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Elaine Sterling Hydrating Sunscreen Zinc Oxide 21 g/100g Cream, 50 g — NDC 87702-409-01 (Billing 87702-0409-01)

by Elaine Sterling Enterprises · 50 g in 1 BOTTLE, DISPENSING

This is a package of 50 g of Elaine Sterling Hydrating Sunscreen Zinc Oxide 21 g/100g Cream from Elaine Sterling Enterprises, marketed since Oct 2024 and currently FDA-listed. It is this product's only package size.

NDC 87702-0409-01
🏷️ FDA NDC (as labeled) 87702-409-01 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 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 87702-409-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
87702 labeler · 409 product · 01 package
Package marketed since
Oct 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8770240901 1
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) 87702-409-01
Product NDC 87702-409
11-digit billing NDC 87702040901
UNII SOI2LOH54Z
Application # M020
SPL Set ID 5479e862-aca5-7541-e063-6394a90ad0c5
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-01
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 87702-409-01 — 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 → 87702-0409-01. 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?

Elaine Sterling Hydrating Sunscreen is a topical cream containing zinc oxide, a mineral sunscreen ingredient. This product is a nonprescription over-the-counter drug marketed under FDA's monograph rule for sunscreen products. Zinc oxide is commonly used in sunscreens to reflect and scatter ultraviolet radiation away from the skin. This cream formulation is typically applied to the skin as part of sun protection routines.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — 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.

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
87702-0409-01 You're viewing this Main listing 50 g in 1 BOTTLE, DISPENSING 2024-10-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Best Skin Days BS SPF 30 21 g/100g 62742-4243-02 Allure 1 jar — — FDA listed —
Chem Free SPF 30 21 g/100g 59958-0404-01 Owen 50 g — — FDA listed —
Elaine Sterling Hydrating Sunscreen 21 g/100gthis 87702-0409-01 Elaine 50 g — — FDA listed —
YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen 21 g/100g 35192-0100-00 CA-Botana 1 bottle — — FDA listed —
Dimples Bath Co - Sunstick New Kid On The Block 21 g/100g 84568-0550-01 Dimples 1 applicator — — FDA listed —
Skinfuse Shield SPF 30 21 g/100g 59958-0240-02 Owen 60 g — — FDA listed —
Lipid Shield SPF 30 21 g/100g 62742-4273-02 Allure 1 bottle — — FDA listed —
Hydrating Mineral Sunscreen BS SPF30 21 g/100g 62742-4260-02 Allure 1 tube — — FDA listed —
Broad Spectrum SPF30 Mineral Sunscreen 21 g/100g 62742-4209-01 Allure 50 g — — FDA listed —
Lather- Daily Defense Mineral Spf 50 21 g/100g 77394-0202-01 Lather, 17 g — — 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

🏛️
2024
On the market since
Oct 2024
📍
2026
Currently FDA-listed
2 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 G0N132Q0ED
    A fat-soluble compound derived from vitamin E, used as an antioxidant to prevent oils and fats in the medicine from breaking down and becoming unstable during storage.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • UNII ANA2NCS6V1
    A natural oil derived from macadamia nuts, used as an emollient and conditioning agent. It helps soften the product's texture and improve how it spreads or absorbs on skin or mucous membranes.
  • UNII 8RQ2839AVG
    A plant oil derived from hazelnuts, used as a solvent or carrier to dissolve or suspend active ingredients. It also helps improve the taste and texture of liquid medicines.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • 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 86FQE96TZ4
    A synthetic polymer, this ingredient acts as a thickener and suspending agent in liquid formulations. It helps maintain uniform consistency and keeps particles evenly distributed throughout the medicine.
  • UNII X33R8U0062
    Isostearic acid is a fatty acid derived from vegetable oils. It acts as an emulsifier and lubricant in medicines, helping blend ingredients together and reducing friction during tablet or capsule manufacturing.
  • UNII PG6M3969SG
    Lysophosphatidic acid is a lipid derived from natural fats. It acts as an emulsifier and penetration enhancer in medications, helping to improve absorption and mix oil and water-based ingredients together in formulations.
  • UNII 0R822556M5
    A stabilized form of vitamin C derived from ascorbic acid and magnesium. It's used as an antioxidant and preservative to prevent ingredient degradation and extend shelf life in medications and supplements.
  • UNII R17X820ROL
    Magnesium aspartate is magnesium combined with the amino acid aspartate. It is used as a mineral supplement ingredient and may help with tablet binding and nutrient delivery in formulations.
  • UNII AMR73HY95Q
    A synthetic peptide derived from amino acids. It functions as a skin-conditioning agent and emollient in topical formulations, helping soften and smooth the product's texture on application.
  • UNII WQ0UW3VFG5
    A plant material derived from oat plants, used as a filler or bulking agent to add volume and help form solid doses like tablets and capsules.
  • UNII 8PI54V663Y
    Oatmeal is ground oat grain used as a natural filler and texture agent in medicines. It absorbs moisture, adds bulk to the formulation, and may help create a soothing base in topical products.
  • UNII TI9T76XD44
    A natural flavoring derived from orange fruit peel. It adds orange taste and aroma to the medicine, making it more pleasant to take, while also providing natural color.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII 5M26W7T072
    Persic oil is a natural oil derived from peach kernels. It's used in medicines as an emollient and solvent to help soften formulations and improve how the product spreads or absorbs.
  • UNII DT9D8Z79ET
    Polyaminopropyl biguanide is a synthetic antimicrobial agent used as a preservative in liquid medicines and topical products. It helps prevent bacterial and fungal growth during storage.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII 03KCY6P7UT
    A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
  • UNII 88R97D8U8A
    A synthetic liquid derived from propylene glycol and myristic acid. It functions as an emollient and solvent in topical formulations, helping to soften the skin and improve the texture and spreadability of the product.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII 3TNW8D08V3
    Rosa canina fruit, also called rosehip, is a natural plant extract used in medicines as a filler and to add nutritional content. It may also help with texture or act as a mild flavoring agent in the formulation.
  • UNII CR7307M3QZ
    Rosa canina fruit oil is a natural oil extracted from rosehip fruit. It's used in medicines as an emollient and skin-conditioning agent to help soften and smooth the product's texture or skin contact surface.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 469OTG57A2
    Sodium pyrrolidone carboxylate is a synthetic polymer derived from pyrrolidone chemistry. It functions as a solubilizer and binder in medications, helping dissolve poorly water-soluble drugs and hold tablet ingredients together.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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.
  • UNII U6WSN5SQ1Z
    Zinc gluconate is a form of zinc, a mineral, combined with gluconic acid. It's used as a supplement ingredient to provide zinc content in the formulation.

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

The official label also statesC12-15 Alkyl Benzoate, Polyhdroxysteric Acid, Isostearic Acid, Coco Caprylate/Caprate, PPG-2, Myristyl Ether Propionate, Glycerin, Stearing Acid, Butylene Glycol, Cetyl Alcohol, Cyclopentasiloxane, Ethyl Macadamiate, Lysophosphatidic Acid, Myristoyl Pentapeptide-17, Panthenol, Sodium Hyaluronate, Allantoin, Sodium PCA, Tocopheryl Linoleate/Oleate, Prunus Persica (Peach) Kernal Oil, Corylus Avellana (Hazel) Seed Oil, Rosa Canina Fruit Oil, Potassium Cetyl Phosphate, Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Straw Extract, Citrus Aurantium, Dulcis (Orange) Peel Extract, Rosa Canina Fruit Extract, Magnesium, Aspartate, Zinc Gluconate, Propanediol, Magnesium Ascorbyl Phosphate, Avena Sativa (Oat) Kernal Flour, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Polysorbate 60, Xanthan Gum, Sodium Chloride, Polyaminopropyl Biguanide, Iron Oxides

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

LabelerElaine Sterling Enterprises
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code87702
First marketedOct 2024
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from Elaine Sterling Enterprises labeler code 87702

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 17 words ▾

Uses Helps protect against sunburn • Higher SPF gives more sunburn protection. Provides moderate protection against sunburn.

⏱️ Dosage and Administration 94 words ▾

Directions Directions Apply generously and evenly 15 minutes before so exposure. Children under 6 months of age: Ask a docto 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 a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including Limit time in the sun, especially from 10 am - 2am Wear long-sleeved shirts, pants, hats and sunglasses Reapply at least every 2 hours sweating Use a water-resistant sunscreen if swimming or sweating

⚠️ Warnings 34 words ▾

Warnings Warnings ◦ 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 doctor if rash occurs

🧪 Active Ingredient 5 words ▾

Active Ingredients Zinc Oxide 21%

🧪 Inactive Ingredients 103 words ▾

Inactive Ingredients C12-15 Alkyl Benzoate, Polyhdroxysteric Acid, Isostearic Acid, Coco Caprylate/Caprate, PPG-2, Myristyl Ether Propionate, Glycerin, Stearing Acid, Butylene Glycol, Cetyl Alcohol, Cyclopentasiloxane , Ethyl Macadamiate, Lysophosphatidic Acid, Myristoyl Pentapeptide-17, Panthenol, Sodium Hyaluronate, Allantoin, Sodium PCA, Tocopheryl Linoleate/Oleate, Prunus Persica (Peach) Kernal Oil, Corylus Avellana (Hazel) Seed Oil, Rosa Canina Fruit Oil, Potassium Cetyl Phosphate, Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Straw Extract, Citrus Aurantium, Dulcis (Orange) Peel Extract, Rosa Canina Fruit Extract, Magnesium, Aspartate, Zinc Gluconate, Propanediol, Magnesium Ascorbyl Phosphate, Avena Sativa (Oat) Kernal Flour, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Polysorbate 60, Xanthan Gum, Sodium Chloride, Polyaminopropyl Biguanide, Iron Oxides

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Keep Out of Reach of Children 17 words ▾

◦ Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center

📄 Package Label / Principal Display Panel 6 words ▾

Zinc Oxide 21% ES Hydrating SPF.jpg

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 Elaine Sterling Hydrating Sunscreen (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
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 270 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 Elaine Sterling Enterprises. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Elaine Sterling Enterprises 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.