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restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex ZINC OXIDE 20 g/100g Lotion — NDC 57670-000-00 (Billing 57670-0000-00)

by RESTORSEA INC · 1 TUBE in 1 CARTON / 50 g in 1 TUBE

This is a package of restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex ZINC OXIDE 20 g/100g Lotion from RESTORSEA INC, marketed since Dec 2012 and currently FDA-listed. It is this product's only package size.

NDC 57670-0000-00
🏷️ FDA NDC (as labeled) 57670-000-00 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 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 57670-000-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
57670 labeler · 000 product · 00 package
Package marketed since
Dec 19, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5767000000 8
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57670-000-00
Product NDC 57670-000
11-digit billing NDC 57670000000
RxCUI 244637
UNII SOI2LOH54Z
Application # M020
SPL Set ID 80ed7b28-16e0-4c9a-8e36-9d32ca3ddb9a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-12-24
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Quick answers
  • RxCUI (RxNorm): 244637
Why two NDCs? The FDA registers this code as 57670-000-00 — 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 → 57670-0000-00. 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?

This is a topical lotion formulated as an over-the-counter sunscreen product marketed under FDA monograph rules. The active ingredient is zinc oxide, a mineral UV filter commonly used to protect skin from both UVA and UVB radiation. The product is designed to be applied to the skin as a daily moisturizer with sun protection. It also contains an ingredient labeled Vibransea Complex, though the specific function of that component is not identified in the active ingredient list.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
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 gPer 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
57670-0000-00 You're viewing this Main listing 1 TUBE in 1 CARTON / 50 g in 1 TUBE 2017-12-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex 20 g/100gthis 57670-0000-00 RESTORSEA 1 tube — — FDA listed —
SPF 50 Mineral Sunscreen 20 g/100g 72667-0101-01 Inspec 50 g — — FDA listed —
Radically Rejuvenating SPF Day Cream 20 g/100g 54136-0152-52 Better 52 g — — FDA listed —
Seriously Soothing SPF Day Cream 20 g/100g 54136-0179-52 Better 52 g — — FDA listed —
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0100-60 9055-7588 60 g — — FDA listed —
Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30 20 g/100g 61649-0162-75 9055-7588 75 g — — FDA listed —
Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30 20 g/100g 61649-0165-15 9055-7588 150 g — — FDA listed —
Zinc Oxide 20 g/100g 69771-0109-38 Geri-Gentle 1 tube — — FDA listed —
Aloe UP SPF 33 Mineral 20 g/100g 61477-0231-01 Aloe 30 g — — FDA listed —
Attitude mineral sunscreen orange blossom SPF 30 20 g/100g 61649-0022-15 9055-7588 150 g — — FDA listed —
Attitude mineral sunscreen unscented SPF 30 20 g/100g 61649-0030-85 Attitude 85 g — — Discontinued —
Attitude mineral sunscreen tropical SPF 30 20 g/100g 61649-0031-85 Attitude 85 g — — Discontinued —
ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0098-60 9055-7588 60 g — — FDA listed —
ATTITUDE Sunly Tinted Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0097-20 9055-7588 20 g — — FDA listed —
All Good Mineral Sport Sunscreen Sunstick SPF 30 20 g/100g 75786-0220-01 Elemental 17 g — — FDA listed —
Mackenzies SPF 40 Ocean Safe Sunscreen 20 g/100g 80325-0040-02 Naturally 80 g — — FDA listed —
Zinctral 20 g/100g 59088-0627-05 PureTek 57 g — — FDA listed —
Aloe Up SPF 50 Mineral 20 g/100g 61477-0234-01 Aloe 89 g — — FDA listed —
Aloe Up SPF 50 Kids Mineral 20 g/100g 61477-0236-01 Aloe 89 g — — FDA listed —
Attitude mineral sunscreen tropical SPF 30 20 g/100g 61649-0021-15 9055-7588 150 g — — FDA listed —
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Terracotta 20 g/100g 61649-0046-08 9055-7588 8.5 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0090-60 9055-7588 60 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30 20 g/100g 61649-0092-60 9055-7588 60 g — — FDA listed —
Attitude Kids mineral sunscreen unscented SPF 30 20 g/100g 61649-0160-15 9055-7588 150 g — — FDA listed —
Mineral Defense Sport Ceramide Spf-30 20 g/100g 73054-0108-11 SOLARA 1 applicator — — FDA listed —
ProCure Zinc Oxide 20 g/100g 55681-0017-01 Twin 28.3 g — — FDA listed —
Attitude Kids mineral sunscreen unscented SPF 30 20 g/100g 61649-0038-85 Attitude 85 g — — Discontinued —
Attitude tinted mineral sunscreen face unscented SPF 30 20 g/100g 61649-0041-30 Attitude 30 g — — Discontinued —
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0101-20 9055-7588 20 g — — FDA listed —
All Good Coconut Mineral Sunscreen Sunstick SPF 30 20 g/100g 75786-0221-01 Elemental 17 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0094-20 9055-7588 20 g — — FDA listed —
Medpride 20 g/100g 52410-3040-03 Shield 28 g — — FDA listed —
Medline 20 g/100g 53329-0220-07 Medline 14 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Stick Tropical SPF 30 20 g/100g 61649-0091-60 9055-7588 60 g — — FDA listed —
Bio Spectra Attitude 20 g/100g 61649-0120-01 9055-7588 75 g — — FDA listed —
BLDG Active Skin Repair Sun Stick Performance Sunscreen 20 g/100g 70489-1423-01 Innovacyn, 15 g — — FDA listed —
Stream2Sea SPF 50 20 g/100g 69555-0050-01 Stream2Sea 1 jar — — FDA listed —
Stream2Sea Sport Lip Balm SPF 50 20 g/100g 69555-0500-01 Stream2Sea, 4 g — — FDA listed —
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0099-20 9055-7588 20 g — — FDA listed —
Bio Spectra Attitude 20 g/100g 61649-0110-15 9055-7588 150 g — — FDA listed —
dabur 20 g/100g 68747-3040-03 Dabur 28 g — — FDA listed —
New Kid on the Block 20 g/100g 84568-0552-12 Dimples 106.8 g — — FDA listed —
Lasso Tallow Sunscreen Spf 50 20 g/100g 87761-0004-01 Moes 140 g — — FDA listed —
Procure 20 g/100g 55681-0304-03 TWIN 28.3 g — — FDA listed —
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose 20 g/100g 61649-0045-08 9055-7588 8.5 g — — FDA listed —
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Peachy Shell 20 g/100g 61649-0047-08 9055-7588 8.5 g — — FDA listed —
Endit Zinc Oxide Skin Protectant 20 g/100g 64068-0402-01 Endit 454 g — — FDA listed —
Stream2Sea Reef Safer Mineral Sunscreen SPF40 20 g/100g 69555-0400-10 Stream2Sea, 1 jar — — FDA listed —
365 Whole Foods Market Sport Mineral Spf 30 20 g/100g 42681-0062-01 Whole 44 g — — FDA listed —
Stream2Sea Ecostock SPF 40 Sunscreen 20 g/100g 69555-0401-01 Stream2Sea, 14 g — — FDA listed —
Utu Broad Spectrum SPF 30 Moisturizing Body Sunscreen 20 g/100g 87952-0004-02 Utu 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.

Availability & generic status

🏛️
2012
On the market since
Dec 2012
📍
2026
Currently FDA-listed
14 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 EJ9JK8J58D
    A brown seaweed extract used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of liquid or semi-solid formulations.
  • UNII 2V52R0NHXW
    Ascorbyl glucoside is a stable form of vitamin C derived from ascorbic acid and glucose. It functions as an antioxidant in medicines to protect other ingredients from breaking down when exposed to air or light.
  • 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 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar formulations.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 77JZM5516Z
    A liquid oil derived from coconut sources, used as a solvent and emollient to help dissolve active ingredients and improve how the medicine spreads or absorbs in the formulation.
  • 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 TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII 5N1WD9784U
    A plant-derived ingredient from honeysuckle flowers, used as a natural flavoring or fragrance component to improve taste or aroma in the medicine.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • 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 MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • UNII LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • 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.

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

The official label also statesWater, Dicaprylyl Ether, Glycerin, Cetearyl Olivate, Sorbitan Olivate, Hydrolyzed Roe, Ascorbyl Glucoside, Alaria Esculenta Extract, Algin, Caprylic/Capric Triglyceride, Citric Acid, Fragrance, Glyceryl Caprylate, Glyceryl Undecylenate, Honeysuckle Flower Extract, Honeysuckle Extract, Microcrystalline Cellulose, Sodium Citrate, Triethoxycapryl silane, 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.

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

LabelerRESTORSEA INC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code57670
First marketedDec 2012
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 📋 Description 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

Uses Helps prevent sunburn If used as directed with other sun protection measures (see directions) decreases the risk of skin cancer and early skin aging caused by the sun.

⏱️ Dosage and Administration 89 words ▾

Directions Apply liberally 15 minutes before sun exposure. Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease this risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other sun protection measures including: Limit time in the sun especially from 10 am - 2 pm Wear long sleeve shirts, pants, hats and sunglasses Reapply at least every two hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months: Ask a doctor.

⚠️ Warnings 56 words ▾

Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient Zinc Oxide 20%

🧪 Inactive Ingredients 40 words ▾

Inactive Ingredients Water, Dicaprylyl Ether, Glycerin, Cetearyl Olivate, Sorbitan Olivate, Hydrolyzed Roe, Ascorbyl Glucoside, Alaria Esculenta Extract, Algin, Caprylic/Capric Triglyceride, Citric Acid, Fragrance, Glyceryl Caprylate, Glyceryl Undecylenate, Honeysuckle Flower Extract, Honeysuckle Extract, Microcrystalline Cellulose, Sodium Citrate, Triethoxycapryl silane, Xanthan Gum

🎯 Purpose 2 words ▾

Purpose Sunscreen

📋 Description 62 words ▾

Providing broad spectrum UVA/UVB protection, Restorsea Rejuvenating Day Lotion SPF 30 protects against damage from environmental factors and helps reduce the appearance of fine lines and wrinkles. Apply in morning either over Restorsea Rejuvenating Day Cream or directly to clean skin. No Parabens. No phthalates. No PEGs. No mineral oil. Hypoallergenic. Clinically tested. Dermatologist tested. Non-comedogenic. Store in a cool, dry place.

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin

📄 When Using This Product 13 words ▾

When using this product keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if rash occurs.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 14 words ▾

Questions or comments? Call 888-785-8878 Monday through Friday 9 am - 5pm US EST

📄 Package Label / Principal Display Panel 48 words ▾

restorsea Rejuvenating Day Lotion SPF 30 Broad Spectrum UVA/UVB with Vibransea Complex net wt. 1.7 oz / 50g www.restorsea.com RESTORSEA LLC, DIST. NEW YORK, NY 10022 MADE IN USA PATENT PENDING TM

restorsea Rejuvenating Day Lotion SPF 30 Broad Spectrum UVA/UVB with Vibransea Complex 1.7oz/50g (57670-000-00) Restorsea Label

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 restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

1,941 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization988
Death204
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 272 82
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 — Not published for this NDC No photo available yet for this listing.
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 RESTORSEA INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
RESTORSEA 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.
← 57664-0993-01 · Sun 57677-0063-01 · Aveda →
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.