Aqua protection Sunscreen Broad Spectrum SPF50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 30 mg/mL; 90 mg/mL; 45 mg/mL; 50 mg/mL Lotion, 50 mL — NDC 14268-122-01 (Billing 14268-0122-01)
by ENGLEWOOD LAB, INC. · 50 mL in 1 TUBE
This is a package of 50 mL of Aqua protection Sunscreen Broad Spectrum SPF50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 30 mg/mL; 90 mg/mL; 45 mg/mL; 50 mg/mL Lotion from ENGLEWOOD LAB, INC., marketed since Mar 2023 and currently FDA-listed. It is this product's only package size.
NDC 14268-0122-01
🏷️ FDA NDC (as labeled)
14268-122-01
billing pads the product segment with a zero
🗂️ 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 14268-122-01 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 14268 labeler · 122 product · 01 package
- Package marketed since
- Mar 1, 2023
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 1426812201 6
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
14268-122-01
Product NDC
14268-122
11-digit billing NDC
14268012201
UNII
G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM
Application #
M020
SPL Set ID
627e6ea5-016b-4ab6-a50c-aa9c27e5cca1
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2023-03-01
Route
TOPICAL
Dosage form
LOTION
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Why two NDCs?
The FDA registers this code as 14268-122-01 — 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 → 14268-0122-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
🧪 What is this product?
Aqua Protection Sunscreen is a topical lotion marketed as an over-the-counter sunscreen product under the FDA's OTC monograph rules. It contains four ultraviolet (UV) filters: avobenzone, homosalate, octisalate, and octocrylene. These ingredients are commonly used together in sunscreen formulations to absorb and scatter UVA and UVB radiation from the sun. The product is labeled with a broad-spectrum SPF 50 rating, indicating its sun protection classification.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
💬 Questions about AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 14268-0122-01 You're viewing this Main listing | 50 mL in 1 TUBE | 2023-03-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Aqua protection Sunscreen Broad Spectrum SPF50 30 mg/mL; 90 mg/mL; 45 mg/mL; 50 mg/mLthis 14268-0122-01 | ENGLEWOOD | 50 ml | — | — | FDA listed | — |
| Essence Light Sunscreen Spf 50 Pa 30 mg/mL; 90 mg/mL; 45 mg/mL; 50 mg/mL 14268-0119-10 | ENGLEWOOD | 10 ml | — | — | FDA listed | — |
| Purito Sunday Adventure Sunscreen SPF 50, 50 mL 30 mg/mL; 90 mg/mL; 45 mg/mL; 50 mg/mL 73251-0010-01 | Hinature | 50 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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.
- FDA Orange Book · refreshed Oct 3, 2026
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 TR046Y3K1G
A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
-
UNII W59H9296ZG
A synthetic polymer made from acrylic compounds and vinylpyrrolidone. It works as a film-former and thickener in topical products, helping create a smooth texture and improve how the medication spreads on skin.
-
UNII 1B33PG6N4K
A plant resin derived from Japanese white birch bark. It acts as a binder and film-former in tablets and capsules, helping hold ingredients together and create protective coatings on medication surfaces.
-
UNII 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective 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 2EH13UN8D3
A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
-
UNII 00YIU5438U
Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
-
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 E107L85C40
Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
-
UNII 1L0VKZ185E
A plant-derived ingredient from horsetail grass. It may be used as a natural filler or texture agent in herbal formulations.
-
UNII S3KFG6Q5X8
An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
-
UNII 147D247K3P
Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
-
UNII ZP9XFG71A7
A plant extract from ivy leaves used as a natural ingredient. It may function as a preservative, emollient, or flavoring agent in medications and topical 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 S270N0TRQY
Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
-
UNII 918X1OUF1E
Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
-
UNII ZV095H5633
A natural flavoring derived from muskmelon fruit. It is used in medicines to add pleasant taste and aroma, making the product more acceptable to take.
-
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 2ZN8DWC0YF
A flavoring agent derived from pear fruit or created synthetically to mimic pear taste. It's added to medicines to improve flavor and make them more palatable, especially in liquid formulations for children.
-
UNII 50C1307PZG
Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
-
UNII 67M3EQ6BE1
Plum is a natural fruit extract or powder used as a flavoring agent and colorant in medicines. It adds taste and visual appeal to make medications more palatable, particularly in liquid or chewable formulations.
-
UNII YRC528SWUY
A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
-
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 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII 18920M3T13
Rosa damascena flower oil is a fragrant plant oil extracted from damask rose petals. It's used in medicines as a flavoring and aromatic agent to improve taste and scent.
-
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 NVZ4I0H58X
A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
-
UNII YA22H34H9Q
A chelating agent derived from sodium and organic compounds. It binds to metal ions in the formulation to improve stability and prevent unwanted chemical reactions that could degrade the medicine.
-
UNII 023C2WHX2V
Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
-
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.
32 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesWater (Aqua), Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Glyceryl Polymethacrylate, Propylene Glycol, Butyloctyl Salicylate, Ceteareth-20, Ethylhexyl Methoxycrylene, Acrylates Copolymer, Polysorbate 60, Sorbitan Stearate, Caprylyl Glycol, Cetearyl Olivate, Panthenol, Sorbitan Olivate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Tromethamine, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, 1,2-Hexanediol, Isohexadecane, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Musa Sapientum Flower Extract, Rosa Damascena Flower Water, Pyrus Communis (Pear) Fruit Extract, Bht, Prunus Domestica Fruit Extract, Polysorbate 80, Cucumis Melo (Melon) Fruit Extract, Trisodium Ethylenediamine Disuccinate, Hedera Helix (Ivy) Leaf/Stem Extract, Xanthan Gum, Butylene Glycol, Glucosylrutin, Equisetum Arvense Extract, Lycopodium Clavatum Extract, Sodium Hyaluronate, Polyglutamic Acid, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Hydroxypropyltrimonium Hyaluronate, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Betula Platyphylla Japonica Juice, Pentylene Glycol
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerENGLEWOOD LAB, INC.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code14268
First marketedMar 2023
Product typeHuman Otc Drug
Portfolio11 products on file
More NDCs from ENGLEWOOD LAB, INC. labeler code 14268
- Dr. Perrys Day Thyme SPF 20 Broad Spectrum Sunscreen ZINC OXIDE 100 mg/mL Gel NDC 14268-017-00
- Youth Activating BB SPF30 Shade 3 ZINC OXIDE, TITANIUM DIOXIDE 63 mg/mL; 23.6 mg/mL Cream NDC 14268-025-30
- BEET THE SUN LIGHTWEIGHT SUNSCREEN BROAD SPECTRUM SPF 40 PA AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 30 mg/mL; 100 mg/mL; 50 mg/mL; 30 mg/mL Lotion NDC 14268-118-50
- ESSENCE LIGHT SUNSCREEN SPF 50 PA AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 30 mg/mL; 90 mg/mL; 45 mg/mL; 50 mg/mL Lotion NDC 14268-119-10
- SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 TITANIUM DIOXIDE, ZINC OXIDE 364 mg/mL; 298 mg/mL Lotion NDC 14268-120-30
- Byoma Moisturizing Gel Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE 30 mg/mL; 100 mg/mL; 50 mg/mL Cream NDC 14268-123-01
- Bass Pro Shops Bass P Sunscreen Broad Spectrum SPF 50 TITANIUM DIOXIDE, ZINC OXIDE 20 mg/mL; 170 mg/mL Lotion NDC 14268-124-01
- Bass Pro Shops Mineral Sun Stick Sunscreen Broad Spec SPF 40 TITANIUM DIOXIDE, ZINC OXIDE 81 mg/g; 60 mg/g Cream NDC 14268-125-01
- MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant 80 Min TITANIUM DIOXIDE, ZINC OXIDE 20 mg/g; 170 mg/g Cream NDC 14268-126-01
- Anua Zero-Cast Moisturizing Finish Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 30 mg/mL; 70 mg/mL; 50 mg/mL; 50 mg/mL Lotion NDC 14268-169-50
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Do Not Use
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses Helps prevent sunburn If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
⏱️ Dosage and Administration ▾
Directions Apply liberally to all exposed skin 15 minutes before sun exposure. Reapply at least evey 2 hours. Use a water-resistant sunscreen if swimming or sweating: Children under 6 months of age: Ask a doctor.
Spending time in the sun increases your risk of skin cancer and early 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: Sun Protection Measures. Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses.
⚠️ Warnings ▾
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 ir rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
🧪 Active Ingredient ▾
Active Ingredients Avobenzone, 3.0% Homosalate 9.0% Octisalate 4.5% Octocrylene, 5.0% Purpose Sunscreen
🧪 Inactive Ingredients ▾
Inactive ingredients Water (Aqua), Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Glyceryl Polymethacrylate, Propylene Glycol, Butyloctyl Salicylate, Ceteareth-20, Ethylhexyl Methoxycrylene, Acrylates Copolymer, Polysorbate 60, Sorbitan Stearate, Caprylyl Glycol, Cetearyl Olivate, Panthenol, Sorbitan Olivate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Tromethamine, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, 1,2-Hexanediol, Isohexadecane, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Musa Sapientum Flower Extract, Rosa Damascena Flower Water, Pyrus Communis (Pear) Fruit Extract, Bht, Prunus Domestica Fruit Extract, Polysorbate 80, Cucumis Melo (Melon) Fruit Extract, Trisodium Ethylenediamine Disuccinate, Hedera Helix (Ivy) Leaf/Stem Extract, Xanthan Gum, Butylene Glycol, Glucosylrutin, Equisetum Arvense Extract, Lycopodium Clavatum Extract, Sodium Hyaluronate, Polyglutamic Acid, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Hydroxypropyltrimonium Hyaluronate, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Betula Platyphylla Japonica Juice, Pentylene Glycol
🎯 Purpose ▾
Purpose Sunscreen
📄 Do Not Use ▾
Do not use on damaged or broken skin.
📄 When Using This Product ▾
When using this product keep out of eyes. Rinse with water to remove.
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor ir rash occurs.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Package Label / Principal Display Panel ▾
Package Labeling: Outer Label Inner Label
No label section mentions that — try another word, or open the full label on DailyMed below.
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 Aqua protection Sunscreen Broad Spectrum SPF50 (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 20%
Female · 80%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 ENGLEWOOD LAB, INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ENGLEWOOD LAB, 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.
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.