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Mineral Glowscreen Soft-Radiance Drops Sunrise Zinc Oxide 15.11 g/100mL Lotion — NDC 75936-0640-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mineral Glowscreen Soft-Radiance Drops Sunrise Zinc Oxide 15.11 g/100mL Lotion — NDC 75936-640-02 (Billing 75936-0640-02)

by Supergoop LLC · 1 BOTTLE, DISPENSING in 1 BOX / 50 mL in 1 BOTTLE, DISPENSING

This is a package of Mineral Glowscreen Soft-Radiance Drops Sunrise Zinc Oxide 15.11 g/100mL Lotion from Supergoop LLC, marketed since Aug 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 75936-0640-02
🏷️ FDA NDC (as labeled) 75936-640-02 billing pads the product segment with a zero
This package
Contains50 mL in 1 bottle, dispensing Pack sizes2 compare ↓
Main listing for product 75936-640 · Also comes in: 10 ml 75936-640-03
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 75936-640-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
75936 labeler · 640 product · 02 package
Package marketed since
Sep 3, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0816218028732, 0810165891050, 0816218029180, 0816218029173
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) 75936-640-02
Product NDC 75936-640
11-digit billing NDC 75936064002
UNII SOI2LOH54Z
UPC 0816218028732, 0810165891050, 0816218029180, 0816218029173
Application # M020
SPL Set ID 1f1be2a7-af96-d73d-e063-6394a90acc1a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-08-07
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 75936-640-02 — 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 → 75936-0640-02. 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 containing zinc oxide, marketed as an over-the-counter sunscreen product under FDA's OTC monograph rules. Zinc oxide is a mineral UV filter commonly used in sunscreens to help reflect and scatter ultraviolet rays from the sun. The lotion form allows for easy application to skin. This product is an OTC drug and is not subject to individual FDA approval as a new drug application, but instead follows established safety and use guidelines for sunscreen ingredients in this product category.

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.
Try another pack size: 10 ml
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
75936-0640-02 You're viewing this Main listing 1 BOTTLE, DISPENSING in 1 BOX / 50 mL in 1 BOTTLE, DISPENSING 2024-09-03 — Active
75936-0640-03 75936-640-03 10 mL in 1 TUBE 2024-08-07 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, dispensing in 1 box / 50 ml in 1 bottle, dispensing.
What NDC number is used to bill for this package of Mineral Glowscreen Soft-Radiance Drops Sunrise Zinc Oxide 15.11 g/100mL Lotion?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mineral Glowscreen Soft-Radiance Drops Sunrise 15.11 g/100mLthis 75936-0640-02 Supergoop 1 bottle — — FDA listed —
Mineral Glowscreen Soft-Radiance Drops Golden Hour 15.11 g/100mL 75936-0639-02 Supergoop 1 bottle — — FDA listed —
Mineral Glowscreen Soft-Radiance Drops Sunset 15.11 g/100mL 75936-0662-02 Supergoop 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

🏛️
2024
On the market since
Aug 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 IC94L30J8M
    A synthetic organic compound used as a pH buffer and stabilizer in liquid medications. It helps maintain the medicine's acidity level and keep active ingredients stable during storage.
  • 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 SQE6VB453K
    A calcium salt derived from gluconic acid. It acts as a buffer and mineral supplement in formulations, helping maintain stable pH and adding nutritional calcium content to the product.
  • UNII 1SYA8HK01B
    A natural plant extract from butterfly pea flowers, used in medicines as a colorant to give products a blue or purple tint and as a traditional ingredient valued for its antioxidant properties.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • UNII 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII WQ29KQ9POT
    Gluconolactone is a mild organic acid derived from glucose. It functions as a buffer and pH regulator in medicines, helping maintain stable acidity levels and improve product stability.
  • UNII JOS53KRJ01
    Inulin is a fiber derived from plants like chicory root. It acts as a filler and binder in medicines to add bulk and help hold tablets together.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • 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 834K0WOS5G
    A natural fat extracted from sunflower seeds. It acts as an emulsifier and lubricant in medicines, helping mix ingredients that don't normally blend together and allowing the product to flow smoothly during manufacturing.
  • UNII ML30MJ2U7I
    A mineral salt form of magnesium and sulfate. It serves as a filler to add bulk to the tablet or capsule and may help the medicine dissolve or disintegrate properly in the body.
  • 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 V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII 88496G1ERL
    Sodium phytate is a plant-derived salt used in medications as a chelating agent and preservative. It helps stabilize formulations and may improve how the body absorbs certain minerals in the medicine.
  • UNII 9229XJ4V12
    A synthetic emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients in formulations, keeping them mixed and preventing separation.
  • UNII MZQ63P0N0W
    A plant-derived emulsifier made from glycerin and castor oil. It helps mix oil and water ingredients together in formulations like creams and lotions, keeping them blended.
  • UNII YPM0ZOC2HR
    A synthetic emulsifier derived from glycerin and castor oil. It helps mix oil and water-based ingredients together in the formulation to create a uniform product and improve texture.
  • 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 C2BRV53B1V
    A plant-derived oil from pongamia seeds used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product texture while improving how it spreads on skin.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 01S2G2C1E4
    Sorbitan isostearate is an emulsifier derived from sorbitol and isostearic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the medicine's shelf life.
  • UNII 9I73N69W76
    A plant oil extracted from strawberry seeds used as a flavoring agent and skin-conditioning ingredient in medicines. It adds strawberry taste and aroma while providing emollient properties to the formulation.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.

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

The official label also statesWater, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Propanediol, Dimethicone, Polyglyceryl-3 Polyricinoleate, Sorbitan Isostearate, Polyglyceryl-2 Dipolyhydroxystearate, Fragaria Ananassa(Strawberry) Seed Oil, Pongamia Pinnata Seed Extract, Clitoria Ternatea Flower Extract, Polyglyceryl-6 Polyricinoleate, Butylene Glycol, Polyhydroxystearic Acid, Polysilicone-11, Inulin, Magnesium Sulfate, Triethoxycaprylylsilane, Sodium Phytate, Lecithin, Isopropyl Myristate, Isostearic Acid, Gluconolactone, Sodium Benzoate, Calcium Gluconate. May Contain: Iron Oxides, Titanium Dioxide, Mica. Water, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Propanediol, Dimethicone, Polyglyceryl-3 Polyricinoleate, Sorbitan Isostearate, Polyglyceryl-2 Dipolyhydroxystearate, Fragaria Ananassa (Strawberry) Seed Oil, Pongamia Pinnata Seed Extract, Clitoria Ternatea Flower Extract, Polyglyceryl-6 Polyricinoleate, Butylene Glycol, Polyhydroxystearic Acid, Polysilicone-11, Inulin, Magnesium Sulfate, Triethoxycaprylylsilane, Sodium Phytate, Lecithin, Isopropyl Myristate, Isostearic Acid, Gluconolactone, Sodium Benzoate, Calcium Gluconate. May Contain: Iron Oxides, Titanium Dioxide, Mica. Inactive Ingredients Water, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Propanediol, Dimethicone, Polyglyceryl-3 Polyricinoleate, Sorbitan Isostearate, Polyglyceryl-2 Dipolyhydroxystearate, Fragaria Ananassa (Strawberry) Seed Oil, Pongamia Pinnata Seed Extract, Clitoria Ternatea Flower Extract, Polyglyceryl-6 Polyricinoleate, Butylene Glycol, Polyhydroxystearic Acid, Polysilicone-11, Inulin, Magnesium Sulfate, Triethoxycaprylylsilane, Sodium Phytate, Lecithin, Isopropyl Myristate, Isostearic Acid, Gluconolactone, Sodium Benzoate, Calcium Gluconate. May Contain: Iron Oxides, Titanium Dioxide, Mica.

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

LabelerSupergoop LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code75936
First marketedAug 2024
Product typeHuman Otc Drug
Portfolio18 products on file

More NDCs from Supergoop LLC labeler code 75936

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 9 words ▾

Stop use and ask a doctor if rash occurs

⏱️ Dosage and Administration 92 words ▾

Directions Apply generously and evenly 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating 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 a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months: Ask a doctor

⚠️ Warnings 25 words ▾

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

🧪 Active Ingredient 3 words ▾

Zinc Oxide 15.11%

🧪 Inactive Ingredients 187 words ▾

Mineral Glowscreen Soft-Radiance Drops - Sunrise Water, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Propanediol, Dimethicone, Polyglyceryl-3 Polyricinoleate, Sorbitan Isostearate, Polyglyceryl-2 Dipolyhydroxystearate, Fragaria Ananassa(Strawberry) Seed Oil, Pongamia Pinnata Seed Extract, Clitoria Ternatea Flower Extract, Polyglyceryl-6 Polyricinoleate, Butylene Glycol, Polyhydroxystearic Acid, Polysilicone-11, Inulin, Magnesium Sulfate, Triethoxycaprylylsilane, Sodium Phytate, Lecithin, Isopropyl Myristate, Isostearic Acid, Gluconolactone, Sodium Benzoate, Calcium Gluconate.

May Contain: Iron Oxides, Titanium Dioxide, Mica.

Mineral Glowscreen Soft-Radiance Drops Golden Hour Water, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Propanediol, Dimethicone, Polyglyceryl-3 Polyricinoleate, Sorbitan Isostearate, Polyglyceryl-2 Dipolyhydroxystearate, Fragaria Ananassa (Strawberry) Seed Oil, Pongamia Pinnata Seed Extract, Clitoria Ternatea Flower Extract, Polyglyceryl-6 Polyricinoleate, Butylene Glycol, Polyhydroxystearic Acid, Polysilicone-11, Inulin, Magnesium Sulfate, Triethoxycaprylylsilane, Sodium Phytate, Lecithin, Isopropyl Myristate, Isostearic Acid, Gluconolactone, Sodium Benzoate, Calcium Gluconate.

May Contain: Iron Oxides, Titanium Dioxide, Mica.

Mineral Glowscreen Soft Radiance Drops Sunset Inactive Ingredients Water, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Propanediol, Dimethicone, Polyglyceryl-3 Polyricinoleate, Sorbitan Isostearate, Polyglyceryl-2 Dipolyhydroxystearate, Fragaria Ananassa (Strawberry) Seed Oil, Pongamia Pinnata Seed Extract, Clitoria Ternatea Flower Extract, Polyglyceryl-6 Polyricinoleate, Butylene Glycol, Polyhydroxystearic Acid, Polysilicone-11, Inulin, Magnesium Sulfate, Triethoxycaprylylsilane, Sodium Phytate, Lecithin, Isopropyl Myristate, Isostearic Acid, Gluconolactone, Sodium Benzoate, Calcium Gluconate.

May Contain: Iron Oxides, Titanium Dioxide, Mica.

🎯 Purpose 29 words ▾

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

📄 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.

📄 Package Label / Principal Display Panel 92 words ▾

Mineral Glowscreen Soft-Radiance Drops Sunrise Mineral Glowscreen Soft Radiance Drops SPF 40 Sunrise Broad Spectrum Sunscreen 10 ml Mineral Glowscreen Soft Radiance Drops SPF 40 Sunrise Broad Spectrum Sunscreen 50 ml tube carton

Mineral Glowscreen Soft-Radiance Drops Golden Hour Mineral Glowscreen Soft Radiance Drops SPF 40 Golden Hour Broad Spectrum Sunscreen 10 ml Mineral Glowscreen Soft Radiance Drops SPF 40 Golden Hour Broad Spectrum Sunscreen 50 ml tube carton

Supergoop! Mineral GLOW SCREEN Soft-Radiance Drops SPF 40 Sunset Broad Spectrum Sunscreen SPF 40 PA +++ 1.7 oz / 50 mL Carton Tube

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 Zinc Oxide — the ingredient across all brands.

Top reported reactions

Macular Degeneration460
Nausea365
Pyrexia351
Pain348
Malaise289
Weight Decreased284
Constipation256

Age at onset

Neonate6
Infant11
Child35
Adolescent8
Adult218
Elderly272

Reporter sex

3,195 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Death290
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 352 0
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 ✓ 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 "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 Supergoop LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 ml (75936-0640-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Supergoop LLC 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.
← 75936-0639-02 · Supergoop 75936-0641-02 · Supergoop →
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.