, Carlsbad Aqua, Adenosinum Triphosphoricum Dinatrum, Germanium Sesquioxide, Hydrogen, Oxygen, Wiesbaden 3 [hp_X]/mL; 4 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 8 [hp_C]/mL; 12 [ LIQUID 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) ✓ 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 ParaDocs All Natural, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ParaDocs All Natural, 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.
← 54633-0712-01 · The 54643-5646-00 · Sandoz →
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.